The heart-related manifestations of COVID-19 are a serious matter, but no one should make the mistake of thinking of COVID-19 as primarily a cardiac disease, according to Jeffrey C. Trost, MD, a cardiologist at Johns Hopkins University, Baltimore.

“One of my take-home messages is this is not a heart illness. This is still an infectious pulmonary illness that most likely causes stress on the heart in both healthy people and those with preexisting heart disease,” he said in offering a preview of his upcoming clinical update at HM20 Virtual, hosted by the Society of Hospital Medicine.

For this reason, in his clinical update talk, titled “COVID-19 and the Heart: What Every Hospitalist Should Know,” he’ll urge hospitalists to be conservative in ordering cardiac biomarker tests such troponin and natriuretic peptide levels. The focus should appropriately be on the subset of COVID-19 patients having the same symptoms suggestive of acute coronary syndrome, heart failure, or new-onset cardiomyopathy that would trigger laboratory testing in non–COVID-19 patients.

“Be more selective. Definitely do not routinely monitor troponin or [N-terminal of the prohormone brain natriuretic peptide] in patients just because they have COVID-19. A lot of patients with COVID-19 have these labs drawn, especially in the emergency department. We see a high signal-to-noise ratio: not infrequently the values are abnormal, and yet we don’t really know what that means,” said Dr. Trost, who is also director of the cardiac catheterization laboratory at Johns Hopkins Bayview Medical Center.

COVID-19 patients with preexisting heart disease are clearly at increased risk of severe forms of the infectious illness. In his talk, Dr. Trost will review the epidemiology of this association. He’ll also discuss the varied cardiac manifestations of COVID-19, consisting of myocarditis or other forms of new-onset cardiomyopathy, acute coronary syndrome, heart failure, and arrhythmias.

Many questions regarding COVID-19 and the heart remain unanswered for now, such as the mechanism and long-term implications of the phenomenon of ST-elevation acute coronary syndrome with chest pain in the presence of unobstructed coronary arteries, which Dr. Trost and others have encountered. Or the extent to which COVID-19–associated myocarditis is directly virus mediated as opposed to an autoimmune process.

“We’re relying completely on case reports at this point,” according to the cardiologist.

But one major issue has, thankfully, been put to rest on the basis of persuasive evidence which Dr. Trost plans to highlight: Millions of patients on ACE inhibitors or angiotensin receptor blockers can now rest assured that taking those medications doesn’t place them at increased risk of becoming infected with the novel coronavirus or, if infected, developing severe complications of COVID-19. Earlier in the pandemic that had been a legitimate theoretic concern based upon a plausible mechanism.

“I think we as physicians can now confidently say that we don’t need to stop these medicines in folks,” Dr. Trost said.

COVID-19 and the Heart: What Every Hospitalist Should Know

Live Q&A: Wednesday, Aug. 19, 3:30 p.m. to 4:30 p.m. ET

The heart-related manifestations of COVID-19 are a serious matter, but no one should make the mistake of thinking of COVID-19 as primarily a cardiac disease, according to Jeffrey C. Trost, MD, a cardiologist at Johns Hopkins University, Baltimore.

“One of my take-home messages is this is not a heart illness. This is still an infectious pulmonary illness that most likely causes stress on the heart in both healthy people and those with preexisting heart disease,” he said in offering a preview of his upcoming clinical update at HM20 Virtual, hosted by the Society of Hospital Medicine.

For this reason, in his clinical update talk, titled “COVID-19 and the Heart: What Every Hospitalist Should Know,” he’ll urge hospitalists to be conservative in ordering cardiac biomarker tests such troponin and natriuretic peptide levels. The focus should appropriately be on the subset of COVID-19 patients having the same symptoms suggestive of acute coronary syndrome, heart failure, or new-onset cardiomyopathy that would trigger laboratory testing in non–COVID-19 patients.

“Be more selective. Definitely do not routinely monitor troponin or [N-terminal of the prohormone brain natriuretic peptide] in patients just because they have COVID-19. A lot of patients with COVID-19 have these labs drawn, especially in the emergency department. We see a high signal-to-noise ratio: not infrequently the values are abnormal, and yet we don’t really know what that means,” said Dr. Trost, who is also director of the cardiac catheterization laboratory at Johns Hopkins Bayview Medical Center.

COVID-19 patients with preexisting heart disease are clearly at increased risk of severe forms of the infectious illness. In his talk, Dr. Trost will review the epidemiology of this association. He’ll also discuss the varied cardiac manifestations of COVID-19, consisting of myocarditis or other forms of new-onset cardiomyopathy, acute coronary syndrome, heart failure, and arrhythmias.

Many questions regarding COVID-19 and the heart remain unanswered for now, such as the mechanism and long-term implications of the phenomenon of ST-elevation acute coronary syndrome with chest pain in the presence of unobstructed coronary arteries, which Dr. Trost and others have encountered. Or the extent to which COVID-19–associated myocarditis is directly virus mediated as opposed to an autoimmune process.

“We’re relying completely on case reports at this point,” according to the cardiologist.

But one major issue has, thankfully, been put to rest on the basis of persuasive evidence which Dr. Trost plans to highlight: Millions of patients on ACE inhibitors or angiotensin receptor blockers can now rest assured that taking those medications doesn’t place them at increased risk of becoming infected with the novel coronavirus or, if infected, developing severe complications of COVID-19. Earlier in the pandemic that had been a legitimate theoretic concern based upon a plausible mechanism.

“I think we as physicians can now confidently say that we don’t need to stop these medicines in folks,” Dr. Trost said.

COVID-19 and the Heart: What Every Hospitalist Should Know

Live Q&A: Wednesday, Aug. 19, 3:30 p.m. to 4:30 p.m. ET

The heart-related manifestations of COVID-19 are a serious matter, but no one should make the mistake of thinking of COVID-19 as primarily a cardiac disease, according to Jeffrey C. Trost, MD, a cardiologist at Johns Hopkins University, Baltimore.

“One of my take-home messages is this is not a heart illness. This is still an infectious pulmonary illness that most likely causes stress on the heart in both healthy people and those with preexisting heart disease,” he said in offering a preview of his upcoming clinical update at HM20 Virtual, hosted by the Society of Hospital Medicine.

For this reason, in his clinical update talk, titled “COVID-19 and the Heart: What Every Hospitalist Should Know,” he’ll urge hospitalists to be conservative in ordering cardiac biomarker tests such troponin and natriuretic peptide levels. The focus should appropriately be on the subset of COVID-19 patients having the same symptoms suggestive of acute coronary syndrome, heart failure, or new-onset cardiomyopathy that would trigger laboratory testing in non–COVID-19 patients.

“Be more selective. Definitely do not routinely monitor troponin or [N-terminal of the prohormone brain natriuretic peptide] in patients just because they have COVID-19. A lot of patients with COVID-19 have these labs drawn, especially in the emergency department. We see a high signal-to-noise ratio: not infrequently the values are abnormal, and yet we don’t really know what that means,” said Dr. Trost, who is also director of the cardiac catheterization laboratory at Johns Hopkins Bayview Medical Center.

COVID-19 patients with preexisting heart disease are clearly at increased risk of severe forms of the infectious illness. In his talk, Dr. Trost will review the epidemiology of this association. He’ll also discuss the varied cardiac manifestations of COVID-19, consisting of myocarditis or other forms of new-onset cardiomyopathy, acute coronary syndrome, heart failure, and arrhythmias.

Many questions regarding COVID-19 and the heart remain unanswered for now, such as the mechanism and long-term implications of the phenomenon of ST-elevation acute coronary syndrome with chest pain in the presence of unobstructed coronary arteries, which Dr. Trost and others have encountered. Or the extent to which COVID-19–associated myocarditis is directly virus mediated as opposed to an autoimmune process.

“We’re relying completely on case reports at this point,” according to the cardiologist.

But one major issue has, thankfully, been put to rest on the basis of persuasive evidence which Dr. Trost plans to highlight: Millions of patients on ACE inhibitors or angiotensin receptor blockers can now rest assured that taking those medications doesn’t place them at increased risk of becoming infected with the novel coronavirus or, if infected, developing severe complications of COVID-19. Earlier in the pandemic that had been a legitimate theoretic concern based upon a plausible mechanism.

“I think we as physicians can now confidently say that we don’t need to stop these medicines in folks,” Dr. Trost said.

COVID-19 and the Heart: What Every Hospitalist Should Know

Live Q&A: Wednesday, Aug. 19, 3:30 p.m. to 4:30 p.m. ET

This pink raised nodule underlying a scaly surface was suspicious for squamous cell carcinoma (SCC). Since this was a virtual visit, and the lesion required pathology due to the likelihood of cancer, the patient was brought into the clinic for additional evaluation. A broad-based deep shave biopsy was performed to remove the visible lesion. Pathology showed SCC in situ, with borders uninvolved.

Patients who have had AKs are extremely likely to develop additional AKs. A notable percentage of AKs will, over time, develop into SCC in situ and then invasive SCC if not treated. While cryosurgery of an SK should not result in SCC, it’s most likely that in this case, an AK adjacent to the SK progressed to the SCC in situ.

There are multiple treatments available for SCC in situ. Topical imiquimod has been shown to be somewhat effective in stimulating the immune system, thus leading to resolution of SCC in situ. But there is a significant risk of recurrence. Topical 5-FU can be utilized on a daily or twice daily basis for 2 weeks (or up to several months). The risk of recurrence ranges from 7% to 33%. Electrodesiccation and curettage is often used for SCC in situ, with recurrence rates of 2% to 19%. Cryosurgery for SCC in situ requires an aggressive freeze, with freeze times of up to 30 seconds. Photodynamic therapy also is an option; however, it requires multiple sessions and is more costly than other treatment options.

This patient’s borders were uninvolved on pathology, but it was possible that there was some residual SCC in situ due to the standard “bread loaf slicing” used for routine pathology. To treat possible residual SCC in situ at the wound site and surrounding tissue, the patient was given a prescription for topical 5-FU to apply twice daily for 6 weeks. The patient was instructed to return for follow-up in 6 months, or sooner, if any problems arose.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

This pink raised nodule underlying a scaly surface was suspicious for squamous cell carcinoma (SCC). Since this was a virtual visit, and the lesion required pathology due to the likelihood of cancer, the patient was brought into the clinic for additional evaluation. A broad-based deep shave biopsy was performed to remove the visible lesion. Pathology showed SCC in situ, with borders uninvolved.

Patients who have had AKs are extremely likely to develop additional AKs. A notable percentage of AKs will, over time, develop into SCC in situ and then invasive SCC if not treated. While cryosurgery of an SK should not result in SCC, it’s most likely that in this case, an AK adjacent to the SK progressed to the SCC in situ.

There are multiple treatments available for SCC in situ. Topical imiquimod has been shown to be somewhat effective in stimulating the immune system, thus leading to resolution of SCC in situ. But there is a significant risk of recurrence. Topical 5-FU can be utilized on a daily or twice daily basis for 2 weeks (or up to several months). The risk of recurrence ranges from 7% to 33%. Electrodesiccation and curettage is often used for SCC in situ, with recurrence rates of 2% to 19%. Cryosurgery for SCC in situ requires an aggressive freeze, with freeze times of up to 30 seconds. Photodynamic therapy also is an option; however, it requires multiple sessions and is more costly than other treatment options.

This patient’s borders were uninvolved on pathology, but it was possible that there was some residual SCC in situ due to the standard “bread loaf slicing” used for routine pathology. To treat possible residual SCC in situ at the wound site and surrounding tissue, the patient was given a prescription for topical 5-FU to apply twice daily for 6 weeks. The patient was instructed to return for follow-up in 6 months, or sooner, if any problems arose.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

This pink raised nodule underlying a scaly surface was suspicious for squamous cell carcinoma (SCC). Since this was a virtual visit, and the lesion required pathology due to the likelihood of cancer, the patient was brought into the clinic for additional evaluation. A broad-based deep shave biopsy was performed to remove the visible lesion. Pathology showed SCC in situ, with borders uninvolved.

Patients who have had AKs are extremely likely to develop additional AKs. A notable percentage of AKs will, over time, develop into SCC in situ and then invasive SCC if not treated. While cryosurgery of an SK should not result in SCC, it’s most likely that in this case, an AK adjacent to the SK progressed to the SCC in situ.

There are multiple treatments available for SCC in situ. Topical imiquimod has been shown to be somewhat effective in stimulating the immune system, thus leading to resolution of SCC in situ. But there is a significant risk of recurrence. Topical 5-FU can be utilized on a daily or twice daily basis for 2 weeks (or up to several months). The risk of recurrence ranges from 7% to 33%. Electrodesiccation and curettage is often used for SCC in situ, with recurrence rates of 2% to 19%. Cryosurgery for SCC in situ requires an aggressive freeze, with freeze times of up to 30 seconds. Photodynamic therapy also is an option; however, it requires multiple sessions and is more costly than other treatment options.

This patient’s borders were uninvolved on pathology, but it was possible that there was some residual SCC in situ due to the standard “bread loaf slicing” used for routine pathology. To treat possible residual SCC in situ at the wound site and surrounding tissue, the patient was given a prescription for topical 5-FU to apply twice daily for 6 weeks. The patient was instructed to return for follow-up in 6 months, or sooner, if any problems arose.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

Psoriasis is a chronic inflammatory skin disease that affects 2% to 3% of individuals worldwide.¹ Despite extensive research, the majority of clinical data are in white patients with limited data in patients of color, yet a number of differences are known. The prevalence of psoriasis differs among racial and ethnic groups, with lower prevalence in racial minorities.² A cross-sectional American study using data from 2009 through 2010 showed the prevalence for psoriasis was 3.6% in white patients, 1.9% in black patients, 1.6% in Hispanic patients, and 1.4% in other racial groups.³ Psoriasis presents differently in patients of color, both in morphology and severity. Cultural differences and stigma may contribute to the differences seen in severity but also to the psychological impact and treatment choices in patients of color compared to white patients.⁴ It has even been theorized that treatment efficacy could differ because of potential genetic differences.⁵ Psoriasis in patients of color is an emerging clinical issue that requires further attention so that dermatologists can learn about, diagnose, and treat them.

We report 3 cases of patients of color with psoriasis who presented to an urban and racially diverse dermatology clinic affiliated with Scarborough General Hospital in Toronto, Ontario, Canada. A retrospective chart review was performed on these high-yield representative cases to demonstrate differences in color and morphology, disease severity, and treatment in patients of various races seen at our clinic. After informed consent was obtained, photographs were taken of patient cutaneous findings to illustrate these differences. Discussion with these selected patients yielded supplementary qualitative data, highlighting individual perspectives of their disease.

Case Series

Patient 1
A 53-year-old black man from Grenada presented to our clinic with a history of psoriasis for a number of years that presented as violaceous plaques throughout large portions of the body (Figure 1). He previously had achieved inadequate results while using topical therapies, methotrexate, acitretin, apremilast, ustekinumab, ixekizumab, and guselkumab at adequate or even maximum doses. His disease affected 30% of the body surface area, with a psoriasis area and severity index score of 27 and a dermatology life quality index score of 23. The patient’s life was quite affected by psoriasis, with emphasis on choice of clothing worn and effect on body image. He also discussed the stigma psoriasis may have in black patients, stating that he has been told multiple times that “black people do not get psoriasis.”

Patient 2
A 27-year-old man from India presented with guttate psoriasis (Figure 2). He was treated with methotrexate 2 years prior and currently is on maintenance therapy with topical treatments alone. His main concerns pertained to the persistent dyschromia that occurred secondary to the psoriatic lesions. Through discussion, the patient stated that he “would do anything to get rid of it.”

Comment

Clinical differences in patients of color with psoriasis affect the management of the disease. Special consideration should be given to variances in morphology, presentation, treatment, and psychosocial factors in the management of psoriasis for these patient populations, as summarized in the eTable.

Morphology
At our clinic, patients of color have been found to have differences in morphology, including lesions that are more violaceous in color, as seen in patient 1; less noticeable inflammation; and more postinflammatory hypopigmentation and hyperpigmentation changes, as seen in patient 2. These changes are supported by the literature and differ from typical psoriasis plaques, which are pink-red and have more overlying scale. The varied morphology also may affect the differential, and other mimickers may be considered, such as lichen planus, cutaneous lupus erythematosus, and sarcoidosis.²

Presentation
There are differences in presentation among patients of color, particularly in distribution, type of psoriasis, and severity. As seen in patient 3, Asian and black patients are more likely to present with scalp psoriasis.^2,5 Hairstyling and hair care practices can differ considerably between racial groups. Given the differences in hairstyling, scalp psoriasis also may have a greater impact on patient quality of life (QOL).

Racial differences affect the type of psoriasis seen. Asian patients are more likely to present with pustular and erythrodermic psoriasis and less likely to present with inverse psoriasis compared to white patients. Hispanic patients are more likely to present with pustular psoriasis.¹¹ Black patients have been reported to have lower frequencies of psoriatic arthritis compared to white patients.¹² Recognition of these differences may help guide initial choice for therapeutics.

Notably, patients of color may present with much more severe psoriasis, particularly Asian and Hispanic patients.⁷ One retrospective study looking at patients with psoriasis treated with etanercept found that Asian patients were more likely to have greater baseline body surface area involvement.⁶ An American cross-sectional study reported higher psoriasis area and severity index scores in black patients compared to white patients,¹² possibly because patients of color do not normalize the experience of having psoriasis and feel stigmatized, which can cause delays in seeking medical attention and worsen disease burden. For patient 1, the stigma of black patients having psoriasis affected his body image and may have led to a delay in seeking medical attention due to him not believing it was possible for people of his skin color to have psoriasis. Increased disease severity may contribute to treatment resistance or numerous trials of topicals or biologics before the disease improves. Patient education in the community as well as patient support groups are paramount, and increased awareness of psoriasis can help improve disease management.

Treatment
Topical therapies are the first-line treatment of psoriasis. Although there is no evidence showing differences in topical treatment efficacy, patient preference for different topical treatments may vary based on race. For example, patients with Afro-textured hair may prefer foams and lotions and would avoid shampoo therapies, as frequent hair washing may not be feasible with certain hairstyles and may cause hair breakage or dryness.²

UV therapy can be an effective treatment modality for patients with psoriasis. The strength of therapy tends to be dictated by the Fitzpatrick skin phototype rather than race. Darker-skinned individuals may have an increased risk for hyperpigmentation, so caution should be taken to prevent burning during therapy. Suberythemogenic dosing—70% of minimal erythema dose—of narrowband UVB treatments has shown the same efficacy as using minimal erythema dose in patients with darker skin types in addition to fair-skinned patients.⁸

Although we found poor efficacy of systemic treatments in patient 1, to our knowledge, studies examining the efficacy of systemic therapeutic options have not shown differences in patients of color.^6,13 Studies show similar efficacy in treatments among races, particularly biologic therapies.⁵ However, patients with skin of color historically have been underrepresented in clinical trials,⁹ which may contribute to these patients, particularly black patients, being less familiar with biologics as a treatment option for psoriasis, as reported by Takeshita et al.¹⁰ Therefore, patient-centered discussions regarding treatment choices are important to ensure patients understand all options available to manage their disease.

Psychosocial Impact
Because of its chronic remitting course, psoriasis has a notable psychosocial impact on the lives of all patients, though the literature suggests there may be more of an impact on QOL in patients of color. Higher baseline dermatology life quality index scores have been reported in patients of color compared to white patients.⁶ Kerr et al¹² reported significantly greater psoriasis area and severity index scores (P=.06) and greater psychological impact in black patients compared to white patients. Stress also was more likely to be reported as a trigger for psoriasis in patients of Hispanic background compared to white patients.¹⁴ Many patients report body image issues with large physical lesions; however, the difference may lie in personal and cultural views about psoriasis, as one of our patients stated, “black people do not get psoriasis.” In addition to the cosmetic challenges that patients face with active lesions, postinflammatory pigmentary changes can be equally as burdensome to patients, as one of our patients stated he “would do anything to get rid of it.” Increased rates of depression and anxiety in patients of color can worsen their outlook on the condition.^15,16 The increased stigma and burden of psoriasis in patients of color calls for clinicians to counsel and address psoriasis in a holistic way and refer patients to psoriasis support groups when appropriate. Although the burden of psoriasis is clear, more studies can be carried out to investigate the impact on QOL in different ethnic populations.

