To the Editor:

Broader availability and utilization of novel biologic treatments has heralded the emergence of unusual infections, including skin and soft tissue infections. These unusual infections may not be seen in clinical trials due to their overall rare incidence. In modern society, exposure to unusual pathogens can occur in locations far from their natural habitat.¹ Tissue culture remains the gold standard, as histopathology and smears may not identify the organisms. Tissue culture of these less-common pathogens is challenging and may require multiple samples and specialized laboratory evaluations.² In some cases, a skin biopsy with histopathologic examination is an efficient means to confirm or exclude a dermatologic manifestation of an inflammatory disease. This information can quickly change the course of treatment, especially for those on immunosuppressive medications.³ We report a case of unusual cutaneous infection with Chaetomium globosum in a patient concomitantly treated with vedolizumab, a gut-specific integrin inhibitor, alongside traditional immunosuppressive therapy.

A 33-year-old woman with Crohn disease on vedolizumab and mercaptopurine was referred to the dermatology clinic with firm, tender, erythematous lesions on the legs of 1 month’s duration (Figure, A). She had a history of inflammatory bowel disease with perianal fistula, sacroiliitis, uveitis, guttate psoriasis, and erythema nodosum. She denied recent medication changes, foreign travel, swimming in freshwater or a hot tub, chills, fever, malaise, night sweats, and weight loss. Physical examination revealed several tender, indurated, erythematous plaques across the legs, ranging in size from 4 to 12 cm. The plaques had central hyperpigmentation, atrophy, and scant scale without ulceration, drainage, or pustules. The largest plaque demonstrated a well-defined area of central fluctuance. Prednisone (60 mg) with taper was initiated for presumed recurrence of erythema nodosum with close follow-up.

This case illustrates the importance of a high index of suspicion for unusual infections in the setting of biologic therapy. An infectious etiology of a cutaneous eruption in an immunosuppressed patient should always be included in the differential diagnosis and actively pursued early on; tissue culture may shorten the treatment course and decrease severity of the disease. Although a direct link between the mechanism of action of vedolizumab and cutaneous infection is not clear, given the rare incidence of this infection, a report of such a case is important to the practicing clinician.

To the Editor:

Broader availability and utilization of novel biologic treatments has heralded the emergence of unusual infections, including skin and soft tissue infections. These unusual infections may not be seen in clinical trials due to their overall rare incidence. In modern society, exposure to unusual pathogens can occur in locations far from their natural habitat.¹ Tissue culture remains the gold standard, as histopathology and smears may not identify the organisms. Tissue culture of these less-common pathogens is challenging and may require multiple samples and specialized laboratory evaluations.² In some cases, a skin biopsy with histopathologic examination is an efficient means to confirm or exclude a dermatologic manifestation of an inflammatory disease. This information can quickly change the course of treatment, especially for those on immunosuppressive medications.³ We report a case of unusual cutaneous infection with Chaetomium globosum in a patient concomitantly treated with vedolizumab, a gut-specific integrin inhibitor, alongside traditional immunosuppressive therapy.

A 33-year-old woman with Crohn disease on vedolizumab and mercaptopurine was referred to the dermatology clinic with firm, tender, erythematous lesions on the legs of 1 month’s duration (Figure, A). She had a history of inflammatory bowel disease with perianal fistula, sacroiliitis, uveitis, guttate psoriasis, and erythema nodosum. She denied recent medication changes, foreign travel, swimming in freshwater or a hot tub, chills, fever, malaise, night sweats, and weight loss. Physical examination revealed several tender, indurated, erythematous plaques across the legs, ranging in size from 4 to 12 cm. The plaques had central hyperpigmentation, atrophy, and scant scale without ulceration, drainage, or pustules. The largest plaque demonstrated a well-defined area of central fluctuance. Prednisone (60 mg) with taper was initiated for presumed recurrence of erythema nodosum with close follow-up.

This case illustrates the importance of a high index of suspicion for unusual infections in the setting of biologic therapy. An infectious etiology of a cutaneous eruption in an immunosuppressed patient should always be included in the differential diagnosis and actively pursued early on; tissue culture may shorten the treatment course and decrease severity of the disease. Although a direct link between the mechanism of action of vedolizumab and cutaneous infection is not clear, given the rare incidence of this infection, a report of such a case is important to the practicing clinician.

To the Editor:

Broader availability and utilization of novel biologic treatments has heralded the emergence of unusual infections, including skin and soft tissue infections. These unusual infections may not be seen in clinical trials due to their overall rare incidence. In modern society, exposure to unusual pathogens can occur in locations far from their natural habitat.¹ Tissue culture remains the gold standard, as histopathology and smears may not identify the organisms. Tissue culture of these less-common pathogens is challenging and may require multiple samples and specialized laboratory evaluations.² In some cases, a skin biopsy with histopathologic examination is an efficient means to confirm or exclude a dermatologic manifestation of an inflammatory disease. This information can quickly change the course of treatment, especially for those on immunosuppressive medications.³ We report a case of unusual cutaneous infection with Chaetomium globosum in a patient concomitantly treated with vedolizumab, a gut-specific integrin inhibitor, alongside traditional immunosuppressive therapy.

A 33-year-old woman with Crohn disease on vedolizumab and mercaptopurine was referred to the dermatology clinic with firm, tender, erythematous lesions on the legs of 1 month’s duration (Figure, A). She had a history of inflammatory bowel disease with perianal fistula, sacroiliitis, uveitis, guttate psoriasis, and erythema nodosum. She denied recent medication changes, foreign travel, swimming in freshwater or a hot tub, chills, fever, malaise, night sweats, and weight loss. Physical examination revealed several tender, indurated, erythematous plaques across the legs, ranging in size from 4 to 12 cm. The plaques had central hyperpigmentation, atrophy, and scant scale without ulceration, drainage, or pustules. The largest plaque demonstrated a well-defined area of central fluctuance. Prednisone (60 mg) with taper was initiated for presumed recurrence of erythema nodosum with close follow-up.

This case illustrates the importance of a high index of suspicion for unusual infections in the setting of biologic therapy. An infectious etiology of a cutaneous eruption in an immunosuppressed patient should always be included in the differential diagnosis and actively pursued early on; tissue culture may shorten the treatment course and decrease severity of the disease. Although a direct link between the mechanism of action of vedolizumab and cutaneous infection is not clear, given the rare incidence of this infection, a report of such a case is important to the practicing clinician.

To the Editor:

Verrucous carcinoma is a rare, well-differentiated, locally aggressive squamous cell carcinoma first described by Ackerman in 1948.¹ There are 4 main clinicopathologic types: oral florid papillomatosis or Ackerman tumor, giant condyloma acuminatum or Buschke-Lowenstein tumor, plantar verrucous carcinoma, and cutaneous verrucous carcinoma.^2,3 Historically, most patients are older white men. The lesion commonly occurs in sites of inflammation⁴ or chronic irritation/trauma. Clinically, patients present with a slowly enlarging, exophytic, verrucous plaque violating the skin, fascia, and occasionally bone. Although these lesions have little tendency to metastasize, substantial morbidity can be seen due to local invasion. Despite surgical excision, recurrence is not uncommon and is associated with a poor prognosis and higher infiltrative potential.⁵

A 45-year-old male veteran initially presented to our dermatology clinic with a 4-cm, macerated, verrucous plaque on the left lateral ankle in the area of a skin graft placed during a prior limb salvage surgery (Figure 1). The patient experienced a traumatic blast injury while deployed 7 years prior with a subsequent right-sided below-the-knee amputation and left lower limb salvage. The lesion was clinically diagnosed as verruca vulgaris and treated with daily salicylic acid. Six weeks after the initial presentation, the lesion remained largely unchanged. A biopsy subsequently was obtained to confirm the diagnosis. At that time, the histopathology was consistent with verruca vulgaris without evidence of carcinoma. Due to the persistence of the lesion, lack of improvement with topical treatment, and overall size, the patient opted for surgical excision.

Verrucous carcinoma can represent a diagnostic dilemma, as histologic sections may mimic benign entities. The features of a well-differentiated squamous epithelium with hyperkeratosis, papillomatosis, and acanthosis can be mistaken for verruca vulgaris, keratoacanthoma, and pseudoepitheliomatous hyperplasia,⁶ which are characteristic of verrucous hyperplasia. Accurate diagnosis can be difficult with a superficial biopsy because of the mature appearance of the epithelium,⁷ prompting the need for multiple and deeper biopsies⁸ to include sampling of the base of the hyperplastic epithelium in which the characteristic bulbous pushing growth pattern of the rete ridges is visualized. Precise histologic diagnosis can be further confounded by external mechanical factors, such as pressure, which can distort the classic histopathology.⁷ The histopathologic features leading to the diagnosis of verrucous carcinoma in our specimen were minimal squamous atypia present in a predominantly exophytic squamous proliferation with human papillomavirus cytopathic effect and focal endophytic pushing borders by rounded bulbous rete ridges into the mid and deep dermis (Figure 2).

To the Editor:

Verrucous carcinoma is a rare, well-differentiated, locally aggressive squamous cell carcinoma first described by Ackerman in 1948.¹ There are 4 main clinicopathologic types: oral florid papillomatosis or Ackerman tumor, giant condyloma acuminatum or Buschke-Lowenstein tumor, plantar verrucous carcinoma, and cutaneous verrucous carcinoma.^2,3 Historically, most patients are older white men. The lesion commonly occurs in sites of inflammation⁴ or chronic irritation/trauma. Clinically, patients present with a slowly enlarging, exophytic, verrucous plaque violating the skin, fascia, and occasionally bone. Although these lesions have little tendency to metastasize, substantial morbidity can be seen due to local invasion. Despite surgical excision, recurrence is not uncommon and is associated with a poor prognosis and higher infiltrative potential.⁵

A 45-year-old male veteran initially presented to our dermatology clinic with a 4-cm, macerated, verrucous plaque on the left lateral ankle in the area of a skin graft placed during a prior limb salvage surgery (Figure 1). The patient experienced a traumatic blast injury while deployed 7 years prior with a subsequent right-sided below-the-knee amputation and left lower limb salvage. The lesion was clinically diagnosed as verruca vulgaris and treated with daily salicylic acid. Six weeks after the initial presentation, the lesion remained largely unchanged. A biopsy subsequently was obtained to confirm the diagnosis. At that time, the histopathology was consistent with verruca vulgaris without evidence of carcinoma. Due to the persistence of the lesion, lack of improvement with topical treatment, and overall size, the patient opted for surgical excision.

Verrucous carcinoma can represent a diagnostic dilemma, as histologic sections may mimic benign entities. The features of a well-differentiated squamous epithelium with hyperkeratosis, papillomatosis, and acanthosis can be mistaken for verruca vulgaris, keratoacanthoma, and pseudoepitheliomatous hyperplasia,⁶ which are characteristic of verrucous hyperplasia. Accurate diagnosis can be difficult with a superficial biopsy because of the mature appearance of the epithelium,⁷ prompting the need for multiple and deeper biopsies⁸ to include sampling of the base of the hyperplastic epithelium in which the characteristic bulbous pushing growth pattern of the rete ridges is visualized. Precise histologic diagnosis can be further confounded by external mechanical factors, such as pressure, which can distort the classic histopathology.⁷ The histopathologic features leading to the diagnosis of verrucous carcinoma in our specimen were minimal squamous atypia present in a predominantly exophytic squamous proliferation with human papillomavirus cytopathic effect and focal endophytic pushing borders by rounded bulbous rete ridges into the mid and deep dermis (Figure 2).

To the Editor:

Verrucous carcinoma is a rare, well-differentiated, locally aggressive squamous cell carcinoma first described by Ackerman in 1948.¹ There are 4 main clinicopathologic types: oral florid papillomatosis or Ackerman tumor, giant condyloma acuminatum or Buschke-Lowenstein tumor, plantar verrucous carcinoma, and cutaneous verrucous carcinoma.^2,3 Historically, most patients are older white men. The lesion commonly occurs in sites of inflammation⁴ or chronic irritation/trauma. Clinically, patients present with a slowly enlarging, exophytic, verrucous plaque violating the skin, fascia, and occasionally bone. Although these lesions have little tendency to metastasize, substantial morbidity can be seen due to local invasion. Despite surgical excision, recurrence is not uncommon and is associated with a poor prognosis and higher infiltrative potential.⁵

A 45-year-old male veteran initially presented to our dermatology clinic with a 4-cm, macerated, verrucous plaque on the left lateral ankle in the area of a skin graft placed during a prior limb salvage surgery (Figure 1). The patient experienced a traumatic blast injury while deployed 7 years prior with a subsequent right-sided below-the-knee amputation and left lower limb salvage. The lesion was clinically diagnosed as verruca vulgaris and treated with daily salicylic acid. Six weeks after the initial presentation, the lesion remained largely unchanged. A biopsy subsequently was obtained to confirm the diagnosis. At that time, the histopathology was consistent with verruca vulgaris without evidence of carcinoma. Due to the persistence of the lesion, lack of improvement with topical treatment, and overall size, the patient opted for surgical excision.

Verrucous carcinoma can represent a diagnostic dilemma, as histologic sections may mimic benign entities. The features of a well-differentiated squamous epithelium with hyperkeratosis, papillomatosis, and acanthosis can be mistaken for verruca vulgaris, keratoacanthoma, and pseudoepitheliomatous hyperplasia,⁶ which are characteristic of verrucous hyperplasia. Accurate diagnosis can be difficult with a superficial biopsy because of the mature appearance of the epithelium,⁷ prompting the need for multiple and deeper biopsies⁸ to include sampling of the base of the hyperplastic epithelium in which the characteristic bulbous pushing growth pattern of the rete ridges is visualized. Precise histologic diagnosis can be further confounded by external mechanical factors, such as pressure, which can distort the classic histopathology.⁷ The histopathologic features leading to the diagnosis of verrucous carcinoma in our specimen were minimal squamous atypia present in a predominantly exophytic squamous proliferation with human papillomavirus cytopathic effect and focal endophytic pushing borders by rounded bulbous rete ridges into the mid and deep dermis (Figure 2).

Globally, the United States has the highest per-capita cost of health care; total costs are expected to account for approximately 20% of the nation’s gross domestic product by 2025.¹ These rising costs have prompted residency programs and medical schools to incorporate business education into their curricula.^2-5 Although medical training is demanding—with little room to add curricular components—these business-focused curricula have consistently received positive feedback from residents.^5,6

In dermatology, more than 50% of residents opt to join a private practice upon graduation.⁷ In the United States, there also is an upward trend of practice acquisition and consolidation by private equity firms. Therefore, dermatology trainees are uniquely positioned to benefit from business education to make well-informed decisions about joining or starting a practice.Furthermore, whether in a private or academic setting, knowledge of foundational economics, business strategy, finance, marketing, and health care policy can equip dermatologists to more effectively advocate for local and national policies that benefit their patient population.⁷

We conducted a survey of dermatology program directors (PDs) to determine the availability of and perceptions regarding business education during residency training.

Materials and Methods

Institutional review board (Vanderbilt University Medical Center, Nashville, Tennessee) approval was obtained. The survey was distributed weekly during a 5-week period from July 2020 to August 2020 through the Research Electronic Data Capture survey application (www.project-redcap.org). Program director email addresses were obtained through the Accreditation Council for Graduate Medical Education (ACGME) program list. A PD was included in the survey if they were employed by an accredited US osteopathic or allopathic program and their email address was provided in the ACGME program list or on their program’s faculty web page; a PD was excluded if an email address was not provided in the ACGME program list or on their program’s faculty web page.

The 8-part questionnaire was designed to assess the following characteristics: details about the respondent’s residency program (institutional affiliation, number of residents), the respondent’s professional background (number of years as a PD, business training experience), resources for business education provided by the program, the respondent’s opinion about business education for residents, and the respondent’s perception of the most important topics to include in a dermatology curriculum’s business education component, which included economics/finance, health care policy/government, management, marketing, negotiation, private equity involvement in health care, business strategy, supply chain/operations, and technology/product development. Responses were kept anonymous. Categorical and continuous variables were analyzed with medians and proportions.

Results

Of the 139 surveys distributed, 35 were completed and returned (response rate, 25.2%). Most programs were university-affiliated (71.4%) or community-affiliated (22.9%). The median number of residents was 12. The respondents had a median of 5 years’ experience in their role. Most respondents (65.7%) had no business training, although 20.0% had completed undergraduate business coursework, and 8.6% had attended formal seminars on business topics; 5.7% were self-taught on business topics.

Business Education Availability
Approximately half (51.4%) of programs offered business training to residents, primarily through seminars or lectures (94.4%) and take-home modules (16.7%). None of the programs offered a formal gap year during which residents could pursue a professional business degree. Most respondents thought business education during residency was important (82.8%) and that programs should implement more training (57.1%). When asked whether residents were competent to handle business aspects of dermatology upon graduation, most respondents disagreed somewhat (22.9%) or were neutral (40.0%).

Topics for Business Education
The most important topics identified for inclusion in a business curriculum were economics or finance (68.6%), management (68.6%), and health care policy or government (57.1%). Other identified topics included negotiation (40.0%), private equity involvement in health care (40.0%), strategy (11.4%), supply chain or operations (11.4%), marketing (2.9%), and technology (2.9%).

Comment

Residency programs and medical schools in the United States have started to integrate formal business training into their curricula; however, the state of business training in dermatology has not been characterized. Overall, this survey revealed largely positive perceptions about business education and identified a demand for more resources.

Whereas most PDs identified business education as important, only one half (51.4%) of the representative programs offered structured training. Notably, most PDs did not agree that graduating residents were competent to handle the business demands of dermatology practice. These responses highlight a gap in the demand and resources available for business training.

Identifying Curricular Resources
During an already demanding residency, additional curricular components need to be beneficial and worthwhile. To avoid significant disruption, business training could take place in the form of online lectures or take-home modules. Most programs represented in the survey responses had an academic affiliation and therefore commonly have access to an affiliated graduate business school and/or hospital administrators who have clinical and business training.

Community dermatologists who own or run their own practice also are uniquely positioned to provide residents with practical, dermatology-specific business education. Programs can utilize their institutional and local colleagues to aid in curricular design and implementation. In addition, a potential long-term solution to obtaining resources for business education is to coordinate with a national dermatology organization to create standardized modules that are available to all residency programs.

Key Curriculum Topics
Our survey identified the most important topics to include in a business curriculum for dermatology residents. Economics and finance, management, and health care policy would be valuable to a trainee regardless of whether they ultimately choose a career in academia or private practice. A thorough understanding of complex health care policy reinforces knowledge about insurance and regional and national regulations, which could ultimately benefit patient care. As an example, the American Academy of Dermatology outlines several advocacy priorities such as Medicare reimbursement policies, access to dermatologic care through public and private insurance, medication access and pricing, and preservation of private practice in the setting of market consolidation. Having a better understanding of health care policy and business could better equip dermatologists to lead these often business-driven advocacy efforts to ultimately improve patient care and advance the specialty.⁸

Limitations
There were notable limitations to this survey, primarily related to its design. With a 25% response rate, there was the potential for response and selection biases; therefore, these results might not be generalizable to all programs. In addition, views held by PDs might not be consistent with those of other members of the dermatology community; for example, surveying residents, other faculty members, and dermatologists in private practice would have provided a more comprehensive characterization of the topic.

Conclusion

This study assessed residency program directors’ perceptions of business education in dermatology training. There appears to be an imbalance between the perceived importance of such education and the resources that are available to provide it. More attention is needed to address this gap to ensure that dermatologists are prepared to manage a rapidly changing health care environment. Results of this survey should encourage efforts to establish (1) a standardized, dermatology-specific business curriculum and (2) a plan to make that curriculum accessible to trainees and other members of the dermatology community.

Globally, the United States has the highest per-capita cost of health care; total costs are expected to account for approximately 20% of the nation’s gross domestic product by 2025.¹ These rising costs have prompted residency programs and medical schools to incorporate business education into their curricula.^2-5 Although medical training is demanding—with little room to add curricular components—these business-focused curricula have consistently received positive feedback from residents.^5,6

In dermatology, more than 50% of residents opt to join a private practice upon graduation.⁷ In the United States, there also is an upward trend of practice acquisition and consolidation by private equity firms. Therefore, dermatology trainees are uniquely positioned to benefit from business education to make well-informed decisions about joining or starting a practice.Furthermore, whether in a private or academic setting, knowledge of foundational economics, business strategy, finance, marketing, and health care policy can equip dermatologists to more effectively advocate for local and national policies that benefit their patient population.⁷

We conducted a survey of dermatology program directors (PDs) to determine the availability of and perceptions regarding business education during residency training.

Materials and Methods

Institutional review board (Vanderbilt University Medical Center, Nashville, Tennessee) approval was obtained. The survey was distributed weekly during a 5-week period from July 2020 to August 2020 through the Research Electronic Data Capture survey application (www.project-redcap.org). Program director email addresses were obtained through the Accreditation Council for Graduate Medical Education (ACGME) program list. A PD was included in the survey if they were employed by an accredited US osteopathic or allopathic program and their email address was provided in the ACGME program list or on their program’s faculty web page; a PD was excluded if an email address was not provided in the ACGME program list or on their program’s faculty web page.

The 8-part questionnaire was designed to assess the following characteristics: details about the respondent’s residency program (institutional affiliation, number of residents), the respondent’s professional background (number of years as a PD, business training experience), resources for business education provided by the program, the respondent’s opinion about business education for residents, and the respondent’s perception of the most important topics to include in a dermatology curriculum’s business education component, which included economics/finance, health care policy/government, management, marketing, negotiation, private equity involvement in health care, business strategy, supply chain/operations, and technology/product development. Responses were kept anonymous. Categorical and continuous variables were analyzed with medians and proportions.