Dermatology Education
Although differences have been found in patients of color with psoriasis, dissemination of this knowledge continues to be a challenge. In dermatology residency programs, the majority of teaching is provided with examples of skin diseases in white patients, which can complicate pattern recognition and diagnostic ability for trainees. Although dermatologists recognize that ethnic skin has unique dermatologic considerations, there is a persistent need for increasing skin of color education within dermatology residency programs.^17,18 Implementing more educational programs on skin of color has been proposed, and these programs will continue to be in demand as our population increasingly diversifies.¹⁹

Conclusion

Psoriasis in patients of color carries unique challenges when compared to psoriasis in white patients. Differences in morphology and presentation can make the disease difficult to accurately diagnose. These differences in addition to cultural differences may contribute to a greater impact on QOL and psychological health. Although treatment preferences and recognition may differ, treatment efficacy has so far been similar, albeit with a low proportion of patients with skin of color included in clinical trials.

Further focus should now lie within knowledge translation of these differences, which would normalize the condition for patients, support them seeking medical attention sooner, and inform them of all treatment options possible. For clinicians, more attention on the differences would help make earlier diagnoses, personalize physician-patient conversations, and advocate for further education on this issue in residency training programs.

Psoriasis is a chronic inflammatory skin disease that affects 2% to 3% of individuals worldwide.¹ Despite extensive research, the majority of clinical data are in white patients with limited data in patients of color, yet a number of differences are known. The prevalence of psoriasis differs among racial and ethnic groups, with lower prevalence in racial minorities.² A cross-sectional American study using data from 2009 through 2010 showed the prevalence for psoriasis was 3.6% in white patients, 1.9% in black patients, 1.6% in Hispanic patients, and 1.4% in other racial groups.³ Psoriasis presents differently in patients of color, both in morphology and severity. Cultural differences and stigma may contribute to the differences seen in severity but also to the psychological impact and treatment choices in patients of color compared to white patients.⁴ It has even been theorized that treatment efficacy could differ because of potential genetic differences.⁵ Psoriasis in patients of color is an emerging clinical issue that requires further attention so that dermatologists can learn about, diagnose, and treat them.

We report 3 cases of patients of color with psoriasis who presented to an urban and racially diverse dermatology clinic affiliated with Scarborough General Hospital in Toronto, Ontario, Canada. A retrospective chart review was performed on these high-yield representative cases to demonstrate differences in color and morphology, disease severity, and treatment in patients of various races seen at our clinic. After informed consent was obtained, photographs were taken of patient cutaneous findings to illustrate these differences. Discussion with these selected patients yielded supplementary qualitative data, highlighting individual perspectives of their disease.

Case Series

Patient 1
A 53-year-old black man from Grenada presented to our clinic with a history of psoriasis for a number of years that presented as violaceous plaques throughout large portions of the body (Figure 1). He previously had achieved inadequate results while using topical therapies, methotrexate, acitretin, apremilast, ustekinumab, ixekizumab, and guselkumab at adequate or even maximum doses. His disease affected 30% of the body surface area, with a psoriasis area and severity index score of 27 and a dermatology life quality index score of 23. The patient’s life was quite affected by psoriasis, with emphasis on choice of clothing worn and effect on body image. He also discussed the stigma psoriasis may have in black patients, stating that he has been told multiple times that “black people do not get psoriasis.”

Patient 2
A 27-year-old man from India presented with guttate psoriasis (Figure 2). He was treated with methotrexate 2 years prior and currently is on maintenance therapy with topical treatments alone. His main concerns pertained to the persistent dyschromia that occurred secondary to the psoriatic lesions. Through discussion, the patient stated that he “would do anything to get rid of it.”

Comment

Clinical differences in patients of color with psoriasis affect the management of the disease. Special consideration should be given to variances in morphology, presentation, treatment, and psychosocial factors in the management of psoriasis for these patient populations, as summarized in the eTable.

Morphology
At our clinic, patients of color have been found to have differences in morphology, including lesions that are more violaceous in color, as seen in patient 1; less noticeable inflammation; and more postinflammatory hypopigmentation and hyperpigmentation changes, as seen in patient 2. These changes are supported by the literature and differ from typical psoriasis plaques, which are pink-red and have more overlying scale. The varied morphology also may affect the differential, and other mimickers may be considered, such as lichen planus, cutaneous lupus erythematosus, and sarcoidosis.²

Presentation
There are differences in presentation among patients of color, particularly in distribution, type of psoriasis, and severity. As seen in patient 3, Asian and black patients are more likely to present with scalp psoriasis.^2,5 Hairstyling and hair care practices can differ considerably between racial groups. Given the differences in hairstyling, scalp psoriasis also may have a greater impact on patient quality of life (QOL).

Racial differences affect the type of psoriasis seen. Asian patients are more likely to present with pustular and erythrodermic psoriasis and less likely to present with inverse psoriasis compared to white patients. Hispanic patients are more likely to present with pustular psoriasis.¹¹ Black patients have been reported to have lower frequencies of psoriatic arthritis compared to white patients.¹² Recognition of these differences may help guide initial choice for therapeutics.

Notably, patients of color may present with much more severe psoriasis, particularly Asian and Hispanic patients.⁷ One retrospective study looking at patients with psoriasis treated with etanercept found that Asian patients were more likely to have greater baseline body surface area involvement.⁶ An American cross-sectional study reported higher psoriasis area and severity index scores in black patients compared to white patients,¹² possibly because patients of color do not normalize the experience of having psoriasis and feel stigmatized, which can cause delays in seeking medical attention and worsen disease burden. For patient 1, the stigma of black patients having psoriasis affected his body image and may have led to a delay in seeking medical attention due to him not believing it was possible for people of his skin color to have psoriasis. Increased disease severity may contribute to treatment resistance or numerous trials of topicals or biologics before the disease improves. Patient education in the community as well as patient support groups are paramount, and increased awareness of psoriasis can help improve disease management.

Treatment
Topical therapies are the first-line treatment of psoriasis. Although there is no evidence showing differences in topical treatment efficacy, patient preference for different topical treatments may vary based on race. For example, patients with Afro-textured hair may prefer foams and lotions and would avoid shampoo therapies, as frequent hair washing may not be feasible with certain hairstyles and may cause hair breakage or dryness.²

UV therapy can be an effective treatment modality for patients with psoriasis. The strength of therapy tends to be dictated by the Fitzpatrick skin phototype rather than race. Darker-skinned individuals may have an increased risk for hyperpigmentation, so caution should be taken to prevent burning during therapy. Suberythemogenic dosing—70% of minimal erythema dose—of narrowband UVB treatments has shown the same efficacy as using minimal erythema dose in patients with darker skin types in addition to fair-skinned patients.⁸

Although we found poor efficacy of systemic treatments in patient 1, to our knowledge, studies examining the efficacy of systemic therapeutic options have not shown differences in patients of color.^6,13 Studies show similar efficacy in treatments among races, particularly biologic therapies.⁵ However, patients with skin of color historically have been underrepresented in clinical trials,⁹ which may contribute to these patients, particularly black patients, being less familiar with biologics as a treatment option for psoriasis, as reported by Takeshita et al.¹⁰ Therefore, patient-centered discussions regarding treatment choices are important to ensure patients understand all options available to manage their disease.

Psychosocial Impact
Because of its chronic remitting course, psoriasis has a notable psychosocial impact on the lives of all patients, though the literature suggests there may be more of an impact on QOL in patients of color. Higher baseline dermatology life quality index scores have been reported in patients of color compared to white patients.⁶ Kerr et al¹² reported significantly greater psoriasis area and severity index scores (P=.06) and greater psychological impact in black patients compared to white patients. Stress also was more likely to be reported as a trigger for psoriasis in patients of Hispanic background compared to white patients.¹⁴ Many patients report body image issues with large physical lesions; however, the difference may lie in personal and cultural views about psoriasis, as one of our patients stated, “black people do not get psoriasis.” In addition to the cosmetic challenges that patients face with active lesions, postinflammatory pigmentary changes can be equally as burdensome to patients, as one of our patients stated he “would do anything to get rid of it.” Increased rates of depression and anxiety in patients of color can worsen their outlook on the condition.^15,16 The increased stigma and burden of psoriasis in patients of color calls for clinicians to counsel and address psoriasis in a holistic way and refer patients to psoriasis support groups when appropriate. Although the burden of psoriasis is clear, more studies can be carried out to investigate the impact on QOL in different ethnic populations.

Dermatology Education
Although differences have been found in patients of color with psoriasis, dissemination of this knowledge continues to be a challenge. In dermatology residency programs, the majority of teaching is provided with examples of skin diseases in white patients, which can complicate pattern recognition and diagnostic ability for trainees. Although dermatologists recognize that ethnic skin has unique dermatologic considerations, there is a persistent need for increasing skin of color education within dermatology residency programs.^17,18 Implementing more educational programs on skin of color has been proposed, and these programs will continue to be in demand as our population increasingly diversifies.¹⁹

Conclusion

Psoriasis in patients of color carries unique challenges when compared to psoriasis in white patients. Differences in morphology and presentation can make the disease difficult to accurately diagnose. These differences in addition to cultural differences may contribute to a greater impact on QOL and psychological health. Although treatment preferences and recognition may differ, treatment efficacy has so far been similar, albeit with a low proportion of patients with skin of color included in clinical trials.

Further focus should now lie within knowledge translation of these differences, which would normalize the condition for patients, support them seeking medical attention sooner, and inform them of all treatment options possible. For clinicians, more attention on the differences would help make earlier diagnoses, personalize physician-patient conversations, and advocate for further education on this issue in residency training programs.

Psoriasis is a chronic inflammatory skin disease that affects 2% to 3% of individuals worldwide.¹ Despite extensive research, the majority of clinical data are in white patients with limited data in patients of color, yet a number of differences are known. The prevalence of psoriasis differs among racial and ethnic groups, with lower prevalence in racial minorities.² A cross-sectional American study using data from 2009 through 2010 showed the prevalence for psoriasis was 3.6% in white patients, 1.9% in black patients, 1.6% in Hispanic patients, and 1.4% in other racial groups.³ Psoriasis presents differently in patients of color, both in morphology and severity. Cultural differences and stigma may contribute to the differences seen in severity but also to the psychological impact and treatment choices in patients of color compared to white patients.⁴ It has even been theorized that treatment efficacy could differ because of potential genetic differences.⁵ Psoriasis in patients of color is an emerging clinical issue that requires further attention so that dermatologists can learn about, diagnose, and treat them.

We report 3 cases of patients of color with psoriasis who presented to an urban and racially diverse dermatology clinic affiliated with Scarborough General Hospital in Toronto, Ontario, Canada. A retrospective chart review was performed on these high-yield representative cases to demonstrate differences in color and morphology, disease severity, and treatment in patients of various races seen at our clinic. After informed consent was obtained, photographs were taken of patient cutaneous findings to illustrate these differences. Discussion with these selected patients yielded supplementary qualitative data, highlighting individual perspectives of their disease.

Case Series

Patient 1
A 53-year-old black man from Grenada presented to our clinic with a history of psoriasis for a number of years that presented as violaceous plaques throughout large portions of the body (Figure 1). He previously had achieved inadequate results while using topical therapies, methotrexate, acitretin, apremilast, ustekinumab, ixekizumab, and guselkumab at adequate or even maximum doses. His disease affected 30% of the body surface area, with a psoriasis area and severity index score of 27 and a dermatology life quality index score of 23. The patient’s life was quite affected by psoriasis, with emphasis on choice of clothing worn and effect on body image. He also discussed the stigma psoriasis may have in black patients, stating that he has been told multiple times that “black people do not get psoriasis.”

Patient 2
A 27-year-old man from India presented with guttate psoriasis (Figure 2). He was treated with methotrexate 2 years prior and currently is on maintenance therapy with topical treatments alone. His main concerns pertained to the persistent dyschromia that occurred secondary to the psoriatic lesions. Through discussion, the patient stated that he “would do anything to get rid of it.”

Comment

Clinical differences in patients of color with psoriasis affect the management of the disease. Special consideration should be given to variances in morphology, presentation, treatment, and psychosocial factors in the management of psoriasis for these patient populations, as summarized in the eTable.

Morphology
At our clinic, patients of color have been found to have differences in morphology, including lesions that are more violaceous in color, as seen in patient 1; less noticeable inflammation; and more postinflammatory hypopigmentation and hyperpigmentation changes, as seen in patient 2. These changes are supported by the literature and differ from typical psoriasis plaques, which are pink-red and have more overlying scale. The varied morphology also may affect the differential, and other mimickers may be considered, such as lichen planus, cutaneous lupus erythematosus, and sarcoidosis.²

Presentation
There are differences in presentation among patients of color, particularly in distribution, type of psoriasis, and severity. As seen in patient 3, Asian and black patients are more likely to present with scalp psoriasis.^2,5 Hairstyling and hair care practices can differ considerably between racial groups. Given the differences in hairstyling, scalp psoriasis also may have a greater impact on patient quality of life (QOL).

Racial differences affect the type of psoriasis seen. Asian patients are more likely to present with pustular and erythrodermic psoriasis and less likely to present with inverse psoriasis compared to white patients. Hispanic patients are more likely to present with pustular psoriasis.¹¹ Black patients have been reported to have lower frequencies of psoriatic arthritis compared to white patients.¹² Recognition of these differences may help guide initial choice for therapeutics.

Notably, patients of color may present with much more severe psoriasis, particularly Asian and Hispanic patients.⁷ One retrospective study looking at patients with psoriasis treated with etanercept found that Asian patients were more likely to have greater baseline body surface area involvement.⁶ An American cross-sectional study reported higher psoriasis area and severity index scores in black patients compared to white patients,¹² possibly because patients of color do not normalize the experience of having psoriasis and feel stigmatized, which can cause delays in seeking medical attention and worsen disease burden. For patient 1, the stigma of black patients having psoriasis affected his body image and may have led to a delay in seeking medical attention due to him not believing it was possible for people of his skin color to have psoriasis. Increased disease severity may contribute to treatment resistance or numerous trials of topicals or biologics before the disease improves. Patient education in the community as well as patient support groups are paramount, and increased awareness of psoriasis can help improve disease management.

Treatment
Topical therapies are the first-line treatment of psoriasis. Although there is no evidence showing differences in topical treatment efficacy, patient preference for different topical treatments may vary based on race. For example, patients with Afro-textured hair may prefer foams and lotions and would avoid shampoo therapies, as frequent hair washing may not be feasible with certain hairstyles and may cause hair breakage or dryness.²

UV therapy can be an effective treatment modality for patients with psoriasis. The strength of therapy tends to be dictated by the Fitzpatrick skin phototype rather than race. Darker-skinned individuals may have an increased risk for hyperpigmentation, so caution should be taken to prevent burning during therapy. Suberythemogenic dosing—70% of minimal erythema dose—of narrowband UVB treatments has shown the same efficacy as using minimal erythema dose in patients with darker skin types in addition to fair-skinned patients.⁸

Although we found poor efficacy of systemic treatments in patient 1, to our knowledge, studies examining the efficacy of systemic therapeutic options have not shown differences in patients of color.^6,13 Studies show similar efficacy in treatments among races, particularly biologic therapies.⁵ However, patients with skin of color historically have been underrepresented in clinical trials,⁹ which may contribute to these patients, particularly black patients, being less familiar with biologics as a treatment option for psoriasis, as reported by Takeshita et al.¹⁰ Therefore, patient-centered discussions regarding treatment choices are important to ensure patients understand all options available to manage their disease.

Psychosocial Impact
Because of its chronic remitting course, psoriasis has a notable psychosocial impact on the lives of all patients, though the literature suggests there may be more of an impact on QOL in patients of color. Higher baseline dermatology life quality index scores have been reported in patients of color compared to white patients.⁶ Kerr et al¹² reported significantly greater psoriasis area and severity index scores (P=.06) and greater psychological impact in black patients compared to white patients. Stress also was more likely to be reported as a trigger for psoriasis in patients of Hispanic background compared to white patients.¹⁴ Many patients report body image issues with large physical lesions; however, the difference may lie in personal and cultural views about psoriasis, as one of our patients stated, “black people do not get psoriasis.” In addition to the cosmetic challenges that patients face with active lesions, postinflammatory pigmentary changes can be equally as burdensome to patients, as one of our patients stated he “would do anything to get rid of it.” Increased rates of depression and anxiety in patients of color can worsen their outlook on the condition.^15,16 The increased stigma and burden of psoriasis in patients of color calls for clinicians to counsel and address psoriasis in a holistic way and refer patients to psoriasis support groups when appropriate. Although the burden of psoriasis is clear, more studies can be carried out to investigate the impact on QOL in different ethnic populations.

Dermatology Education
Although differences have been found in patients of color with psoriasis, dissemination of this knowledge continues to be a challenge. In dermatology residency programs, the majority of teaching is provided with examples of skin diseases in white patients, which can complicate pattern recognition and diagnostic ability for trainees. Although dermatologists recognize that ethnic skin has unique dermatologic considerations, there is a persistent need for increasing skin of color education within dermatology residency programs.^17,18 Implementing more educational programs on skin of color has been proposed, and these programs will continue to be in demand as our population increasingly diversifies.¹⁹

Conclusion

Psoriasis in patients of color carries unique challenges when compared to psoriasis in white patients. Differences in morphology and presentation can make the disease difficult to accurately diagnose. These differences in addition to cultural differences may contribute to a greater impact on QOL and psychological health. Although treatment preferences and recognition may differ, treatment efficacy has so far been similar, albeit with a low proportion of patients with skin of color included in clinical trials.

Further focus should now lie within knowledge translation of these differences, which would normalize the condition for patients, support them seeking medical attention sooner, and inform them of all treatment options possible. For clinicians, more attention on the differences would help make earlier diagnoses, personalize physician-patient conversations, and advocate for further education on this issue in residency training programs.

After learning about coronavirus disease 2019 (COVID-19) on the news, we were all aware that it would eventually affect our lives and our dermatology practices. However, once the COVID-19 pandemic arrived in the United States, we were under a shelter-in-place order, schools were shut, and most businesses were closed within a few weeks.

As dermatologists, we were considered essential workers, and our offices could remain open. However, as the numbers of cases accelerated in New York City—the global epicenter of the pandemic—and we approached our peak, I closed down my practice, except for emergencies.

One of the first medical challenges dermatologists faced in the early days of the COVID-19 pandemic was the proper management of our psoriasis patients. The major concern was that patients on biologics and other immunomodulatory therapies might be at an increased risk for COVID-19 infection and increased morbidity if affected. I received a multitude of telephone calls from patients taking these therapies who expressed high levels of concern and anxiety and were looking for direction as to whether they should continue their medications.

Early on, several of our professional societies provided guidelines regarding the use of systemic immunosuppressive agents during the COVID-19 pandemic. On April 15, 2020, the American Academy of Dermatology (AAD) advised, “Dermatologists must delicately balance the risk of immunosuppression with the risk of disease flare requiring urgent intervention with patient-specific risks.”¹ The AAD strongly recommended that patients should not stop their ongoing systemic immunosuppressive therapy without consulting their physicians. The AAD’s guidance provided specific recommendations for the following groups: (1) patients on systemic immunosuppressive agents who have not tested positive or exhibited signs/symptoms of COVID-19, (2) patients on systemic immunosuppressive agents who have tested positive for COVID-19 or exhibit signs/symptoms of COVID-19, (3) patients who have halted systemic immunosuppressive therapy after testing positive for COVID-19 (in whom it recommended physicians could reinitiate treatment), and (4) patients being considered for systemic immunosuppressive agents.¹

The National Psoriasis Foundation (NPF) also recognized the need for additional guidelines for health care providers and patients on managing psoriatic disease during the COVID-19 pandemic. In June 2020, the NPF formed a COVID-19 Task Force, which released its own recommendations for adult and pediatric patients with psoriatic disease.² Similar to the AAD, the NPF COVID-19 Task Force recommended that patients do not stop biologic or oral therapies for psoriasis during the current health crisis, stating the following: “While some uncertainties remain, initial data suggest that the benefit of continuing treatments for psoriatic diseases outweighs the hypothetical risks associated with immune modulating treatment of poor COVID-19–related outcomes for most patients.” Individuals in high-risk groups were advised to consult their health care providers regarding whether they should continue or alter therapy during the pandemic, and the clinical decision would be guided by the specific treatment regimen; the patient’s age, disease characteristics, and underlying medical conditions; or any particular concerns. Additionally, the task force emphasized that patients with psoriatic disease should continue to follow common sense measures to lower the risk of becoming infected with COVID-19, including practicing physical distancing, wearing face coverings in public settings, and washing their hands regularly.²

We remain in the midst of the COVID-19 pandemic with no true guidance as to the future course and impact of the infection. It is important to realize that our understanding of the coronavirus and its impact on our patients is constantly evolving. I encourage all providers to stay current with updates on clinical guidelines. In addition, we should pay attention to the myriad of clinical trials and registries now underway, as they may provide more insight into optimal clinical management in these challenging times.

Most importantly, stay safe!

After learning about coronavirus disease 2019 (COVID-19) on the news, we were all aware that it would eventually affect our lives and our dermatology practices. However, once the COVID-19 pandemic arrived in the United States, we were under a shelter-in-place order, schools were shut, and most businesses were closed within a few weeks.

As dermatologists, we were considered essential workers, and our offices could remain open. However, as the numbers of cases accelerated in New York City—the global epicenter of the pandemic—and we approached our peak, I closed down my practice, except for emergencies.

One of the first medical challenges dermatologists faced in the early days of the COVID-19 pandemic was the proper management of our psoriasis patients. The major concern was that patients on biologics and other immunomodulatory therapies might be at an increased risk for COVID-19 infection and increased morbidity if affected. I received a multitude of telephone calls from patients taking these therapies who expressed high levels of concern and anxiety and were looking for direction as to whether they should continue their medications.

Early on, several of our professional societies provided guidelines regarding the use of systemic immunosuppressive agents during the COVID-19 pandemic. On April 15, 2020, the American Academy of Dermatology (AAD) advised, “Dermatologists must delicately balance the risk of immunosuppression with the risk of disease flare requiring urgent intervention with patient-specific risks.”¹ The AAD strongly recommended that patients should not stop their ongoing systemic immunosuppressive therapy without consulting their physicians. The AAD’s guidance provided specific recommendations for the following groups: (1) patients on systemic immunosuppressive agents who have not tested positive or exhibited signs/symptoms of COVID-19, (2) patients on systemic immunosuppressive agents who have tested positive for COVID-19 or exhibit signs/symptoms of COVID-19, (3) patients who have halted systemic immunosuppressive therapy after testing positive for COVID-19 (in whom it recommended physicians could reinitiate treatment), and (4) patients being considered for systemic immunosuppressive agents.¹

The National Psoriasis Foundation (NPF) also recognized the need for additional guidelines for health care providers and patients on managing psoriatic disease during the COVID-19 pandemic. In June 2020, the NPF formed a COVID-19 Task Force, which released its own recommendations for adult and pediatric patients with psoriatic disease.² Similar to the AAD, the NPF COVID-19 Task Force recommended that patients do not stop biologic or oral therapies for psoriasis during the current health crisis, stating the following: “While some uncertainties remain, initial data suggest that the benefit of continuing treatments for psoriatic diseases outweighs the hypothetical risks associated with immune modulating treatment of poor COVID-19–related outcomes for most patients.” Individuals in high-risk groups were advised to consult their health care providers regarding whether they should continue or alter therapy during the pandemic, and the clinical decision would be guided by the specific treatment regimen; the patient’s age, disease characteristics, and underlying medical conditions; or any particular concerns. Additionally, the task force emphasized that patients with psoriatic disease should continue to follow common sense measures to lower the risk of becoming infected with COVID-19, including practicing physical distancing, wearing face coverings in public settings, and washing their hands regularly.²

We remain in the midst of the COVID-19 pandemic with no true guidance as to the future course and impact of the infection. It is important to realize that our understanding of the coronavirus and its impact on our patients is constantly evolving. I encourage all providers to stay current with updates on clinical guidelines. In addition, we should pay attention to the myriad of clinical trials and registries now underway, as they may provide more insight into optimal clinical management in these challenging times.

Most importantly, stay safe!

After learning about coronavirus disease 2019 (COVID-19) on the news, we were all aware that it would eventually affect our lives and our dermatology practices. However, once the COVID-19 pandemic arrived in the United States, we were under a shelter-in-place order, schools were shut, and most businesses were closed within a few weeks.

As dermatologists, we were considered essential workers, and our offices could remain open. However, as the numbers of cases accelerated in New York City—the global epicenter of the pandemic—and we approached our peak, I closed down my practice, except for emergencies.

One of the first medical challenges dermatologists faced in the early days of the COVID-19 pandemic was the proper management of our psoriasis patients. The major concern was that patients on biologics and other immunomodulatory therapies might be at an increased risk for COVID-19 infection and increased morbidity if affected. I received a multitude of telephone calls from patients taking these therapies who expressed high levels of concern and anxiety and were looking for direction as to whether they should continue their medications.

Early on, several of our professional societies provided guidelines regarding the use of systemic immunosuppressive agents during the COVID-19 pandemic. On April 15, 2020, the American Academy of Dermatology (AAD) advised, “Dermatologists must delicately balance the risk of immunosuppression with the risk of disease flare requiring urgent intervention with patient-specific risks.”¹ The AAD strongly recommended that patients should not stop their ongoing systemic immunosuppressive therapy without consulting their physicians. The AAD’s guidance provided specific recommendations for the following groups: (1) patients on systemic immunosuppressive agents who have not tested positive or exhibited signs/symptoms of COVID-19, (2) patients on systemic immunosuppressive agents who have tested positive for COVID-19 or exhibit signs/symptoms of COVID-19, (3) patients who have halted systemic immunosuppressive therapy after testing positive for COVID-19 (in whom it recommended physicians could reinitiate treatment), and (4) patients being considered for systemic immunosuppressive agents.¹

The National Psoriasis Foundation (NPF) also recognized the need for additional guidelines for health care providers and patients on managing psoriatic disease during the COVID-19 pandemic. In June 2020, the NPF formed a COVID-19 Task Force, which released its own recommendations for adult and pediatric patients with psoriatic disease.² Similar to the AAD, the NPF COVID-19 Task Force recommended that patients do not stop biologic or oral therapies for psoriasis during the current health crisis, stating the following: “While some uncertainties remain, initial data suggest that the benefit of continuing treatments for psoriatic diseases outweighs the hypothetical risks associated with immune modulating treatment of poor COVID-19–related outcomes for most patients.” Individuals in high-risk groups were advised to consult their health care providers regarding whether they should continue or alter therapy during the pandemic, and the clinical decision would be guided by the specific treatment regimen; the patient’s age, disease characteristics, and underlying medical conditions; or any particular concerns. Additionally, the task force emphasized that patients with psoriatic disease should continue to follow common sense measures to lower the risk of becoming infected with COVID-19, including practicing physical distancing, wearing face coverings in public settings, and washing their hands regularly.²

We remain in the midst of the COVID-19 pandemic with no true guidance as to the future course and impact of the infection. It is important to realize that our understanding of the coronavirus and its impact on our patients is constantly evolving. I encourage all providers to stay current with updates on clinical guidelines. In addition, we should pay attention to the myriad of clinical trials and registries now underway, as they may provide more insight into optimal clinical management in these challenging times.

Most importantly, stay safe!

The advent of biologic therapy over the last 2 decades has transformed the treatment of psoriasis; patients who either are not good candidates for or have an inadequate response to traditional treatments (topicals and/or phototherapy) now have numerous options for treatment.¹ Patients burdened by extensive disease, recurrent flares, and stubborn treatment areas are ideal candidates for biologics. There are 11 biologics approved by the US Food and Drug Administration (FDA)(Table) for treating moderate to severe plaque psoriasis as supported by grade A evidence. The FDA has authorized 1 new biologic—risankizumab—since the joint guidelines from the American Academy of Dermatology and National Psoriasis Foundation were released for the treatment of psoriasis with biologics.² This article aims to address updates on recent clinical trial findings (April 2019 to April 2020) regarding biologic therapy initiation and maintenance for adult patients. Prescribers should use this update as guidance for determining the appropriate biologic class based on patient characteristics and for approaching biologic-experienced patients with refractory psoriasis. This update also may serve as a reference for the recommended dosing regimens of the 11 approved biologics.

Using Risankizumab

Risankizumab is a new biologic that selectively targets the IL-23 pathway by binding the p19 subunit of IL-23. It was approved by the FDA in April 2019. Two recent studies have demonstrated the efficacy of risankizumab in disease management.^3,4

IMMvent was a double-blind, 2-part, phase 3, randomized controlled trial (RCT) of participants 18 years and older (N=605) with moderate to severe psoriasis (with or without psoriatic arthritis) across 11 countries.³ Inclusion criteria consisted of psoriasis involving at least 10% of the body surface area (BSA), absolute psoriasis area and severity index (PASI) score of 12 or higher, and static physician global assessment (sPGA) score of 3 or higher. Prior biologic treatment did not preclude study entry (excluding risankizumab or adalimumab), and nearly 40% of participants previously had been on a different biologic. Notably, this trial allowed for inclusion of patients with prior malignancy (>5 years prior) and patients who tested positive for exposure to tuberculosis (TB) but were not shown to have active TB (provided appropriate treatment for latent TB was started). Study participants identified as white (81%), Asian (14%), black/African American (4%), or other ethnicity (1%). Part A involved administration of 150 mg risankizumab (n=301) at weeks 0 and 4 or 80 mg adalimumab (n=304) loading dose at week 0 followed by 40 mg at week 1 and 40 mg every other week thereafter until the end of week 15. At week 16 there was a significant difference in proportion of participants achieving 90% or more improvement (PASI-90) with risankizumab (72%) vs adalimumab (47%)(P<.0001) and achieving an sPGA score of 0 or 1 (clear or almost clear) with risankizumab (84%) vs adalimumab (60%)(P<.0001). In part B (weeks 16–44), adalimumab immediate responder (PASI ≥50 to PASI <90) participants were re-randomized to continue adalimumab 40 mg every other week (starting from week 17 and stopping at week 44) or switch to 150 mg risankizumab administered at weeks 16, 20, and 32. Patients taking risankizumab in part A continued the drug, administered at weeks 16 and 28. At week 44, there was a significant difference in percentage of participants achieving PASI-90 with risankizumab (66%) vs adalimumab (21%)(P<.0001).³

IMMhance was another double-blind phase 3 RCT with 2 parts that assessed the clinical efficacy of risankizumab compared to placebo in patients 18 years or older (N=507) across 9 countries with the same inclusion criteria for patients as IMMvent.⁴ Part A involved administration of 150 mg risankizumab (n=407) or placebo (n=100) at weeks 0 and 4 using a 4:1 random allocation ratio. At week 16, regardless of initial treatment, all participants received 150 mg risankizumab. Treatment results at week 16 showed a significant difference in percentage of participants achieving PASI-90 with risankizumab (73.2%) vs placebo (2.0%)(P<.001) and sPGA score of 0 or 1 with risankizumab (83.5%) vs placebo (7.0%)(P<.001). Furthermore, in part B (weeks 16–104), at week 28 participants on risankizumab with an sPGA score of 0 or 1 were randomized with a 1:2 allocation ratio to continue 150 mg risankizumab or switch to placebo to produce a treatment withdrawal effect. Part B results showed a significant difference in the proportion of participants achieving an sPGA score of 0 or 1 with risankizumab (87.4%) vs placebo (61.3%)(P<.001) at week 52 and at week 104 with risankizumab (81.1%) vs placebo (7.1%)(P<.001). Risankizumab was well tolerated, with the most common adverse events (AEs) being nasopharyngitis (23.4%), upper respiratory tract infection (15.4%), and headache (6.8%). Serious AEs included cancer (2.6%; 2.2 events per 100 patient-years), hepatic events (4.6%) including hepatic cirrhosis (0.2%), and serious infections (1.8%; 1.4 events per 100 patient-years).⁴

Overall, the strengths of risankizumab with regard to its clinical efficacy and utility in biologic-experienced patients were confirmed in these studies. The inclusion of patients with prior treated malignancy and positive TB tests also was more in line with what one might encounter with real-world practice and, as such, provided valuable data to help aid treatment decisions. These 2 studies provided valuable evidence for the therapeutic benefit and relatively mild safety profile of risankizumab in treatment of moderate to severe psoriasis for patients with and without prior biologic therapy.

Choosing a Biologic

Refractory psoriasis involves nonresponse (primary failure) or return of disease symptoms after initial improvement (secondary failure) with a biologic. Selecting a biologic for patients who have experienced prior biologic failure is difficult. It is still unknown whether it is more efficacious for patients to try a same-class drug or a biologic targeting a different inflammatory pathway or cytokine. Studies have shown mixed results regarding how to manage patients with biologic failure, with both approaches demonstrating positive outcomes.

One analysis of the Corrona Psoriasis Registry included 144 patients, the majority of whom (89.8%) were biologic experienced, who began secukinumab treatment and returned for a 6-month follow-up (5–9 months).⁵ Patients enrolled in the registry were 18 years or older, had been diagnosed with psoriasis by a dermatologist, and initiated or switched an FDA-approved systemic agent or biologic within the last 12 months. Of biologic-experienced participants, 37.7% had used 3 or more biologics. More than half of included participants were either male (55%) or obese (53.4%). Comorbidities included hypertension (43.2%), hyperlipidemia (33.9%), anxiety (20.3%), diabetes mellitus (15.3%), cardiovascular disease (14.4%), and depression (13.6%). After 6 months of treatment, there was significant improvement in the involvement of BSA (mean difference, −12.1), investigator global assessment score (−1.5), dermatology life quality index (DLQI)(−4.8), pain (−23.2), itch (−30.8), fatigue (−8.8), and work productivity (−9.2)(P<.01). Secukinumab therapy displayed notable reduction in symptom severity in this population with difficult-to-treat psoriasis. Its relative success in this cohort provides support for its use in treating patients who have failed other classes of biologics.⁵

Evidence supporting reduction of pruritus and pain with secukinumab also was notable. The CLEAR phase 3 RCT involved participants treated with 300 mg secukinumab every week for the first 4 weeks and then every 4 weeks thereafter for 48 weeks (n=312), up to 100 weeks (n=277).⁶ Participants had complete relief of pain (score 0), itching, and scaling at week 16 (69.4%, 49.7%, and 61.2%, respectively), week 52 (67.1%, 48.9%, and 53.3%, respectively), and week 104 (70.9%, 47.4%, and 54.8%, respectively). Reported AEs included candida infections (7.2%), malignant or unspecified tumors (1.5%), and neutropenia (<1%).⁶

Researchers investigated intraclass switching to brodalumab with prior failure of IL-17 inhibitors. An open-label study involved participants (n=39) with prior failure with secukinumab or ixekizumab therapy.⁷ Participants were administered 210 mg brodalumab with standard dosing at weeks 0, 1, and 2, and then every 2 weeks thereafter. At week 16, 69% of participants achieved PASI-75, 44% achieved PASI-90, 28% achieved PASI-100, and 62% achieved an sPGA score of 0 or 1. The authors attributed the relative success of brodalumab compared to prior anti–IL-17 agents to inhibition of the IL-17 receptor with brodalumab rather than the IL-17A ligand.⁷ Brodalumab may be a useful alternative biologic for patients with nonresponse to and secondary failure with biologics, including the IL-17A inhibitors.

Recent findings support effective skin clearance and improved symptom management with ixekizumab and ustekinumab. Of note, ixekizumab was reported to provide rapid improvement in skin lesions and quality of life to a greater extent than guselkumab.

The IXORA-R double-blinded RCT compared the clinical benefit of participants 18 years and older taking standard approved dosages of ixekizumab (n=520) or guselkumab (n=507).⁸ Patients were included if they had plaque psoriasis for at least 6 months before baseline, an sPGA score of at least 3, PASI score of 12 or higher, 10% or greater BSA, no prior IL-17 inhibitor failure, no use of IL-23 p19 inhibitors, and no use of any biologic within the specified period prior to baseline. At week 12, ixekizumab showed superior clinical improvement measured by the proportion of participants achieving complete skin clearance (ie, PASI-100)(41%) compared to guselkumab (25%)(P<.001). There were more participants taking ixekizumab who reported DLQI of 0 or 1 (no impact of disease on quality of life)(34%) compared to guselkumab (21%)(P<.001) as early on as week 4. The most common AE was upper respiratory tract infection (7%) in both groups. The risk of treatment-emergent AEs (56%), discontinuation because of AEs (2%), and serious AEs (3%) were comparable in both groups. The number of injection-site reactions was higher with ixekizumab (13%) vs guselkumab (3%). The authors concluded that ixekizumab offers the ability to provide rapid relief of symptoms, which is associated with improved DLQI.⁸

Response to ustekinumab therapy was assessed in a patient cohort enrolled in the Corrona Psoriasis Registry. This study involved 178 participants 18 years and older with psoriasis involvement of 3% or greater BSA who were treated with ustekinumab.⁹ By their 6-month follow-up visit, 55.6% of participants achieved adequate treatment response (BSA improving to <3% or 75% from enrollment). Increasing patient age was significantly associated with decreased likelihood of achieving a response (odds ratio, 0.981 [95% confidence interval, 0.962-0.999]; P=.049). Ustekinumab is a practical option for psoriasis treatment that seems to yield better results in younger patients.⁹ This evidence reveals that increased patient age is a characteristic that may contribute to poor treatment response and should be considered when choosing the best fit for biologic therapy.

Final Thoughts

Using evidence-based interventions to treat patients is the cornerstone of ethical and high-quality medical care. This guide sought to provide relevant updates in a variety of both comparator and pivotal trials, with the goal of summarizing clinically relevant information that may be extracted from these trials to guide patient care. It is not an exhaustive review but may be utilized as a reference tool to fine-tune selection criteria in choosing 1 of 11 biologics for the treatment of psoriasis.

The advent of biologic therapy over the last 2 decades has transformed the treatment of psoriasis; patients who either are not good candidates for or have an inadequate response to traditional treatments (topicals and/or phototherapy) now have numerous options for treatment.¹ Patients burdened by extensive disease, recurrent flares, and stubborn treatment areas are ideal candidates for biologics. There are 11 biologics approved by the US Food and Drug Administration (FDA)(Table) for treating moderate to severe plaque psoriasis as supported by grade A evidence. The FDA has authorized 1 new biologic—risankizumab—since the joint guidelines from the American Academy of Dermatology and National Psoriasis Foundation were released for the treatment of psoriasis with biologics.² This article aims to address updates on recent clinical trial findings (April 2019 to April 2020) regarding biologic therapy initiation and maintenance for adult patients. Prescribers should use this update as guidance for determining the appropriate biologic class based on patient characteristics and for approaching biologic-experienced patients with refractory psoriasis. This update also may serve as a reference for the recommended dosing regimens of the 11 approved biologics.

Using Risankizumab

Risankizumab is a new biologic that selectively targets the IL-23 pathway by binding the p19 subunit of IL-23. It was approved by the FDA in April 2019. Two recent studies have demonstrated the efficacy of risankizumab in disease management.^3,4

IMMvent was a double-blind, 2-part, phase 3, randomized controlled trial (RCT) of participants 18 years and older (N=605) with moderate to severe psoriasis (with or without psoriatic arthritis) across 11 countries.³ Inclusion criteria consisted of psoriasis involving at least 10% of the body surface area (BSA), absolute psoriasis area and severity index (PASI) score of 12 or higher, and static physician global assessment (sPGA) score of 3 or higher. Prior biologic treatment did not preclude study entry (excluding risankizumab or adalimumab), and nearly 40% of participants previously had been on a different biologic. Notably, this trial allowed for inclusion of patients with prior malignancy (>5 years prior) and patients who tested positive for exposure to tuberculosis (TB) but were not shown to have active TB (provided appropriate treatment for latent TB was started). Study participants identified as white (81%), Asian (14%), black/African American (4%), or other ethnicity (1%). Part A involved administration of 150 mg risankizumab (n=301) at weeks 0 and 4 or 80 mg adalimumab (n=304) loading dose at week 0 followed by 40 mg at week 1 and 40 mg every other week thereafter until the end of week 15. At week 16 there was a significant difference in proportion of participants achieving 90% or more improvement (PASI-90) with risankizumab (72%) vs adalimumab (47%)(P<.0001) and achieving an sPGA score of 0 or 1 (clear or almost clear) with risankizumab (84%) vs adalimumab (60%)(P<.0001). In part B (weeks 16–44), adalimumab immediate responder (PASI ≥50 to PASI <90) participants were re-randomized to continue adalimumab 40 mg every other week (starting from week 17 and stopping at week 44) or switch to 150 mg risankizumab administered at weeks 16, 20, and 32. Patients taking risankizumab in part A continued the drug, administered at weeks 16 and 28. At week 44, there was a significant difference in percentage of participants achieving PASI-90 with risankizumab (66%) vs adalimumab (21%)(P<.0001).³

IMMhance was another double-blind phase 3 RCT with 2 parts that assessed the clinical efficacy of risankizumab compared to placebo in patients 18 years or older (N=507) across 9 countries with the same inclusion criteria for patients as IMMvent.⁴ Part A involved administration of 150 mg risankizumab (n=407) or placebo (n=100) at weeks 0 and 4 using a 4:1 random allocation ratio. At week 16, regardless of initial treatment, all participants received 150 mg risankizumab. Treatment results at week 16 showed a significant difference in percentage of participants achieving PASI-90 with risankizumab (73.2%) vs placebo (2.0%)(P<.001) and sPGA score of 0 or 1 with risankizumab (83.5%) vs placebo (7.0%)(P<.001). Furthermore, in part B (weeks 16–104), at week 28 participants on risankizumab with an sPGA score of 0 or 1 were randomized with a 1:2 allocation ratio to continue 150 mg risankizumab or switch to placebo to produce a treatment withdrawal effect. Part B results showed a significant difference in the proportion of participants achieving an sPGA score of 0 or 1 with risankizumab (87.4%) vs placebo (61.3%)(P<.001) at week 52 and at week 104 with risankizumab (81.1%) vs placebo (7.1%)(P<.001). Risankizumab was well tolerated, with the most common adverse events (AEs) being nasopharyngitis (23.4%), upper respiratory tract infection (15.4%), and headache (6.8%). Serious AEs included cancer (2.6%; 2.2 events per 100 patient-years), hepatic events (4.6%) including hepatic cirrhosis (0.2%), and serious infections (1.8%; 1.4 events per 100 patient-years).⁴

Overall, the strengths of risankizumab with regard to its clinical efficacy and utility in biologic-experienced patients were confirmed in these studies. The inclusion of patients with prior treated malignancy and positive TB tests also was more in line with what one might encounter with real-world practice and, as such, provided valuable data to help aid treatment decisions. These 2 studies provided valuable evidence for the therapeutic benefit and relatively mild safety profile of risankizumab in treatment of moderate to severe psoriasis for patients with and without prior biologic therapy.