Results

Of the 139 surveys distributed, 35 were completed and returned (response rate, 25.2%). Most programs were university-affiliated (71.4%) or community-affiliated (22.9%). The median number of residents was 12. The respondents had a median of 5 years’ experience in their role. Most respondents (65.7%) had no business training, although 20.0% had completed undergraduate business coursework, and 8.6% had attended formal seminars on business topics; 5.7% were self-taught on business topics.

Business Education Availability
Approximately half (51.4%) of programs offered business training to residents, primarily through seminars or lectures (94.4%) and take-home modules (16.7%). None of the programs offered a formal gap year during which residents could pursue a professional business degree. Most respondents thought business education during residency was important (82.8%) and that programs should implement more training (57.1%). When asked whether residents were competent to handle business aspects of dermatology upon graduation, most respondents disagreed somewhat (22.9%) or were neutral (40.0%).

Topics for Business Education
The most important topics identified for inclusion in a business curriculum were economics or finance (68.6%), management (68.6%), and health care policy or government (57.1%). Other identified topics included negotiation (40.0%), private equity involvement in health care (40.0%), strategy (11.4%), supply chain or operations (11.4%), marketing (2.9%), and technology (2.9%).

Comment

Residency programs and medical schools in the United States have started to integrate formal business training into their curricula; however, the state of business training in dermatology has not been characterized. Overall, this survey revealed largely positive perceptions about business education and identified a demand for more resources.

Whereas most PDs identified business education as important, only one half (51.4%) of the representative programs offered structured training. Notably, most PDs did not agree that graduating residents were competent to handle the business demands of dermatology practice. These responses highlight a gap in the demand and resources available for business training.

Identifying Curricular Resources
During an already demanding residency, additional curricular components need to be beneficial and worthwhile. To avoid significant disruption, business training could take place in the form of online lectures or take-home modules. Most programs represented in the survey responses had an academic affiliation and therefore commonly have access to an affiliated graduate business school and/or hospital administrators who have clinical and business training.

Community dermatologists who own or run their own practice also are uniquely positioned to provide residents with practical, dermatology-specific business education. Programs can utilize their institutional and local colleagues to aid in curricular design and implementation. In addition, a potential long-term solution to obtaining resources for business education is to coordinate with a national dermatology organization to create standardized modules that are available to all residency programs.

Key Curriculum Topics
Our survey identified the most important topics to include in a business curriculum for dermatology residents. Economics and finance, management, and health care policy would be valuable to a trainee regardless of whether they ultimately choose a career in academia or private practice. A thorough understanding of complex health care policy reinforces knowledge about insurance and regional and national regulations, which could ultimately benefit patient care. As an example, the American Academy of Dermatology outlines several advocacy priorities such as Medicare reimbursement policies, access to dermatologic care through public and private insurance, medication access and pricing, and preservation of private practice in the setting of market consolidation. Having a better understanding of health care policy and business could better equip dermatologists to lead these often business-driven advocacy efforts to ultimately improve patient care and advance the specialty.⁸

Limitations
There were notable limitations to this survey, primarily related to its design. With a 25% response rate, there was the potential for response and selection biases; therefore, these results might not be generalizable to all programs. In addition, views held by PDs might not be consistent with those of other members of the dermatology community; for example, surveying residents, other faculty members, and dermatologists in private practice would have provided a more comprehensive characterization of the topic.

Conclusion

This study assessed residency program directors’ perceptions of business education in dermatology training. There appears to be an imbalance between the perceived importance of such education and the resources that are available to provide it. More attention is needed to address this gap to ensure that dermatologists are prepared to manage a rapidly changing health care environment. Results of this survey should encourage efforts to establish (1) a standardized, dermatology-specific business curriculum and (2) a plan to make that curriculum accessible to trainees and other members of the dermatology community.

Globally, the United States has the highest per-capita cost of health care; total costs are expected to account for approximately 20% of the nation’s gross domestic product by 2025.¹ These rising costs have prompted residency programs and medical schools to incorporate business education into their curricula.^2-5 Although medical training is demanding—with little room to add curricular components—these business-focused curricula have consistently received positive feedback from residents.^5,6

In dermatology, more than 50% of residents opt to join a private practice upon graduation.⁷ In the United States, there also is an upward trend of practice acquisition and consolidation by private equity firms. Therefore, dermatology trainees are uniquely positioned to benefit from business education to make well-informed decisions about joining or starting a practice.Furthermore, whether in a private or academic setting, knowledge of foundational economics, business strategy, finance, marketing, and health care policy can equip dermatologists to more effectively advocate for local and national policies that benefit their patient population.⁷

We conducted a survey of dermatology program directors (PDs) to determine the availability of and perceptions regarding business education during residency training.

Materials and Methods

Institutional review board (Vanderbilt University Medical Center, Nashville, Tennessee) approval was obtained. The survey was distributed weekly during a 5-week period from July 2020 to August 2020 through the Research Electronic Data Capture survey application (www.project-redcap.org). Program director email addresses were obtained through the Accreditation Council for Graduate Medical Education (ACGME) program list. A PD was included in the survey if they were employed by an accredited US osteopathic or allopathic program and their email address was provided in the ACGME program list or on their program’s faculty web page; a PD was excluded if an email address was not provided in the ACGME program list or on their program’s faculty web page.

The 8-part questionnaire was designed to assess the following characteristics: details about the respondent’s residency program (institutional affiliation, number of residents), the respondent’s professional background (number of years as a PD, business training experience), resources for business education provided by the program, the respondent’s opinion about business education for residents, and the respondent’s perception of the most important topics to include in a dermatology curriculum’s business education component, which included economics/finance, health care policy/government, management, marketing, negotiation, private equity involvement in health care, business strategy, supply chain/operations, and technology/product development. Responses were kept anonymous. Categorical and continuous variables were analyzed with medians and proportions.

Results

Of the 139 surveys distributed, 35 were completed and returned (response rate, 25.2%). Most programs were university-affiliated (71.4%) or community-affiliated (22.9%). The median number of residents was 12. The respondents had a median of 5 years’ experience in their role. Most respondents (65.7%) had no business training, although 20.0% had completed undergraduate business coursework, and 8.6% had attended formal seminars on business topics; 5.7% were self-taught on business topics.

Business Education Availability
Approximately half (51.4%) of programs offered business training to residents, primarily through seminars or lectures (94.4%) and take-home modules (16.7%). None of the programs offered a formal gap year during which residents could pursue a professional business degree. Most respondents thought business education during residency was important (82.8%) and that programs should implement more training (57.1%). When asked whether residents were competent to handle business aspects of dermatology upon graduation, most respondents disagreed somewhat (22.9%) or were neutral (40.0%).

Topics for Business Education
The most important topics identified for inclusion in a business curriculum were economics or finance (68.6%), management (68.6%), and health care policy or government (57.1%). Other identified topics included negotiation (40.0%), private equity involvement in health care (40.0%), strategy (11.4%), supply chain or operations (11.4%), marketing (2.9%), and technology (2.9%).

Comment

Residency programs and medical schools in the United States have started to integrate formal business training into their curricula; however, the state of business training in dermatology has not been characterized. Overall, this survey revealed largely positive perceptions about business education and identified a demand for more resources.

Whereas most PDs identified business education as important, only one half (51.4%) of the representative programs offered structured training. Notably, most PDs did not agree that graduating residents were competent to handle the business demands of dermatology practice. These responses highlight a gap in the demand and resources available for business training.

Identifying Curricular Resources
During an already demanding residency, additional curricular components need to be beneficial and worthwhile. To avoid significant disruption, business training could take place in the form of online lectures or take-home modules. Most programs represented in the survey responses had an academic affiliation and therefore commonly have access to an affiliated graduate business school and/or hospital administrators who have clinical and business training.

Community dermatologists who own or run their own practice also are uniquely positioned to provide residents with practical, dermatology-specific business education. Programs can utilize their institutional and local colleagues to aid in curricular design and implementation. In addition, a potential long-term solution to obtaining resources for business education is to coordinate with a national dermatology organization to create standardized modules that are available to all residency programs.

Key Curriculum Topics
Our survey identified the most important topics to include in a business curriculum for dermatology residents. Economics and finance, management, and health care policy would be valuable to a trainee regardless of whether they ultimately choose a career in academia or private practice. A thorough understanding of complex health care policy reinforces knowledge about insurance and regional and national regulations, which could ultimately benefit patient care. As an example, the American Academy of Dermatology outlines several advocacy priorities such as Medicare reimbursement policies, access to dermatologic care through public and private insurance, medication access and pricing, and preservation of private practice in the setting of market consolidation. Having a better understanding of health care policy and business could better equip dermatologists to lead these often business-driven advocacy efforts to ultimately improve patient care and advance the specialty.⁸

Limitations
There were notable limitations to this survey, primarily related to its design. With a 25% response rate, there was the potential for response and selection biases; therefore, these results might not be generalizable to all programs. In addition, views held by PDs might not be consistent with those of other members of the dermatology community; for example, surveying residents, other faculty members, and dermatologists in private practice would have provided a more comprehensive characterization of the topic.

Conclusion

This study assessed residency program directors’ perceptions of business education in dermatology training. There appears to be an imbalance between the perceived importance of such education and the resources that are available to provide it. More attention is needed to address this gap to ensure that dermatologists are prepared to manage a rapidly changing health care environment. Results of this survey should encourage efforts to establish (1) a standardized, dermatology-specific business curriculum and (2) a plan to make that curriculum accessible to trainees and other members of the dermatology community.

Psoriasis is a chronic and relapsing systemic inflammatory disease that predisposes patients to a host of other conditions. It is believed that these widespread effects are due to chronic inflammation and cytokine activation, which affect multiple body processes and lead to the development of various comorbidities that need to be proactively managed.

In April 2019, the American Academy of Dermatology (AAD) and National Psoriasis Foundation (NPF) released recommendation guidelines for managing psoriasis in adults with an emphasis on common disease comorbidities, including psoriatic arthritis (PsA), cardiovascular disease (CVD), inflammatory bowel disease (IBD), metabolic syndrome, and mood disorders. Psychosocial wellness, mental health, and quality of life (QOL) measures in relation to psoriatic disease also were discussed.¹

The AAD-NPF guidelines address current screening, monitoring, education, and treatment recommendations for the management of psoriatic comorbidities. The Table and eTable summarize the screening recommendations. These guidelines aim to assist dermatologists with comprehensive disease management by addressing potential extracutaneous manifestations of psoriasis in adults.

Screening and Risk Assessment

Patients with psoriasis should receive a thorough history and physical examination to assess disease severity and risk for potential comorbidities. Patients with greater disease severity—as measured by body surface area (BSA) involvement and type of therapy required—have a greater risk for other disease-related comorbidities, specifically metabolic syndrome, renal disease, chronic obstructive pulmonary disease (COPD), obstructive sleep apnea, uveitis, IBD, malignancy, and increased mortality.² Because the likelihood of comorbidities is greatest with severe disease, more frequent monitoring is recommended for these patients.

Psoriatic Arthritis

Patients with psoriasis need to be evaluated for PsA at every visit. Patients presenting with signs and symptoms suspicious for PsA—joint swelling, peripheral joint involvement, and joint inflammation—warrant further evaluation and consultation. Early detection and treatment of PsA is essential for preventing unnecessary suffering and progressive joint destruction.³

There are several PsA screening questionnaires currently available, including the Psoriatic Arthritis Screening Evaluation, Psoriasis Epidemiology Screening Tool, and Toronto Psoriatic Arthritis Screen. No significant differences in sensitivity and specificity were found among these questionnaires when using the Classification Criteria for Psoriatic Arthritis as the gold standard. All 3 questionnaires—the Psoriatic Arthritis Screening Evaluation and the Psoriasis Epidemiology Screening Tool were developed for use in dermatology and rheumatology clinics, and the Toronto Psoriatic Arthritis Screen was developed for use in the primary care setting—were found to be effective in dermatology/rheumatology clinics and primary care clinics, respectively.³ False-positive results predominantly were seen in patients with degenerative joint disease or osteoarthritis. Dermatologists should conduct a thorough physical examination to distinguish PsA from degenerative joint disease. Imaging and laboratory tests to evaluate for signs of systemic inflammation (erythrocyte sedimentation rate, C-reactive protein) also can be helpful in distinguishing the 2 conditions; however, these metrics have not been shown to contribute to PsA diagnosis.¹ Full rheumatologic consultation is warranted in challenging cases.

Cardiovascular Disease

The American Heart Association and the American College of Cardiology have identified chronic inflammatory states, such as psoriasis, as inducing factors that predispose patients to CVD. Many studies have found an association among psoriasis, coronary artery disease, myocardial infarction (MI), and stroke.^4-7 It is strongly recommended that dermatologists educate patients of their increased risk for CVD, given the association between psoriasis and major adverse cardiovascular events (eg, stroke, heart failure, MI) and cardiovascular health. However, patients with congestive heart failure were found to have an increased risk of mortality associated with use of tumor necrosis factor (TNF) α inhibitors (P=.016).⁸ Thus, TNF inhibitors are contraindicated in patients with New York Heart Association Class III or Class IV congestive heart failure.⁹

Primary care physicians (PCPs) are recommended to screen patients for CVD risk factors using height, weight, blood pressure, blood glucose, hemoglobin A_1C, lipid levels, abdominal circumference, and body mass index (BMI). Lifestyle modifications such as smoking cessation, exercise, and dietary changes are encouraged to achieve and maintain a normal BMI.

Dermatologists also need to give special consideration to comorbidities when selecting medications and/or therapies for disease management. Patients on TNF inhibitors have a lower risk for MI compared with patients using topical medications, phototherapy, and other oral agents.¹⁰ Additionally, patients on TNF inhibitors have a lower risk for occurrence of major adverse cardiovascular events compared with patients treated with methotrexate or phototherapy.^11,12

Metabolic Syndrome

Numerous studies have demonstrated an association between psoriasis and metabolic syndrome. Patients with increased BSA involvement and psoriasis area and severity index scores have a higher prevalence of metabolic syndrome.¹³ Patients with psoriasis have an increased risk for the following conditions compared to controls: obesity (38% vs 31%; odds ratio [OR], 1.38; 95% CI, 1.29-1.48), elevated triglycerides (36% vs 28%; OR, 1.49; 95% CI, 1.39-1.60), hypertension (31% vs 28%; OR, 1.20; 95% CI, 1.11-12.9), and elevated glucose levels (22% vs 16%; OR, 1.44; 95% CI, 1.33-1.56).¹⁴ Dermatologists are strongly recommended to inform patients about the risk for metabolic syndrome and to encourage the measurement of blood pressure, waist circumference, fasting blood glucose, hemoglobin A_1C, and fasting lipid levels with their PCP when indicated. Body mass index and waist circumference also should be measured annually in patients with moderate to severe psoriasis because of the association with disease severity.

The association between psoriasis and weight loss has been analyzed in several studies. Weight loss, particularly in obese patients, has been shown to improve psoriasis severity, as measured by psoriasis area and severity index score and QOL measures.¹⁵ Another study found that gastric bypass was associated with a significant risk reduction in the development of psoriasis (P=.004) and the disease prognosis (P=.02 for severe psoriasis; P=.01 for PsA).¹⁶ Therefore, patients with moderate to severe psoriasis are recommended to have their obesity status determined according to national guidelines. For patients with a BMI above 40 kg/m² and standard weight-loss measures fail, bariatric surgery is recommended. Additionally, the impact of psoriasis medications on weight has been studied. Apremilast has been associated with weight loss, whereas etanercept and infliximab have been linked to weight gain.^17,18

An association between psoriasis and hypertension also has been demonstrated by studies, especially among patients with severe disease. Therefore, patients with moderate to severe psoriasis are recommended to have their blood pressure evaluated according to national guidelines, and those with a blood pressure of 140/90 mm Hg or higher should be referred to their PCP for assessment and treatment. Current evidence does not support restrictions on antihypertensive medications in patients with psoriasis. Physicians should be aware of the potential for cyclosporine to induce hypertension, which should be treated, specifically with amlodipine.¹⁹

Many studies have demonstrated an association between psoriasis and dyslipidemia, though the results are somewhat conflicting. In 2018, the American Heart Association and the American College of Cardiology deemed psoriasis as an atherosclerotic CVD risk-enhancing condition, favoring early initiation of statin therapy. Because dyslipidemia plays a prominent role in atherosclerosis and CVD, patients with moderate to severe psoriasis are recommended to undergo periodic screening with lipid tests (eg, fasting total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides).²⁰ Patients with elevated fasting triglycerides or low-density lipoprotein cholesterol should be referred to their PCP for further management. Certain psoriasis medications also have been linked to dyslipidemia. Acitretin and cyclosporine are known to adversely affect lipid levels, so patients treated with either agent should undergo routine monitoring of serum lipid levels.

Psoriasis is strongly associated with diabetes mellitus. Because of the increased risk for diabetes in patients with severe disease, regular monitoring of fasting blood glucose and/or hemoglobin A_1C levels in patients with moderate to severe psoriasis is recommended. Patients who meet criteria for prediabetes or diabetes should be referred to their PCP for further assessment and management.^21,22

Mood Disorders

Psoriasis affects QOL and can have a major impact on patients’ interpersonal relationships. Studies have shown an association between psoriasis and mood disorders, specifically depression and anxiety. Unfortunately, patients with mood disorders are less likely to seek intervention for their skin disease, which poses a tremendous treatment barrier. Dermatologists should regularly monitor patients for psychiatric symptoms so that resources and treatments can be offered.

Certain psoriasis therapies have been shown to help alleviate associated depression and anxiety. Improvements in Beck Depression Inventory and Hamilton Depression Rating Scale scores were seen with etanercept.²³ Adalimumab and ustekinumab showed improvement in Dermatology Life Quality Index compared with placebo.^24,25 Patients receiving Goeckerman treatment also had improvement in anxiety and depression scores compared with conventional therapy.²⁶ Biologic medications had the largest impact on improving depression symptoms compared with conventional systemic therapy and phototherapy.²⁷ The recommendations support use of biologics and the Goeckerman regimen for the concomitant treatment of mood disorders and psoriasis.

Renal Disease

Studies have supported an association between psoriasis and chronic kidney disease (CKD), independent of risk factors including vascular disease, hypertension, and diabetes. The prevalence of moderate to advanced CKD also has been found to be directly related to increasing BSA affected by psoriasis.²⁸ Patients should receive testing of blood urea nitrogen, creatinine, and urine microalbumin levels to assess for occult renal disease. In addition, physicians should be cautious when prescribing nephrotoxic drugs (nonsteroidal anti-inflammatory drugs and cyclosporine) and renally excreted agents (methotrexate and apremilast) because of the risk for underlying renal disease in patients with psoriasis. If newly acquired renal disease is suspected, physicians should withhold the offending agents. Patients with psoriasis with CKD are recommended to follow up with their PCP or nephrologist for evaluation and management.

Pulmonary Disease

Psoriasis also has an independent association with COPD. Patients with psoriasis have a higher likelihood of developing COPD (hazard ratio, 2.35; 95% CI, 1.42-3.89; P<.01) than controls.²⁹ The prevalence of COPD also was found to correlate with psoriasis severity. Dermatologists should educate patients about the association between smoking and psoriasis as well as advise patients to discontinue smoking to reduce their risk for developing COPD and cancer.

Patients with psoriasis also are at an increased risk for obstructive sleep apnea. Obstructive sleep apnea should be considered in patients with risk factors including snoring, obesity, hypertension, or diabetes.

Inflammatory Bowel Disease

Patients with psoriasis have an increased risk for developing IBD. The prevalence ratios of both Crohn disease (2.49) and ulcerative colitis (1.64) are increased in patients with psoriasis relative to patients without psoriasis.³⁰ Physicians need to be aware of the association between psoriasis and IBD and the effect that their coexistence may have on treatment choice for patients.

Adalimumab and infliximab are approved for the treatment of IBD, and certolizumab and ustekinumab are approved for Crohn disease. Use of TNF inhibitors in patients with IBD may cause psoriasiform lesions to develop.³¹ Nonetheless, treatment should be individualized and psoriasiform lesions treated with standard psoriasis measures. Psoriasis patients with IBD are recommended to avoid IL-17–inhibitor therapy, given its potential to worsen IBD flares.

Malignancy

Psoriasis patients aged 0 to 79 years have a greater overall risk for malignancy compared with patients without psoriasis.³² Patients with psoriasis have an increased risk for respiratory tract cancer, upper aerodigestive tract cancer, urinary tract cancer, and non-Hodgkin lymphoma.³³ A mild association exists between PsA and lymphoma, nonmelanoma skin cancer (NMSC), and lung cancer.³⁴ More severe psoriasis is associated with greater risk for lymphoma and NMSC. Dermatologists are recommended to educate patients on their risk for certain malignancies and to refer patients to specialists upon suspicion of malignancy.

Risk for malignancy has been shown to be affected by psoriasis treatments. Patients treated with UVB have reduced overall cancer rates for all age groups (hazard ratio, 0.52; P=.3), while those treated with psoralen plus UVA have an increased incidence of squamous cell carcinoma.^32,33 Adalimumab was correlated with increased risk for NMSC in patients with psoriasis but did not have an increased risk for all cancers collectively when used for various immune-mediated inflammatory diseases.³⁵ In contrast, a meta-analysis of randomized clinical trials found no association with TNF inhibitor use and NMSC.³⁶ Ustekinumab had no association with malignancy.³⁷ Treatment history should be elucidated because of higher rates of squamous cell carcinoma in patients with prior psoralen plus UVA, cyclosporine, or methotrexate use.³³ To address malignancy risk, patients with psoriasis should undergo regular screenings for skin cancer and follow national guidelines for age-appropriate cancer screenings.