Choosing a Biologic

Refractory psoriasis involves nonresponse (primary failure) or return of disease symptoms after initial improvement (secondary failure) with a biologic. Selecting a biologic for patients who have experienced prior biologic failure is difficult. It is still unknown whether it is more efficacious for patients to try a same-class drug or a biologic targeting a different inflammatory pathway or cytokine. Studies have shown mixed results regarding how to manage patients with biologic failure, with both approaches demonstrating positive outcomes.

One analysis of the Corrona Psoriasis Registry included 144 patients, the majority of whom (89.8%) were biologic experienced, who began secukinumab treatment and returned for a 6-month follow-up (5–9 months).⁵ Patients enrolled in the registry were 18 years or older, had been diagnosed with psoriasis by a dermatologist, and initiated or switched an FDA-approved systemic agent or biologic within the last 12 months. Of biologic-experienced participants, 37.7% had used 3 or more biologics. More than half of included participants were either male (55%) or obese (53.4%). Comorbidities included hypertension (43.2%), hyperlipidemia (33.9%), anxiety (20.3%), diabetes mellitus (15.3%), cardiovascular disease (14.4%), and depression (13.6%). After 6 months of treatment, there was significant improvement in the involvement of BSA (mean difference, −12.1), investigator global assessment score (−1.5), dermatology life quality index (DLQI)(−4.8), pain (−23.2), itch (−30.8), fatigue (−8.8), and work productivity (−9.2)(P<.01). Secukinumab therapy displayed notable reduction in symptom severity in this population with difficult-to-treat psoriasis. Its relative success in this cohort provides support for its use in treating patients who have failed other classes of biologics.⁵

Evidence supporting reduction of pruritus and pain with secukinumab also was notable. The CLEAR phase 3 RCT involved participants treated with 300 mg secukinumab every week for the first 4 weeks and then every 4 weeks thereafter for 48 weeks (n=312), up to 100 weeks (n=277).⁶ Participants had complete relief of pain (score 0), itching, and scaling at week 16 (69.4%, 49.7%, and 61.2%, respectively), week 52 (67.1%, 48.9%, and 53.3%, respectively), and week 104 (70.9%, 47.4%, and 54.8%, respectively). Reported AEs included candida infections (7.2%), malignant or unspecified tumors (1.5%), and neutropenia (<1%).⁶

Researchers investigated intraclass switching to brodalumab with prior failure of IL-17 inhibitors. An open-label study involved participants (n=39) with prior failure with secukinumab or ixekizumab therapy.⁷ Participants were administered 210 mg brodalumab with standard dosing at weeks 0, 1, and 2, and then every 2 weeks thereafter. At week 16, 69% of participants achieved PASI-75, 44% achieved PASI-90, 28% achieved PASI-100, and 62% achieved an sPGA score of 0 or 1. The authors attributed the relative success of brodalumab compared to prior anti–IL-17 agents to inhibition of the IL-17 receptor with brodalumab rather than the IL-17A ligand.⁷ Brodalumab may be a useful alternative biologic for patients with nonresponse to and secondary failure with biologics, including the IL-17A inhibitors.

Recent findings support effective skin clearance and improved symptom management with ixekizumab and ustekinumab. Of note, ixekizumab was reported to provide rapid improvement in skin lesions and quality of life to a greater extent than guselkumab.

The IXORA-R double-blinded RCT compared the clinical benefit of participants 18 years and older taking standard approved dosages of ixekizumab (n=520) or guselkumab (n=507).⁸ Patients were included if they had plaque psoriasis for at least 6 months before baseline, an sPGA score of at least 3, PASI score of 12 or higher, 10% or greater BSA, no prior IL-17 inhibitor failure, no use of IL-23 p19 inhibitors, and no use of any biologic within the specified period prior to baseline. At week 12, ixekizumab showed superior clinical improvement measured by the proportion of participants achieving complete skin clearance (ie, PASI-100)(41%) compared to guselkumab (25%)(P<.001). There were more participants taking ixekizumab who reported DLQI of 0 or 1 (no impact of disease on quality of life)(34%) compared to guselkumab (21%)(P<.001) as early on as week 4. The most common AE was upper respiratory tract infection (7%) in both groups. The risk of treatment-emergent AEs (56%), discontinuation because of AEs (2%), and serious AEs (3%) were comparable in both groups. The number of injection-site reactions was higher with ixekizumab (13%) vs guselkumab (3%). The authors concluded that ixekizumab offers the ability to provide rapid relief of symptoms, which is associated with improved DLQI.⁸

Response to ustekinumab therapy was assessed in a patient cohort enrolled in the Corrona Psoriasis Registry. This study involved 178 participants 18 years and older with psoriasis involvement of 3% or greater BSA who were treated with ustekinumab.⁹ By their 6-month follow-up visit, 55.6% of participants achieved adequate treatment response (BSA improving to <3% or 75% from enrollment). Increasing patient age was significantly associated with decreased likelihood of achieving a response (odds ratio, 0.981 [95% confidence interval, 0.962-0.999]; P=.049). Ustekinumab is a practical option for psoriasis treatment that seems to yield better results in younger patients.⁹ This evidence reveals that increased patient age is a characteristic that may contribute to poor treatment response and should be considered when choosing the best fit for biologic therapy.

Final Thoughts

Using evidence-based interventions to treat patients is the cornerstone of ethical and high-quality medical care. This guide sought to provide relevant updates in a variety of both comparator and pivotal trials, with the goal of summarizing clinically relevant information that may be extracted from these trials to guide patient care. It is not an exhaustive review but may be utilized as a reference tool to fine-tune selection criteria in choosing 1 of 11 biologics for the treatment of psoriasis.

The advent of biologic therapy over the last 2 decades has transformed the treatment of psoriasis; patients who either are not good candidates for or have an inadequate response to traditional treatments (topicals and/or phototherapy) now have numerous options for treatment.¹ Patients burdened by extensive disease, recurrent flares, and stubborn treatment areas are ideal candidates for biologics. There are 11 biologics approved by the US Food and Drug Administration (FDA)(Table) for treating moderate to severe plaque psoriasis as supported by grade A evidence. The FDA has authorized 1 new biologic—risankizumab—since the joint guidelines from the American Academy of Dermatology and National Psoriasis Foundation were released for the treatment of psoriasis with biologics.² This article aims to address updates on recent clinical trial findings (April 2019 to April 2020) regarding biologic therapy initiation and maintenance for adult patients. Prescribers should use this update as guidance for determining the appropriate biologic class based on patient characteristics and for approaching biologic-experienced patients with refractory psoriasis. This update also may serve as a reference for the recommended dosing regimens of the 11 approved biologics.

Using Risankizumab

Risankizumab is a new biologic that selectively targets the IL-23 pathway by binding the p19 subunit of IL-23. It was approved by the FDA in April 2019. Two recent studies have demonstrated the efficacy of risankizumab in disease management.^3,4

IMMvent was a double-blind, 2-part, phase 3, randomized controlled trial (RCT) of participants 18 years and older (N=605) with moderate to severe psoriasis (with or without psoriatic arthritis) across 11 countries.³ Inclusion criteria consisted of psoriasis involving at least 10% of the body surface area (BSA), absolute psoriasis area and severity index (PASI) score of 12 or higher, and static physician global assessment (sPGA) score of 3 or higher. Prior biologic treatment did not preclude study entry (excluding risankizumab or adalimumab), and nearly 40% of participants previously had been on a different biologic. Notably, this trial allowed for inclusion of patients with prior malignancy (>5 years prior) and patients who tested positive for exposure to tuberculosis (TB) but were not shown to have active TB (provided appropriate treatment for latent TB was started). Study participants identified as white (81%), Asian (14%), black/African American (4%), or other ethnicity (1%). Part A involved administration of 150 mg risankizumab (n=301) at weeks 0 and 4 or 80 mg adalimumab (n=304) loading dose at week 0 followed by 40 mg at week 1 and 40 mg every other week thereafter until the end of week 15. At week 16 there was a significant difference in proportion of participants achieving 90% or more improvement (PASI-90) with risankizumab (72%) vs adalimumab (47%)(P<.0001) and achieving an sPGA score of 0 or 1 (clear or almost clear) with risankizumab (84%) vs adalimumab (60%)(P<.0001). In part B (weeks 16–44), adalimumab immediate responder (PASI ≥50 to PASI <90) participants were re-randomized to continue adalimumab 40 mg every other week (starting from week 17 and stopping at week 44) or switch to 150 mg risankizumab administered at weeks 16, 20, and 32. Patients taking risankizumab in part A continued the drug, administered at weeks 16 and 28. At week 44, there was a significant difference in percentage of participants achieving PASI-90 with risankizumab (66%) vs adalimumab (21%)(P<.0001).³

IMMhance was another double-blind phase 3 RCT with 2 parts that assessed the clinical efficacy of risankizumab compared to placebo in patients 18 years or older (N=507) across 9 countries with the same inclusion criteria for patients as IMMvent.⁴ Part A involved administration of 150 mg risankizumab (n=407) or placebo (n=100) at weeks 0 and 4 using a 4:1 random allocation ratio. At week 16, regardless of initial treatment, all participants received 150 mg risankizumab. Treatment results at week 16 showed a significant difference in percentage of participants achieving PASI-90 with risankizumab (73.2%) vs placebo (2.0%)(P<.001) and sPGA score of 0 or 1 with risankizumab (83.5%) vs placebo (7.0%)(P<.001). Furthermore, in part B (weeks 16–104), at week 28 participants on risankizumab with an sPGA score of 0 or 1 were randomized with a 1:2 allocation ratio to continue 150 mg risankizumab or switch to placebo to produce a treatment withdrawal effect. Part B results showed a significant difference in the proportion of participants achieving an sPGA score of 0 or 1 with risankizumab (87.4%) vs placebo (61.3%)(P<.001) at week 52 and at week 104 with risankizumab (81.1%) vs placebo (7.1%)(P<.001). Risankizumab was well tolerated, with the most common adverse events (AEs) being nasopharyngitis (23.4%), upper respiratory tract infection (15.4%), and headache (6.8%). Serious AEs included cancer (2.6%; 2.2 events per 100 patient-years), hepatic events (4.6%) including hepatic cirrhosis (0.2%), and serious infections (1.8%; 1.4 events per 100 patient-years).⁴

Overall, the strengths of risankizumab with regard to its clinical efficacy and utility in biologic-experienced patients were confirmed in these studies. The inclusion of patients with prior treated malignancy and positive TB tests also was more in line with what one might encounter with real-world practice and, as such, provided valuable data to help aid treatment decisions. These 2 studies provided valuable evidence for the therapeutic benefit and relatively mild safety profile of risankizumab in treatment of moderate to severe psoriasis for patients with and without prior biologic therapy.

Choosing a Biologic

Refractory psoriasis involves nonresponse (primary failure) or return of disease symptoms after initial improvement (secondary failure) with a biologic. Selecting a biologic for patients who have experienced prior biologic failure is difficult. It is still unknown whether it is more efficacious for patients to try a same-class drug or a biologic targeting a different inflammatory pathway or cytokine. Studies have shown mixed results regarding how to manage patients with biologic failure, with both approaches demonstrating positive outcomes.

One analysis of the Corrona Psoriasis Registry included 144 patients, the majority of whom (89.8%) were biologic experienced, who began secukinumab treatment and returned for a 6-month follow-up (5–9 months).⁵ Patients enrolled in the registry were 18 years or older, had been diagnosed with psoriasis by a dermatologist, and initiated or switched an FDA-approved systemic agent or biologic within the last 12 months. Of biologic-experienced participants, 37.7% had used 3 or more biologics. More than half of included participants were either male (55%) or obese (53.4%). Comorbidities included hypertension (43.2%), hyperlipidemia (33.9%), anxiety (20.3%), diabetes mellitus (15.3%), cardiovascular disease (14.4%), and depression (13.6%). After 6 months of treatment, there was significant improvement in the involvement of BSA (mean difference, −12.1), investigator global assessment score (−1.5), dermatology life quality index (DLQI)(−4.8), pain (−23.2), itch (−30.8), fatigue (−8.8), and work productivity (−9.2)(P<.01). Secukinumab therapy displayed notable reduction in symptom severity in this population with difficult-to-treat psoriasis. Its relative success in this cohort provides support for its use in treating patients who have failed other classes of biologics.⁵

Evidence supporting reduction of pruritus and pain with secukinumab also was notable. The CLEAR phase 3 RCT involved participants treated with 300 mg secukinumab every week for the first 4 weeks and then every 4 weeks thereafter for 48 weeks (n=312), up to 100 weeks (n=277).⁶ Participants had complete relief of pain (score 0), itching, and scaling at week 16 (69.4%, 49.7%, and 61.2%, respectively), week 52 (67.1%, 48.9%, and 53.3%, respectively), and week 104 (70.9%, 47.4%, and 54.8%, respectively). Reported AEs included candida infections (7.2%), malignant or unspecified tumors (1.5%), and neutropenia (<1%).⁶

Researchers investigated intraclass switching to brodalumab with prior failure of IL-17 inhibitors. An open-label study involved participants (n=39) with prior failure with secukinumab or ixekizumab therapy.⁷ Participants were administered 210 mg brodalumab with standard dosing at weeks 0, 1, and 2, and then every 2 weeks thereafter. At week 16, 69% of participants achieved PASI-75, 44% achieved PASI-90, 28% achieved PASI-100, and 62% achieved an sPGA score of 0 or 1. The authors attributed the relative success of brodalumab compared to prior anti–IL-17 agents to inhibition of the IL-17 receptor with brodalumab rather than the IL-17A ligand.⁷ Brodalumab may be a useful alternative biologic for patients with nonresponse to and secondary failure with biologics, including the IL-17A inhibitors.

Recent findings support effective skin clearance and improved symptom management with ixekizumab and ustekinumab. Of note, ixekizumab was reported to provide rapid improvement in skin lesions and quality of life to a greater extent than guselkumab.

The IXORA-R double-blinded RCT compared the clinical benefit of participants 18 years and older taking standard approved dosages of ixekizumab (n=520) or guselkumab (n=507).⁸ Patients were included if they had plaque psoriasis for at least 6 months before baseline, an sPGA score of at least 3, PASI score of 12 or higher, 10% or greater BSA, no prior IL-17 inhibitor failure, no use of IL-23 p19 inhibitors, and no use of any biologic within the specified period prior to baseline. At week 12, ixekizumab showed superior clinical improvement measured by the proportion of participants achieving complete skin clearance (ie, PASI-100)(41%) compared to guselkumab (25%)(P<.001). There were more participants taking ixekizumab who reported DLQI of 0 or 1 (no impact of disease on quality of life)(34%) compared to guselkumab (21%)(P<.001) as early on as week 4. The most common AE was upper respiratory tract infection (7%) in both groups. The risk of treatment-emergent AEs (56%), discontinuation because of AEs (2%), and serious AEs (3%) were comparable in both groups. The number of injection-site reactions was higher with ixekizumab (13%) vs guselkumab (3%). The authors concluded that ixekizumab offers the ability to provide rapid relief of symptoms, which is associated with improved DLQI.⁸

Response to ustekinumab therapy was assessed in a patient cohort enrolled in the Corrona Psoriasis Registry. This study involved 178 participants 18 years and older with psoriasis involvement of 3% or greater BSA who were treated with ustekinumab.⁹ By their 6-month follow-up visit, 55.6% of participants achieved adequate treatment response (BSA improving to <3% or 75% from enrollment). Increasing patient age was significantly associated with decreased likelihood of achieving a response (odds ratio, 0.981 [95% confidence interval, 0.962-0.999]; P=.049). Ustekinumab is a practical option for psoriasis treatment that seems to yield better results in younger patients.⁹ This evidence reveals that increased patient age is a characteristic that may contribute to poor treatment response and should be considered when choosing the best fit for biologic therapy.

Final Thoughts

Using evidence-based interventions to treat patients is the cornerstone of ethical and high-quality medical care. This guide sought to provide relevant updates in a variety of both comparator and pivotal trials, with the goal of summarizing clinically relevant information that may be extracted from these trials to guide patient care. It is not an exhaustive review but may be utilized as a reference tool to fine-tune selection criteria in choosing 1 of 11 biologics for the treatment of psoriasis.

Historically, there have been limited data available on the management of psoriasis in pregnancy. The most comprehensive discussion of treatment guidelines is from 2012.¹ In the interim, many biologics have been approved for treating psoriasis, with slow accumulation of pregnancy safety data. The 2019 American Academy of Dermatology–National Psoriasis Foundation guidelines on biologics for psoriasis contain updated information but also highlight the paucity of pregnancy safety data.² This gap is in part a consequence of the exclusion and disenrollment of pregnant women from clinical trials.³ Additionally, lack of detection through registries contributes; pregnancy capture in registries is low compared to the expected number of pregnancies estimated from US Census data.⁴ Despite these shortcomings, psoriasis patients who are already pregnant or are considering becoming pregnant frequently are encountered in practice and may need treatment. This article reviews the evidence on commonly used treatments for psoriasis in pregnancy.

Background

For many patients, psoriasis improves during pregnancy^5,6 and becomes worse postpartum. In a prospective study, most patients reported improvement in pregnancy corresponding to a significant decrease in affected body surface area (P<.001) by 10 to 20 weeks’ gestation. Most patients also reported worsening of psoriasis postpartum; a significant increase in psoriatic body surface area (P=.001) was observed after delivery.⁷ Despite these findings, a considerable number of patients also experience stable disease or worsening of disease during pregnancy.

In addition to the maternal disease state, the issue of pregnancy outcomes is paramount. In the inflammatory bowel disease and rheumatology literature, it is established that uncontrolled disease is associated with poorer pregnancy outcomes.^8-10 Guidelines vary among societies on the use of biologics in pregnancy generally (eTable 1^1,2,9,11-24), but some societies recommend systemic agents to achieve disease control during pregnancy.^9,25

Assessing the potential interplay between disease severity and outcomes in pregnant women with psoriasis is further complicated by the slowly growing body of literature demonstrating that women with psoriasis have more comorbidities²⁶ and worse pregnancy outcomes.^27,28 Pregnant psoriasis patients are more likely to smoke, have depression, and be overweight or obese prior to pregnancy and are less likely to take prenatal vitamins.²⁶ They also have an increased risk for cesarean birth, gestational diabetes, gestational hypertension, and preeclampsia.²⁸ In contrast to these prior studies, a systematic review revealed no risk for adverse outcomes in pregnant women with psoriasis.²⁹

Assessment of Treatments for Psoriasis in Pregnancy

In light of these issues, treatment of psoriasis during pregnancy should be assessed from several vantage points. Of note, the US Food and Drug Administration changed its classification scheme in 2015 to a more narrative format called the Pregnancy and Lactation Labeling Rule.³⁰ Prior classifications, however, provide a reasonable starting point for categorizing the safety of drugs (Table³¹). Importantly, time of exposure to systemic agents also matters; first-trimester exposure is more likely to affect embryogenesis, whereas second- and third-trimester exposures are more prone to affect other aspects of fetal growth. eTable 2 provides data on the use of oral and topical medications to treat psoriasis in pregnancy.^1,8,22,32-45

Topical Agents
Topical steroids are largely understood to be reasonable treatment options, though consideration of potency, formulation, area of application, and use of occlusion is important.^1,46 Risk for orofacial cleft has been noted with first-trimester topical steroid exposure, though a 2015 Cochrane review update determined that the relative risk of this association was not significantly elevated.³²

The impact of topical calcipotriene and salicylic acid has not been studied in human pregnancies,¹ but systemic absorption can occur for both. There is potential for vitamin D toxicity with calcipotriene⁴⁶; consequently, use during pregnancy is not recommended.^1,46 Some authors recommend against topical salicylic acid in pregnancy; others report that limited exposure is permissible.⁴⁷ In fact, as salicylic acid commonly is found in over-the-counter acne products, many women of childbearing potential likely have quotidian exposure.

Preterm delivery and low birthweight have been reported with oral tacrolimus; however, risk with topical tacrolimus is thought to be low¹ because the molecular size likely prohibits notable absorption.⁴⁷ Evidence for the use of anthralin and coal tar also is scarce. First-trimester coal tar use should be avoided; subsequent use in pregnancy should be restricted given concern for adverse outcomes.¹

Phototherapy
Broadband or narrowband UVB therapy is recommended as second-line therapy in pregnancy. No cases of fetal risk or premature delivery associated with UVB therapy were found in our search.¹ Phototherapy can exacerbate melasma⁴⁷ and decrease folate levels⁴⁸; as such, some authors recommend folate supplementation in females of childbearing age who are being treated with phototherapy.⁴⁹ Psoralen, used in psoralen plus UVA therapy, is mutagenic and therefore contraindicated in pregnancy.¹

Oral Medications
Both methotrexate, which is a teratogen, abortifacient, and mutagen,¹ and systemic retinoids, which are teratogens, are contraindicated in pregnancy.^1,47 Acitretin labeling recommends avoiding pregnancy for 3 years posttreatment⁵⁰ because alcohol intake prolongs the medication’s half-life.²²

Apremilast use is not documented in pregnant psoriasis patients⁵¹; an ongoing registry of the Organization of Tetralogy Information Specialists has not reported publicly to date.⁵² Animal studies of apremilast have documented dose-related decreased birthweight and fetal loss.²²

Safety data for systemic steroids, used infrequently in psoriasis, are not well established. First-trimester prednisone exposure has been associated with prematurity, low birthweight, and congenital abnormalities.³⁸ A separate evaluation of 1047 children exposed to betamethasone in utero failed to demonstrate significant change in birthweight or head circumference. However, repeat antenatal corticosteroid exposure was associated with attention problems at 2 years of age.³⁹

Data regarding cyclosporine use, derived primarily from organ transplant recipients, suggest elevated risk for prematurity and low birthweight.^53,54 A meta-analysis demonstrated that organ transplant recipients taking cyclosporine had a nonsignificantly elevated odds ratio for congenital malformations, prematurity, and low birthweight.⁴² Cyclosporine use for psoriasis in pregnancy is not well described; in a study, rates of prematurity and low birthweight were both 21%.⁴³ Limited data are available for Janus kinase inhibitors, none of which are approved for psoriasis, though clinical trials in psoriasis and psoriatic arthritis are underway (ClinicalTrials.gov identifiers NCT04246372, NCT03104374, NCT03104400).

Biologics and Small-Molecule Inhibitors
Limited data on biologics in pregnancy exist²⁵ (eTable 3). Placental transport of IgG antibodies, including biologics, increases throughout pregnancy, especially in the third trimester.⁸² Infants of mothers treated with a biologic with potential for placental transfer are therefore considered by some authors to be immunosuppressed during the first months of life.²

Looking globally across biologics used for psoriasis, limited safety data are encouraging. In a review of PSOLAR (Psoriasis Longitudinal Assessment and Registry), 83 pregnancies with biologic exposure resulted in 59 live births (71%); 18 spontaneous abortions (22%); 6 induced abortions (7%); no congenital abnormalities; and 7 reports of neonatal problems, including respiratory issues, ABO blood group mismatch, hospitalization, and opioid withdrawal.⁸³

Use of tumor necrosis factor (TNF) inhibitors in pregnancy has the most data²⁵ and is considered a reasonable treatment option. Historically, there was concern about the risk for VACTERL syndrome (vertebral defects, anal atresia, cardiac defects, tracheoesophageal fistula, renal anomalies, limb abnormalities) with exposure to a TNF inhibitor,^25,84-86 but further reports have alleviated these concerns. Active transplacental transport occurs for adalimumab, infliximab, and golimumab,⁸⁷ but given structural differences, transport of certolizumab and etanercept is substantially less.^88,89 In the CRIB study of placental transfer of certolizumab from mother to infant (N=14), pharmacokinetic data demonstrated no quantifiable certolizumab levels in 13 infants and minimal levels in 1 infant at birth.⁸⁸ There are fewer data available on the use of other biologics in pregnancy, but for those in which active placental transport is relevant, similar concerns (ie, immunosuppression) might arise (eTable 3).

Concern over biologics largely involves risk for newborn immunosuppression. A case report detailed a Crohn disease patient treated with infliximab who gave birth to an infant who died of disseminated bacille Calmette-Guérin infection at 4.5 months after receiving the vaccine at 3 months.⁹⁰ This case underscores the importance of delaying live vaccination in infants born to mothers who were treated with a biologic during pregnancy. Authors have provided various data on how long to avoid vaccination; some state as long as 1 year.⁹¹

In pregnant females with inflammatory bowel disease treated with a biologic, no correlation was observed among maternal, placental, and infant serum biologic levels and neonatal infection. However, an association between preterm birth and the level of the biologic in maternal and placental (but not infant) serum and preterm birth was observed.⁹²

In another report from the same registry, combination therapy with a TNF inhibitor and another immunomodulator led to an increased risk for infection in infants at 12 months of age, compared to infants exposed to monotherapy⁸⁹ or exposed to neither agent.⁹³ A strategy to circumvent this potential problem is to avoid treatment with actively transported molecules in the third trimester.

Conclusion

Limited data exist to guide providers who are treating pregnant women with psoriasis. Our understanding of treatment of psoriasis in pregnancy is limited as a consequence of regulations surrounding clinical trials and inadequate detection of pregnancies in registries. Further efforts are necessary to better understand the relationship between psoriasis and pregnancy and how to manage pregnant women with psoriasis.

Historically, there have been limited data available on the management of psoriasis in pregnancy. The most comprehensive discussion of treatment guidelines is from 2012.¹ In the interim, many biologics have been approved for treating psoriasis, with slow accumulation of pregnancy safety data. The 2019 American Academy of Dermatology–National Psoriasis Foundation guidelines on biologics for psoriasis contain updated information but also highlight the paucity of pregnancy safety data.² This gap is in part a consequence of the exclusion and disenrollment of pregnant women from clinical trials.³ Additionally, lack of detection through registries contributes; pregnancy capture in registries is low compared to the expected number of pregnancies estimated from US Census data.⁴ Despite these shortcomings, psoriasis patients who are already pregnant or are considering becoming pregnant frequently are encountered in practice and may need treatment. This article reviews the evidence on commonly used treatments for psoriasis in pregnancy.

Background

For many patients, psoriasis improves during pregnancy^5,6 and becomes worse postpartum. In a prospective study, most patients reported improvement in pregnancy corresponding to a significant decrease in affected body surface area (P<.001) by 10 to 20 weeks’ gestation. Most patients also reported worsening of psoriasis postpartum; a significant increase in psoriatic body surface area (P=.001) was observed after delivery.⁷ Despite these findings, a considerable number of patients also experience stable disease or worsening of disease during pregnancy.

In addition to the maternal disease state, the issue of pregnancy outcomes is paramount. In the inflammatory bowel disease and rheumatology literature, it is established that uncontrolled disease is associated with poorer pregnancy outcomes.^8-10 Guidelines vary among societies on the use of biologics in pregnancy generally (eTable 1^1,2,9,11-24), but some societies recommend systemic agents to achieve disease control during pregnancy.^9,25

Assessing the potential interplay between disease severity and outcomes in pregnant women with psoriasis is further complicated by the slowly growing body of literature demonstrating that women with psoriasis have more comorbidities²⁶ and worse pregnancy outcomes.^27,28 Pregnant psoriasis patients are more likely to smoke, have depression, and be overweight or obese prior to pregnancy and are less likely to take prenatal vitamins.²⁶ They also have an increased risk for cesarean birth, gestational diabetes, gestational hypertension, and preeclampsia.²⁸ In contrast to these prior studies, a systematic review revealed no risk for adverse outcomes in pregnant women with psoriasis.²⁹

Assessment of Treatments for Psoriasis in Pregnancy

In light of these issues, treatment of psoriasis during pregnancy should be assessed from several vantage points. Of note, the US Food and Drug Administration changed its classification scheme in 2015 to a more narrative format called the Pregnancy and Lactation Labeling Rule.³⁰ Prior classifications, however, provide a reasonable starting point for categorizing the safety of drugs (Table³¹). Importantly, time of exposure to systemic agents also matters; first-trimester exposure is more likely to affect embryogenesis, whereas second- and third-trimester exposures are more prone to affect other aspects of fetal growth. eTable 2 provides data on the use of oral and topical medications to treat psoriasis in pregnancy.^1,8,22,32-45

Topical Agents
Topical steroids are largely understood to be reasonable treatment options, though consideration of potency, formulation, area of application, and use of occlusion is important.^1,46 Risk for orofacial cleft has been noted with first-trimester topical steroid exposure, though a 2015 Cochrane review update determined that the relative risk of this association was not significantly elevated.³²

The impact of topical calcipotriene and salicylic acid has not been studied in human pregnancies,¹ but systemic absorption can occur for both. There is potential for vitamin D toxicity with calcipotriene⁴⁶; consequently, use during pregnancy is not recommended.^1,46 Some authors recommend against topical salicylic acid in pregnancy; others report that limited exposure is permissible.⁴⁷ In fact, as salicylic acid commonly is found in over-the-counter acne products, many women of childbearing potential likely have quotidian exposure.

Preterm delivery and low birthweight have been reported with oral tacrolimus; however, risk with topical tacrolimus is thought to be low¹ because the molecular size likely prohibits notable absorption.⁴⁷ Evidence for the use of anthralin and coal tar also is scarce. First-trimester coal tar use should be avoided; subsequent use in pregnancy should be restricted given concern for adverse outcomes.¹

Phototherapy
Broadband or narrowband UVB therapy is recommended as second-line therapy in pregnancy. No cases of fetal risk or premature delivery associated with UVB therapy were found in our search.¹ Phototherapy can exacerbate melasma⁴⁷ and decrease folate levels⁴⁸; as such, some authors recommend folate supplementation in females of childbearing age who are being treated with phototherapy.⁴⁹ Psoralen, used in psoralen plus UVA therapy, is mutagenic and therefore contraindicated in pregnancy.¹

Oral Medications
Both methotrexate, which is a teratogen, abortifacient, and mutagen,¹ and systemic retinoids, which are teratogens, are contraindicated in pregnancy.^1,47 Acitretin labeling recommends avoiding pregnancy for 3 years posttreatment⁵⁰ because alcohol intake prolongs the medication’s half-life.²²

Apremilast use is not documented in pregnant psoriasis patients⁵¹; an ongoing registry of the Organization of Tetralogy Information Specialists has not reported publicly to date.⁵² Animal studies of apremilast have documented dose-related decreased birthweight and fetal loss.²²

Safety data for systemic steroids, used infrequently in psoriasis, are not well established. First-trimester prednisone exposure has been associated with prematurity, low birthweight, and congenital abnormalities.³⁸ A separate evaluation of 1047 children exposed to betamethasone in utero failed to demonstrate significant change in birthweight or head circumference. However, repeat antenatal corticosteroid exposure was associated with attention problems at 2 years of age.³⁹

Data regarding cyclosporine use, derived primarily from organ transplant recipients, suggest elevated risk for prematurity and low birthweight.^53,54 A meta-analysis demonstrated that organ transplant recipients taking cyclosporine had a nonsignificantly elevated odds ratio for congenital malformations, prematurity, and low birthweight.⁴² Cyclosporine use for psoriasis in pregnancy is not well described; in a study, rates of prematurity and low birthweight were both 21%.⁴³ Limited data are available for Janus kinase inhibitors, none of which are approved for psoriasis, though clinical trials in psoriasis and psoriatic arthritis are underway (ClinicalTrials.gov identifiers NCT04246372, NCT03104374, NCT03104400).

Biologics and Small-Molecule Inhibitors
Limited data on biologics in pregnancy exist²⁵ (eTable 3). Placental transport of IgG antibodies, including biologics, increases throughout pregnancy, especially in the third trimester.⁸² Infants of mothers treated with a biologic with potential for placental transfer are therefore considered by some authors to be immunosuppressed during the first months of life.²

Looking globally across biologics used for psoriasis, limited safety data are encouraging. In a review of PSOLAR (Psoriasis Longitudinal Assessment and Registry), 83 pregnancies with biologic exposure resulted in 59 live births (71%); 18 spontaneous abortions (22%); 6 induced abortions (7%); no congenital abnormalities; and 7 reports of neonatal problems, including respiratory issues, ABO blood group mismatch, hospitalization, and opioid withdrawal.⁸³

Use of tumor necrosis factor (TNF) inhibitors in pregnancy has the most data²⁵ and is considered a reasonable treatment option. Historically, there was concern about the risk for VACTERL syndrome (vertebral defects, anal atresia, cardiac defects, tracheoesophageal fistula, renal anomalies, limb abnormalities) with exposure to a TNF inhibitor,^25,84-86 but further reports have alleviated these concerns. Active transplacental transport occurs for adalimumab, infliximab, and golimumab,⁸⁷ but given structural differences, transport of certolizumab and etanercept is substantially less.^88,89 In the CRIB study of placental transfer of certolizumab from mother to infant (N=14), pharmacokinetic data demonstrated no quantifiable certolizumab levels in 13 infants and minimal levels in 1 infant at birth.⁸⁸ There are fewer data available on the use of other biologics in pregnancy, but for those in which active placental transport is relevant, similar concerns (ie, immunosuppression) might arise (eTable 3).

Concern over biologics largely involves risk for newborn immunosuppression. A case report detailed a Crohn disease patient treated with infliximab who gave birth to an infant who died of disseminated bacille Calmette-Guérin infection at 4.5 months after receiving the vaccine at 3 months.⁹⁰ This case underscores the importance of delaying live vaccination in infants born to mothers who were treated with a biologic during pregnancy. Authors have provided various data on how long to avoid vaccination; some state as long as 1 year.⁹¹

In pregnant females with inflammatory bowel disease treated with a biologic, no correlation was observed among maternal, placental, and infant serum biologic levels and neonatal infection. However, an association between preterm birth and the level of the biologic in maternal and placental (but not infant) serum and preterm birth was observed.⁹²

In another report from the same registry, combination therapy with a TNF inhibitor and another immunomodulator led to an increased risk for infection in infants at 12 months of age, compared to infants exposed to monotherapy⁸⁹ or exposed to neither agent.⁹³ A strategy to circumvent this potential problem is to avoid treatment with actively transported molecules in the third trimester.

Conclusion

Limited data exist to guide providers who are treating pregnant women with psoriasis. Our understanding of treatment of psoriasis in pregnancy is limited as a consequence of regulations surrounding clinical trials and inadequate detection of pregnancies in registries. Further efforts are necessary to better understand the relationship between psoriasis and pregnancy and how to manage pregnant women with psoriasis.

Historically, there have been limited data available on the management of psoriasis in pregnancy. The most comprehensive discussion of treatment guidelines is from 2012.¹ In the interim, many biologics have been approved for treating psoriasis, with slow accumulation of pregnancy safety data. The 2019 American Academy of Dermatology–National Psoriasis Foundation guidelines on biologics for psoriasis contain updated information but also highlight the paucity of pregnancy safety data.² This gap is in part a consequence of the exclusion and disenrollment of pregnant women from clinical trials.³ Additionally, lack of detection through registries contributes; pregnancy capture in registries is low compared to the expected number of pregnancies estimated from US Census data.⁴ Despite these shortcomings, psoriasis patients who are already pregnant or are considering becoming pregnant frequently are encountered in practice and may need treatment. This article reviews the evidence on commonly used treatments for psoriasis in pregnancy.

Background

For many patients, psoriasis improves during pregnancy^5,6 and becomes worse postpartum. In a prospective study, most patients reported improvement in pregnancy corresponding to a significant decrease in affected body surface area (P<.001) by 10 to 20 weeks’ gestation. Most patients also reported worsening of psoriasis postpartum; a significant increase in psoriatic body surface area (P=.001) was observed after delivery.⁷ Despite these findings, a considerable number of patients also experience stable disease or worsening of disease during pregnancy.

In addition to the maternal disease state, the issue of pregnancy outcomes is paramount. In the inflammatory bowel disease and rheumatology literature, it is established that uncontrolled disease is associated with poorer pregnancy outcomes.^8-10 Guidelines vary among societies on the use of biologics in pregnancy generally (eTable 1^1,2,9,11-24), but some societies recommend systemic agents to achieve disease control during pregnancy.^9,25

Assessing the potential interplay between disease severity and outcomes in pregnant women with psoriasis is further complicated by the slowly growing body of literature demonstrating that women with psoriasis have more comorbidities²⁶ and worse pregnancy outcomes.^27,28 Pregnant psoriasis patients are more likely to smoke, have depression, and be overweight or obese prior to pregnancy and are less likely to take prenatal vitamins.²⁶ They also have an increased risk for cesarean birth, gestational diabetes, gestational hypertension, and preeclampsia.²⁸ In contrast to these prior studies, a systematic review revealed no risk for adverse outcomes in pregnant women with psoriasis.²⁹

Assessment of Treatments for Psoriasis in Pregnancy

In light of these issues, treatment of psoriasis during pregnancy should be assessed from several vantage points. Of note, the US Food and Drug Administration changed its classification scheme in 2015 to a more narrative format called the Pregnancy and Lactation Labeling Rule.³⁰ Prior classifications, however, provide a reasonable starting point for categorizing the safety of drugs (Table³¹). Importantly, time of exposure to systemic agents also matters; first-trimester exposure is more likely to affect embryogenesis, whereas second- and third-trimester exposures are more prone to affect other aspects of fetal growth. eTable 2 provides data on the use of oral and topical medications to treat psoriasis in pregnancy.^1,8,22,32-45

Topical Agents
Topical steroids are largely understood to be reasonable treatment options, though consideration of potency, formulation, area of application, and use of occlusion is important.^1,46 Risk for orofacial cleft has been noted with first-trimester topical steroid exposure, though a 2015 Cochrane review update determined that the relative risk of this association was not significantly elevated.³²

The impact of topical calcipotriene and salicylic acid has not been studied in human pregnancies,¹ but systemic absorption can occur for both. There is potential for vitamin D toxicity with calcipotriene⁴⁶; consequently, use during pregnancy is not recommended.^1,46 Some authors recommend against topical salicylic acid in pregnancy; others report that limited exposure is permissible.⁴⁷ In fact, as salicylic acid commonly is found in over-the-counter acne products, many women of childbearing potential likely have quotidian exposure.