Lifestyle Choices and QOL

A crucial aspect of successful psoriasis management is patient education. The strongest recommendations support lifestyle changes, such as smoking cessation and limitation of alcohol use. A tactful discussion regarding substance use, work productivity, interpersonal relationships, and sexual function can address substantial effects of psoriasis on QOL so that support and resources can be provided.

Final Thoughts

Management of psoriasis is multifaceted and involves screening, education, monitoring, and collaboration with PCPs and specialists. Regular follow-up with a dermatologist and PCP is strongly recommended for patients with psoriasis given the systemic nature of the disease. The 2019 AAD-NPF recommendations provide important information for dermatologists to coordinate care for complicated psoriasis cases, but clinical judgment is paramount when making medical decisions. The consideration of comorbidities is critical for developing a comprehensive treatment approach, and this approach will lead to better health outcomes and improved QOL for patients with psoriasis.

Psoriasis is a chronic and relapsing systemic inflammatory disease that predisposes patients to a host of other conditions. It is believed that these widespread effects are due to chronic inflammation and cytokine activation, which affect multiple body processes and lead to the development of various comorbidities that need to be proactively managed.

In April 2019, the American Academy of Dermatology (AAD) and National Psoriasis Foundation (NPF) released recommendation guidelines for managing psoriasis in adults with an emphasis on common disease comorbidities, including psoriatic arthritis (PsA), cardiovascular disease (CVD), inflammatory bowel disease (IBD), metabolic syndrome, and mood disorders. Psychosocial wellness, mental health, and quality of life (QOL) measures in relation to psoriatic disease also were discussed.¹

The AAD-NPF guidelines address current screening, monitoring, education, and treatment recommendations for the management of psoriatic comorbidities. The Table and eTable summarize the screening recommendations. These guidelines aim to assist dermatologists with comprehensive disease management by addressing potential extracutaneous manifestations of psoriasis in adults.

Screening and Risk Assessment

Patients with psoriasis should receive a thorough history and physical examination to assess disease severity and risk for potential comorbidities. Patients with greater disease severity—as measured by body surface area (BSA) involvement and type of therapy required—have a greater risk for other disease-related comorbidities, specifically metabolic syndrome, renal disease, chronic obstructive pulmonary disease (COPD), obstructive sleep apnea, uveitis, IBD, malignancy, and increased mortality.² Because the likelihood of comorbidities is greatest with severe disease, more frequent monitoring is recommended for these patients.

Psoriatic Arthritis

Patients with psoriasis need to be evaluated for PsA at every visit. Patients presenting with signs and symptoms suspicious for PsA—joint swelling, peripheral joint involvement, and joint inflammation—warrant further evaluation and consultation. Early detection and treatment of PsA is essential for preventing unnecessary suffering and progressive joint destruction.³

There are several PsA screening questionnaires currently available, including the Psoriatic Arthritis Screening Evaluation, Psoriasis Epidemiology Screening Tool, and Toronto Psoriatic Arthritis Screen. No significant differences in sensitivity and specificity were found among these questionnaires when using the Classification Criteria for Psoriatic Arthritis as the gold standard. All 3 questionnaires—the Psoriatic Arthritis Screening Evaluation and the Psoriasis Epidemiology Screening Tool were developed for use in dermatology and rheumatology clinics, and the Toronto Psoriatic Arthritis Screen was developed for use in the primary care setting—were found to be effective in dermatology/rheumatology clinics and primary care clinics, respectively.³ False-positive results predominantly were seen in patients with degenerative joint disease or osteoarthritis. Dermatologists should conduct a thorough physical examination to distinguish PsA from degenerative joint disease. Imaging and laboratory tests to evaluate for signs of systemic inflammation (erythrocyte sedimentation rate, C-reactive protein) also can be helpful in distinguishing the 2 conditions; however, these metrics have not been shown to contribute to PsA diagnosis.¹ Full rheumatologic consultation is warranted in challenging cases.

Cardiovascular Disease

The American Heart Association and the American College of Cardiology have identified chronic inflammatory states, such as psoriasis, as inducing factors that predispose patients to CVD. Many studies have found an association among psoriasis, coronary artery disease, myocardial infarction (MI), and stroke.^4-7 It is strongly recommended that dermatologists educate patients of their increased risk for CVD, given the association between psoriasis and major adverse cardiovascular events (eg, stroke, heart failure, MI) and cardiovascular health. However, patients with congestive heart failure were found to have an increased risk of mortality associated with use of tumor necrosis factor (TNF) α inhibitors (P=.016).⁸ Thus, TNF inhibitors are contraindicated in patients with New York Heart Association Class III or Class IV congestive heart failure.⁹

Primary care physicians (PCPs) are recommended to screen patients for CVD risk factors using height, weight, blood pressure, blood glucose, hemoglobin A_1C, lipid levels, abdominal circumference, and body mass index (BMI). Lifestyle modifications such as smoking cessation, exercise, and dietary changes are encouraged to achieve and maintain a normal BMI.

Dermatologists also need to give special consideration to comorbidities when selecting medications and/or therapies for disease management. Patients on TNF inhibitors have a lower risk for MI compared with patients using topical medications, phototherapy, and other oral agents.¹⁰ Additionally, patients on TNF inhibitors have a lower risk for occurrence of major adverse cardiovascular events compared with patients treated with methotrexate or phototherapy.^11,12

Metabolic Syndrome

Numerous studies have demonstrated an association between psoriasis and metabolic syndrome. Patients with increased BSA involvement and psoriasis area and severity index scores have a higher prevalence of metabolic syndrome.¹³ Patients with psoriasis have an increased risk for the following conditions compared to controls: obesity (38% vs 31%; odds ratio [OR], 1.38; 95% CI, 1.29-1.48), elevated triglycerides (36% vs 28%; OR, 1.49; 95% CI, 1.39-1.60), hypertension (31% vs 28%; OR, 1.20; 95% CI, 1.11-12.9), and elevated glucose levels (22% vs 16%; OR, 1.44; 95% CI, 1.33-1.56).¹⁴ Dermatologists are strongly recommended to inform patients about the risk for metabolic syndrome and to encourage the measurement of blood pressure, waist circumference, fasting blood glucose, hemoglobin A_1C, and fasting lipid levels with their PCP when indicated. Body mass index and waist circumference also should be measured annually in patients with moderate to severe psoriasis because of the association with disease severity.

The association between psoriasis and weight loss has been analyzed in several studies. Weight loss, particularly in obese patients, has been shown to improve psoriasis severity, as measured by psoriasis area and severity index score and QOL measures.¹⁵ Another study found that gastric bypass was associated with a significant risk reduction in the development of psoriasis (P=.004) and the disease prognosis (P=.02 for severe psoriasis; P=.01 for PsA).¹⁶ Therefore, patients with moderate to severe psoriasis are recommended to have their obesity status determined according to national guidelines. For patients with a BMI above 40 kg/m² and standard weight-loss measures fail, bariatric surgery is recommended. Additionally, the impact of psoriasis medications on weight has been studied. Apremilast has been associated with weight loss, whereas etanercept and infliximab have been linked to weight gain.^17,18

An association between psoriasis and hypertension also has been demonstrated by studies, especially among patients with severe disease. Therefore, patients with moderate to severe psoriasis are recommended to have their blood pressure evaluated according to national guidelines, and those with a blood pressure of 140/90 mm Hg or higher should be referred to their PCP for assessment and treatment. Current evidence does not support restrictions on antihypertensive medications in patients with psoriasis. Physicians should be aware of the potential for cyclosporine to induce hypertension, which should be treated, specifically with amlodipine.¹⁹

Many studies have demonstrated an association between psoriasis and dyslipidemia, though the results are somewhat conflicting. In 2018, the American Heart Association and the American College of Cardiology deemed psoriasis as an atherosclerotic CVD risk-enhancing condition, favoring early initiation of statin therapy. Because dyslipidemia plays a prominent role in atherosclerosis and CVD, patients with moderate to severe psoriasis are recommended to undergo periodic screening with lipid tests (eg, fasting total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides).²⁰ Patients with elevated fasting triglycerides or low-density lipoprotein cholesterol should be referred to their PCP for further management. Certain psoriasis medications also have been linked to dyslipidemia. Acitretin and cyclosporine are known to adversely affect lipid levels, so patients treated with either agent should undergo routine monitoring of serum lipid levels.

Psoriasis is strongly associated with diabetes mellitus. Because of the increased risk for diabetes in patients with severe disease, regular monitoring of fasting blood glucose and/or hemoglobin A_1C levels in patients with moderate to severe psoriasis is recommended. Patients who meet criteria for prediabetes or diabetes should be referred to their PCP for further assessment and management.^21,22

Mood Disorders

Psoriasis affects QOL and can have a major impact on patients’ interpersonal relationships. Studies have shown an association between psoriasis and mood disorders, specifically depression and anxiety. Unfortunately, patients with mood disorders are less likely to seek intervention for their skin disease, which poses a tremendous treatment barrier. Dermatologists should regularly monitor patients for psychiatric symptoms so that resources and treatments can be offered.

Certain psoriasis therapies have been shown to help alleviate associated depression and anxiety. Improvements in Beck Depression Inventory and Hamilton Depression Rating Scale scores were seen with etanercept.²³ Adalimumab and ustekinumab showed improvement in Dermatology Life Quality Index compared with placebo.^24,25 Patients receiving Goeckerman treatment also had improvement in anxiety and depression scores compared with conventional therapy.²⁶ Biologic medications had the largest impact on improving depression symptoms compared with conventional systemic therapy and phototherapy.²⁷ The recommendations support use of biologics and the Goeckerman regimen for the concomitant treatment of mood disorders and psoriasis.

Renal Disease

Studies have supported an association between psoriasis and chronic kidney disease (CKD), independent of risk factors including vascular disease, hypertension, and diabetes. The prevalence of moderate to advanced CKD also has been found to be directly related to increasing BSA affected by psoriasis.²⁸ Patients should receive testing of blood urea nitrogen, creatinine, and urine microalbumin levels to assess for occult renal disease. In addition, physicians should be cautious when prescribing nephrotoxic drugs (nonsteroidal anti-inflammatory drugs and cyclosporine) and renally excreted agents (methotrexate and apremilast) because of the risk for underlying renal disease in patients with psoriasis. If newly acquired renal disease is suspected, physicians should withhold the offending agents. Patients with psoriasis with CKD are recommended to follow up with their PCP or nephrologist for evaluation and management.

Pulmonary Disease

Psoriasis also has an independent association with COPD. Patients with psoriasis have a higher likelihood of developing COPD (hazard ratio, 2.35; 95% CI, 1.42-3.89; P<.01) than controls.²⁹ The prevalence of COPD also was found to correlate with psoriasis severity. Dermatologists should educate patients about the association between smoking and psoriasis as well as advise patients to discontinue smoking to reduce their risk for developing COPD and cancer.

Patients with psoriasis also are at an increased risk for obstructive sleep apnea. Obstructive sleep apnea should be considered in patients with risk factors including snoring, obesity, hypertension, or diabetes.

Inflammatory Bowel Disease

Patients with psoriasis have an increased risk for developing IBD. The prevalence ratios of both Crohn disease (2.49) and ulcerative colitis (1.64) are increased in patients with psoriasis relative to patients without psoriasis.³⁰ Physicians need to be aware of the association between psoriasis and IBD and the effect that their coexistence may have on treatment choice for patients.

Adalimumab and infliximab are approved for the treatment of IBD, and certolizumab and ustekinumab are approved for Crohn disease. Use of TNF inhibitors in patients with IBD may cause psoriasiform lesions to develop.³¹ Nonetheless, treatment should be individualized and psoriasiform lesions treated with standard psoriasis measures. Psoriasis patients with IBD are recommended to avoid IL-17–inhibitor therapy, given its potential to worsen IBD flares.

Malignancy

Psoriasis patients aged 0 to 79 years have a greater overall risk for malignancy compared with patients without psoriasis.³² Patients with psoriasis have an increased risk for respiratory tract cancer, upper aerodigestive tract cancer, urinary tract cancer, and non-Hodgkin lymphoma.³³ A mild association exists between PsA and lymphoma, nonmelanoma skin cancer (NMSC), and lung cancer.³⁴ More severe psoriasis is associated with greater risk for lymphoma and NMSC. Dermatologists are recommended to educate patients on their risk for certain malignancies and to refer patients to specialists upon suspicion of malignancy.

Risk for malignancy has been shown to be affected by psoriasis treatments. Patients treated with UVB have reduced overall cancer rates for all age groups (hazard ratio, 0.52; P=.3), while those treated with psoralen plus UVA have an increased incidence of squamous cell carcinoma.^32,33 Adalimumab was correlated with increased risk for NMSC in patients with psoriasis but did not have an increased risk for all cancers collectively when used for various immune-mediated inflammatory diseases.³⁵ In contrast, a meta-analysis of randomized clinical trials found no association with TNF inhibitor use and NMSC.³⁶ Ustekinumab had no association with malignancy.³⁷ Treatment history should be elucidated because of higher rates of squamous cell carcinoma in patients with prior psoralen plus UVA, cyclosporine, or methotrexate use.³³ To address malignancy risk, patients with psoriasis should undergo regular screenings for skin cancer and follow national guidelines for age-appropriate cancer screenings.

Lifestyle Choices and QOL

A crucial aspect of successful psoriasis management is patient education. The strongest recommendations support lifestyle changes, such as smoking cessation and limitation of alcohol use. A tactful discussion regarding substance use, work productivity, interpersonal relationships, and sexual function can address substantial effects of psoriasis on QOL so that support and resources can be provided.

Final Thoughts

Management of psoriasis is multifaceted and involves screening, education, monitoring, and collaboration with PCPs and specialists. Regular follow-up with a dermatologist and PCP is strongly recommended for patients with psoriasis given the systemic nature of the disease. The 2019 AAD-NPF recommendations provide important information for dermatologists to coordinate care for complicated psoriasis cases, but clinical judgment is paramount when making medical decisions. The consideration of comorbidities is critical for developing a comprehensive treatment approach, and this approach will lead to better health outcomes and improved QOL for patients with psoriasis.

Psoriasis is a chronic and relapsing systemic inflammatory disease that predisposes patients to a host of other conditions. It is believed that these widespread effects are due to chronic inflammation and cytokine activation, which affect multiple body processes and lead to the development of various comorbidities that need to be proactively managed.

In April 2019, the American Academy of Dermatology (AAD) and National Psoriasis Foundation (NPF) released recommendation guidelines for managing psoriasis in adults with an emphasis on common disease comorbidities, including psoriatic arthritis (PsA), cardiovascular disease (CVD), inflammatory bowel disease (IBD), metabolic syndrome, and mood disorders. Psychosocial wellness, mental health, and quality of life (QOL) measures in relation to psoriatic disease also were discussed.¹

The AAD-NPF guidelines address current screening, monitoring, education, and treatment recommendations for the management of psoriatic comorbidities. The Table and eTable summarize the screening recommendations. These guidelines aim to assist dermatologists with comprehensive disease management by addressing potential extracutaneous manifestations of psoriasis in adults.

Screening and Risk Assessment

Patients with psoriasis should receive a thorough history and physical examination to assess disease severity and risk for potential comorbidities. Patients with greater disease severity—as measured by body surface area (BSA) involvement and type of therapy required—have a greater risk for other disease-related comorbidities, specifically metabolic syndrome, renal disease, chronic obstructive pulmonary disease (COPD), obstructive sleep apnea, uveitis, IBD, malignancy, and increased mortality.² Because the likelihood of comorbidities is greatest with severe disease, more frequent monitoring is recommended for these patients.

Psoriatic Arthritis

Patients with psoriasis need to be evaluated for PsA at every visit. Patients presenting with signs and symptoms suspicious for PsA—joint swelling, peripheral joint involvement, and joint inflammation—warrant further evaluation and consultation. Early detection and treatment of PsA is essential for preventing unnecessary suffering and progressive joint destruction.³

There are several PsA screening questionnaires currently available, including the Psoriatic Arthritis Screening Evaluation, Psoriasis Epidemiology Screening Tool, and Toronto Psoriatic Arthritis Screen. No significant differences in sensitivity and specificity were found among these questionnaires when using the Classification Criteria for Psoriatic Arthritis as the gold standard. All 3 questionnaires—the Psoriatic Arthritis Screening Evaluation and the Psoriasis Epidemiology Screening Tool were developed for use in dermatology and rheumatology clinics, and the Toronto Psoriatic Arthritis Screen was developed for use in the primary care setting—were found to be effective in dermatology/rheumatology clinics and primary care clinics, respectively.³ False-positive results predominantly were seen in patients with degenerative joint disease or osteoarthritis. Dermatologists should conduct a thorough physical examination to distinguish PsA from degenerative joint disease. Imaging and laboratory tests to evaluate for signs of systemic inflammation (erythrocyte sedimentation rate, C-reactive protein) also can be helpful in distinguishing the 2 conditions; however, these metrics have not been shown to contribute to PsA diagnosis.¹ Full rheumatologic consultation is warranted in challenging cases.

Cardiovascular Disease

The American Heart Association and the American College of Cardiology have identified chronic inflammatory states, such as psoriasis, as inducing factors that predispose patients to CVD. Many studies have found an association among psoriasis, coronary artery disease, myocardial infarction (MI), and stroke.^4-7 It is strongly recommended that dermatologists educate patients of their increased risk for CVD, given the association between psoriasis and major adverse cardiovascular events (eg, stroke, heart failure, MI) and cardiovascular health. However, patients with congestive heart failure were found to have an increased risk of mortality associated with use of tumor necrosis factor (TNF) α inhibitors (P=.016).⁸ Thus, TNF inhibitors are contraindicated in patients with New York Heart Association Class III or Class IV congestive heart failure.⁹

Primary care physicians (PCPs) are recommended to screen patients for CVD risk factors using height, weight, blood pressure, blood glucose, hemoglobin A_1C, lipid levels, abdominal circumference, and body mass index (BMI). Lifestyle modifications such as smoking cessation, exercise, and dietary changes are encouraged to achieve and maintain a normal BMI.

Dermatologists also need to give special consideration to comorbidities when selecting medications and/or therapies for disease management. Patients on TNF inhibitors have a lower risk for MI compared with patients using topical medications, phototherapy, and other oral agents.¹⁰ Additionally, patients on TNF inhibitors have a lower risk for occurrence of major adverse cardiovascular events compared with patients treated with methotrexate or phototherapy.^11,12

Metabolic Syndrome

Numerous studies have demonstrated an association between psoriasis and metabolic syndrome. Patients with increased BSA involvement and psoriasis area and severity index scores have a higher prevalence of metabolic syndrome.¹³ Patients with psoriasis have an increased risk for the following conditions compared to controls: obesity (38% vs 31%; odds ratio [OR], 1.38; 95% CI, 1.29-1.48), elevated triglycerides (36% vs 28%; OR, 1.49; 95% CI, 1.39-1.60), hypertension (31% vs 28%; OR, 1.20; 95% CI, 1.11-12.9), and elevated glucose levels (22% vs 16%; OR, 1.44; 95% CI, 1.33-1.56).¹⁴ Dermatologists are strongly recommended to inform patients about the risk for metabolic syndrome and to encourage the measurement of blood pressure, waist circumference, fasting blood glucose, hemoglobin A_1C, and fasting lipid levels with their PCP when indicated. Body mass index and waist circumference also should be measured annually in patients with moderate to severe psoriasis because of the association with disease severity.

The association between psoriasis and weight loss has been analyzed in several studies. Weight loss, particularly in obese patients, has been shown to improve psoriasis severity, as measured by psoriasis area and severity index score and QOL measures.¹⁵ Another study found that gastric bypass was associated with a significant risk reduction in the development of psoriasis (P=.004) and the disease prognosis (P=.02 for severe psoriasis; P=.01 for PsA).¹⁶ Therefore, patients with moderate to severe psoriasis are recommended to have their obesity status determined according to national guidelines. For patients with a BMI above 40 kg/m² and standard weight-loss measures fail, bariatric surgery is recommended. Additionally, the impact of psoriasis medications on weight has been studied. Apremilast has been associated with weight loss, whereas etanercept and infliximab have been linked to weight gain.^17,18

An association between psoriasis and hypertension also has been demonstrated by studies, especially among patients with severe disease. Therefore, patients with moderate to severe psoriasis are recommended to have their blood pressure evaluated according to national guidelines, and those with a blood pressure of 140/90 mm Hg or higher should be referred to their PCP for assessment and treatment. Current evidence does not support restrictions on antihypertensive medications in patients with psoriasis. Physicians should be aware of the potential for cyclosporine to induce hypertension, which should be treated, specifically with amlodipine.¹⁹

Many studies have demonstrated an association between psoriasis and dyslipidemia, though the results are somewhat conflicting. In 2018, the American Heart Association and the American College of Cardiology deemed psoriasis as an atherosclerotic CVD risk-enhancing condition, favoring early initiation of statin therapy. Because dyslipidemia plays a prominent role in atherosclerosis and CVD, patients with moderate to severe psoriasis are recommended to undergo periodic screening with lipid tests (eg, fasting total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides).²⁰ Patients with elevated fasting triglycerides or low-density lipoprotein cholesterol should be referred to their PCP for further management. Certain psoriasis medications also have been linked to dyslipidemia. Acitretin and cyclosporine are known to adversely affect lipid levels, so patients treated with either agent should undergo routine monitoring of serum lipid levels.