Preterm delivery and low birthweight have been reported with oral tacrolimus; however, risk with topical tacrolimus is thought to be low¹ because the molecular size likely prohibits notable absorption.⁴⁷ Evidence for the use of anthralin and coal tar also is scarce. First-trimester coal tar use should be avoided; subsequent use in pregnancy should be restricted given concern for adverse outcomes.¹

Phototherapy
Broadband or narrowband UVB therapy is recommended as second-line therapy in pregnancy. No cases of fetal risk or premature delivery associated with UVB therapy were found in our search.¹ Phototherapy can exacerbate melasma⁴⁷ and decrease folate levels⁴⁸; as such, some authors recommend folate supplementation in females of childbearing age who are being treated with phototherapy.⁴⁹ Psoralen, used in psoralen plus UVA therapy, is mutagenic and therefore contraindicated in pregnancy.¹

Oral Medications
Both methotrexate, which is a teratogen, abortifacient, and mutagen,¹ and systemic retinoids, which are teratogens, are contraindicated in pregnancy.^1,47 Acitretin labeling recommends avoiding pregnancy for 3 years posttreatment⁵⁰ because alcohol intake prolongs the medication’s half-life.²²

Apremilast use is not documented in pregnant psoriasis patients⁵¹; an ongoing registry of the Organization of Tetralogy Information Specialists has not reported publicly to date.⁵² Animal studies of apremilast have documented dose-related decreased birthweight and fetal loss.²²

Safety data for systemic steroids, used infrequently in psoriasis, are not well established. First-trimester prednisone exposure has been associated with prematurity, low birthweight, and congenital abnormalities.³⁸ A separate evaluation of 1047 children exposed to betamethasone in utero failed to demonstrate significant change in birthweight or head circumference. However, repeat antenatal corticosteroid exposure was associated with attention problems at 2 years of age.³⁹

Data regarding cyclosporine use, derived primarily from organ transplant recipients, suggest elevated risk for prematurity and low birthweight.^53,54 A meta-analysis demonstrated that organ transplant recipients taking cyclosporine had a nonsignificantly elevated odds ratio for congenital malformations, prematurity, and low birthweight.⁴² Cyclosporine use for psoriasis in pregnancy is not well described; in a study, rates of prematurity and low birthweight were both 21%.⁴³ Limited data are available for Janus kinase inhibitors, none of which are approved for psoriasis, though clinical trials in psoriasis and psoriatic arthritis are underway (ClinicalTrials.gov identifiers NCT04246372, NCT03104374, NCT03104400).

Biologics and Small-Molecule Inhibitors
Limited data on biologics in pregnancy exist²⁵ (eTable 3). Placental transport of IgG antibodies, including biologics, increases throughout pregnancy, especially in the third trimester.⁸² Infants of mothers treated with a biologic with potential for placental transfer are therefore considered by some authors to be immunosuppressed during the first months of life.²

Looking globally across biologics used for psoriasis, limited safety data are encouraging. In a review of PSOLAR (Psoriasis Longitudinal Assessment and Registry), 83 pregnancies with biologic exposure resulted in 59 live births (71%); 18 spontaneous abortions (22%); 6 induced abortions (7%); no congenital abnormalities; and 7 reports of neonatal problems, including respiratory issues, ABO blood group mismatch, hospitalization, and opioid withdrawal.⁸³

Use of tumor necrosis factor (TNF) inhibitors in pregnancy has the most data²⁵ and is considered a reasonable treatment option. Historically, there was concern about the risk for VACTERL syndrome (vertebral defects, anal atresia, cardiac defects, tracheoesophageal fistula, renal anomalies, limb abnormalities) with exposure to a TNF inhibitor,^25,84-86 but further reports have alleviated these concerns. Active transplacental transport occurs for adalimumab, infliximab, and golimumab,⁸⁷ but given structural differences, transport of certolizumab and etanercept is substantially less.^88,89 In the CRIB study of placental transfer of certolizumab from mother to infant (N=14), pharmacokinetic data demonstrated no quantifiable certolizumab levels in 13 infants and minimal levels in 1 infant at birth.⁸⁸ There are fewer data available on the use of other biologics in pregnancy, but for those in which active placental transport is relevant, similar concerns (ie, immunosuppression) might arise (eTable 3).

Concern over biologics largely involves risk for newborn immunosuppression. A case report detailed a Crohn disease patient treated with infliximab who gave birth to an infant who died of disseminated bacille Calmette-Guérin infection at 4.5 months after receiving the vaccine at 3 months.⁹⁰ This case underscores the importance of delaying live vaccination in infants born to mothers who were treated with a biologic during pregnancy. Authors have provided various data on how long to avoid vaccination; some state as long as 1 year.⁹¹

In pregnant females with inflammatory bowel disease treated with a biologic, no correlation was observed among maternal, placental, and infant serum biologic levels and neonatal infection. However, an association between preterm birth and the level of the biologic in maternal and placental (but not infant) serum and preterm birth was observed.⁹²

In another report from the same registry, combination therapy with a TNF inhibitor and another immunomodulator led to an increased risk for infection in infants at 12 months of age, compared to infants exposed to monotherapy⁸⁹ or exposed to neither agent.⁹³ A strategy to circumvent this potential problem is to avoid treatment with actively transported molecules in the third trimester.

Conclusion

Limited data exist to guide providers who are treating pregnant women with psoriasis. Our understanding of treatment of psoriasis in pregnancy is limited as a consequence of regulations surrounding clinical trials and inadequate detection of pregnancies in registries. Further efforts are necessary to better understand the relationship between psoriasis and pregnancy and how to manage pregnant women with psoriasis.

Limited data exist comparing staples and sutures for scalp closures during Mohs micrographic surgery (MMS). As a result, the closure method for these scalp wounds is based on surgeon preference without established consensus. The purpose of this study was to survey practicing Mohs surgeons on their scalp wound closure preferences as well as the clinical and economic variables that impact their decisions. Understanding practice habits can guide future trial design, with a goal of creating established criterion for MMS scalp wound closures.

Methods

An anonymous survey was distributed from April 2019 to June 2019 to fellowship-trained Mohs surgeons using an electronic mailing list from the American College of Mohs Surgery (ACMS). The 10-question survey was approved by the University of Kansas institutional review board and the executive committee of the ACMS. Surgeons were asked about their preferred method for scalp wound closure as well as clinical and economic variables that impacted those preferences. Respondents indicated their frequency of using deep sutures, epidermal sutures, and wound undermining on a sliding scale of 0% to 100%. Comparisons were made between practice habits, preferences, and surgeon demographics using t tests. Statistical significance was determined as P<.05.

Results

Sixty-eight ACMS fellowship-trained Mohs surgeons completed the survey. The average age of respondents was 45 years; 69.1% (n=47) of respondents were male, and 76.5% (n=52) practiced in a private setting (Table 1). Regardless of epidermal closure type, deep suture placement was used in an average (standard deviation [SD]) of 88.8% (19.5%) of cases overall, which did not statistically differ between years of Mohs experience or practice setting (Table 2). Wound undermining was performed in an average (SD) of 83.0% (24.3%) of cases overall and was more prevalent in private vs academic settings (87.6% [17.8%] vs 65.7% [35.0%]; P<.01). Epidermal sutures were used in an average (SD) of 27.1% (33.5%) of scalp wound cases overall. Surgeons with less experience (≤5 years) used them more frequently (average [SD], 42.7% [36.2%] of cases) than surgeons with more experience (≥16 years; average [SD], 18.8% [32.6%] of cases; P=.037). There was no significant difference between epidermal suture placement rates and practice setting (average [SD], 18.1% [28.1%] of cases for academic providers vs 30.0% [34.8%] of cases with private providers; P=.210).

Clinical and economic factors that were most important during wound closure were ranked (beginning with most important) as the following: risk of complications, cosmetic outcome, hair preservation, patient comfort during closure, healing time, and closure cost. In all demographic cases, risk of complications was ranked 1 or 2 (1=most important; 6=least important) overall; cost was the least important factor overall (Table 2).

Surgeons perceived staples to be superior for speed of closure and for closing wounds in high-tension areas, whereas sutures were perceived as superior when considering cost of closure and ease of removal (Table 3). Successful healing rate, healing time, hair preservation, overall cosmetic outcome, and lower risk of complications were viewed as equivalent when comparing staples and sutures.

Comment

Epidermal closure with sutures was reportedly used in an average of only 27.1% of scalp wound cases, with clinical factors such as cosmetic outcome, risk of complications, and closure time seen as either equivalent or inferior to staples. Our data suggest that surgeon closure perceptions generally are in agreement with established head and neck literature within different medical specialties that favor staple closures, particularly in high-tension areas.¹ Interestingly, the most common reasons given for not using staples included patient discomfort, cost, and worse cosmetic outcomes, which are unsubstantiated with head and neck comparative studies.^2-4

Although cost was the least important variable for determining closure type in our surveyed cohort, it is likely that the overall cost of closure is frequently underestimated. A higher material cost is noted with staples; however, the largest determinant of overall cost remains the surgeon’s time, which is reduced by factors of 10 or more when closing with staples.^2,3 This difference—coupled with the unchanged cosmetic outcome and complication rates—makes staples more advantageous for high-tension scalp wounds.⁴ Moreover, the stapling technique is more reproducible than suturing, which requires more surgical skill and experience.

Limitations of this study include a lack of directly comparable data for staple and suture scalp wound closures. In addition, the small cohort of respondents in this preliminary study can serve to guide future studies.

Conclusion

Scalp wounds during MMS were most frequently closed using staples vs sutures, with the perception that these methods are equivalent in complication risk, cosmetic outcome, and overall patient satisfaction. These results agree with comparative literature for head and neck surgery and assist with establishing an epidemiologic baseline for future studies comparing their use during MMS.

Limited data exist comparing staples and sutures for scalp closures during Mohs micrographic surgery (MMS). As a result, the closure method for these scalp wounds is based on surgeon preference without established consensus. The purpose of this study was to survey practicing Mohs surgeons on their scalp wound closure preferences as well as the clinical and economic variables that impact their decisions. Understanding practice habits can guide future trial design, with a goal of creating established criterion for MMS scalp wound closures.

Methods

An anonymous survey was distributed from April 2019 to June 2019 to fellowship-trained Mohs surgeons using an electronic mailing list from the American College of Mohs Surgery (ACMS). The 10-question survey was approved by the University of Kansas institutional review board and the executive committee of the ACMS. Surgeons were asked about their preferred method for scalp wound closure as well as clinical and economic variables that impacted those preferences. Respondents indicated their frequency of using deep sutures, epidermal sutures, and wound undermining on a sliding scale of 0% to 100%. Comparisons were made between practice habits, preferences, and surgeon demographics using t tests. Statistical significance was determined as P<.05.

Results

Sixty-eight ACMS fellowship-trained Mohs surgeons completed the survey. The average age of respondents was 45 years; 69.1% (n=47) of respondents were male, and 76.5% (n=52) practiced in a private setting (Table 1). Regardless of epidermal closure type, deep suture placement was used in an average (standard deviation [SD]) of 88.8% (19.5%) of cases overall, which did not statistically differ between years of Mohs experience or practice setting (Table 2). Wound undermining was performed in an average (SD) of 83.0% (24.3%) of cases overall and was more prevalent in private vs academic settings (87.6% [17.8%] vs 65.7% [35.0%]; P<.01). Epidermal sutures were used in an average (SD) of 27.1% (33.5%) of scalp wound cases overall. Surgeons with less experience (≤5 years) used them more frequently (average [SD], 42.7% [36.2%] of cases) than surgeons with more experience (≥16 years; average [SD], 18.8% [32.6%] of cases; P=.037). There was no significant difference between epidermal suture placement rates and practice setting (average [SD], 18.1% [28.1%] of cases for academic providers vs 30.0% [34.8%] of cases with private providers; P=.210).

Clinical and economic factors that were most important during wound closure were ranked (beginning with most important) as the following: risk of complications, cosmetic outcome, hair preservation, patient comfort during closure, healing time, and closure cost. In all demographic cases, risk of complications was ranked 1 or 2 (1=most important; 6=least important) overall; cost was the least important factor overall (Table 2).

Surgeons perceived staples to be superior for speed of closure and for closing wounds in high-tension areas, whereas sutures were perceived as superior when considering cost of closure and ease of removal (Table 3). Successful healing rate, healing time, hair preservation, overall cosmetic outcome, and lower risk of complications were viewed as equivalent when comparing staples and sutures.

Comment

Epidermal closure with sutures was reportedly used in an average of only 27.1% of scalp wound cases, with clinical factors such as cosmetic outcome, risk of complications, and closure time seen as either equivalent or inferior to staples. Our data suggest that surgeon closure perceptions generally are in agreement with established head and neck literature within different medical specialties that favor staple closures, particularly in high-tension areas.¹ Interestingly, the most common reasons given for not using staples included patient discomfort, cost, and worse cosmetic outcomes, which are unsubstantiated with head and neck comparative studies.^2-4

Although cost was the least important variable for determining closure type in our surveyed cohort, it is likely that the overall cost of closure is frequently underestimated. A higher material cost is noted with staples; however, the largest determinant of overall cost remains the surgeon’s time, which is reduced by factors of 10 or more when closing with staples.^2,3 This difference—coupled with the unchanged cosmetic outcome and complication rates—makes staples more advantageous for high-tension scalp wounds.⁴ Moreover, the stapling technique is more reproducible than suturing, which requires more surgical skill and experience.

Limitations of this study include a lack of directly comparable data for staple and suture scalp wound closures. In addition, the small cohort of respondents in this preliminary study can serve to guide future studies.

Conclusion

Scalp wounds during MMS were most frequently closed using staples vs sutures, with the perception that these methods are equivalent in complication risk, cosmetic outcome, and overall patient satisfaction. These results agree with comparative literature for head and neck surgery and assist with establishing an epidemiologic baseline for future studies comparing their use during MMS.

Limited data exist comparing staples and sutures for scalp closures during Mohs micrographic surgery (MMS). As a result, the closure method for these scalp wounds is based on surgeon preference without established consensus. The purpose of this study was to survey practicing Mohs surgeons on their scalp wound closure preferences as well as the clinical and economic variables that impact their decisions. Understanding practice habits can guide future trial design, with a goal of creating established criterion for MMS scalp wound closures.

Methods

An anonymous survey was distributed from April 2019 to June 2019 to fellowship-trained Mohs surgeons using an electronic mailing list from the American College of Mohs Surgery (ACMS). The 10-question survey was approved by the University of Kansas institutional review board and the executive committee of the ACMS. Surgeons were asked about their preferred method for scalp wound closure as well as clinical and economic variables that impacted those preferences. Respondents indicated their frequency of using deep sutures, epidermal sutures, and wound undermining on a sliding scale of 0% to 100%. Comparisons were made between practice habits, preferences, and surgeon demographics using t tests. Statistical significance was determined as P<.05.

Results

Sixty-eight ACMS fellowship-trained Mohs surgeons completed the survey. The average age of respondents was 45 years; 69.1% (n=47) of respondents were male, and 76.5% (n=52) practiced in a private setting (Table 1). Regardless of epidermal closure type, deep suture placement was used in an average (standard deviation [SD]) of 88.8% (19.5%) of cases overall, which did not statistically differ between years of Mohs experience or practice setting (Table 2). Wound undermining was performed in an average (SD) of 83.0% (24.3%) of cases overall and was more prevalent in private vs academic settings (87.6% [17.8%] vs 65.7% [35.0%]; P<.01). Epidermal sutures were used in an average (SD) of 27.1% (33.5%) of scalp wound cases overall. Surgeons with less experience (≤5 years) used them more frequently (average [SD], 42.7% [36.2%] of cases) than surgeons with more experience (≥16 years; average [SD], 18.8% [32.6%] of cases; P=.037). There was no significant difference between epidermal suture placement rates and practice setting (average [SD], 18.1% [28.1%] of cases for academic providers vs 30.0% [34.8%] of cases with private providers; P=.210).

Clinical and economic factors that were most important during wound closure were ranked (beginning with most important) as the following: risk of complications, cosmetic outcome, hair preservation, patient comfort during closure, healing time, and closure cost. In all demographic cases, risk of complications was ranked 1 or 2 (1=most important; 6=least important) overall; cost was the least important factor overall (Table 2).

Surgeons perceived staples to be superior for speed of closure and for closing wounds in high-tension areas, whereas sutures were perceived as superior when considering cost of closure and ease of removal (Table 3). Successful healing rate, healing time, hair preservation, overall cosmetic outcome, and lower risk of complications were viewed as equivalent when comparing staples and sutures.

Comment

Epidermal closure with sutures was reportedly used in an average of only 27.1% of scalp wound cases, with clinical factors such as cosmetic outcome, risk of complications, and closure time seen as either equivalent or inferior to staples. Our data suggest that surgeon closure perceptions generally are in agreement with established head and neck literature within different medical specialties that favor staple closures, particularly in high-tension areas.¹ Interestingly, the most common reasons given for not using staples included patient discomfort, cost, and worse cosmetic outcomes, which are unsubstantiated with head and neck comparative studies.^2-4

Although cost was the least important variable for determining closure type in our surveyed cohort, it is likely that the overall cost of closure is frequently underestimated. A higher material cost is noted with staples; however, the largest determinant of overall cost remains the surgeon’s time, which is reduced by factors of 10 or more when closing with staples.^2,3 This difference—coupled with the unchanged cosmetic outcome and complication rates—makes staples more advantageous for high-tension scalp wounds.⁴ Moreover, the stapling technique is more reproducible than suturing, which requires more surgical skill and experience.

Limitations of this study include a lack of directly comparable data for staple and suture scalp wound closures. In addition, the small cohort of respondents in this preliminary study can serve to guide future studies.

Conclusion

Scalp wounds during MMS were most frequently closed using staples vs sutures, with the perception that these methods are equivalent in complication risk, cosmetic outcome, and overall patient satisfaction. These results agree with comparative literature for head and neck surgery and assist with establishing an epidemiologic baseline for future studies comparing their use during MMS.

FDA Approves Wynzora Cream for Plaque Psoriasis

MC2 Therapeutics announces US Food and Drug Administration (FDA) approval of Wynzora Cream (calcipotriene 0.005% and betamethasone dipropionate 0.064%) for once-daily treatment of plaque psoriasis in adults.

Wynzora Cream is based on PAD Technology, which enables stability of calcipotriene and betamethasone dipropionate in an aqueous formulation. Key features of PAD Technology formulations are high penetration of active ingredients to the target tissue, improved solubility and stability of active ingredients, high tolerability, and excellent treatment convenience. In the phase 3 trials conducted at multiple sites in the United States and the European Union, Wynzora Cream has demonstrated a combination of clinical efficacy, a favorable safety profile, and high convenience, offering overall better patient satisfaction in the topical treatment of plaque psoriasis in the real-world setting.

WynzoraCream is applied to affected areas once daily for up to 8 weeks and not more than 100 g per week. Patients should stop treatment when the plaque psoriasis is under control, unless a health care provider gives other instructions.

MC2 Therapeutics also has submitted a Marketing Authorization Application in the European Union for Wynzora Cream (50 µg/g calcipotriol and 0.5 mg/g betamethasone [as dipropionate]) for the treatment of plaque psoriasis. For more information, visit www.mc2therapeutics.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].

FDA Approves Wynzora Cream for Plaque Psoriasis

MC2 Therapeutics announces US Food and Drug Administration (FDA) approval of Wynzora Cream (calcipotriene 0.005% and betamethasone dipropionate 0.064%) for once-daily treatment of plaque psoriasis in adults.

Wynzora Cream is based on PAD Technology, which enables stability of calcipotriene and betamethasone dipropionate in an aqueous formulation. Key features of PAD Technology formulations are high penetration of active ingredients to the target tissue, improved solubility and stability of active ingredients, high tolerability, and excellent treatment convenience. In the phase 3 trials conducted at multiple sites in the United States and the European Union, Wynzora Cream has demonstrated a combination of clinical efficacy, a favorable safety profile, and high convenience, offering overall better patient satisfaction in the topical treatment of plaque psoriasis in the real-world setting.

WynzoraCream is applied to affected areas once daily for up to 8 weeks and not more than 100 g per week. Patients should stop treatment when the plaque psoriasis is under control, unless a health care provider gives other instructions.

MC2 Therapeutics also has submitted a Marketing Authorization Application in the European Union for Wynzora Cream (50 µg/g calcipotriol and 0.5 mg/g betamethasone [as dipropionate]) for the treatment of plaque psoriasis. For more information, visit www.mc2therapeutics.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].

FDA Approves Wynzora Cream for Plaque Psoriasis

MC2 Therapeutics announces US Food and Drug Administration (FDA) approval of Wynzora Cream (calcipotriene 0.005% and betamethasone dipropionate 0.064%) for once-daily treatment of plaque psoriasis in adults.

Wynzora Cream is based on PAD Technology, which enables stability of calcipotriene and betamethasone dipropionate in an aqueous formulation. Key features of PAD Technology formulations are high penetration of active ingredients to the target tissue, improved solubility and stability of active ingredients, high tolerability, and excellent treatment convenience. In the phase 3 trials conducted at multiple sites in the United States and the European Union, Wynzora Cream has demonstrated a combination of clinical efficacy, a favorable safety profile, and high convenience, offering overall better patient satisfaction in the topical treatment of plaque psoriasis in the real-world setting.

WynzoraCream is applied to affected areas once daily for up to 8 weeks and not more than 100 g per week. Patients should stop treatment when the plaque psoriasis is under control, unless a health care provider gives other instructions.

MC2 Therapeutics also has submitted a Marketing Authorization Application in the European Union for Wynzora Cream (50 µg/g calcipotriol and 0.5 mg/g betamethasone [as dipropionate]) for the treatment of plaque psoriasis. For more information, visit www.mc2therapeutics.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].

To the Editor:

Patients with skin, hair, or nail concerns often utilize online resources to self-diagnose or learn more about physician-diagnosed conditions. The American Academy of Dermatology (AAD) website offers the public access to informational pages categorized by disease or treatment (https://www.aad.org/public). We sought to evaluate the nail content by searching the Patients and Public section of the AAD website to qualitatively and quantitatively describe mentions of nail conditions. Psoriasis, psoriatic arthritis, atopic dermatitis, and ringworm content also were analyzed and compared to nail content. The analysis was performed on September 7, 2019.

Of the 73 topics listed in the Diseases and Treatments section of the site, 17 (23%) specifically mentioned nail symptoms or pathology (Table). Three additional topics—atopic dermatitis, cellulitis, and neurodermatitis—recommended keeping nails short to prevent injury from scratching. There was 1 mention of obtaining fungal cultures, 2 of nail scraping microscopy, 2 of nail clippings, and 2 of nail-related cancers. There were no mentions of nail biopsies. The total number of unique clinical images across all sections was 300, with 12 of nails. The video library contained 84 videos, of which 6 focused on nail health.

Many of the included images were not representative of common clinical findings. The nail lichen planus image showed pitting instead of more typical findings of nail plate atrophy and pterygium. The nail melanoma image showed thickened yellow toenails and the fifth toenail with a thin gray-brown band instead of an isolated wide black band. The nail fungus section included images of superficial onychomycosis and severe onychodystrophy instead of showing more common changes such as distal onycholysis with subungual hyperkeratosis, which is typical of the most common subtype, distal lateral subungual onychomycosis.⁵ Onychomycosis was referenced again in the ringworm section with 1 image repeated from the nail fungus section and another image that appeared to be a subungual hematoma.

The AAD website offers important patient education resources; however, nail content is underrepresented on this platform. Dermatologists are experts on nail disease, and increased efforts are needed to educate the public about frequently encountered nail signs and symptoms that could signify a serious underlying condition.

After our original search and analysis, new nail topics, images, and videos have been added; therefore, there has been a positive trend toward new nail content being added to site, which will greatly benefit patients.

To the Editor:

Patients with skin, hair, or nail concerns often utilize online resources to self-diagnose or learn more about physician-diagnosed conditions. The American Academy of Dermatology (AAD) website offers the public access to informational pages categorized by disease or treatment (https://www.aad.org/public). We sought to evaluate the nail content by searching the Patients and Public section of the AAD website to qualitatively and quantitatively describe mentions of nail conditions. Psoriasis, psoriatic arthritis, atopic dermatitis, and ringworm content also were analyzed and compared to nail content. The analysis was performed on September 7, 2019.

Of the 73 topics listed in the Diseases and Treatments section of the site, 17 (23%) specifically mentioned nail symptoms or pathology (Table). Three additional topics—atopic dermatitis, cellulitis, and neurodermatitis—recommended keeping nails short to prevent injury from scratching. There was 1 mention of obtaining fungal cultures, 2 of nail scraping microscopy, 2 of nail clippings, and 2 of nail-related cancers. There were no mentions of nail biopsies. The total number of unique clinical images across all sections was 300, with 12 of nails. The video library contained 84 videos, of which 6 focused on nail health.

Many of the included images were not representative of common clinical findings. The nail lichen planus image showed pitting instead of more typical findings of nail plate atrophy and pterygium. The nail melanoma image showed thickened yellow toenails and the fifth toenail with a thin gray-brown band instead of an isolated wide black band. The nail fungus section included images of superficial onychomycosis and severe onychodystrophy instead of showing more common changes such as distal onycholysis with subungual hyperkeratosis, which is typical of the most common subtype, distal lateral subungual onychomycosis.⁵ Onychomycosis was referenced again in the ringworm section with 1 image repeated from the nail fungus section and another image that appeared to be a subungual hematoma.

The AAD website offers important patient education resources; however, nail content is underrepresented on this platform. Dermatologists are experts on nail disease, and increased efforts are needed to educate the public about frequently encountered nail signs and symptoms that could signify a serious underlying condition.

After our original search and analysis, new nail topics, images, and videos have been added; therefore, there has been a positive trend toward new nail content being added to site, which will greatly benefit patients.

To the Editor:

Patients with skin, hair, or nail concerns often utilize online resources to self-diagnose or learn more about physician-diagnosed conditions. The American Academy of Dermatology (AAD) website offers the public access to informational pages categorized by disease or treatment (https://www.aad.org/public). We sought to evaluate the nail content by searching the Patients and Public section of the AAD website to qualitatively and quantitatively describe mentions of nail conditions. Psoriasis, psoriatic arthritis, atopic dermatitis, and ringworm content also were analyzed and compared to nail content. The analysis was performed on September 7, 2019.

Of the 73 topics listed in the Diseases and Treatments section of the site, 17 (23%) specifically mentioned nail symptoms or pathology (Table). Three additional topics—atopic dermatitis, cellulitis, and neurodermatitis—recommended keeping nails short to prevent injury from scratching. There was 1 mention of obtaining fungal cultures, 2 of nail scraping microscopy, 2 of nail clippings, and 2 of nail-related cancers. There were no mentions of nail biopsies. The total number of unique clinical images across all sections was 300, with 12 of nails. The video library contained 84 videos, of which 6 focused on nail health.

Many of the included images were not representative of common clinical findings. The nail lichen planus image showed pitting instead of more typical findings of nail plate atrophy and pterygium. The nail melanoma image showed thickened yellow toenails and the fifth toenail with a thin gray-brown band instead of an isolated wide black band. The nail fungus section included images of superficial onychomycosis and severe onychodystrophy instead of showing more common changes such as distal onycholysis with subungual hyperkeratosis, which is typical of the most common subtype, distal lateral subungual onychomycosis.⁵ Onychomycosis was referenced again in the ringworm section with 1 image repeated from the nail fungus section and another image that appeared to be a subungual hematoma.

The AAD website offers important patient education resources; however, nail content is underrepresented on this platform. Dermatologists are experts on nail disease, and increased efforts are needed to educate the public about frequently encountered nail signs and symptoms that could signify a serious underlying condition.

After our original search and analysis, new nail topics, images, and videos have been added; therefore, there has been a positive trend toward new nail content being added to site, which will greatly benefit patients.

The use of lasers in dermatology has evolved and expanded since their first cutaneous use in 1963.¹ As the fundamental understanding of the interaction of laser energy with biological tissues increased, the need for laser safety became apparent. Since then, lasers of varying wavelengths have been developed, each with its specific chromophore target and specific safety need. Protocols, such as a checklist, that have been shown to reduce adverse events in surgery and in the intensive care unit can be borrowed to decrease risk from laser injury and optimize laser safety in dermatology.² The safety of the patient, the laser operator, and the other health care providers involved in the delivery of laser therapy led to the first US Food and Drug Administration (FDA) guidelines for laser use in 1984.³

There are 4 regulatory organizations for laser safety in the United States: the American National Standards Institute (ANSI), the Occupational Health and Safety Administration (OSHA), the FDA’s Center for Devices and Radiological Health, and The Joint Commission. The American National Standards Institute is a nonprofit group composed of laser manufacturers, government agencies, professional societies, educational institutions, and consumer and labor groups. It publishes voluntary safety standards and periodic updates (the series is labelled ANSI Z136) for the use of lasers in general (ANSI Z136.1) and for health care use in particular (ANSI Z136.3), including their use in dermatology. Laser hazard classifications also originate from ANSI. The standards of care established by ANSI guidelines are those by which health care providers are judged in health care litigation and are used by the other 3 organizations listed above. The Center for Devices and Radiological Health oversees laser manufacturers and their adherence to safety standards, determines laser hazard classifications such as ANSI, and requires manufacturers to affix a hazard class to the laser when manufactured. The Joint Commission is the accreditation body for health care programs and inspects hospitals and clinics for compliance with ANSI standards. Additionally, the American Society for Laser Medicine and Surgery, the American Academy of Dermatology, and the American Society for Dermatologic Surgery are professional organizations involved in laser operational safety training.³

Laser Principles

The basic principles of lasers include transmission, absorption, scatter, and reflection, all occurring when laser light is applied to biological tissues. The effects of the laser are a function of the target tissue (the chromophore) and the wavelength of light being used.⁴ In the skin, there are 3 main endogenous chromophores: water, hemoglobin, and melanin. Some experts consider collagen to be a fourth and separate entity as a chromophore. Tattoos are considered exogenous chromophores.³ The basic principles of lasers are important to understand and keep in mind when discussing laser safety, as they are the mechanisms through which unintended consequences can occur.

Laser Safety

Ocular Hazards
Ocular hazards are a notable concern in laser surgery. The eye is uniquely susceptible to laser light, and eye injuries represent a majority of reported injuries, which can occur through direct beam, mirror reflection by surgical instruments, and beam reflection off the skin (4%–7% of light that hits the skin is reflected because of the refractive index between air and the stratum corneum).³ The different wavelengths of lasers affect different parts of the eye. The 3 parts of the eye affected most are the retina, cornea, and lens. Not only is the lens primarily at risk for acute (lenticular burns) and chronic (cataracts) injury from the laser, but secondarily the lens also can concentrate a laser beam onto the retina by a factor of 100,000 (Table 1).³

The use of ocular protective equipment, sometimes referred to as personal protective eyewear (PPE), is essential and is mandated by ANSI and OSHA for all class 3 and class 4 lasers. The eyewear must be labeled with the wavelength and the degree of optical protection—termed the optical density (OD) or filter factor—of each lens and should match the laser being used. Laser manufacturers, as required by ANSI, must provide the wavelength and OD of their lasers, and both can be found on each laser as well as in ANSI Z136.1.³

Vendors supplying PPE generally provide the material, usually glass or polycarbonate; color; visible light transmission, which is the actual amount of light that reaches one’s eye through the lens; filter specifications, which contain the OD at certain wavelengths; and the types of lasers for which each specific PPE is used. It is important to match the laser to the correct PPE. The use of multiple types of lasers in the same office or laser treatment area can present challenges regarding eye safety. Matching the PPE to the laser in use is critical, and therefore all steps to prevent error for patients and personnel should be employed. One recommendation is to place each laser in a separate room with the appropriate PPE hung outside on the door of that room.

When the treatment area is in the periocular region, protection of the patient’s cornea is essential. Leaded eye shields with nonreflective surfaces have been shown to offer the best protection.⁵ Prior to placement, anesthetic eye drops and lubrication are important for patient comfort and protection from corneal injury.

Laser-Generated Airborne Contaminants
Other hazards associated with laser use not directly related to the beam are laser-generated airborne contaminants (LGACs), including chemicals, viruses, bacteria, aerosolized blood products, and nanoparticles (<1 µm) known as ultrafine particles (UFPs). According to ANSI, electrosurgical devices and lasers generate the same smoke. The plume (surgical smoke) is known to contain as many as 60 chemicals, including but not limited to carbon monoxide, acrylonitrite, hydrocyanide, benzene, toluene, naphthalene, and formaldehyde. Several are known carcinogens, and others are environmental toxins.^6,7

Smoke management is an important consideration for dermatologists and their patients and generally includes respiratory protection via masks and ventilation techniques. However, the practice is not universal, and oversight agencies such as OSHA and the National Institute for Occupational Safety and Health (NIOSH) provide guidelines only; they do not enforce. As such, smoke management is voluntary and not widely practiced. In a 2014 survey of 997 dermatologic surgeons who were asked if smoke management is used in their practice, 77% of respondents indicated no smoke management was used.⁶

The Surgical Plume: Composition
A 2014 study from the University of California, San Diego Department of Dermatology analyzed surgical smoke.⁶ The researchers placed the smoke collection probe 16 to 18 inches above the electrocautery site, which approximates the location of the surgeon’s head during the procedure. Assessing smoke composition, they found high levels of carcinogens and irritants. Two compounds found in their assay—1,3-butadiene and benzene—also are found in secondhand cigarette smoke. However, the concentrations in the plume were 17-fold higher for 1,3-butadiene and 10-fold higher for benzene than those found in secondhand cigarette smoke. The risk from chronic, long-term exposure to these airborne contaminants is notable, as benzene (a known carcinogen as determined by the US Department of Health and Human Services) is known to cause leukemia. For example, a busy Mohs surgeon can reach the equivalent of as many as 50 hours of continuous smoke exposure over the course of a year.⁶

The Surgical Plume: Particle Concentration
Ultrafine particles can bypass conventional filtering systems (surgical masks and N95 respirators) because of their extremely small size, which allows them to pass further into the lungs and all the way to the alveolar spaces. Geographic regions with high UFPs have been shown to have higher overall mortality rates, as well as higher rates of reactive airway disease, cardiovascular disease, and lung cancer. A 2016 study by Chuang et al⁷ published in JAMA Dermatology looked at the UFPs in the surgical plume from laser hair removal (LHR) procedures. The plume of LHR has a distinct odor and easily discernible particulates. The investigators measured the UFPs at the level of the laser practitioner and the patient’s face during LHR with a smoke evacuator turned on and again with it turned off for 30 seconds, and then compared them to UFPs measured in the treatment room, the waiting room, and outside the building. There were substantial increases in UFPs from the LHR procedure, especially for the laser practitioner, when the smoke evacuator was off. The ambient baseline particle count, as measured in the clinic waiting area, began at 15,300 particles per cubic centimeter (PPC), and once the LHR procedure began (smoke evacuator on), there was a greater than 8-fold PPC increase above baseline (15,300 PPC to 129,376 PPC) in UFPs measured for the laser practitioner. Importantly, during LHR when the smoke evacuator was turned off for 30 seconds, there was a more than 28-fold increase (15,300 PPC to 435,888 PPC) over baseline to the practitioner (Figure).⁷

The Surgical Plume: Smoke Management
Many virus particles and UFPs are less than 0.1 µm in size. It is important to note that neither surgical masks nor high-filtration masks, such as the N95 respirator, filter particles smaller than 0.1 µm. The first line of defense in smoke management is the local exhaust ventilation (LEV) system, which includes wall suction and/or a smoke evacuator. The smoke evacuator is considered the more important of the two. General filtration, such as wall suction, is a low-flow system and is really used for liquids. It can be used as a supplement to the smoke evacuator to control small amounts of plume if fitted with an in-line filter. There are 2 types of LEV filters: ultralow particulate air filters filter particles larger than 0.1µm, whereas high-efficiency particulate air filters filter particles larger than 0.3 µm. The ultralow particulate filters are used in most of the newer LEVs in use today and filter 0.1-µm particles at 99.99% efficiency.³

Of utmost importance when using a smoke evacuator system is suction tip placement. Placing the suction tip 1 cm from the tissue damage site has been shown to be 98.6% effective at removing laser plume. If moved to 2 cm, effectiveness decreases to less than 50%.¹¹ Proper management recommendations based on current evidence suggest that use of a smoke evacuator and an approved fit-tested N95 respirator might provide maximum protection.⁶ In addition to plume exposure, tissue splatter can occur, especially during ablative (CO₂) and tattoo laser therapy, which should prompt consideration of a face shield.¹¹ There are several vendors and models available online, and a simple Internet search for surgical tissue splatter face shields will provide multiple options.

The standard surgical mask is not NIOSH approved and only effectively (99%) filters particles larger than 5 µm (vs 25% efficacy for 0.3-µm particles). Its main purpose is to protect the patient from the wearer.¹²

High-filtration masks, which capture particles as small as 0.1 µm, should be used instead. The surgical N95 respirator is a NIOSH-certified respirator and is recommended for use in cases when smoke management is necessary. The FDA does not test or certify these masks; it only clears them after reviewing manufacturer test data. Technically, to be called a surgical mask, it must be cleared by the FDA.¹² The 95 of N95 indicates filter efficiency ratings of 95% when testing the filter efficiency using particles of approximately 0.3 µm in diameter (Table 2).¹³ Because 77% of surgical smoke particles are smaller than 1.1 µm, surgical masks and N95 respirators are never sufficient as stand-alone protection.¹⁴ An LEV system is much more important for safe surgical smoke management. However, recommendations call for the use of a smoke evacuator and a high-filtration mask together to obtain the most protection available.¹⁴

Checklists

Checklists are ubiquitous throughout many occupations and many medical specialties. Their usefulness in preventing adverse events is well established. Any patient-provider encounter in which a series of sequential actions is required is a perfect situation for a checklist. In dermatologic laser surgery where the eye is uniquely susceptible to injury, a laser safety checklist is essential. Additionally, there are issues with LGACs and fire that are important to consider. Having protocols (ie, a checklist) in place that address these safety issues has been shown to reduce adverse outcomes.² There are a number of templates available from various sources that can be customized to the laser treatment area. We provide a modifiable example (Table 3).

Conclusion

Laser usage in dermatologic surgery has increased. According to surveys from the American Society for Dermatologic Surgery, in 2012 there were approximately 2 million laser/light/energy-based procedures performed. By 2017, there were 3.27 million, up from 2.79 million in 2016, representing an approximate 1-year increase of 17%.¹⁶ Lasers have allowed interventions for skin, vascular, and aesthetic conditions that were once untreatable. As their use increases in number and broadens in scope, there also has been an increase in litigation alleging malpractice for misuse of the laser.¹⁷ Adverse events, which include photochemical or thermal injuries to the skin, pigmentation issues, scarring, plume-related issues, and fires, do occur. One solution to reduce the chance of an adverse outcome is to implement a checklist. Research using checklists has shown that adverse events are reduced when checklists are created and implemented properly. Improving checklist compliance also improves patient outcomes.¹⁷ The American National Standards Institute, in their ANSI Z136 series, and the World Health Organization provide checklist templates. We include our checklist for use in laser surgery (Table 3). Understanding that each laser treatment area is unique, the templates can serve as a starting point and can then be customized to suit the needs of each dermatologist.

The use of lasers in dermatology has evolved and expanded since their first cutaneous use in 1963.¹ As the fundamental understanding of the interaction of laser energy with biological tissues increased, the need for laser safety became apparent. Since then, lasers of varying wavelengths have been developed, each with its specific chromophore target and specific safety need. Protocols, such as a checklist, that have been shown to reduce adverse events in surgery and in the intensive care unit can be borrowed to decrease risk from laser injury and optimize laser safety in dermatology.² The safety of the patient, the laser operator, and the other health care providers involved in the delivery of laser therapy led to the first US Food and Drug Administration (FDA) guidelines for laser use in 1984.³

There are 4 regulatory organizations for laser safety in the United States: the American National Standards Institute (ANSI), the Occupational Health and Safety Administration (OSHA), the FDA’s Center for Devices and Radiological Health, and The Joint Commission. The American National Standards Institute is a nonprofit group composed of laser manufacturers, government agencies, professional societies, educational institutions, and consumer and labor groups. It publishes voluntary safety standards and periodic updates (the series is labelled ANSI Z136) for the use of lasers in general (ANSI Z136.1) and for health care use in particular (ANSI Z136.3), including their use in dermatology. Laser hazard classifications also originate from ANSI. The standards of care established by ANSI guidelines are those by which health care providers are judged in health care litigation and are used by the other 3 organizations listed above. The Center for Devices and Radiological Health oversees laser manufacturers and their adherence to safety standards, determines laser hazard classifications such as ANSI, and requires manufacturers to affix a hazard class to the laser when manufactured. The Joint Commission is the accreditation body for health care programs and inspects hospitals and clinics for compliance with ANSI standards. Additionally, the American Society for Laser Medicine and Surgery, the American Academy of Dermatology, and the American Society for Dermatologic Surgery are professional organizations involved in laser operational safety training.³

Laser Principles

The basic principles of lasers include transmission, absorption, scatter, and reflection, all occurring when laser light is applied to biological tissues. The effects of the laser are a function of the target tissue (the chromophore) and the wavelength of light being used.⁴ In the skin, there are 3 main endogenous chromophores: water, hemoglobin, and melanin. Some experts consider collagen to be a fourth and separate entity as a chromophore. Tattoos are considered exogenous chromophores.³ The basic principles of lasers are important to understand and keep in mind when discussing laser safety, as they are the mechanisms through which unintended consequences can occur.