Psoriasis is strongly associated with diabetes mellitus. Because of the increased risk for diabetes in patients with severe disease, regular monitoring of fasting blood glucose and/or hemoglobin A_1C levels in patients with moderate to severe psoriasis is recommended. Patients who meet criteria for prediabetes or diabetes should be referred to their PCP for further assessment and management.^21,22

Mood Disorders

Psoriasis affects QOL and can have a major impact on patients’ interpersonal relationships. Studies have shown an association between psoriasis and mood disorders, specifically depression and anxiety. Unfortunately, patients with mood disorders are less likely to seek intervention for their skin disease, which poses a tremendous treatment barrier. Dermatologists should regularly monitor patients for psychiatric symptoms so that resources and treatments can be offered.

Certain psoriasis therapies have been shown to help alleviate associated depression and anxiety. Improvements in Beck Depression Inventory and Hamilton Depression Rating Scale scores were seen with etanercept.²³ Adalimumab and ustekinumab showed improvement in Dermatology Life Quality Index compared with placebo.^24,25 Patients receiving Goeckerman treatment also had improvement in anxiety and depression scores compared with conventional therapy.²⁶ Biologic medications had the largest impact on improving depression symptoms compared with conventional systemic therapy and phototherapy.²⁷ The recommendations support use of biologics and the Goeckerman regimen for the concomitant treatment of mood disorders and psoriasis.

Renal Disease

Studies have supported an association between psoriasis and chronic kidney disease (CKD), independent of risk factors including vascular disease, hypertension, and diabetes. The prevalence of moderate to advanced CKD also has been found to be directly related to increasing BSA affected by psoriasis.²⁸ Patients should receive testing of blood urea nitrogen, creatinine, and urine microalbumin levels to assess for occult renal disease. In addition, physicians should be cautious when prescribing nephrotoxic drugs (nonsteroidal anti-inflammatory drugs and cyclosporine) and renally excreted agents (methotrexate and apremilast) because of the risk for underlying renal disease in patients with psoriasis. If newly acquired renal disease is suspected, physicians should withhold the offending agents. Patients with psoriasis with CKD are recommended to follow up with their PCP or nephrologist for evaluation and management.

Pulmonary Disease

Psoriasis also has an independent association with COPD. Patients with psoriasis have a higher likelihood of developing COPD (hazard ratio, 2.35; 95% CI, 1.42-3.89; P<.01) than controls.²⁹ The prevalence of COPD also was found to correlate with psoriasis severity. Dermatologists should educate patients about the association between smoking and psoriasis as well as advise patients to discontinue smoking to reduce their risk for developing COPD and cancer.

Patients with psoriasis also are at an increased risk for obstructive sleep apnea. Obstructive sleep apnea should be considered in patients with risk factors including snoring, obesity, hypertension, or diabetes.

Inflammatory Bowel Disease

Patients with psoriasis have an increased risk for developing IBD. The prevalence ratios of both Crohn disease (2.49) and ulcerative colitis (1.64) are increased in patients with psoriasis relative to patients without psoriasis.³⁰ Physicians need to be aware of the association between psoriasis and IBD and the effect that their coexistence may have on treatment choice for patients.

Adalimumab and infliximab are approved for the treatment of IBD, and certolizumab and ustekinumab are approved for Crohn disease. Use of TNF inhibitors in patients with IBD may cause psoriasiform lesions to develop.³¹ Nonetheless, treatment should be individualized and psoriasiform lesions treated with standard psoriasis measures. Psoriasis patients with IBD are recommended to avoid IL-17–inhibitor therapy, given its potential to worsen IBD flares.

Malignancy

Psoriasis patients aged 0 to 79 years have a greater overall risk for malignancy compared with patients without psoriasis.³² Patients with psoriasis have an increased risk for respiratory tract cancer, upper aerodigestive tract cancer, urinary tract cancer, and non-Hodgkin lymphoma.³³ A mild association exists between PsA and lymphoma, nonmelanoma skin cancer (NMSC), and lung cancer.³⁴ More severe psoriasis is associated with greater risk for lymphoma and NMSC. Dermatologists are recommended to educate patients on their risk for certain malignancies and to refer patients to specialists upon suspicion of malignancy.

Risk for malignancy has been shown to be affected by psoriasis treatments. Patients treated with UVB have reduced overall cancer rates for all age groups (hazard ratio, 0.52; P=.3), while those treated with psoralen plus UVA have an increased incidence of squamous cell carcinoma.^32,33 Adalimumab was correlated with increased risk for NMSC in patients with psoriasis but did not have an increased risk for all cancers collectively when used for various immune-mediated inflammatory diseases.³⁵ In contrast, a meta-analysis of randomized clinical trials found no association with TNF inhibitor use and NMSC.³⁶ Ustekinumab had no association with malignancy.³⁷ Treatment history should be elucidated because of higher rates of squamous cell carcinoma in patients with prior psoralen plus UVA, cyclosporine, or methotrexate use.³³ To address malignancy risk, patients with psoriasis should undergo regular screenings for skin cancer and follow national guidelines for age-appropriate cancer screenings.

Lifestyle Choices and QOL

A crucial aspect of successful psoriasis management is patient education. The strongest recommendations support lifestyle changes, such as smoking cessation and limitation of alcohol use. A tactful discussion regarding substance use, work productivity, interpersonal relationships, and sexual function can address substantial effects of psoriasis on QOL so that support and resources can be provided.

Final Thoughts

Management of psoriasis is multifaceted and involves screening, education, monitoring, and collaboration with PCPs and specialists. Regular follow-up with a dermatologist and PCP is strongly recommended for patients with psoriasis given the systemic nature of the disease. The 2019 AAD-NPF recommendations provide important information for dermatologists to coordinate care for complicated psoriasis cases, but clinical judgment is paramount when making medical decisions. The consideration of comorbidities is critical for developing a comprehensive treatment approach, and this approach will lead to better health outcomes and improved QOL for patients with psoriasis.

With the rise of telehealth utilization during the COVID-19 pandemic, clinical care delivery has undergone a substantial shift. This is especially true in dermatology, as utilization of telehealth has jumped from under 15% to more than 95% of dermatologists after the COVID-19 pandemic.¹ However, with this new form of care delivery, it is important to ensure that patients don’t get left behind, either due to socioeconomic/language barriers² or hesitancy about the conditions being treated.

It may not be surprising to know that the idea of using telemedicine for rheumatology is not new. Indeed, a report from 20 years ago outlined the high level of both satisfaction with live interactive telehealth visits for rheumatologic conditions and diagnostic accuracy as compared to in-person visits.³ Through guided palpation and careful history taking, it is possible to conduct a thorough visit and even manage biologics, diagnose active arthritis/enthesitis via photographs, and evaluate pain through a visual analog scale.⁴ As far as dermatology is concerned, it is clear that certain situations seem to be better suited for teledermatology, such as follow-up visits for acne/rosacea.¹ But what of psoriatic arthritis (PsA)? Does telehealth have the potential to mitigate our undertreatment of this important condition, which finds about half of patients being treated with only topical therapy or no treatment at all?⁵ Or can we modulate our visits to accommodate these patients, taking care of not only their visible psoriasis but also the underlying PsA?

Psoriasis is well suited for teledermatology management in general, especially once the diagnosis is made. Multiple studies have shown diagnostic equivalence with in-person care and even similar outcomes after treatment.^6,7 However, most studies have looked at telemedicine primarily for cutaneous psoriasis, and translating this to screening for and management of PsA is paramount. After all, a delay of only 6 months in diagnosing and treating PsA has been associated with poor outcomes.⁸ Thankfully, we do have some tools that can help. There are 3 validated screening tools for PsA: the Psoriasis Epidemiology Screening Tool (PEST), the Psoriatic Arthritis Screening and Evaluation (PASE), and the Toronto Psoriatic Arthritis Screen (ToPAS) questionnaire.⁹ Of these, the PEST seems to be a reasonable option that is quick and easily deployed; it has shown strong performance in terms of sensitivity, specificity, and negative predictive value/positive predictive value when compared to similar screening tools.¹⁰ It also should be facile to direct patients to complete the screening tool, as an online version is available on the National Psoriasis Foundation’s website (https://www.psoriasis.org/psoriatic-arthritis-screening-test/) where patients can be directed to answer 5 simple questions and report back the outcome. For treatment decisions, this tool also can be used to help identify patients who are good candidates for systemic or biologic therapy or those who should see a rheumatologist. Of course, an in-depth discussion of joint pain, morning stiffness, and tender/swollen joints may be more fruitful but also more challenging to conduct. I would propose that this can be pared down to a more direct conversation about finger pain/tenderness, tenderness at the elbow/knee (lateral epicondyle/medial femoral condyle), or heel (Achilles) as more common sites of enthesitis, and questioning about back pain or stiffness that improves with movement.⁹ By combining the screening tool with these pointed questions, even via telehealth, we can greatly improve our yield in diagnosing PsA while only adding a minute or two to our visits. I’d argue that this is much more fruitful than asking the patient to contort their bodies and camera to show an obscure lesion!

It is interesting to consider areas in dermatology where we might make a notable impact on mortality and morbidity by expanding access to care. Earlier diagnosis of melanoma, for instance, certainly would be in consideration, especially in areas of the country where access to dermatologic care is challenging. Better management of PsA has to be up there on the list of conditions where we immediately can make a tangible difference; we have the tools to do so and excellent therapeutics that are safe and effective. Our colleagues in rheumatology have embraced telemedicine with a “how, not if” approach to embracing new technology,¹¹ and it is about time that dermatology takes a similar attitude. The gap between access to dermatologic care in urban areas vs either nonmetropolitan or rural areas is increasing, and dermatology tends to be much more available in well-resourced, urban areas.¹² There are patients who need our expertise, and if it takes the compromise of adopting a technology that sometimes gives us headaches (we’ve all been on video visits with a choppy signal and inadequate lighting), we still should try to figure out the best way to do it because it’s the right thing to do for these patients. If we don’t, the determination of how to conduct teledermatology care will be taken away from us and either insurance companies or corporations not guided by dermatologists may try to enter this health care void and decide how to provide these services.

With the rise of telehealth utilization during the COVID-19 pandemic, clinical care delivery has undergone a substantial shift. This is especially true in dermatology, as utilization of telehealth has jumped from under 15% to more than 95% of dermatologists after the COVID-19 pandemic.¹ However, with this new form of care delivery, it is important to ensure that patients don’t get left behind, either due to socioeconomic/language barriers² or hesitancy about the conditions being treated.

It may not be surprising to know that the idea of using telemedicine for rheumatology is not new. Indeed, a report from 20 years ago outlined the high level of both satisfaction with live interactive telehealth visits for rheumatologic conditions and diagnostic accuracy as compared to in-person visits.³ Through guided palpation and careful history taking, it is possible to conduct a thorough visit and even manage biologics, diagnose active arthritis/enthesitis via photographs, and evaluate pain through a visual analog scale.⁴ As far as dermatology is concerned, it is clear that certain situations seem to be better suited for teledermatology, such as follow-up visits for acne/rosacea.¹ But what of psoriatic arthritis (PsA)? Does telehealth have the potential to mitigate our undertreatment of this important condition, which finds about half of patients being treated with only topical therapy or no treatment at all?⁵ Or can we modulate our visits to accommodate these patients, taking care of not only their visible psoriasis but also the underlying PsA?

Psoriasis is well suited for teledermatology management in general, especially once the diagnosis is made. Multiple studies have shown diagnostic equivalence with in-person care and even similar outcomes after treatment.^6,7 However, most studies have looked at telemedicine primarily for cutaneous psoriasis, and translating this to screening for and management of PsA is paramount. After all, a delay of only 6 months in diagnosing and treating PsA has been associated with poor outcomes.⁸ Thankfully, we do have some tools that can help. There are 3 validated screening tools for PsA: the Psoriasis Epidemiology Screening Tool (PEST), the Psoriatic Arthritis Screening and Evaluation (PASE), and the Toronto Psoriatic Arthritis Screen (ToPAS) questionnaire.⁹ Of these, the PEST seems to be a reasonable option that is quick and easily deployed; it has shown strong performance in terms of sensitivity, specificity, and negative predictive value/positive predictive value when compared to similar screening tools.¹⁰ It also should be facile to direct patients to complete the screening tool, as an online version is available on the National Psoriasis Foundation’s website (https://www.psoriasis.org/psoriatic-arthritis-screening-test/) where patients can be directed to answer 5 simple questions and report back the outcome. For treatment decisions, this tool also can be used to help identify patients who are good candidates for systemic or biologic therapy or those who should see a rheumatologist. Of course, an in-depth discussion of joint pain, morning stiffness, and tender/swollen joints may be more fruitful but also more challenging to conduct. I would propose that this can be pared down to a more direct conversation about finger pain/tenderness, tenderness at the elbow/knee (lateral epicondyle/medial femoral condyle), or heel (Achilles) as more common sites of enthesitis, and questioning about back pain or stiffness that improves with movement.⁹ By combining the screening tool with these pointed questions, even via telehealth, we can greatly improve our yield in diagnosing PsA while only adding a minute or two to our visits. I’d argue that this is much more fruitful than asking the patient to contort their bodies and camera to show an obscure lesion!

It is interesting to consider areas in dermatology where we might make a notable impact on mortality and morbidity by expanding access to care. Earlier diagnosis of melanoma, for instance, certainly would be in consideration, especially in areas of the country where access to dermatologic care is challenging. Better management of PsA has to be up there on the list of conditions where we immediately can make a tangible difference; we have the tools to do so and excellent therapeutics that are safe and effective. Our colleagues in rheumatology have embraced telemedicine with a “how, not if” approach to embracing new technology,¹¹ and it is about time that dermatology takes a similar attitude. The gap between access to dermatologic care in urban areas vs either nonmetropolitan or rural areas is increasing, and dermatology tends to be much more available in well-resourced, urban areas.¹² There are patients who need our expertise, and if it takes the compromise of adopting a technology that sometimes gives us headaches (we’ve all been on video visits with a choppy signal and inadequate lighting), we still should try to figure out the best way to do it because it’s the right thing to do for these patients. If we don’t, the determination of how to conduct teledermatology care will be taken away from us and either insurance companies or corporations not guided by dermatologists may try to enter this health care void and decide how to provide these services.

With the rise of telehealth utilization during the COVID-19 pandemic, clinical care delivery has undergone a substantial shift. This is especially true in dermatology, as utilization of telehealth has jumped from under 15% to more than 95% of dermatologists after the COVID-19 pandemic.¹ However, with this new form of care delivery, it is important to ensure that patients don’t get left behind, either due to socioeconomic/language barriers² or hesitancy about the conditions being treated.

It may not be surprising to know that the idea of using telemedicine for rheumatology is not new. Indeed, a report from 20 years ago outlined the high level of both satisfaction with live interactive telehealth visits for rheumatologic conditions and diagnostic accuracy as compared to in-person visits.³ Through guided palpation and careful history taking, it is possible to conduct a thorough visit and even manage biologics, diagnose active arthritis/enthesitis via photographs, and evaluate pain through a visual analog scale.⁴ As far as dermatology is concerned, it is clear that certain situations seem to be better suited for teledermatology, such as follow-up visits for acne/rosacea.¹ But what of psoriatic arthritis (PsA)? Does telehealth have the potential to mitigate our undertreatment of this important condition, which finds about half of patients being treated with only topical therapy or no treatment at all?⁵ Or can we modulate our visits to accommodate these patients, taking care of not only their visible psoriasis but also the underlying PsA?

Psoriasis is well suited for teledermatology management in general, especially once the diagnosis is made. Multiple studies have shown diagnostic equivalence with in-person care and even similar outcomes after treatment.^6,7 However, most studies have looked at telemedicine primarily for cutaneous psoriasis, and translating this to screening for and management of PsA is paramount. After all, a delay of only 6 months in diagnosing and treating PsA has been associated with poor outcomes.⁸ Thankfully, we do have some tools that can help. There are 3 validated screening tools for PsA: the Psoriasis Epidemiology Screening Tool (PEST), the Psoriatic Arthritis Screening and Evaluation (PASE), and the Toronto Psoriatic Arthritis Screen (ToPAS) questionnaire.⁹ Of these, the PEST seems to be a reasonable option that is quick and easily deployed; it has shown strong performance in terms of sensitivity, specificity, and negative predictive value/positive predictive value when compared to similar screening tools.¹⁰ It also should be facile to direct patients to complete the screening tool, as an online version is available on the National Psoriasis Foundation’s website (https://www.psoriasis.org/psoriatic-arthritis-screening-test/) where patients can be directed to answer 5 simple questions and report back the outcome. For treatment decisions, this tool also can be used to help identify patients who are good candidates for systemic or biologic therapy or those who should see a rheumatologist. Of course, an in-depth discussion of joint pain, morning stiffness, and tender/swollen joints may be more fruitful but also more challenging to conduct. I would propose that this can be pared down to a more direct conversation about finger pain/tenderness, tenderness at the elbow/knee (lateral epicondyle/medial femoral condyle), or heel (Achilles) as more common sites of enthesitis, and questioning about back pain or stiffness that improves with movement.⁹ By combining the screening tool with these pointed questions, even via telehealth, we can greatly improve our yield in diagnosing PsA while only adding a minute or two to our visits. I’d argue that this is much more fruitful than asking the patient to contort their bodies and camera to show an obscure lesion!

It is interesting to consider areas in dermatology where we might make a notable impact on mortality and morbidity by expanding access to care. Earlier diagnosis of melanoma, for instance, certainly would be in consideration, especially in areas of the country where access to dermatologic care is challenging. Better management of PsA has to be up there on the list of conditions where we immediately can make a tangible difference; we have the tools to do so and excellent therapeutics that are safe and effective. Our colleagues in rheumatology have embraced telemedicine with a “how, not if” approach to embracing new technology,¹¹ and it is about time that dermatology takes a similar attitude. The gap between access to dermatologic care in urban areas vs either nonmetropolitan or rural areas is increasing, and dermatology tends to be much more available in well-resourced, urban areas.¹² There are patients who need our expertise, and if it takes the compromise of adopting a technology that sometimes gives us headaches (we’ve all been on video visits with a choppy signal and inadequate lighting), we still should try to figure out the best way to do it because it’s the right thing to do for these patients. If we don’t, the determination of how to conduct teledermatology care will be taken away from us and either insurance companies or corporations not guided by dermatologists may try to enter this health care void and decide how to provide these services.

Biologics have transformed the management of moderate to severe psoriasis. There currently are 11 biologics approved by the US Food and Drug Administration (Table) for psoriasis treatment that have been affirmed by various clinical studies. This article provides dosing initiation, maintenance information, and updated clinical data using phase 3 studies (N=8) published between May 2020 and February 2021. Generic names of the 11 biologics were searched separately in the PubMed database within the specified date range. Subsequent results were reviewed by title and selected for phase 3 and 4 trials. Clinical data in this review focus on reducing patient disease burden by allocating a biologic best fit for each patient’s individual health profile.