Laser Safety

Ocular Hazards
Ocular hazards are a notable concern in laser surgery. The eye is uniquely susceptible to laser light, and eye injuries represent a majority of reported injuries, which can occur through direct beam, mirror reflection by surgical instruments, and beam reflection off the skin (4%–7% of light that hits the skin is reflected because of the refractive index between air and the stratum corneum).³ The different wavelengths of lasers affect different parts of the eye. The 3 parts of the eye affected most are the retina, cornea, and lens. Not only is the lens primarily at risk for acute (lenticular burns) and chronic (cataracts) injury from the laser, but secondarily the lens also can concentrate a laser beam onto the retina by a factor of 100,000 (Table 1).³

The use of ocular protective equipment, sometimes referred to as personal protective eyewear (PPE), is essential and is mandated by ANSI and OSHA for all class 3 and class 4 lasers. The eyewear must be labeled with the wavelength and the degree of optical protection—termed the optical density (OD) or filter factor—of each lens and should match the laser being used. Laser manufacturers, as required by ANSI, must provide the wavelength and OD of their lasers, and both can be found on each laser as well as in ANSI Z136.1.³

Vendors supplying PPE generally provide the material, usually glass or polycarbonate; color; visible light transmission, which is the actual amount of light that reaches one’s eye through the lens; filter specifications, which contain the OD at certain wavelengths; and the types of lasers for which each specific PPE is used. It is important to match the laser to the correct PPE. The use of multiple types of lasers in the same office or laser treatment area can present challenges regarding eye safety. Matching the PPE to the laser in use is critical, and therefore all steps to prevent error for patients and personnel should be employed. One recommendation is to place each laser in a separate room with the appropriate PPE hung outside on the door of that room.

When the treatment area is in the periocular region, protection of the patient’s cornea is essential. Leaded eye shields with nonreflective surfaces have been shown to offer the best protection.⁵ Prior to placement, anesthetic eye drops and lubrication are important for patient comfort and protection from corneal injury.

Laser-Generated Airborne Contaminants
Other hazards associated with laser use not directly related to the beam are laser-generated airborne contaminants (LGACs), including chemicals, viruses, bacteria, aerosolized blood products, and nanoparticles (<1 µm) known as ultrafine particles (UFPs). According to ANSI, electrosurgical devices and lasers generate the same smoke. The plume (surgical smoke) is known to contain as many as 60 chemicals, including but not limited to carbon monoxide, acrylonitrite, hydrocyanide, benzene, toluene, naphthalene, and formaldehyde. Several are known carcinogens, and others are environmental toxins.^6,7

Smoke management is an important consideration for dermatologists and their patients and generally includes respiratory protection via masks and ventilation techniques. However, the practice is not universal, and oversight agencies such as OSHA and the National Institute for Occupational Safety and Health (NIOSH) provide guidelines only; they do not enforce. As such, smoke management is voluntary and not widely practiced. In a 2014 survey of 997 dermatologic surgeons who were asked if smoke management is used in their practice, 77% of respondents indicated no smoke management was used.⁶

The Surgical Plume: Composition
A 2014 study from the University of California, San Diego Department of Dermatology analyzed surgical smoke.⁶ The researchers placed the smoke collection probe 16 to 18 inches above the electrocautery site, which approximates the location of the surgeon’s head during the procedure. Assessing smoke composition, they found high levels of carcinogens and irritants. Two compounds found in their assay—1,3-butadiene and benzene—also are found in secondhand cigarette smoke. However, the concentrations in the plume were 17-fold higher for 1,3-butadiene and 10-fold higher for benzene than those found in secondhand cigarette smoke. The risk from chronic, long-term exposure to these airborne contaminants is notable, as benzene (a known carcinogen as determined by the US Department of Health and Human Services) is known to cause leukemia. For example, a busy Mohs surgeon can reach the equivalent of as many as 50 hours of continuous smoke exposure over the course of a year.⁶

The Surgical Plume: Particle Concentration
Ultrafine particles can bypass conventional filtering systems (surgical masks and N95 respirators) because of their extremely small size, which allows them to pass further into the lungs and all the way to the alveolar spaces. Geographic regions with high UFPs have been shown to have higher overall mortality rates, as well as higher rates of reactive airway disease, cardiovascular disease, and lung cancer. A 2016 study by Chuang et al⁷ published in JAMA Dermatology looked at the UFPs in the surgical plume from laser hair removal (LHR) procedures. The plume of LHR has a distinct odor and easily discernible particulates. The investigators measured the UFPs at the level of the laser practitioner and the patient’s face during LHR with a smoke evacuator turned on and again with it turned off for 30 seconds, and then compared them to UFPs measured in the treatment room, the waiting room, and outside the building. There were substantial increases in UFPs from the LHR procedure, especially for the laser practitioner, when the smoke evacuator was off. The ambient baseline particle count, as measured in the clinic waiting area, began at 15,300 particles per cubic centimeter (PPC), and once the LHR procedure began (smoke evacuator on), there was a greater than 8-fold PPC increase above baseline (15,300 PPC to 129,376 PPC) in UFPs measured for the laser practitioner. Importantly, during LHR when the smoke evacuator was turned off for 30 seconds, there was a more than 28-fold increase (15,300 PPC to 435,888 PPC) over baseline to the practitioner (Figure).⁷

The Surgical Plume: Smoke Management
Many virus particles and UFPs are less than 0.1 µm in size. It is important to note that neither surgical masks nor high-filtration masks, such as the N95 respirator, filter particles smaller than 0.1 µm. The first line of defense in smoke management is the local exhaust ventilation (LEV) system, which includes wall suction and/or a smoke evacuator. The smoke evacuator is considered the more important of the two. General filtration, such as wall suction, is a low-flow system and is really used for liquids. It can be used as a supplement to the smoke evacuator to control small amounts of plume if fitted with an in-line filter. There are 2 types of LEV filters: ultralow particulate air filters filter particles larger than 0.1µm, whereas high-efficiency particulate air filters filter particles larger than 0.3 µm. The ultralow particulate filters are used in most of the newer LEVs in use today and filter 0.1-µm particles at 99.99% efficiency.³

Of utmost importance when using a smoke evacuator system is suction tip placement. Placing the suction tip 1 cm from the tissue damage site has been shown to be 98.6% effective at removing laser plume. If moved to 2 cm, effectiveness decreases to less than 50%.¹¹ Proper management recommendations based on current evidence suggest that use of a smoke evacuator and an approved fit-tested N95 respirator might provide maximum protection.⁶ In addition to plume exposure, tissue splatter can occur, especially during ablative (CO₂) and tattoo laser therapy, which should prompt consideration of a face shield.¹¹ There are several vendors and models available online, and a simple Internet search for surgical tissue splatter face shields will provide multiple options.

The standard surgical mask is not NIOSH approved and only effectively (99%) filters particles larger than 5 µm (vs 25% efficacy for 0.3-µm particles). Its main purpose is to protect the patient from the wearer.¹²

High-filtration masks, which capture particles as small as 0.1 µm, should be used instead. The surgical N95 respirator is a NIOSH-certified respirator and is recommended for use in cases when smoke management is necessary. The FDA does not test or certify these masks; it only clears them after reviewing manufacturer test data. Technically, to be called a surgical mask, it must be cleared by the FDA.¹² The 95 of N95 indicates filter efficiency ratings of 95% when testing the filter efficiency using particles of approximately 0.3 µm in diameter (Table 2).¹³ Because 77% of surgical smoke particles are smaller than 1.1 µm, surgical masks and N95 respirators are never sufficient as stand-alone protection.¹⁴ An LEV system is much more important for safe surgical smoke management. However, recommendations call for the use of a smoke evacuator and a high-filtration mask together to obtain the most protection available.¹⁴

Checklists

Checklists are ubiquitous throughout many occupations and many medical specialties. Their usefulness in preventing adverse events is well established. Any patient-provider encounter in which a series of sequential actions is required is a perfect situation for a checklist. In dermatologic laser surgery where the eye is uniquely susceptible to injury, a laser safety checklist is essential. Additionally, there are issues with LGACs and fire that are important to consider. Having protocols (ie, a checklist) in place that address these safety issues has been shown to reduce adverse outcomes.² There are a number of templates available from various sources that can be customized to the laser treatment area. We provide a modifiable example (Table 3).

Conclusion

Laser usage in dermatologic surgery has increased. According to surveys from the American Society for Dermatologic Surgery, in 2012 there were approximately 2 million laser/light/energy-based procedures performed. By 2017, there were 3.27 million, up from 2.79 million in 2016, representing an approximate 1-year increase of 17%.¹⁶ Lasers have allowed interventions for skin, vascular, and aesthetic conditions that were once untreatable. As their use increases in number and broadens in scope, there also has been an increase in litigation alleging malpractice for misuse of the laser.¹⁷ Adverse events, which include photochemical or thermal injuries to the skin, pigmentation issues, scarring, plume-related issues, and fires, do occur. One solution to reduce the chance of an adverse outcome is to implement a checklist. Research using checklists has shown that adverse events are reduced when checklists are created and implemented properly. Improving checklist compliance also improves patient outcomes.¹⁷ The American National Standards Institute, in their ANSI Z136 series, and the World Health Organization provide checklist templates. We include our checklist for use in laser surgery (Table 3). Understanding that each laser treatment area is unique, the templates can serve as a starting point and can then be customized to suit the needs of each dermatologist.

The use of lasers in dermatology has evolved and expanded since their first cutaneous use in 1963.¹ As the fundamental understanding of the interaction of laser energy with biological tissues increased, the need for laser safety became apparent. Since then, lasers of varying wavelengths have been developed, each with its specific chromophore target and specific safety need. Protocols, such as a checklist, that have been shown to reduce adverse events in surgery and in the intensive care unit can be borrowed to decrease risk from laser injury and optimize laser safety in dermatology.² The safety of the patient, the laser operator, and the other health care providers involved in the delivery of laser therapy led to the first US Food and Drug Administration (FDA) guidelines for laser use in 1984.³

There are 4 regulatory organizations for laser safety in the United States: the American National Standards Institute (ANSI), the Occupational Health and Safety Administration (OSHA), the FDA’s Center for Devices and Radiological Health, and The Joint Commission. The American National Standards Institute is a nonprofit group composed of laser manufacturers, government agencies, professional societies, educational institutions, and consumer and labor groups. It publishes voluntary safety standards and periodic updates (the series is labelled ANSI Z136) for the use of lasers in general (ANSI Z136.1) and for health care use in particular (ANSI Z136.3), including their use in dermatology. Laser hazard classifications also originate from ANSI. The standards of care established by ANSI guidelines are those by which health care providers are judged in health care litigation and are used by the other 3 organizations listed above. The Center for Devices and Radiological Health oversees laser manufacturers and their adherence to safety standards, determines laser hazard classifications such as ANSI, and requires manufacturers to affix a hazard class to the laser when manufactured. The Joint Commission is the accreditation body for health care programs and inspects hospitals and clinics for compliance with ANSI standards. Additionally, the American Society for Laser Medicine and Surgery, the American Academy of Dermatology, and the American Society for Dermatologic Surgery are professional organizations involved in laser operational safety training.³

Laser Principles

The basic principles of lasers include transmission, absorption, scatter, and reflection, all occurring when laser light is applied to biological tissues. The effects of the laser are a function of the target tissue (the chromophore) and the wavelength of light being used.⁴ In the skin, there are 3 main endogenous chromophores: water, hemoglobin, and melanin. Some experts consider collagen to be a fourth and separate entity as a chromophore. Tattoos are considered exogenous chromophores.³ The basic principles of lasers are important to understand and keep in mind when discussing laser safety, as they are the mechanisms through which unintended consequences can occur.

Laser Safety

Ocular Hazards
Ocular hazards are a notable concern in laser surgery. The eye is uniquely susceptible to laser light, and eye injuries represent a majority of reported injuries, which can occur through direct beam, mirror reflection by surgical instruments, and beam reflection off the skin (4%–7% of light that hits the skin is reflected because of the refractive index between air and the stratum corneum).³ The different wavelengths of lasers affect different parts of the eye. The 3 parts of the eye affected most are the retina, cornea, and lens. Not only is the lens primarily at risk for acute (lenticular burns) and chronic (cataracts) injury from the laser, but secondarily the lens also can concentrate a laser beam onto the retina by a factor of 100,000 (Table 1).³

The use of ocular protective equipment, sometimes referred to as personal protective eyewear (PPE), is essential and is mandated by ANSI and OSHA for all class 3 and class 4 lasers. The eyewear must be labeled with the wavelength and the degree of optical protection—termed the optical density (OD) or filter factor—of each lens and should match the laser being used. Laser manufacturers, as required by ANSI, must provide the wavelength and OD of their lasers, and both can be found on each laser as well as in ANSI Z136.1.³

Vendors supplying PPE generally provide the material, usually glass or polycarbonate; color; visible light transmission, which is the actual amount of light that reaches one’s eye through the lens; filter specifications, which contain the OD at certain wavelengths; and the types of lasers for which each specific PPE is used. It is important to match the laser to the correct PPE. The use of multiple types of lasers in the same office or laser treatment area can present challenges regarding eye safety. Matching the PPE to the laser in use is critical, and therefore all steps to prevent error for patients and personnel should be employed. One recommendation is to place each laser in a separate room with the appropriate PPE hung outside on the door of that room.

When the treatment area is in the periocular region, protection of the patient’s cornea is essential. Leaded eye shields with nonreflective surfaces have been shown to offer the best protection.⁵ Prior to placement, anesthetic eye drops and lubrication are important for patient comfort and protection from corneal injury.

Laser-Generated Airborne Contaminants
Other hazards associated with laser use not directly related to the beam are laser-generated airborne contaminants (LGACs), including chemicals, viruses, bacteria, aerosolized blood products, and nanoparticles (<1 µm) known as ultrafine particles (UFPs). According to ANSI, electrosurgical devices and lasers generate the same smoke. The plume (surgical smoke) is known to contain as many as 60 chemicals, including but not limited to carbon monoxide, acrylonitrite, hydrocyanide, benzene, toluene, naphthalene, and formaldehyde. Several are known carcinogens, and others are environmental toxins.^6,7

Smoke management is an important consideration for dermatologists and their patients and generally includes respiratory protection via masks and ventilation techniques. However, the practice is not universal, and oversight agencies such as OSHA and the National Institute for Occupational Safety and Health (NIOSH) provide guidelines only; they do not enforce. As such, smoke management is voluntary and not widely practiced. In a 2014 survey of 997 dermatologic surgeons who were asked if smoke management is used in their practice, 77% of respondents indicated no smoke management was used.⁶

The Surgical Plume: Composition
A 2014 study from the University of California, San Diego Department of Dermatology analyzed surgical smoke.⁶ The researchers placed the smoke collection probe 16 to 18 inches above the electrocautery site, which approximates the location of the surgeon’s head during the procedure. Assessing smoke composition, they found high levels of carcinogens and irritants. Two compounds found in their assay—1,3-butadiene and benzene—also are found in secondhand cigarette smoke. However, the concentrations in the plume were 17-fold higher for 1,3-butadiene and 10-fold higher for benzene than those found in secondhand cigarette smoke. The risk from chronic, long-term exposure to these airborne contaminants is notable, as benzene (a known carcinogen as determined by the US Department of Health and Human Services) is known to cause leukemia. For example, a busy Mohs surgeon can reach the equivalent of as many as 50 hours of continuous smoke exposure over the course of a year.⁶

The Surgical Plume: Particle Concentration
Ultrafine particles can bypass conventional filtering systems (surgical masks and N95 respirators) because of their extremely small size, which allows them to pass further into the lungs and all the way to the alveolar spaces. Geographic regions with high UFPs have been shown to have higher overall mortality rates, as well as higher rates of reactive airway disease, cardiovascular disease, and lung cancer. A 2016 study by Chuang et al⁷ published in JAMA Dermatology looked at the UFPs in the surgical plume from laser hair removal (LHR) procedures. The plume of LHR has a distinct odor and easily discernible particulates. The investigators measured the UFPs at the level of the laser practitioner and the patient’s face during LHR with a smoke evacuator turned on and again with it turned off for 30 seconds, and then compared them to UFPs measured in the treatment room, the waiting room, and outside the building. There were substantial increases in UFPs from the LHR procedure, especially for the laser practitioner, when the smoke evacuator was off. The ambient baseline particle count, as measured in the clinic waiting area, began at 15,300 particles per cubic centimeter (PPC), and once the LHR procedure began (smoke evacuator on), there was a greater than 8-fold PPC increase above baseline (15,300 PPC to 129,376 PPC) in UFPs measured for the laser practitioner. Importantly, during LHR when the smoke evacuator was turned off for 30 seconds, there was a more than 28-fold increase (15,300 PPC to 435,888 PPC) over baseline to the practitioner (Figure).⁷

The Surgical Plume: Smoke Management
Many virus particles and UFPs are less than 0.1 µm in size. It is important to note that neither surgical masks nor high-filtration masks, such as the N95 respirator, filter particles smaller than 0.1 µm. The first line of defense in smoke management is the local exhaust ventilation (LEV) system, which includes wall suction and/or a smoke evacuator. The smoke evacuator is considered the more important of the two. General filtration, such as wall suction, is a low-flow system and is really used for liquids. It can be used as a supplement to the smoke evacuator to control small amounts of plume if fitted with an in-line filter. There are 2 types of LEV filters: ultralow particulate air filters filter particles larger than 0.1µm, whereas high-efficiency particulate air filters filter particles larger than 0.3 µm. The ultralow particulate filters are used in most of the newer LEVs in use today and filter 0.1-µm particles at 99.99% efficiency.³

Of utmost importance when using a smoke evacuator system is suction tip placement. Placing the suction tip 1 cm from the tissue damage site has been shown to be 98.6% effective at removing laser plume. If moved to 2 cm, effectiveness decreases to less than 50%.¹¹ Proper management recommendations based on current evidence suggest that use of a smoke evacuator and an approved fit-tested N95 respirator might provide maximum protection.⁶ In addition to plume exposure, tissue splatter can occur, especially during ablative (CO₂) and tattoo laser therapy, which should prompt consideration of a face shield.¹¹ There are several vendors and models available online, and a simple Internet search for surgical tissue splatter face shields will provide multiple options.

The standard surgical mask is not NIOSH approved and only effectively (99%) filters particles larger than 5 µm (vs 25% efficacy for 0.3-µm particles). Its main purpose is to protect the patient from the wearer.¹²

High-filtration masks, which capture particles as small as 0.1 µm, should be used instead. The surgical N95 respirator is a NIOSH-certified respirator and is recommended for use in cases when smoke management is necessary. The FDA does not test or certify these masks; it only clears them after reviewing manufacturer test data. Technically, to be called a surgical mask, it must be cleared by the FDA.¹² The 95 of N95 indicates filter efficiency ratings of 95% when testing the filter efficiency using particles of approximately 0.3 µm in diameter (Table 2).¹³ Because 77% of surgical smoke particles are smaller than 1.1 µm, surgical masks and N95 respirators are never sufficient as stand-alone protection.¹⁴ An LEV system is much more important for safe surgical smoke management. However, recommendations call for the use of a smoke evacuator and a high-filtration mask together to obtain the most protection available.¹⁴

Checklists

Checklists are ubiquitous throughout many occupations and many medical specialties. Their usefulness in preventing adverse events is well established. Any patient-provider encounter in which a series of sequential actions is required is a perfect situation for a checklist. In dermatologic laser surgery where the eye is uniquely susceptible to injury, a laser safety checklist is essential. Additionally, there are issues with LGACs and fire that are important to consider. Having protocols (ie, a checklist) in place that address these safety issues has been shown to reduce adverse outcomes.² There are a number of templates available from various sources that can be customized to the laser treatment area. We provide a modifiable example (Table 3).

Conclusion

Laser usage in dermatologic surgery has increased. According to surveys from the American Society for Dermatologic Surgery, in 2012 there were approximately 2 million laser/light/energy-based procedures performed. By 2017, there were 3.27 million, up from 2.79 million in 2016, representing an approximate 1-year increase of 17%.¹⁶ Lasers have allowed interventions for skin, vascular, and aesthetic conditions that were once untreatable. As their use increases in number and broadens in scope, there also has been an increase in litigation alleging malpractice for misuse of the laser.¹⁷ Adverse events, which include photochemical or thermal injuries to the skin, pigmentation issues, scarring, plume-related issues, and fires, do occur. One solution to reduce the chance of an adverse outcome is to implement a checklist. Research using checklists has shown that adverse events are reduced when checklists are created and implemented properly. Improving checklist compliance also improves patient outcomes.¹⁷ The American National Standards Institute, in their ANSI Z136 series, and the World Health Organization provide checklist templates. We include our checklist for use in laser surgery (Table 3). Understanding that each laser treatment area is unique, the templates can serve as a starting point and can then be customized to suit the needs of each dermatologist.