IL-17A Inhibitors Update

Secukinumab is safe and efficacious for skin clearance in the presence of comorbidities and can be used for improving plaque psoriasis and palmoplantar pustular psoriasis. An extension of a phase 3 randomized controlled trial (RCT)—2PRECISE—evaluated the efficacy and safety of secukinumab dosing at 300 mg (n=79) and 150 mg (n=80) in adults with moderate to severe palmoplantar pustular psoriasis (palmoplantar psoriasis area and severity index [PPPASI] score ≥12 and dermatology life quality index [DLQI] ≥10) over 148 weeks.¹ Extension patients were included from the 52-week 2PRECISE study per the investigator’s judgement of a meaningful clinical response (exact criteria not described). All treatment groups demonstrated a mean (SD) PPPASI of 22.7 (9.5) by the extension trial’s start. Results affirmed that clinical response waned after week 148 in all groups excluding placebo/secukinumab 150 mg, which maintained a mean (SD) PPPASI of 22.7 (9.5). The most frequent adverse events were nasopharyngitis, pustular psoriasis, headache, and pruritus.¹

Comorbidities do not have a major impact on secukinumab’s efficacy. A post hoc analysis of 4 phase 3 RCTs—ERASURE, FIXTURE, FEATURE, and JUNCTURE—gathered data from adult patients (N=2401) to assess baseline comorbidities with efficacy and safety of secukinumab vs etanercept after 12 weeks of treatment.² Sixty-one percent (n=1469) had at least 1 comorbidity, most frequently obesity, hypertension, psoriatic arthritis, hyperlipidemia, or diabetes mellitus. All patient groups had a greater likelihood of a psoriasis area and severity index (PASI) response with any dose of secukinumab vs patients with comorbidities who were taking etanercept or placebo (P<.05) at week 12. All groups had a greater likelihood of achieving investigator global assessment scores of 0/1 (clear/almost clear) vs patients with comorbidities taking etanercept or placebo (P<.05). Baseline comorbidities did not significantly affect treatment response, except obesity, which was associated with decreased probability of achieving all PASI and investigator global assessment (P<.01) responses. Secukinumab-treated patients with and without comorbidities had equivalent likelihood of treatment-emergent adverse events (TEAEs).²

Brodalumab is an effective biologic that has shown long-term safety with continuous administration. Continuous brodalumab and brodalumab after placebo demonstrated impactful skin clearance after 120 weeks in AMAGINE-1, a phase 3 RCT involving adults (N=442) with moderate to severe plaque psoriasis.³ Patients randomized to brodalumab 210 mg (n=222) or placebo (n=220) were rerandomized according to initial treatment response. In patients switching from brodalumab to placebo at week 12, 55% and 94% achieved PASI 75 at week 20 and week 120, respectively, and 75% reached PASI 100 at week 120. Of patients with static physician global assessment (sPGA) scores of 0/1 (clear/almost clear) at week 12 who were rerandomized to brodalumab, 96% and 80% (using observed data) achieved PASI 75 and PASI 100, respectively. Mean (SD) time to return of skin disease following withdrawal of brodalumab was 74.7 (50.5) days. Treatment-emergent adverse events included headaches, arthralgia, diarrhea, and nausea. Suicidal ideation was rare (this study had 1 completed suicide), and authors cited that no causal association has been made between brodalumab and suicidality. Brodalumab also demonstrated favorable treatment response in patients who underwent a lapse in treatment, offering real-world value, as intermittent treatment administration can occur because of personal or financial reasons.³

Ixekizumab is associated with more rapid skin clearance, better resolution of nail psoriasis, and superior improvement in quality-of-life measures when compared with guselkumab. The phase 3 study IXORA-R compared skin and nail clearance as well as patient-reported outcomes over 24 weeks with ixekizumab 80 mg (n=520) vs guselkumab 100 mg (n=507) in adults with moderate to severe plaque psoriasis.⁴ Ixekizumab (50%) was shown to be no worse than guselkumab (52%; difference, –2.3%) using a noninferiority test (noninferiority margin of –11.4%). The treatments exhibited similar efficacy, with no significant difference in proportion of patients reaching PASI 100 (P=.41). Ixekizumab patients tended to have skin clearance sooner than guselkumab patients, reaching PASI 50/75/90 and PASI 100 in a median time that was 2 weeks and 7.5 weeks earlier, respectively. More ixekizumab patients (52%) achieved clear nails vs guselkumab patients (31%; P=.007). Ixekizumab patients reported greater satisfaction with their skin disease affecting quality of life (DLQI), with more DLQI 0/1 (no effect at all on patient’s life) scores and being itch free (P<.05). Ixekizumab was associated with significantly more days of complete skin clearance (PASI 100) vs guselkumab (55.6 days vs 42.2 days; P<.001). Although an upper respiratory tract infection was the most common TEAE, the proportion of TEAEs was similar between treatments.⁴

IL-23 Inhibitors Update

Tildrakizumab has similar long-term skin clearance efficacy and safety in patients with psoriasis with and without comorbid metabolic syndrome (MetS). A post hoc analysis of 2 phase 2 RCTs (reSURFACE 1/2) involving adults (N=338 and N=307) with moderate to severe plaque psoriasis assessed long-term efficacy (3 years), drug survival, and safety for 5 years of continuous tildrakizumab 100 mg and 200 mg in adults with comorbid MetS.⁵ Although no difference in efficacy was concluded, greater body mass index of the MetS population was shown to be associated with lower biologic efficacy compared to the general population. The proportion of patients who achieved PASI 75 at week 52 was comparable in patients with MetS and patients without MetS (tildrakizumab 100 mg, 85% and 86% vs 86% and 94% for reSURFACE 1/2, respectively; tildrakizumab 200 mg, 76% and 87% vs 76% and 87% for reSURFACE 1/2, respectively).⁵

Tildrakizumab also demonstrated efficacy and safety for up to 5 years in 2 other phase 3 RCTs with no dose-related differences in frequency of injections and malignancies. Tildrakizumab 100 mg is the recommended dose. The 200-mg dose can be utilized in patients with a high burden of disease and disability. reSURFACE 1 and reSURFACE 2 involved adults with chronic moderate to severe plaque psoriasis randomized to tildrakizumab 100 mg, 200 mg, or placebo with the option of long-term extension to week 244 if patients reached 50% or greater improvement from baseline PASI score.⁶ Patients in reSURFACE 2 also were randomized to etanercept 50 mg with partial responders and nonresponders at week 28 switching to tildrakizumab 200 mg until week 244. Extension results showed PASI 75 achievement in 88.7% (95% CI, 84.6%-92.1%) of patients taking tildrakizumab 100 mg (n=235), 92.5% (95% CI, 88.1%-95.7%) of patients taking tildrakizumab 200 mg (n=176), and 81.3% (95% CI, 72.6%-88.2%) of patients taking etanercept/partial nonresponders (n=85). The most common TEAE was nasopharyngitis (10.5/100 patient-years for tildrakizumab 100 mg and 10.7/100 patient-years for tildrakizumab 200 mg). The frequency of severe infections (eg, diverticulitis, pneumonia, cellulitis, appendicitis) was 1.2 per 100 patient-years for tildrakizumab 100 mg and 1.3 per 100 patient-years for tildrakizumab 200 mg.⁶

Risankizumab and tildrakizumab require the lowest number of injections, thereby providing sustainable skin clearance with a convenient injection dosing schedule for patients. Risankizumab efficacy (8.2% with inferiority margin of 12%) was noninferior to secukinumab when assessing the proportion of PASI 90 responders at week 16 (after 2 doses of risankizumab vs 7 doses of secukinumab).⁷ IMMerge, an international phase 3 RCT, involved adults (N=327) with moderate to severe plaque psoriasis to compare the safety and efficacy of risankizumab 150 mg (n=164) vs secukinumab 300 mg (n=163) up to 52 weeks. A greater proportion of the risankizumab arm (86.6%) achieved PASI 90 in 52 weeks compared to the secukinumab arm (57.1%). Superior skin clearance (PASI 90) at week 52 was achieved after 5 doses with risankizumab vs 16 doses of secukinumab. Risankizumab TEAEs were nasopharyngitis, upper respiratory tract infection, headache, arthralgia, diarrhea, and bronchitis.⁷

Continuous risankizumab treatment shows substantially stronger skin clearing performance compared with intermittent treatment following drug withdrawal, demonstrating that treatment gaps minimize therapeutic response. IMMhance, an international phase 3 RCT involving adults (N=507) with moderate to severe plaque psoriasis, evaluated the safety and efficacy with risankizumab 150 mg after 52 weeks and 104 weeks.⁸ Part A randomized patients to risankizumab 150 mg (n=407) or placebo (n=100). Part B rerandomized patients at week 28 to continue risankizumab 150 mg or placebo (designated as withdrawal of treatment; later re-treated with risankizumab 150 mg if patients had sPGA ≥3). At week 52, significantly more patients reached sPGA score of 0/1 with risankizumab/risankizumab (n=97 [87.4%]) vs risankizumab/placebo (n=138 [61.3%]; P<.001). At week 104, significantly more patients reached an sPGA score of 0/1 with risankizumab/risankizumab (n=90 [81.1%]) vs risankizumab/placebo (n=16 [7.1%]; P<.001). Risankizumab exhibited longevity following withdrawal, as median time to loss of response and relapse was 42 weeks (sPGA ≥3). The extent of TEAEs was similar between risankizumab and placebo and included nasopharyngitis, upper respiratory tract infection, headache, and back pain.⁸

Final Thoughts

Biologics for psoriasis help produce intended results for skin disease clearance and are tools for precision medicine. Recent data demonstrate safe, durable, and continuous efficacy with biologics, which offer patients a better chance of treatment success. This guide may serve as a quick reference for biologic selection with special consideration of individual disease characteristics and comorbidities.

Biologics have transformed the management of moderate to severe psoriasis. There currently are 11 biologics approved by the US Food and Drug Administration (Table) for psoriasis treatment that have been affirmed by various clinical studies. This article provides dosing initiation, maintenance information, and updated clinical data using phase 3 studies (N=8) published between May 2020 and February 2021. Generic names of the 11 biologics were searched separately in the PubMed database within the specified date range. Subsequent results were reviewed by title and selected for phase 3 and 4 trials. Clinical data in this review focus on reducing patient disease burden by allocating a biologic best fit for each patient’s individual health profile.

IL-17A Inhibitors Update

Secukinumab is safe and efficacious for skin clearance in the presence of comorbidities and can be used for improving plaque psoriasis and palmoplantar pustular psoriasis. An extension of a phase 3 randomized controlled trial (RCT)—2PRECISE—evaluated the efficacy and safety of secukinumab dosing at 300 mg (n=79) and 150 mg (n=80) in adults with moderate to severe palmoplantar pustular psoriasis (palmoplantar psoriasis area and severity index [PPPASI] score ≥12 and dermatology life quality index [DLQI] ≥10) over 148 weeks.¹ Extension patients were included from the 52-week 2PRECISE study per the investigator’s judgement of a meaningful clinical response (exact criteria not described). All treatment groups demonstrated a mean (SD) PPPASI of 22.7 (9.5) by the extension trial’s start. Results affirmed that clinical response waned after week 148 in all groups excluding placebo/secukinumab 150 mg, which maintained a mean (SD) PPPASI of 22.7 (9.5). The most frequent adverse events were nasopharyngitis, pustular psoriasis, headache, and pruritus.¹

Comorbidities do not have a major impact on secukinumab’s efficacy. A post hoc analysis of 4 phase 3 RCTs—ERASURE, FIXTURE, FEATURE, and JUNCTURE—gathered data from adult patients (N=2401) to assess baseline comorbidities with efficacy and safety of secukinumab vs etanercept after 12 weeks of treatment.² Sixty-one percent (n=1469) had at least 1 comorbidity, most frequently obesity, hypertension, psoriatic arthritis, hyperlipidemia, or diabetes mellitus. All patient groups had a greater likelihood of a psoriasis area and severity index (PASI) response with any dose of secukinumab vs patients with comorbidities who were taking etanercept or placebo (P<.05) at week 12. All groups had a greater likelihood of achieving investigator global assessment scores of 0/1 (clear/almost clear) vs patients with comorbidities taking etanercept or placebo (P<.05). Baseline comorbidities did not significantly affect treatment response, except obesity, which was associated with decreased probability of achieving all PASI and investigator global assessment (P<.01) responses. Secukinumab-treated patients with and without comorbidities had equivalent likelihood of treatment-emergent adverse events (TEAEs).²

Brodalumab is an effective biologic that has shown long-term safety with continuous administration. Continuous brodalumab and brodalumab after placebo demonstrated impactful skin clearance after 120 weeks in AMAGINE-1, a phase 3 RCT involving adults (N=442) with moderate to severe plaque psoriasis.³ Patients randomized to brodalumab 210 mg (n=222) or placebo (n=220) were rerandomized according to initial treatment response. In patients switching from brodalumab to placebo at week 12, 55% and 94% achieved PASI 75 at week 20 and week 120, respectively, and 75% reached PASI 100 at week 120. Of patients with static physician global assessment (sPGA) scores of 0/1 (clear/almost clear) at week 12 who were rerandomized to brodalumab, 96% and 80% (using observed data) achieved PASI 75 and PASI 100, respectively. Mean (SD) time to return of skin disease following withdrawal of brodalumab was 74.7 (50.5) days. Treatment-emergent adverse events included headaches, arthralgia, diarrhea, and nausea. Suicidal ideation was rare (this study had 1 completed suicide), and authors cited that no causal association has been made between brodalumab and suicidality. Brodalumab also demonstrated favorable treatment response in patients who underwent a lapse in treatment, offering real-world value, as intermittent treatment administration can occur because of personal or financial reasons.³

Ixekizumab is associated with more rapid skin clearance, better resolution of nail psoriasis, and superior improvement in quality-of-life measures when compared with guselkumab. The phase 3 study IXORA-R compared skin and nail clearance as well as patient-reported outcomes over 24 weeks with ixekizumab 80 mg (n=520) vs guselkumab 100 mg (n=507) in adults with moderate to severe plaque psoriasis.⁴ Ixekizumab (50%) was shown to be no worse than guselkumab (52%; difference, –2.3%) using a noninferiority test (noninferiority margin of –11.4%). The treatments exhibited similar efficacy, with no significant difference in proportion of patients reaching PASI 100 (P=.41). Ixekizumab patients tended to have skin clearance sooner than guselkumab patients, reaching PASI 50/75/90 and PASI 100 in a median time that was 2 weeks and 7.5 weeks earlier, respectively. More ixekizumab patients (52%) achieved clear nails vs guselkumab patients (31%; P=.007). Ixekizumab patients reported greater satisfaction with their skin disease affecting quality of life (DLQI), with more DLQI 0/1 (no effect at all on patient’s life) scores and being itch free (P<.05). Ixekizumab was associated with significantly more days of complete skin clearance (PASI 100) vs guselkumab (55.6 days vs 42.2 days; P<.001). Although an upper respiratory tract infection was the most common TEAE, the proportion of TEAEs was similar between treatments.⁴

IL-23 Inhibitors Update

Tildrakizumab has similar long-term skin clearance efficacy and safety in patients with psoriasis with and without comorbid metabolic syndrome (MetS). A post hoc analysis of 2 phase 2 RCTs (reSURFACE 1/2) involving adults (N=338 and N=307) with moderate to severe plaque psoriasis assessed long-term efficacy (3 years), drug survival, and safety for 5 years of continuous tildrakizumab 100 mg and 200 mg in adults with comorbid MetS.⁵ Although no difference in efficacy was concluded, greater body mass index of the MetS population was shown to be associated with lower biologic efficacy compared to the general population. The proportion of patients who achieved PASI 75 at week 52 was comparable in patients with MetS and patients without MetS (tildrakizumab 100 mg, 85% and 86% vs 86% and 94% for reSURFACE 1/2, respectively; tildrakizumab 200 mg, 76% and 87% vs 76% and 87% for reSURFACE 1/2, respectively).⁵

Tildrakizumab also demonstrated efficacy and safety for up to 5 years in 2 other phase 3 RCTs with no dose-related differences in frequency of injections and malignancies. Tildrakizumab 100 mg is the recommended dose. The 200-mg dose can be utilized in patients with a high burden of disease and disability. reSURFACE 1 and reSURFACE 2 involved adults with chronic moderate to severe plaque psoriasis randomized to tildrakizumab 100 mg, 200 mg, or placebo with the option of long-term extension to week 244 if patients reached 50% or greater improvement from baseline PASI score.⁶ Patients in reSURFACE 2 also were randomized to etanercept 50 mg with partial responders and nonresponders at week 28 switching to tildrakizumab 200 mg until week 244. Extension results showed PASI 75 achievement in 88.7% (95% CI, 84.6%-92.1%) of patients taking tildrakizumab 100 mg (n=235), 92.5% (95% CI, 88.1%-95.7%) of patients taking tildrakizumab 200 mg (n=176), and 81.3% (95% CI, 72.6%-88.2%) of patients taking etanercept/partial nonresponders (n=85). The most common TEAE was nasopharyngitis (10.5/100 patient-years for tildrakizumab 100 mg and 10.7/100 patient-years for tildrakizumab 200 mg). The frequency of severe infections (eg, diverticulitis, pneumonia, cellulitis, appendicitis) was 1.2 per 100 patient-years for tildrakizumab 100 mg and 1.3 per 100 patient-years for tildrakizumab 200 mg.⁶

Risankizumab and tildrakizumab require the lowest number of injections, thereby providing sustainable skin clearance with a convenient injection dosing schedule for patients. Risankizumab efficacy (8.2% with inferiority margin of 12%) was noninferior to secukinumab when assessing the proportion of PASI 90 responders at week 16 (after 2 doses of risankizumab vs 7 doses of secukinumab).⁷ IMMerge, an international phase 3 RCT, involved adults (N=327) with moderate to severe plaque psoriasis to compare the safety and efficacy of risankizumab 150 mg (n=164) vs secukinumab 300 mg (n=163) up to 52 weeks. A greater proportion of the risankizumab arm (86.6%) achieved PASI 90 in 52 weeks compared to the secukinumab arm (57.1%). Superior skin clearance (PASI 90) at week 52 was achieved after 5 doses with risankizumab vs 16 doses of secukinumab. Risankizumab TEAEs were nasopharyngitis, upper respiratory tract infection, headache, arthralgia, diarrhea, and bronchitis.⁷

Continuous risankizumab treatment shows substantially stronger skin clearing performance compared with intermittent treatment following drug withdrawal, demonstrating that treatment gaps minimize therapeutic response. IMMhance, an international phase 3 RCT involving adults (N=507) with moderate to severe plaque psoriasis, evaluated the safety and efficacy with risankizumab 150 mg after 52 weeks and 104 weeks.⁸ Part A randomized patients to risankizumab 150 mg (n=407) or placebo (n=100). Part B rerandomized patients at week 28 to continue risankizumab 150 mg or placebo (designated as withdrawal of treatment; later re-treated with risankizumab 150 mg if patients had sPGA ≥3). At week 52, significantly more patients reached sPGA score of 0/1 with risankizumab/risankizumab (n=97 [87.4%]) vs risankizumab/placebo (n=138 [61.3%]; P<.001). At week 104, significantly more patients reached an sPGA score of 0/1 with risankizumab/risankizumab (n=90 [81.1%]) vs risankizumab/placebo (n=16 [7.1%]; P<.001). Risankizumab exhibited longevity following withdrawal, as median time to loss of response and relapse was 42 weeks (sPGA ≥3). The extent of TEAEs was similar between risankizumab and placebo and included nasopharyngitis, upper respiratory tract infection, headache, and back pain.⁸

Final Thoughts

Biologics for psoriasis help produce intended results for skin disease clearance and are tools for precision medicine. Recent data demonstrate safe, durable, and continuous efficacy with biologics, which offer patients a better chance of treatment success. This guide may serve as a quick reference for biologic selection with special consideration of individual disease characteristics and comorbidities.

Biologics have transformed the management of moderate to severe psoriasis. There currently are 11 biologics approved by the US Food and Drug Administration (Table) for psoriasis treatment that have been affirmed by various clinical studies. This article provides dosing initiation, maintenance information, and updated clinical data using phase 3 studies (N=8) published between May 2020 and February 2021. Generic names of the 11 biologics were searched separately in the PubMed database within the specified date range. Subsequent results were reviewed by title and selected for phase 3 and 4 trials. Clinical data in this review focus on reducing patient disease burden by allocating a biologic best fit for each patient’s individual health profile.

IL-17A Inhibitors Update

Secukinumab is safe and efficacious for skin clearance in the presence of comorbidities and can be used for improving plaque psoriasis and palmoplantar pustular psoriasis. An extension of a phase 3 randomized controlled trial (RCT)—2PRECISE—evaluated the efficacy and safety of secukinumab dosing at 300 mg (n=79) and 150 mg (n=80) in adults with moderate to severe palmoplantar pustular psoriasis (palmoplantar psoriasis area and severity index [PPPASI] score ≥12 and dermatology life quality index [DLQI] ≥10) over 148 weeks.¹ Extension patients were included from the 52-week 2PRECISE study per the investigator’s judgement of a meaningful clinical response (exact criteria not described). All treatment groups demonstrated a mean (SD) PPPASI of 22.7 (9.5) by the extension trial’s start. Results affirmed that clinical response waned after week 148 in all groups excluding placebo/secukinumab 150 mg, which maintained a mean (SD) PPPASI of 22.7 (9.5). The most frequent adverse events were nasopharyngitis, pustular psoriasis, headache, and pruritus.¹

Comorbidities do not have a major impact on secukinumab’s efficacy. A post hoc analysis of 4 phase 3 RCTs—ERASURE, FIXTURE, FEATURE, and JUNCTURE—gathered data from adult patients (N=2401) to assess baseline comorbidities with efficacy and safety of secukinumab vs etanercept after 12 weeks of treatment.² Sixty-one percent (n=1469) had at least 1 comorbidity, most frequently obesity, hypertension, psoriatic arthritis, hyperlipidemia, or diabetes mellitus. All patient groups had a greater likelihood of a psoriasis area and severity index (PASI) response with any dose of secukinumab vs patients with comorbidities who were taking etanercept or placebo (P<.05) at week 12. All groups had a greater likelihood of achieving investigator global assessment scores of 0/1 (clear/almost clear) vs patients with comorbidities taking etanercept or placebo (P<.05). Baseline comorbidities did not significantly affect treatment response, except obesity, which was associated with decreased probability of achieving all PASI and investigator global assessment (P<.01) responses. Secukinumab-treated patients with and without comorbidities had equivalent likelihood of treatment-emergent adverse events (TEAEs).²

Brodalumab is an effective biologic that has shown long-term safety with continuous administration. Continuous brodalumab and brodalumab after placebo demonstrated impactful skin clearance after 120 weeks in AMAGINE-1, a phase 3 RCT involving adults (N=442) with moderate to severe plaque psoriasis.³ Patients randomized to brodalumab 210 mg (n=222) or placebo (n=220) were rerandomized according to initial treatment response. In patients switching from brodalumab to placebo at week 12, 55% and 94% achieved PASI 75 at week 20 and week 120, respectively, and 75% reached PASI 100 at week 120. Of patients with static physician global assessment (sPGA) scores of 0/1 (clear/almost clear) at week 12 who were rerandomized to brodalumab, 96% and 80% (using observed data) achieved PASI 75 and PASI 100, respectively. Mean (SD) time to return of skin disease following withdrawal of brodalumab was 74.7 (50.5) days. Treatment-emergent adverse events included headaches, arthralgia, diarrhea, and nausea. Suicidal ideation was rare (this study had 1 completed suicide), and authors cited that no causal association has been made between brodalumab and suicidality. Brodalumab also demonstrated favorable treatment response in patients who underwent a lapse in treatment, offering real-world value, as intermittent treatment administration can occur because of personal or financial reasons.³

Ixekizumab is associated with more rapid skin clearance, better resolution of nail psoriasis, and superior improvement in quality-of-life measures when compared with guselkumab. The phase 3 study IXORA-R compared skin and nail clearance as well as patient-reported outcomes over 24 weeks with ixekizumab 80 mg (n=520) vs guselkumab 100 mg (n=507) in adults with moderate to severe plaque psoriasis.⁴ Ixekizumab (50%) was shown to be no worse than guselkumab (52%; difference, –2.3%) using a noninferiority test (noninferiority margin of –11.4%). The treatments exhibited similar efficacy, with no significant difference in proportion of patients reaching PASI 100 (P=.41). Ixekizumab patients tended to have skin clearance sooner than guselkumab patients, reaching PASI 50/75/90 and PASI 100 in a median time that was 2 weeks and 7.5 weeks earlier, respectively. More ixekizumab patients (52%) achieved clear nails vs guselkumab patients (31%; P=.007). Ixekizumab patients reported greater satisfaction with their skin disease affecting quality of life (DLQI), with more DLQI 0/1 (no effect at all on patient’s life) scores and being itch free (P<.05). Ixekizumab was associated with significantly more days of complete skin clearance (PASI 100) vs guselkumab (55.6 days vs 42.2 days; P<.001). Although an upper respiratory tract infection was the most common TEAE, the proportion of TEAEs was similar between treatments.⁴

IL-23 Inhibitors Update

Tildrakizumab has similar long-term skin clearance efficacy and safety in patients with psoriasis with and without comorbid metabolic syndrome (MetS). A post hoc analysis of 2 phase 2 RCTs (reSURFACE 1/2) involving adults (N=338 and N=307) with moderate to severe plaque psoriasis assessed long-term efficacy (3 years), drug survival, and safety for 5 years of continuous tildrakizumab 100 mg and 200 mg in adults with comorbid MetS.⁵ Although no difference in efficacy was concluded, greater body mass index of the MetS population was shown to be associated with lower biologic efficacy compared to the general population. The proportion of patients who achieved PASI 75 at week 52 was comparable in patients with MetS and patients without MetS (tildrakizumab 100 mg, 85% and 86% vs 86% and 94% for reSURFACE 1/2, respectively; tildrakizumab 200 mg, 76% and 87% vs 76% and 87% for reSURFACE 1/2, respectively).⁵

Tildrakizumab also demonstrated efficacy and safety for up to 5 years in 2 other phase 3 RCTs with no dose-related differences in frequency of injections and malignancies. Tildrakizumab 100 mg is the recommended dose. The 200-mg dose can be utilized in patients with a high burden of disease and disability. reSURFACE 1 and reSURFACE 2 involved adults with chronic moderate to severe plaque psoriasis randomized to tildrakizumab 100 mg, 200 mg, or placebo with the option of long-term extension to week 244 if patients reached 50% or greater improvement from baseline PASI score.⁶ Patients in reSURFACE 2 also were randomized to etanercept 50 mg with partial responders and nonresponders at week 28 switching to tildrakizumab 200 mg until week 244. Extension results showed PASI 75 achievement in 88.7% (95% CI, 84.6%-92.1%) of patients taking tildrakizumab 100 mg (n=235), 92.5% (95% CI, 88.1%-95.7%) of patients taking tildrakizumab 200 mg (n=176), and 81.3% (95% CI, 72.6%-88.2%) of patients taking etanercept/partial nonresponders (n=85). The most common TEAE was nasopharyngitis (10.5/100 patient-years for tildrakizumab 100 mg and 10.7/100 patient-years for tildrakizumab 200 mg). The frequency of severe infections (eg, diverticulitis, pneumonia, cellulitis, appendicitis) was 1.2 per 100 patient-years for tildrakizumab 100 mg and 1.3 per 100 patient-years for tildrakizumab 200 mg.⁶

Risankizumab and tildrakizumab require the lowest number of injections, thereby providing sustainable skin clearance with a convenient injection dosing schedule for patients. Risankizumab efficacy (8.2% with inferiority margin of 12%) was noninferior to secukinumab when assessing the proportion of PASI 90 responders at week 16 (after 2 doses of risankizumab vs 7 doses of secukinumab).⁷ IMMerge, an international phase 3 RCT, involved adults (N=327) with moderate to severe plaque psoriasis to compare the safety and efficacy of risankizumab 150 mg (n=164) vs secukinumab 300 mg (n=163) up to 52 weeks. A greater proportion of the risankizumab arm (86.6%) achieved PASI 90 in 52 weeks compared to the secukinumab arm (57.1%). Superior skin clearance (PASI 90) at week 52 was achieved after 5 doses with risankizumab vs 16 doses of secukinumab. Risankizumab TEAEs were nasopharyngitis, upper respiratory tract infection, headache, arthralgia, diarrhea, and bronchitis.⁷

Continuous risankizumab treatment shows substantially stronger skin clearing performance compared with intermittent treatment following drug withdrawal, demonstrating that treatment gaps minimize therapeutic response. IMMhance, an international phase 3 RCT involving adults (N=507) with moderate to severe plaque psoriasis, evaluated the safety and efficacy with risankizumab 150 mg after 52 weeks and 104 weeks.⁸ Part A randomized patients to risankizumab 150 mg (n=407) or placebo (n=100). Part B rerandomized patients at week 28 to continue risankizumab 150 mg or placebo (designated as withdrawal of treatment; later re-treated with risankizumab 150 mg if patients had sPGA ≥3). At week 52, significantly more patients reached sPGA score of 0/1 with risankizumab/risankizumab (n=97 [87.4%]) vs risankizumab/placebo (n=138 [61.3%]; P<.001). At week 104, significantly more patients reached an sPGA score of 0/1 with risankizumab/risankizumab (n=90 [81.1%]) vs risankizumab/placebo (n=16 [7.1%]; P<.001). Risankizumab exhibited longevity following withdrawal, as median time to loss of response and relapse was 42 weeks (sPGA ≥3). The extent of TEAEs was similar between risankizumab and placebo and included nasopharyngitis, upper respiratory tract infection, headache, and back pain.⁸

Final Thoughts

Biologics for psoriasis help produce intended results for skin disease clearance and are tools for precision medicine. Recent data demonstrate safe, durable, and continuous efficacy with biologics, which offer patients a better chance of treatment success. This guide may serve as a quick reference for biologic selection with special consideration of individual disease characteristics and comorbidities.

Biologic medications are highly effective in treating moderate to severe psoriasis, yet many patients are apprehensive about taking a biologic medication for a variety of reasons, such as hearing negative information about the drug from friends or family, being nervous about injection, or seeing the drug or its side effects negatively portrayed in the media.^1-3 Because biologic medications are costly, many patients may fear needing to discontinue use of the medication owing to lack of affordability, which may result in subsequent rebound of psoriasis. Because patients’ fear of a drug is inherently subjective, it can be modified with appropriate reassurance and presentation of evidence. By understanding what information increases patients’ confidence in their willingness to take a biologic medication, patients may be more willing to initiate use of the drug and improve treatment outcomes.

There are mixed findings about whether statistical evidence or an anecdote is more effective in persuasion.^4-6 The specific context in which the persuasion takes place may be important in determining which method is superior. In most nonthreatening situations, people appear to be more easily persuaded by statistical evidence rather than an anecdote. However, in circumstances where emotional engagement is high, such as regarding one’s own health, an anecdote tends to be more persuasive compared to statistical evidence.⁷ The purpose of this study was to evaluate patients’ willingness to take a biologic medication for the management of their psoriasis if presented with either clinical trial evidence of the agent’s efficacy and safety, an anecdote of a single patient’s positive experience, or both.

Methods

Patient Inclusion Criteria
Following Wake Forest School of Medicine institutional review board approval, a prospective parallel-arm survey study was performed on eligible patients 18 years or older with a self-reported diagnosis of psoriasis. Patients were required to have a working knowledge of English and not have been previously prescribed a biologic medication for their psoriasis. If patients did not meet inclusion criteria after answering the survey eligibility screening questions, then they were unable to complete the remainder of the survey and were excluded from the analysis.

Survey Administration
A total of 222 patients were recruited through Amazon Mechanical Turk, an online crowdsourcing platform. (Amazon Mechanical Turk is a validated tool in conducting research in psychology and other social sciences and is considered as diverse as and perhaps more representative than traditional samples.^8,9) Patients received a fact sheet and were taken to the survey hosted on Qualtrics, a secure web-based survey software that supports data collection for research studies. Amazon Mechanical Turk requires some amount of compensation to patients; therefore, recruited patients were compensated $0.03.

Statistical Analysis
Patients were randomized using SPSS Statistics version 23.0 (IBM) in a 1:1 ratio to assess how willing they would be to take a biologic medication for their psoriasis if presented with one of the following: (1) a control that queried patients about their willingness to take treatment without having been informed on its efficacy or safety, (2) clinical trial evidence of the agent’s efficacy and safety, (3) an anecdote of a single patient’s positive experience, or (4) both clinical trial evidence of the agent’s efficacy and safety and an anecdote of a single patient’s positive experience (Table 1). Demographic information including sex, age, ethnicity, and education level was collected, in addition to other baseline characteristics such as having friends or family with a history of psoriasis, history of participation in a clinical trial with use of an experimental drug, and the number of years since clinical diagnosis of psoriasis.

Results

There were no statistically significant differences among the baseline characteristics of the 4 information assignment groups (Table 2). Patients in the control group not given either clinical trial evidence of a biologic medication’s efficacy and safety or anecdote of a single patient’s positive experience had the lowest reported willingness to take treatment (median, 4.0)(Figure). Patients in the group given clinical trial evidence had an intermediate level of reported willingness to take treatment (median, 7.0). Patients in the groups given an anecdote or clinical trial evidence and anecdote had the highest reported willingness to take treatment (median, 8.0). Patients presented with an anecdote or clinical trial evidence and anecdote were significantly more likely to report willingness to take treatment than those not presented with either clinical trial evidence or anecdote (P<.001). Although patients presented with an anecdote or clinical trial evidence and anecdote were more likely to take a biologic medication than those presented with only clinical trial evidence, the difference between these groups was not significant (P=.75).

Based on regression analysis, age, sex, and having friends or family with a history of psoriasis were not significantly associated with patients’ responses (eTable). The number of years since clinical diagnosis of psoriasis (P=.034) and history of participation in a clinical trial with use of an experimental drug (P=.018) were significantly associated with the willingness of patients presented with an anecdote to take a biologic medication.

Comment

Anecdotal Reassurance
The presentation of clinical trial and/or anecdotal evidence had a strong effect on patients’ willingness to take a biologic medication for their psoriasis. Human perception of a treatment is inherently subjective, and such perceptions can be modified with appropriate reassurance and presentation of evidence.¹ Across the population we studied, presenting a brief anecdote of a single patient’s positive experience is a quick and efficient means—and as or more effective as giving details on efficacy and safety—to help patients decide to take a treatment for their psoriasis.

Anecdotal reassurance is powerful. Both health care providers and patients have a natural tendency to focus on anecdotal experiences rather than statistical reasoning when making treatment decisions.^10-12 Although negative anecdotal experiences may make patients unwilling to take a medication (or may make them overly desirous of an inappropriate treatment), clinicians can harness this psychological phenomenon to both increase patient willingness to take potentially beneficial treatments or to deter them from engaging in activities that can be harmful to their health, such as tanning and smoking.

Psoriasis Duration and Willingness to Take a Biologic Medication
In general, patient demographics did not appear to have an association with reported willingness to take a biologic medication for psoriasis. However, the number of years since clinical diagnosis of psoriasis had an effect on willingness to take a biologic medication, with patients with a longer personal history of psoriasis showing a higher willingness to take a treatment after being presented with an anecdote than patients with a shorter personal history of psoriasis. We can only speculate on the reasons why. Patients with a longer personal history of psoriasis may have tried and failed more treatments and therefore have a distrust in the validity of clinical trial evidence. These patients may feel their psoriasis is different than that of other clinical trial participants and thus may be more willing to rely on the success stories of individual patients.

Prior participation in a clinical trial with use of an experimental drug was associated with a lower willingness to choose treatment after being presented with anecdotal reassurance. This finding may be attributable to these patients understanding the subjective nature of anecdotes and preferring more objective information in the form of randomized clinical trials in making treatment decisions. Overall, the presentation of evidence about the efficacy and safety of biologic medications in the treatment of psoriasis has a greater impact on patient decision-making than patients’ age, sex, and having friends or family with a history of psoriasis.

Limitations
Limitations of the study were typical of survey-based research. With closed-ended questions, patients were not able to explain their responses. In addition, hypothetical informational statements of a biologic’s efficacy and safety may not always imitate clinical reality. However, we believe the study is valid in exploring the power of an anecdote in influencing patients’ willingness to take biologic medications for psoriasis. Furthermore, educational level and ethnicity were excluded from the ordinal regression analysis because the assumption of parallel lines was not met.

Ethics Behind an Anecdote
An important consideration is the ethical implications of sharing an anecdote to guide patients’ perceptions of treatment and behavior. Although clinicians rely heavily on the available data to determine the best course of treatment, providing patients with comprehensive information on all risks and benefits is rarely, if ever, feasible. Moreover, even objective clinical data will inevitably be subjectively interpreted by patients. For example, describing a medication side effect as occurring in 1 in 100 patients may discourage patients from pursuing treatment, whereas describing that risk as not occurring in 99 in 100 patients may encourage patients, despite these 2 choices being mathematically identical.¹³ Because the subjective interpretation of data is inevitable, presenting patients with subjective information in the form of an anecdote to help them overcome fears of starting treatment and achieve their desired clinical outcomes may be one of the appropriate approaches to present what is objectively the best option, particularly if the anecdote is representative of the expected treatment response. Clinicians can harness this understanding of human psychology to better educate patients about their treatment options while fulfilling their ethical duty to act in their patients’ best interest.

Conclusion

Using an anecdote to help patients overcome fears of starting a biologic medication may be appropriate if the anecdote is reasonably representative of an expected treatment outcome. Patients should have an accurate understanding of the common risks and benefits of a medication for purposes of shared decision-making.

Biologic medications are highly effective in treating moderate to severe psoriasis, yet many patients are apprehensive about taking a biologic medication for a variety of reasons, such as hearing negative information about the drug from friends or family, being nervous about injection, or seeing the drug or its side effects negatively portrayed in the media.^1-3 Because biologic medications are costly, many patients may fear needing to discontinue use of the medication owing to lack of affordability, which may result in subsequent rebound of psoriasis. Because patients’ fear of a drug is inherently subjective, it can be modified with appropriate reassurance and presentation of evidence. By understanding what information increases patients’ confidence in their willingness to take a biologic medication, patients may be more willing to initiate use of the drug and improve treatment outcomes.

There are mixed findings about whether statistical evidence or an anecdote is more effective in persuasion.^4-6 The specific context in which the persuasion takes place may be important in determining which method is superior. In most nonthreatening situations, people appear to be more easily persuaded by statistical evidence rather than an anecdote. However, in circumstances where emotional engagement is high, such as regarding one’s own health, an anecdote tends to be more persuasive compared to statistical evidence.⁷ The purpose of this study was to evaluate patients’ willingness to take a biologic medication for the management of their psoriasis if presented with either clinical trial evidence of the agent’s efficacy and safety, an anecdote of a single patient’s positive experience, or both.

Methods

Patient Inclusion Criteria
Following Wake Forest School of Medicine institutional review board approval, a prospective parallel-arm survey study was performed on eligible patients 18 years or older with a self-reported diagnosis of psoriasis. Patients were required to have a working knowledge of English and not have been previously prescribed a biologic medication for their psoriasis. If patients did not meet inclusion criteria after answering the survey eligibility screening questions, then they were unable to complete the remainder of the survey and were excluded from the analysis.

Survey Administration
A total of 222 patients were recruited through Amazon Mechanical Turk, an online crowdsourcing platform. (Amazon Mechanical Turk is a validated tool in conducting research in psychology and other social sciences and is considered as diverse as and perhaps more representative than traditional samples.^8,9) Patients received a fact sheet and were taken to the survey hosted on Qualtrics, a secure web-based survey software that supports data collection for research studies. Amazon Mechanical Turk requires some amount of compensation to patients; therefore, recruited patients were compensated $0.03.

Statistical Analysis
Patients were randomized using SPSS Statistics version 23.0 (IBM) in a 1:1 ratio to assess how willing they would be to take a biologic medication for their psoriasis if presented with one of the following: (1) a control that queried patients about their willingness to take treatment without having been informed on its efficacy or safety, (2) clinical trial evidence of the agent’s efficacy and safety, (3) an anecdote of a single patient’s positive experience, or (4) both clinical trial evidence of the agent’s efficacy and safety and an anecdote of a single patient’s positive experience (Table 1). Demographic information including sex, age, ethnicity, and education level was collected, in addition to other baseline characteristics such as having friends or family with a history of psoriasis, history of participation in a clinical trial with use of an experimental drug, and the number of years since clinical diagnosis of psoriasis.

Results

There were no statistically significant differences among the baseline characteristics of the 4 information assignment groups (Table 2). Patients in the control group not given either clinical trial evidence of a biologic medication’s efficacy and safety or anecdote of a single patient’s positive experience had the lowest reported willingness to take treatment (median, 4.0)(Figure). Patients in the group given clinical trial evidence had an intermediate level of reported willingness to take treatment (median, 7.0). Patients in the groups given an anecdote or clinical trial evidence and anecdote had the highest reported willingness to take treatment (median, 8.0). Patients presented with an anecdote or clinical trial evidence and anecdote were significantly more likely to report willingness to take treatment than those not presented with either clinical trial evidence or anecdote (P<.001). Although patients presented with an anecdote or clinical trial evidence and anecdote were more likely to take a biologic medication than those presented with only clinical trial evidence, the difference between these groups was not significant (P=.75).

Based on regression analysis, age, sex, and having friends or family with a history of psoriasis were not significantly associated with patients’ responses (eTable). The number of years since clinical diagnosis of psoriasis (P=.034) and history of participation in a clinical trial with use of an experimental drug (P=.018) were significantly associated with the willingness of patients presented with an anecdote to take a biologic medication.

Comment

Anecdotal Reassurance
The presentation of clinical trial and/or anecdotal evidence had a strong effect on patients’ willingness to take a biologic medication for their psoriasis. Human perception of a treatment is inherently subjective, and such perceptions can be modified with appropriate reassurance and presentation of evidence.¹ Across the population we studied, presenting a brief anecdote of a single patient’s positive experience is a quick and efficient means—and as or more effective as giving details on efficacy and safety—to help patients decide to take a treatment for their psoriasis.

Anecdotal reassurance is powerful. Both health care providers and patients have a natural tendency to focus on anecdotal experiences rather than statistical reasoning when making treatment decisions.^10-12 Although negative anecdotal experiences may make patients unwilling to take a medication (or may make them overly desirous of an inappropriate treatment), clinicians can harness this psychological phenomenon to both increase patient willingness to take potentially beneficial treatments or to deter them from engaging in activities that can be harmful to their health, such as tanning and smoking.

Psoriasis Duration and Willingness to Take a Biologic Medication
In general, patient demographics did not appear to have an association with reported willingness to take a biologic medication for psoriasis. However, the number of years since clinical diagnosis of psoriasis had an effect on willingness to take a biologic medication, with patients with a longer personal history of psoriasis showing a higher willingness to take a treatment after being presented with an anecdote than patients with a shorter personal history of psoriasis. We can only speculate on the reasons why. Patients with a longer personal history of psoriasis may have tried and failed more treatments and therefore have a distrust in the validity of clinical trial evidence. These patients may feel their psoriasis is different than that of other clinical trial participants and thus may be more willing to rely on the success stories of individual patients.

Prior participation in a clinical trial with use of an experimental drug was associated with a lower willingness to choose treatment after being presented with anecdotal reassurance. This finding may be attributable to these patients understanding the subjective nature of anecdotes and preferring more objective information in the form of randomized clinical trials in making treatment decisions. Overall, the presentation of evidence about the efficacy and safety of biologic medications in the treatment of psoriasis has a greater impact on patient decision-making than patients’ age, sex, and having friends or family with a history of psoriasis.

Limitations
Limitations of the study were typical of survey-based research. With closed-ended questions, patients were not able to explain their responses. In addition, hypothetical informational statements of a biologic’s efficacy and safety may not always imitate clinical reality. However, we believe the study is valid in exploring the power of an anecdote in influencing patients’ willingness to take biologic medications for psoriasis. Furthermore, educational level and ethnicity were excluded from the ordinal regression analysis because the assumption of parallel lines was not met.

Ethics Behind an Anecdote
An important consideration is the ethical implications of sharing an anecdote to guide patients’ perceptions of treatment and behavior. Although clinicians rely heavily on the available data to determine the best course of treatment, providing patients with comprehensive information on all risks and benefits is rarely, if ever, feasible. Moreover, even objective clinical data will inevitably be subjectively interpreted by patients. For example, describing a medication side effect as occurring in 1 in 100 patients may discourage patients from pursuing treatment, whereas describing that risk as not occurring in 99 in 100 patients may encourage patients, despite these 2 choices being mathematically identical.¹³ Because the subjective interpretation of data is inevitable, presenting patients with subjective information in the form of an anecdote to help them overcome fears of starting treatment and achieve their desired clinical outcomes may be one of the appropriate approaches to present what is objectively the best option, particularly if the anecdote is representative of the expected treatment response. Clinicians can harness this understanding of human psychology to better educate patients about their treatment options while fulfilling their ethical duty to act in their patients’ best interest.

Conclusion

Using an anecdote to help patients overcome fears of starting a biologic medication may be appropriate if the anecdote is reasonably representative of an expected treatment outcome. Patients should have an accurate understanding of the common risks and benefits of a medication for purposes of shared decision-making.

Biologic medications are highly effective in treating moderate to severe psoriasis, yet many patients are apprehensive about taking a biologic medication for a variety of reasons, such as hearing negative information about the drug from friends or family, being nervous about injection, or seeing the drug or its side effects negatively portrayed in the media.^1-3 Because biologic medications are costly, many patients may fear needing to discontinue use of the medication owing to lack of affordability, which may result in subsequent rebound of psoriasis. Because patients’ fear of a drug is inherently subjective, it can be modified with appropriate reassurance and presentation of evidence. By understanding what information increases patients’ confidence in their willingness to take a biologic medication, patients may be more willing to initiate use of the drug and improve treatment outcomes.

There are mixed findings about whether statistical evidence or an anecdote is more effective in persuasion.^4-6 The specific context in which the persuasion takes place may be important in determining which method is superior. In most nonthreatening situations, people appear to be more easily persuaded by statistical evidence rather than an anecdote. However, in circumstances where emotional engagement is high, such as regarding one’s own health, an anecdote tends to be more persuasive compared to statistical evidence.⁷ The purpose of this study was to evaluate patients’ willingness to take a biologic medication for the management of their psoriasis if presented with either clinical trial evidence of the agent’s efficacy and safety, an anecdote of a single patient’s positive experience, or both.

Methods

Patient Inclusion Criteria
Following Wake Forest School of Medicine institutional review board approval, a prospective parallel-arm survey study was performed on eligible patients 18 years or older with a self-reported diagnosis of psoriasis. Patients were required to have a working knowledge of English and not have been previously prescribed a biologic medication for their psoriasis. If patients did not meet inclusion criteria after answering the survey eligibility screening questions, then they were unable to complete the remainder of the survey and were excluded from the analysis.

Survey Administration
A total of 222 patients were recruited through Amazon Mechanical Turk, an online crowdsourcing platform. (Amazon Mechanical Turk is a validated tool in conducting research in psychology and other social sciences and is considered as diverse as and perhaps more representative than traditional samples.^8,9) Patients received a fact sheet and were taken to the survey hosted on Qualtrics, a secure web-based survey software that supports data collection for research studies. Amazon Mechanical Turk requires some amount of compensation to patients; therefore, recruited patients were compensated $0.03.

Statistical Analysis
Patients were randomized using SPSS Statistics version 23.0 (IBM) in a 1:1 ratio to assess how willing they would be to take a biologic medication for their psoriasis if presented with one of the following: (1) a control that queried patients about their willingness to take treatment without having been informed on its efficacy or safety, (2) clinical trial evidence of the agent’s efficacy and safety, (3) an anecdote of a single patient’s positive experience, or (4) both clinical trial evidence of the agent’s efficacy and safety and an anecdote of a single patient’s positive experience (Table 1). Demographic information including sex, age, ethnicity, and education level was collected, in addition to other baseline characteristics such as having friends or family with a history of psoriasis, history of participation in a clinical trial with use of an experimental drug, and the number of years since clinical diagnosis of psoriasis.

Results

There were no statistically significant differences among the baseline characteristics of the 4 information assignment groups (Table 2). Patients in the control group not given either clinical trial evidence of a biologic medication’s efficacy and safety or anecdote of a single patient’s positive experience had the lowest reported willingness to take treatment (median, 4.0)(Figure). Patients in the group given clinical trial evidence had an intermediate level of reported willingness to take treatment (median, 7.0). Patients in the groups given an anecdote or clinical trial evidence and anecdote had the highest reported willingness to take treatment (median, 8.0). Patients presented with an anecdote or clinical trial evidence and anecdote were significantly more likely to report willingness to take treatment than those not presented with either clinical trial evidence or anecdote (P<.001). Although patients presented with an anecdote or clinical trial evidence and anecdote were more likely to take a biologic medication than those presented with only clinical trial evidence, the difference between these groups was not significant (P=.75).

Based on regression analysis, age, sex, and having friends or family with a history of psoriasis were not significantly associated with patients’ responses (eTable). The number of years since clinical diagnosis of psoriasis (P=.034) and history of participation in a clinical trial with use of an experimental drug (P=.018) were significantly associated with the willingness of patients presented with an anecdote to take a biologic medication.

Comment

Anecdotal Reassurance
The presentation of clinical trial and/or anecdotal evidence had a strong effect on patients’ willingness to take a biologic medication for their psoriasis. Human perception of a treatment is inherently subjective, and such perceptions can be modified with appropriate reassurance and presentation of evidence.¹ Across the population we studied, presenting a brief anecdote of a single patient’s positive experience is a quick and efficient means—and as or more effective as giving details on efficacy and safety—to help patients decide to take a treatment for their psoriasis.

Anecdotal reassurance is powerful. Both health care providers and patients have a natural tendency to focus on anecdotal experiences rather than statistical reasoning when making treatment decisions.^10-12 Although negative anecdotal experiences may make patients unwilling to take a medication (or may make them overly desirous of an inappropriate treatment), clinicians can harness this psychological phenomenon to both increase patient willingness to take potentially beneficial treatments or to deter them from engaging in activities that can be harmful to their health, such as tanning and smoking.

Psoriasis Duration and Willingness to Take a Biologic Medication
In general, patient demographics did not appear to have an association with reported willingness to take a biologic medication for psoriasis. However, the number of years since clinical diagnosis of psoriasis had an effect on willingness to take a biologic medication, with patients with a longer personal history of psoriasis showing a higher willingness to take a treatment after being presented with an anecdote than patients with a shorter personal history of psoriasis. We can only speculate on the reasons why. Patients with a longer personal history of psoriasis may have tried and failed more treatments and therefore have a distrust in the validity of clinical trial evidence. These patients may feel their psoriasis is different than that of other clinical trial participants and thus may be more willing to rely on the success stories of individual patients.

Prior participation in a clinical trial with use of an experimental drug was associated with a lower willingness to choose treatment after being presented with anecdotal reassurance. This finding may be attributable to these patients understanding the subjective nature of anecdotes and preferring more objective information in the form of randomized clinical trials in making treatment decisions. Overall, the presentation of evidence about the efficacy and safety of biologic medications in the treatment of psoriasis has a greater impact on patient decision-making than patients’ age, sex, and having friends or family with a history of psoriasis.

Limitations
Limitations of the study were typical of survey-based research. With closed-ended questions, patients were not able to explain their responses. In addition, hypothetical informational statements of a biologic’s efficacy and safety may not always imitate clinical reality. However, we believe the study is valid in exploring the power of an anecdote in influencing patients’ willingness to take biologic medications for psoriasis. Furthermore, educational level and ethnicity were excluded from the ordinal regression analysis because the assumption of parallel lines was not met.

Ethics Behind an Anecdote
An important consideration is the ethical implications of sharing an anecdote to guide patients’ perceptions of treatment and behavior. Although clinicians rely heavily on the available data to determine the best course of treatment, providing patients with comprehensive information on all risks and benefits is rarely, if ever, feasible. Moreover, even objective clinical data will inevitably be subjectively interpreted by patients. For example, describing a medication side effect as occurring in 1 in 100 patients may discourage patients from pursuing treatment, whereas describing that risk as not occurring in 99 in 100 patients may encourage patients, despite these 2 choices being mathematically identical.¹³ Because the subjective interpretation of data is inevitable, presenting patients with subjective information in the form of an anecdote to help them overcome fears of starting treatment and achieve their desired clinical outcomes may be one of the appropriate approaches to present what is objectively the best option, particularly if the anecdote is representative of the expected treatment response. Clinicians can harness this understanding of human psychology to better educate patients about their treatment options while fulfilling their ethical duty to act in their patients’ best interest.

Conclusion

Using an anecdote to help patients overcome fears of starting a biologic medication may be appropriate if the anecdote is reasonably representative of an expected treatment outcome. Patients should have an accurate understanding of the common risks and benefits of a medication for purposes of shared decision-making.

In a real-life setting, fecal calprotectin (FC) home testing performed well at predicting disease endoscopic activity in patients with inflammatory bowel disease (IBD) being treated with adalimumab.

The study published in the European Journal of Gastroenterology & Hepatology, could be a boon to patients and physicians employing the treat-to-target (T2T) strategy, which relies on disease monitoring through methods like endoscopy, histology, and serum and fecal biomarkers.

One goal of T2T is to identify patients who are asymptomatic in order to prevent or minimize flare-ups. Colonoscopy is the preferred approach for achieving this, but cost, risk, and patient reluctance limit its use. FC has gained attention in recent years, as it outperforms serum biomarkers in its correlation with clinical, endoscopic, and histological disease activity. Consecutive FC measurements predict disease relapse among asymptomatic patients with high specificity and sensitivity. There’s also evidence that it could be useful for perioperative monitoring.

FC is typically assessed in a lab, but the recent availability of smartphone-based tests has allowed patients to collect and test their stool at home. The method has been tested through clinical research, but real-world data have so far been lacking.
 

First real-life results

In what they described as the first real-life study of its kind, researchers offered at-home FC testing every 4 months to all 72 current IBD patients taking adalimumab at the University Hospital of Heraklion, University of Crete, Irakleio, Greece; seven patients (10%) declined to take part in at-home FC testing. Of the remaining 65, the mean age was 42.3 years, and 58% were male; 89% had a diagnosis of Crohn’s disease. The mean disease duration was 13.3 years.

Abnormal FC values were confirmed with a follow-up test 1 month later, after which point a colonoscopy was scheduled to inform treatment modification. Twenty-four patients (37% of the population) had two positive tests, and 19 who were able underwent colonoscopy. Twelve patients (19%) underwent adalimumab dose intensification, 9 (14%) switched to a different biologic, and 2 (3%) had surgery.

The group of patients who required treatment modification had a significantly higher median FC concentration of 761 mcg/g (37% had values ≥ 1,000 mcg/g), compared with a median concentration of 108 mcg/g for those who did not have their dose modified (P < .0001). With a cutoff of 250 mcg/g, FC correctly identified a need for treatment with an area under the receiver operating characteristic curve (AUC) value of 0.90 (95% confidence interval, 0.80-0.96).

FC was significantly correlated to endoscopic activity (r = 0.543, P < .001), and patients with endoscopic disease had higher median FC concentrations (689 vs. 99 mcg/g; P < .001).

The researchers calculated that a cutoff value of FC levels greater than 413 mcg/g is optimal for predicting endoscopic disease, with a sensitivity of 75%, a specificity of 76%, a positive likelihood ratio of 3.12, and a negative likelihood ratio of 0.33.
 

Diabeteslike home monitoring for IBD?

“Home monitoring of disease activity and drug levels will be a paradigm shift in management of IBD, because it will place in the patient’s hands the opportunity to assess their disease activity and to have a better understanding of what’s going on when they have symptoms or concerns about their disease control,” commented David Rubin, MD, who did not participate in the study.

He noted that patients are often unsure whether a new symptom is the beginning of another episode of IBD or something unrelated.

“One of the biggest challenges of having IBD is just the perception of loss of control of the disease and knowing when things are going to happen,” said Dr. Rubin, a professor of medicine and the codirector of the digestive diseases center at the University of Chicago, and the chair of the scientific advisory committee for the Crohn’s & Colitis Foundation. “I often explain to people that using a tool like this would be similar to patients with diabetes checking their blood sugar – getting a feel for what’s actually happening closer to the time that it’s happening, rather than waiting for it to progress. I really think that the general idea of home monitoring is going to be a major advance in our field.”

Although the new study proved the technique’s acceptability and efficacy, it isn’t without pitfalls, according to Dr. Rubin. False positives or negatives are a concern, and other factors might influence the results. For example, proton pump inhibitors can increase FC levels. Another concern is that some patients can become obsessed with their FC levels, and may want to test themselves at any sign of illness. They may develop unrealistic expectations about the impact of medications on their FC levels.

“That’s going to open up a whole dialogue with people, so that we all are on the same page about it. But I think that the benefits of having this far outweigh those potential risks,” said Dr. Rubin.

The authors reported no conflicts of interest. Dr. Rubin has consulted for TECHLAB.

In a real-life setting, fecal calprotectin (FC) home testing performed well at predicting disease endoscopic activity in patients with inflammatory bowel disease (IBD) being treated with adalimumab.

The study published in the European Journal of Gastroenterology & Hepatology, could be a boon to patients and physicians employing the treat-to-target (T2T) strategy, which relies on disease monitoring through methods like endoscopy, histology, and serum and fecal biomarkers.

One goal of T2T is to identify patients who are asymptomatic in order to prevent or minimize flare-ups. Colonoscopy is the preferred approach for achieving this, but cost, risk, and patient reluctance limit its use. FC has gained attention in recent years, as it outperforms serum biomarkers in its correlation with clinical, endoscopic, and histological disease activity. Consecutive FC measurements predict disease relapse among asymptomatic patients with high specificity and sensitivity. There’s also evidence that it could be useful for perioperative monitoring.

FC is typically assessed in a lab, but the recent availability of smartphone-based tests has allowed patients to collect and test their stool at home. The method has been tested through clinical research, but real-world data have so far been lacking.
 

First real-life results

In what they described as the first real-life study of its kind, researchers offered at-home FC testing every 4 months to all 72 current IBD patients taking adalimumab at the University Hospital of Heraklion, University of Crete, Irakleio, Greece; seven patients (10%) declined to take part in at-home FC testing. Of the remaining 65, the mean age was 42.3 years, and 58% were male; 89% had a diagnosis of Crohn’s disease. The mean disease duration was 13.3 years.

Abnormal FC values were confirmed with a follow-up test 1 month later, after which point a colonoscopy was scheduled to inform treatment modification. Twenty-four patients (37% of the population) had two positive tests, and 19 who were able underwent colonoscopy. Twelve patients (19%) underwent adalimumab dose intensification, 9 (14%) switched to a different biologic, and 2 (3%) had surgery.

The group of patients who required treatment modification had a significantly higher median FC concentration of 761 mcg/g (37% had values ≥ 1,000 mcg/g), compared with a median concentration of 108 mcg/g for those who did not have their dose modified (P < .0001). With a cutoff of 250 mcg/g, FC correctly identified a need for treatment with an area under the receiver operating characteristic curve (AUC) value of 0.90 (95% confidence interval, 0.80-0.96).

FC was significantly correlated to endoscopic activity (r = 0.543, P < .001), and patients with endoscopic disease had higher median FC concentrations (689 vs. 99 mcg/g; P < .001).

The researchers calculated that a cutoff value of FC levels greater than 413 mcg/g is optimal for predicting endoscopic disease, with a sensitivity of 75%, a specificity of 76%, a positive likelihood ratio of 3.12, and a negative likelihood ratio of 0.33.
 

Diabeteslike home monitoring for IBD?

“Home monitoring of disease activity and drug levels will be a paradigm shift in management of IBD, because it will place in the patient’s hands the opportunity to assess their disease activity and to have a better understanding of what’s going on when they have symptoms or concerns about their disease control,” commented David Rubin, MD, who did not participate in the study.

He noted that patients are often unsure whether a new symptom is the beginning of another episode of IBD or something unrelated.

“One of the biggest challenges of having IBD is just the perception of loss of control of the disease and knowing when things are going to happen,” said Dr. Rubin, a professor of medicine and the codirector of the digestive diseases center at the University of Chicago, and the chair of the scientific advisory committee for the Crohn’s & Colitis Foundation. “I often explain to people that using a tool like this would be similar to patients with diabetes checking their blood sugar – getting a feel for what’s actually happening closer to the time that it’s happening, rather than waiting for it to progress. I really think that the general idea of home monitoring is going to be a major advance in our field.”

Although the new study proved the technique’s acceptability and efficacy, it isn’t without pitfalls, according to Dr. Rubin. False positives or negatives are a concern, and other factors might influence the results. For example, proton pump inhibitors can increase FC levels. Another concern is that some patients can become obsessed with their FC levels, and may want to test themselves at any sign of illness. They may develop unrealistic expectations about the impact of medications on their FC levels.

“That’s going to open up a whole dialogue with people, so that we all are on the same page about it. But I think that the benefits of having this far outweigh those potential risks,” said Dr. Rubin.

The authors reported no conflicts of interest. Dr. Rubin has consulted for TECHLAB.

In a real-life setting, fecal calprotectin (FC) home testing performed well at predicting disease endoscopic activity in patients with inflammatory bowel disease (IBD) being treated with adalimumab.

The study published in the European Journal of Gastroenterology & Hepatology, could be a boon to patients and physicians employing the treat-to-target (T2T) strategy, which relies on disease monitoring through methods like endoscopy, histology, and serum and fecal biomarkers.

One goal of T2T is to identify patients who are asymptomatic in order to prevent or minimize flare-ups. Colonoscopy is the preferred approach for achieving this, but cost, risk, and patient reluctance limit its use. FC has gained attention in recent years, as it outperforms serum biomarkers in its correlation with clinical, endoscopic, and histological disease activity. Consecutive FC measurements predict disease relapse among asymptomatic patients with high specificity and sensitivity. There’s also evidence that it could be useful for perioperative monitoring.

FC is typically assessed in a lab, but the recent availability of smartphone-based tests has allowed patients to collect and test their stool at home. The method has been tested through clinical research, but real-world data have so far been lacking.
 

First real-life results

In what they described as the first real-life study of its kind, researchers offered at-home FC testing every 4 months to all 72 current IBD patients taking adalimumab at the University Hospital of Heraklion, University of Crete, Irakleio, Greece; seven patients (10%) declined to take part in at-home FC testing. Of the remaining 65, the mean age was 42.3 years, and 58% were male; 89% had a diagnosis of Crohn’s disease. The mean disease duration was 13.3 years.

Abnormal FC values were confirmed with a follow-up test 1 month later, after which point a colonoscopy was scheduled to inform treatment modification. Twenty-four patients (37% of the population) had two positive tests, and 19 who were able underwent colonoscopy. Twelve patients (19%) underwent adalimumab dose intensification, 9 (14%) switched to a different biologic, and 2 (3%) had surgery.

The group of patients who required treatment modification had a significantly higher median FC concentration of 761 mcg/g (37% had values ≥ 1,000 mcg/g), compared with a median concentration of 108 mcg/g for those who did not have their dose modified (P < .0001). With a cutoff of 250 mcg/g, FC correctly identified a need for treatment with an area under the receiver operating characteristic curve (AUC) value of 0.90 (95% confidence interval, 0.80-0.96).

FC was significantly correlated to endoscopic activity (r = 0.543, P < .001), and patients with endoscopic disease had higher median FC concentrations (689 vs. 99 mcg/g; P < .001).

The researchers calculated that a cutoff value of FC levels greater than 413 mcg/g is optimal for predicting endoscopic disease, with a sensitivity of 75%, a specificity of 76%, a positive likelihood ratio of 3.12, and a negative likelihood ratio of 0.33.
 

Diabeteslike home monitoring for IBD?

“Home monitoring of disease activity and drug levels will be a paradigm shift in management of IBD, because it will place in the patient’s hands the opportunity to assess their disease activity and to have a better understanding of what’s going on when they have symptoms or concerns about their disease control,” commented David Rubin, MD, who did not participate in the study.

He noted that patients are often unsure whether a new symptom is the beginning of another episode of IBD or something unrelated.

“One of the biggest challenges of having IBD is just the perception of loss of control of the disease and knowing when things are going to happen,” said Dr. Rubin, a professor of medicine and the codirector of the digestive diseases center at the University of Chicago, and the chair of the scientific advisory committee for the Crohn’s & Colitis Foundation. “I often explain to people that using a tool like this would be similar to patients with diabetes checking their blood sugar – getting a feel for what’s actually happening closer to the time that it’s happening, rather than waiting for it to progress. I really think that the general idea of home monitoring is going to be a major advance in our field.”

Although the new study proved the technique’s acceptability and efficacy, it isn’t without pitfalls, according to Dr. Rubin. False positives or negatives are a concern, and other factors might influence the results. For example, proton pump inhibitors can increase FC levels. Another concern is that some patients can become obsessed with their FC levels, and may want to test themselves at any sign of illness. They may develop unrealistic expectations about the impact of medications on their FC levels.

“That’s going to open up a whole dialogue with people, so that we all are on the same page about it. But I think that the benefits of having this far outweigh those potential risks,” said Dr. Rubin.

The authors reported no conflicts of interest. Dr. Rubin has consulted for TECHLAB.

WASHINGTON – Those who self-identify as Hispanic or Black have a lower self-perceived risk of melanoma. In fact, people of color receive little to no information concerning skin cancer risks and prevention strategies and experience a longer time from diagnosis to definitive surgery, resulting in far worse outcomes, compared with non-Hispanic Whites.

This disparity is reflected in statistics showing that the average 5-year survival rate for melanoma is 92% in White patients but drops down to 67% in Black patients. Low income is also a contributing factor: Patients with lower incomes experience greater difficulty accessing health care and have greater time to diagnosis and a worse prognosis and survival time with melanoma. Despite economic advancements, Black Americans are still economically deprived when compared with White Americans.

This reality is what led Sarah Millan, a 4th-year medical student at George Washington University, Washington, to focus on the Ward 8 community in Washington – one of the poorest regions in our nation’s capital – well known for limited access to medical care and referred to as a health care desert. “Ward 8 has a population that is 92% Black and does not have a single dermatology clinic in the vicinity – my vision was to bring together the community through an enjoyable attraction conducive to the delivery of quality dermatologic care and education to a community that has none,” said Ms. Millan.

This low-resource population that is socioeconomically and geographically isolated is likely unaware of skin cancer risks, prevention strategies, and signs or symptoms that would warrant a visit to the dermatologist.

In light of these inequalities, “Learn2Derm: Skin Cancer Prevention Fair” was born – an attempt to close this disparity through educational interventions focused on skin cancer presentation, prevention, and early detection, while also exploring the attitudes and behaviors around skin cancer and sunscreen use in the community through data collected from optional surveys.

On Saturday, July 10, 2021, dermatologists from George Washington University, department of dermatology and medical students from George Washington School of Medicine and Health Sciences and Howard University College of Medicine in Washington, transformed Martha’s Outfitters in Ward 8 into a decorated, music-filled venue. Part of the Ward 8 council member’s 40 Days of Peace initiative, the Learn2Derm fair provided free skin cancer screenings by dermatologists, while students staffed various stations, delivering fun and interactive educational lessons organized by Ms. Millan under the mentorship of Adam Friedman, MD, chair of dermatology at George Washington University.

1: Harvey VM et al. Cancer Control. 2014 Oct;21(4):343-9.

2: Tripathi R et al. J Am Acad Dermatol. 2020 Sep;83(3):854-9.

3. Beyer Don. “The Economic State of Black America in 2020” U.S. Congress: Joint Economic Committee.

4. Culp MaryBeth B and Lunsford Natasha Buchanan. “Melanoma Among Non-Hispanic Black Americans” Prev Chronic Dis;16. 2019 Jun 20. doi: 10.5888/pcd16.180640.

5. “Ask the Expert: Is There a Skin Cancer Crisis in People of Color?” The Skin Cancer Foundation. 2020 Jul 5.

6. Salvaggio C et al. Oncology. 2016;90(2):79-87.
 

WASHINGTON – Those who self-identify as Hispanic or Black have a lower self-perceived risk of melanoma. In fact, people of color receive little to no information concerning skin cancer risks and prevention strategies and experience a longer time from diagnosis to definitive surgery, resulting in far worse outcomes, compared with non-Hispanic Whites.

This disparity is reflected in statistics showing that the average 5-year survival rate for melanoma is 92% in White patients but drops down to 67% in Black patients. Low income is also a contributing factor: Patients with lower incomes experience greater difficulty accessing health care and have greater time to diagnosis and a worse prognosis and survival time with melanoma. Despite economic advancements, Black Americans are still economically deprived when compared with White Americans.

This reality is what led Sarah Millan, a 4th-year medical student at George Washington University, Washington, to focus on the Ward 8 community in Washington – one of the poorest regions in our nation’s capital – well known for limited access to medical care and referred to as a health care desert. “Ward 8 has a population that is 92% Black and does not have a single dermatology clinic in the vicinity – my vision was to bring together the community through an enjoyable attraction conducive to the delivery of quality dermatologic care and education to a community that has none,” said Ms. Millan.

This low-resource population that is socioeconomically and geographically isolated is likely unaware of skin cancer risks, prevention strategies, and signs or symptoms that would warrant a visit to the dermatologist.

In light of these inequalities, “Learn2Derm: Skin Cancer Prevention Fair” was born – an attempt to close this disparity through educational interventions focused on skin cancer presentation, prevention, and early detection, while also exploring the attitudes and behaviors around skin cancer and sunscreen use in the community through data collected from optional surveys.

On Saturday, July 10, 2021, dermatologists from George Washington University, department of dermatology and medical students from George Washington School of Medicine and Health Sciences and Howard University College of Medicine in Washington, transformed Martha’s Outfitters in Ward 8 into a decorated, music-filled venue. Part of the Ward 8 council member’s 40 Days of Peace initiative, the Learn2Derm fair provided free skin cancer screenings by dermatologists, while students staffed various stations, delivering fun and interactive educational lessons organized by Ms. Millan under the mentorship of Adam Friedman, MD, chair of dermatology at George Washington University.

1: Harvey VM et al. Cancer Control. 2014 Oct;21(4):343-9.

2: Tripathi R et al. J Am Acad Dermatol. 2020 Sep;83(3):854-9.

3. Beyer Don. “The Economic State of Black America in 2020” U.S. Congress: Joint Economic Committee.

4. Culp MaryBeth B and Lunsford Natasha Buchanan. “Melanoma Among Non-Hispanic Black Americans” Prev Chronic Dis;16. 2019 Jun 20. doi: 10.5888/pcd16.180640.

5. “Ask the Expert: Is There a Skin Cancer Crisis in People of Color?” The Skin Cancer Foundation. 2020 Jul 5.

6. Salvaggio C et al. Oncology. 2016;90(2):79-87.
 

WASHINGTON – Those who self-identify as Hispanic or Black have a lower self-perceived risk of melanoma. In fact, people of color receive little to no information concerning skin cancer risks and prevention strategies and experience a longer time from diagnosis to definitive surgery, resulting in far worse outcomes, compared with non-Hispanic Whites.

This disparity is reflected in statistics showing that the average 5-year survival rate for melanoma is 92% in White patients but drops down to 67% in Black patients. Low income is also a contributing factor: Patients with lower incomes experience greater difficulty accessing health care and have greater time to diagnosis and a worse prognosis and survival time with melanoma. Despite economic advancements, Black Americans are still economically deprived when compared with White Americans.

This reality is what led Sarah Millan, a 4th-year medical student at George Washington University, Washington, to focus on the Ward 8 community in Washington – one of the poorest regions in our nation’s capital – well known for limited access to medical care and referred to as a health care desert. “Ward 8 has a population that is 92% Black and does not have a single dermatology clinic in the vicinity – my vision was to bring together the community through an enjoyable attraction conducive to the delivery of quality dermatologic care and education to a community that has none,” said Ms. Millan.

This low-resource population that is socioeconomically and geographically isolated is likely unaware of skin cancer risks, prevention strategies, and signs or symptoms that would warrant a visit to the dermatologist.

In light of these inequalities, “Learn2Derm: Skin Cancer Prevention Fair” was born – an attempt to close this disparity through educational interventions focused on skin cancer presentation, prevention, and early detection, while also exploring the attitudes and behaviors around skin cancer and sunscreen use in the community through data collected from optional surveys.

On Saturday, July 10, 2021, dermatologists from George Washington University, department of dermatology and medical students from George Washington School of Medicine and Health Sciences and Howard University College of Medicine in Washington, transformed Martha’s Outfitters in Ward 8 into a decorated, music-filled venue. Part of the Ward 8 council member’s 40 Days of Peace initiative, the Learn2Derm fair provided free skin cancer screenings by dermatologists, while students staffed various stations, delivering fun and interactive educational lessons organized by Ms. Millan under the mentorship of Adam Friedman, MD, chair of dermatology at George Washington University.

1: Harvey VM et al. Cancer Control. 2014 Oct;21(4):343-9.

2: Tripathi R et al. J Am Acad Dermatol. 2020 Sep;83(3):854-9.

3. Beyer Don. “The Economic State of Black America in 2020” U.S. Congress: Joint Economic Committee.

4. Culp MaryBeth B and Lunsford Natasha Buchanan. “Melanoma Among Non-Hispanic Black Americans” Prev Chronic Dis;16. 2019 Jun 20. doi: 10.5888/pcd16.180640.

5. “Ask the Expert: Is There a Skin Cancer Crisis in People of Color?” The Skin Cancer Foundation. 2020 Jul 5.

6. Salvaggio C et al. Oncology. 2016;90(2):79-87.
 

Pimavanserin, a novel antipsychotic drug used to manage hallucinations and delusions in Parkinson’s disease, may lead to increased hospitalizations and deaths, according to a new study.

A retrospective cohort study of elderly patients with Parkinson’s disease who were in long-term care facilities found that the use of pimavanserin (Nuplazid) was associated with an increased risk of 30-day hospitalization and mortality for up to a year.

“Given that a previous study showed typical and atypical antipsychotics more than doubled mortality risk in patients with Parkinson’s disease, we aimed to assess the risk of hospitalization and death associated with pimavanserin,” wrote lead author Y. Joseph Hwang, MD, Johns Hopkins University, Baltimore, and colleagues in the paper. “These findings, in a large real-world cohort within long-term care facilities, may help to inform decisions regarding its risk-benefit balance among patients with Parkinson’s disease.”

The findings were published online Aug. 13 in Neurology.

The researchers enrolled 2,186 patients with Parkinson’s disease aged 65 years and older in Medicare-certified long-term care facilities who also had a pimavanserin prescription and 18,212 nonusers of pimavanserin between Nov. 1, 2015, and December 31, 2018. Patients in the pimavanserin group used the drug over the course of the entire study period. Hospitalization and mortality were calculated from the date of pimavanserin prescription. Propensity score–based inverse probability of treatment weighting (IPTW) was used to balance the two groups on 24 baseline characteristics such as age, sex, and comorbidities.

Pimavanserin use was associated with a 24% higher risk of 30-day hospitalization (adjusted hazard ratio, 1.24; 95% confidence interval, 1.06-1.43). However, “the association did not reach statistical significance in a smaller subcohort of propensity score-matched users and nonusers,” Dr. Hwang and colleagues wrote.

Pimavanserin use was also linked to higher mortality at:

• 90 days (aHR, 1.20; 95% CI, 1.02-1.41).
• 180 days (aHR, 1.28; 95% CI, 1.13-1.45).
• 365 days (aHR, 1.56; 95% CI, 1.42-1.72).

No associations were found between pimavanserin use and 90-day hospitalization (aHR, 1.10; 95% CI, 0.99-1.24) nor with 30-day mortality (aHR, 0.76; 95% CI, 0.56-1.03).
 

Important considerations

“This study raises three important points to consider for any practicing neurology provider: 1) how to address and interpret risks associated with pimavanserin use in this patient population 2) utility of pimavanserin 3) interpretation of data showing increased mortality in patients being treated for Parkinson’s disease psychosis,” wrote Farwa Ali, MBBS, of the Mayo Clinic, Rochester, Minn., in an accompanying editorial published in Neurology.

Hallucinations and delusions are highly prevalent in Parkinson’s disease; as many as 60% of patients will develop psychosis over the course of their illness. Pimavanserin is a selective serotonin inverse agonist which targets 5-HT_2A serotonin receptors in the brain, decreasing their activity in order to attenuate hallucinations and delusions.

“Pimavanserin has been approved by the FDA [Food and Drug Administration] for Parkinson’s disease psychosis, but its safety has been called into question based on previous reports of increased mortality risk, compared with a rather modest benefit seen in a 6-week clinical trial, the duration of which limits determination of long-term safety,” wrote Dr. Ali.

Pimavanserin carries a boxed warning that elderly patients with dementia may be at an increased risk of death. After its approval in 2016, the U.S. FDA later reviewed 893 deaths in association with pimavanserin during the postmarketing surveillance period – “an unexpected number in a new drug,” Dr. Hwang and colleagues noted. “It [the FDA] noted that most reports occurred in a population with high underlying death rates and did not signal any additional risk beyond the current warning for all antipsychotics, which could have resulted in annual mortality rates of up to 60%.”

As the first cohort study to examine hospitalization and death between pimavanserin users and nonusers, “the study confirms previous concerns regarding safety of pimavanserin and more importantly brings to attention the importance of carefully considering risks and benefits of pharmacotherapy in Parkinson’s disease psychosis, clear communication with patients and families, and close observation to ensure safety,” wrote Dr. Ali.

The study limitations include its observational design, which subjected the findings to residual confounding.

“While we developed models to maximize the strength of causal inference, our comparison group was pimavanserin nonusers and the very reason for prescription of pimavanserin could have predisposed its users to the outcomes of hospitalization and death, introducing confounding by indication,” Dr. Hwang and colleagues wrote in the paper.

Additionally, “while robust analyses were conducted to ensure pimavanserin users and nonusers were comparable, Dr. Hwang et al. did find that pimavanserin users were more likely to concomitantly use other antipsychotic drugs which has been demonstrated as increasing the mortality risk,” Dr. Ali pointed out.

Since patients living in long-term care facilities may have a higher risk of mortality because of more severe or later-stage Parkinson’s disease, the study results “may not be generalizable to community-dwelling PD patients,” Dr. Ali wrote. “These factors are important to consider while making individual management decisions.”

Dr. Hwang and Dr. Ali disclosed no relevant financial relationships. The study authors reported no targeted funding.

Pimavanserin, a novel antipsychotic drug used to manage hallucinations and delusions in Parkinson’s disease, may lead to increased hospitalizations and deaths, according to a new study.

A retrospective cohort study of elderly patients with Parkinson’s disease who were in long-term care facilities found that the use of pimavanserin (Nuplazid) was associated with an increased risk of 30-day hospitalization and mortality for up to a year.

“Given that a previous study showed typical and atypical antipsychotics more than doubled mortality risk in patients with Parkinson’s disease, we aimed to assess the risk of hospitalization and death associated with pimavanserin,” wrote lead author Y. Joseph Hwang, MD, Johns Hopkins University, Baltimore, and colleagues in the paper. “These findings, in a large real-world cohort within long-term care facilities, may help to inform decisions regarding its risk-benefit balance among patients with Parkinson’s disease.”

The findings were published online Aug. 13 in Neurology.

The researchers enrolled 2,186 patients with Parkinson’s disease aged 65 years and older in Medicare-certified long-term care facilities who also had a pimavanserin prescription and 18,212 nonusers of pimavanserin between Nov. 1, 2015, and December 31, 2018. Patients in the pimavanserin group used the drug over the course of the entire study period. Hospitalization and mortality were calculated from the date of pimavanserin prescription. Propensity score–based inverse probability of treatment weighting (IPTW) was used to balance the two groups on 24 baseline characteristics such as age, sex, and comorbidities.

Pimavanserin use was associated with a 24% higher risk of 30-day hospitalization (adjusted hazard ratio, 1.24; 95% confidence interval, 1.06-1.43). However, “the association did not reach statistical significance in a smaller subcohort of propensity score-matched users and nonusers,” Dr. Hwang and colleagues wrote.

Pimavanserin use was also linked to higher mortality at:

• 90 days (aHR, 1.20; 95% CI, 1.02-1.41).
• 180 days (aHR, 1.28; 95% CI, 1.13-1.45).
• 365 days (aHR, 1.56; 95% CI, 1.42-1.72).

No associations were found between pimavanserin use and 90-day hospitalization (aHR, 1.10; 95% CI, 0.99-1.24) nor with 30-day mortality (aHR, 0.76; 95% CI, 0.56-1.03).
 

Important considerations

“This study raises three important points to consider for any practicing neurology provider: 1) how to address and interpret risks associated with pimavanserin use in this patient population 2) utility of pimavanserin 3) interpretation of data showing increased mortality in patients being treated for Parkinson’s disease psychosis,” wrote Farwa Ali, MBBS, of the Mayo Clinic, Rochester, Minn., in an accompanying editorial published in Neurology.

Hallucinations and delusions are highly prevalent in Parkinson’s disease; as many as 60% of patients will develop psychosis over the course of their illness. Pimavanserin is a selective serotonin inverse agonist which targets 5-HT_2A serotonin receptors in the brain, decreasing their activity in order to attenuate hallucinations and delusions.

“Pimavanserin has been approved by the FDA [Food and Drug Administration] for Parkinson’s disease psychosis, but its safety has been called into question based on previous reports of increased mortality risk, compared with a rather modest benefit seen in a 6-week clinical trial, the duration of which limits determination of long-term safety,” wrote Dr. Ali.

Pimavanserin carries a boxed warning that elderly patients with dementia may be at an increased risk of death. After its approval in 2016, the U.S. FDA later reviewed 893 deaths in association with pimavanserin during the postmarketing surveillance period – “an unexpected number in a new drug,” Dr. Hwang and colleagues noted. “It [the FDA] noted that most reports occurred in a population with high underlying death rates and did not signal any additional risk beyond the current warning for all antipsychotics, which could have resulted in annual mortality rates of up to 60%.”

As the first cohort study to examine hospitalization and death between pimavanserin users and nonusers, “the study confirms previous concerns regarding safety of pimavanserin and more importantly brings to attention the importance of carefully considering risks and benefits of pharmacotherapy in Parkinson’s disease psychosis, clear communication with patients and families, and close observation to ensure safety,” wrote Dr. Ali.

The study limitations include its observational design, which subjected the findings to residual confounding.

“While we developed models to maximize the strength of causal inference, our comparison group was pimavanserin nonusers and the very reason for prescription of pimavanserin could have predisposed its users to the outcomes of hospitalization and death, introducing confounding by indication,” Dr. Hwang and colleagues wrote in the paper.

Additionally, “while robust analyses were conducted to ensure pimavanserin users and nonusers were comparable, Dr. Hwang et al. did find that pimavanserin users were more likely to concomitantly use other antipsychotic drugs which has been demonstrated as increasing the mortality risk,” Dr. Ali pointed out.

Since patients living in long-term care facilities may have a higher risk of mortality because of more severe or later-stage Parkinson’s disease, the study results “may not be generalizable to community-dwelling PD patients,” Dr. Ali wrote. “These factors are important to consider while making individual management decisions.”

Dr. Hwang and Dr. Ali disclosed no relevant financial relationships. The study authors reported no targeted funding.

Pimavanserin, a novel antipsychotic drug used to manage hallucinations and delusions in Parkinson’s disease, may lead to increased hospitalizations and deaths, according to a new study.

A retrospective cohort study of elderly patients with Parkinson’s disease who were in long-term care facilities found that the use of pimavanserin (Nuplazid) was associated with an increased risk of 30-day hospitalization and mortality for up to a year.

“Given that a previous study showed typical and atypical antipsychotics more than doubled mortality risk in patients with Parkinson’s disease, we aimed to assess the risk of hospitalization and death associated with pimavanserin,” wrote lead author Y. Joseph Hwang, MD, Johns Hopkins University, Baltimore, and colleagues in the paper. “These findings, in a large real-world cohort within long-term care facilities, may help to inform decisions regarding its risk-benefit balance among patients with Parkinson’s disease.”

The findings were published online Aug. 13 in Neurology.

The researchers enrolled 2,186 patients with Parkinson’s disease aged 65 years and older in Medicare-certified long-term care facilities who also had a pimavanserin prescription and 18,212 nonusers of pimavanserin between Nov. 1, 2015, and December 31, 2018. Patients in the pimavanserin group used the drug over the course of the entire study period. Hospitalization and mortality were calculated from the date of pimavanserin prescription. Propensity score–based inverse probability of treatment weighting (IPTW) was used to balance the two groups on 24 baseline characteristics such as age, sex, and comorbidities.

Pimavanserin use was associated with a 24% higher risk of 30-day hospitalization (adjusted hazard ratio, 1.24; 95% confidence interval, 1.06-1.43). However, “the association did not reach statistical significance in a smaller subcohort of propensity score-matched users and nonusers,” Dr. Hwang and colleagues wrote.

Pimavanserin use was also linked to higher mortality at:

• 90 days (aHR, 1.20; 95% CI, 1.02-1.41).
• 180 days (aHR, 1.28; 95% CI, 1.13-1.45).
• 365 days (aHR, 1.56; 95% CI, 1.42-1.72).

No associations were found between pimavanserin use and 90-day hospitalization (aHR, 1.10; 95% CI, 0.99-1.24) nor with 30-day mortality (aHR, 0.76; 95% CI, 0.56-1.03).
 

Important considerations

“This study raises three important points to consider for any practicing neurology provider: 1) how to address and interpret risks associated with pimavanserin use in this patient population 2) utility of pimavanserin 3) interpretation of data showing increased mortality in patients being treated for Parkinson’s disease psychosis,” wrote Farwa Ali, MBBS, of the Mayo Clinic, Rochester, Minn., in an accompanying editorial published in Neurology.

Hallucinations and delusions are highly prevalent in Parkinson’s disease; as many as 60% of patients will develop psychosis over the course of their illness. Pimavanserin is a selective serotonin inverse agonist which targets 5-HT_2A serotonin receptors in the brain, decreasing their activity in order to attenuate hallucinations and delusions.

“Pimavanserin has been approved by the FDA [Food and Drug Administration] for Parkinson’s disease psychosis, but its safety has been called into question based on previous reports of increased mortality risk, compared with a rather modest benefit seen in a 6-week clinical trial, the duration of which limits determination of long-term safety,” wrote Dr. Ali.

Pimavanserin carries a boxed warning that elderly patients with dementia may be at an increased risk of death. After its approval in 2016, the U.S. FDA later reviewed 893 deaths in association with pimavanserin during the postmarketing surveillance period – “an unexpected number in a new drug,” Dr. Hwang and colleagues noted. “It [the FDA] noted that most reports occurred in a population with high underlying death rates and did not signal any additional risk beyond the current warning for all antipsychotics, which could have resulted in annual mortality rates of up to 60%.”

As the first cohort study to examine hospitalization and death between pimavanserin users and nonusers, “the study confirms previous concerns regarding safety of pimavanserin and more importantly brings to attention the importance of carefully considering risks and benefits of pharmacotherapy in Parkinson’s disease psychosis, clear communication with patients and families, and close observation to ensure safety,” wrote Dr. Ali.

The study limitations include its observational design, which subjected the findings to residual confounding.

“While we developed models to maximize the strength of causal inference, our comparison group was pimavanserin nonusers and the very reason for prescription of pimavanserin could have predisposed its users to the outcomes of hospitalization and death, introducing confounding by indication,” Dr. Hwang and colleagues wrote in the paper.

Additionally, “while robust analyses were conducted to ensure pimavanserin users and nonusers were comparable, Dr. Hwang et al. did find that pimavanserin users were more likely to concomitantly use other antipsychotic drugs which has been demonstrated as increasing the mortality risk,” Dr. Ali pointed out.

Since patients living in long-term care facilities may have a higher risk of mortality because of more severe or later-stage Parkinson’s disease, the study results “may not be generalizable to community-dwelling PD patients,” Dr. Ali wrote. “These factors are important to consider while making individual management decisions.”

Dr. Hwang and Dr. Ali disclosed no relevant financial relationships. The study authors reported no targeted funding.