Dermatology

During examination, the patient was observed repetitively cracking his knuckles, making a fist with the right hand, placing the left hand on top, and rubbing the hand, a behavior he routinely did multiple times daily. The observed pattern of finger involvement on the dorsum of the right hand corresponded to areas subjected to significant pressure during the described activity. Consequently, a diagnosis of lichen simplex chronicus (LSC) secondary to mechanical rubbing, along with associated pachydermodactyly on the fingers of the right hand, was established.

Lichen simplex chronicus and pachydermodactyly are both attributed to microtrauma inflicted upon the skin. Lichen simplex chronicus often constitutes a diagnosis of exclusion and is characterized by repetitive trauma-induced keratinocyte proliferation and melanocyte activation, resulting in hyperpigmentation and skin thickening. Although typically observed in women between the fourth and fifth decades of life, LSC is rarely reported in children. In adults, LSC-related rubbing or scratching frequently arises from chronic pruritic dermatitis such as eczema or psoriasis, neurodermatitis from dysesthesia, or habitual movements, as exhibited by this young patient. While generally benign, LSC may become infected. In rare instances, malignant transformation may occur.

The association with pachydermodactyly implicates microtrauma, necessitating careful observation and questioning to elucidate the cause, as demonstrated in this case. Lesions are typically hyperpigmented, though cases of associated hypopigmentation or depigmentation have been documented. Affected areas typically fall within the patient’s hand and finger reach, with lesion improvement over several months achievable through trigger avoidance.
 

Pachydermodactyly, a rare but benign fibromatosis around the proximal interphalangeal joints, is often misdiagnosed as juvenile idiopathic arthritis, potentially leading to unnecessary treatments and patient anxiety. Microtrauma history due to digit manipulation is prevalent among affected individuals, with most also exhibiting neuropsychiatric disorders. Histological examination of pachydermodactyly reveals hypergranulosis and dermal thickening, accompanied by increased fibroblasts and collagen types I, III, and V, differing from the epidermal changes seen in LSC.

The differential diagnosis also included phytophotodermatitis, a phototoxic dermatologic reaction following exposure to ultraviolet light subsequent to contact with furocoumarin-containing plant chemicals. However, the persistence of the patient’s lesions for over a year precluded this diagnosis. Secondary hyperpigmentation was also contemplated but excluded due to the absence of preceding inflammatory dermatitis.

Treatment of LSC primarily involves identifying and addressing any underlying conditions, repairing the skin barrier, reducing inflammation, and modifying behaviors contributing to chronic microtrauma, as observed in this patient. Topical corticosteroids may aid in decreasing epidermal thickening and discoloration, though lesion resolution necessitates behavior cessation.

It’s important to identify these types of skin changes in children to avoid unnecessary medical treatments for these benign conditions.
 

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.

Suggested Reading

Seier JA, Dissemond J. Lichen Simplex Chronicus Due to Mechanical Irritation. Dtsch Arztebl Int. 2022 Nov 18;119(46):802. doi: 10.3238/arztebl.m2022.0213.

Small S et al. A 12-Year-Old Boy Presenting With Unilateral Proximal Interphalangeal Joint Swelling. BMJ Case Rep. 2011 Apr 13:2011:bcr0120113719. doi: 10.1136/bcr.01.2011.3719.

Voicu C et al Lichen Simplex Chronicus as an Essential Part of the Dermatologic Masquerade. Open Access Maced J Med Sci. 2017 Jul 24;5(4):556-557. doi: 10.3889/oamjms.2017.133.

During examination, the patient was observed repetitively cracking his knuckles, making a fist with the right hand, placing the left hand on top, and rubbing the hand, a behavior he routinely did multiple times daily. The observed pattern of finger involvement on the dorsum of the right hand corresponded to areas subjected to significant pressure during the described activity. Consequently, a diagnosis of lichen simplex chronicus (LSC) secondary to mechanical rubbing, along with associated pachydermodactyly on the fingers of the right hand, was established.

Lichen simplex chronicus and pachydermodactyly are both attributed to microtrauma inflicted upon the skin. Lichen simplex chronicus often constitutes a diagnosis of exclusion and is characterized by repetitive trauma-induced keratinocyte proliferation and melanocyte activation, resulting in hyperpigmentation and skin thickening. Although typically observed in women between the fourth and fifth decades of life, LSC is rarely reported in children. In adults, LSC-related rubbing or scratching frequently arises from chronic pruritic dermatitis such as eczema or psoriasis, neurodermatitis from dysesthesia, or habitual movements, as exhibited by this young patient. While generally benign, LSC may become infected. In rare instances, malignant transformation may occur.

The association with pachydermodactyly implicates microtrauma, necessitating careful observation and questioning to elucidate the cause, as demonstrated in this case. Lesions are typically hyperpigmented, though cases of associated hypopigmentation or depigmentation have been documented. Affected areas typically fall within the patient’s hand and finger reach, with lesion improvement over several months achievable through trigger avoidance.
 

Pachydermodactyly, a rare but benign fibromatosis around the proximal interphalangeal joints, is often misdiagnosed as juvenile idiopathic arthritis, potentially leading to unnecessary treatments and patient anxiety. Microtrauma history due to digit manipulation is prevalent among affected individuals, with most also exhibiting neuropsychiatric disorders. Histological examination of pachydermodactyly reveals hypergranulosis and dermal thickening, accompanied by increased fibroblasts and collagen types I, III, and V, differing from the epidermal changes seen in LSC.

The differential diagnosis also included phytophotodermatitis, a phototoxic dermatologic reaction following exposure to ultraviolet light subsequent to contact with furocoumarin-containing plant chemicals. However, the persistence of the patient’s lesions for over a year precluded this diagnosis. Secondary hyperpigmentation was also contemplated but excluded due to the absence of preceding inflammatory dermatitis.

Treatment of LSC primarily involves identifying and addressing any underlying conditions, repairing the skin barrier, reducing inflammation, and modifying behaviors contributing to chronic microtrauma, as observed in this patient. Topical corticosteroids may aid in decreasing epidermal thickening and discoloration, though lesion resolution necessitates behavior cessation.

It’s important to identify these types of skin changes in children to avoid unnecessary medical treatments for these benign conditions.
 

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.

Suggested Reading

Seier JA, Dissemond J. Lichen Simplex Chronicus Due to Mechanical Irritation. Dtsch Arztebl Int. 2022 Nov 18;119(46):802. doi: 10.3238/arztebl.m2022.0213.

Small S et al. A 12-Year-Old Boy Presenting With Unilateral Proximal Interphalangeal Joint Swelling. BMJ Case Rep. 2011 Apr 13:2011:bcr0120113719. doi: 10.1136/bcr.01.2011.3719.

Voicu C et al Lichen Simplex Chronicus as an Essential Part of the Dermatologic Masquerade. Open Access Maced J Med Sci. 2017 Jul 24;5(4):556-557. doi: 10.3889/oamjms.2017.133.

During examination, the patient was observed repetitively cracking his knuckles, making a fist with the right hand, placing the left hand on top, and rubbing the hand, a behavior he routinely did multiple times daily. The observed pattern of finger involvement on the dorsum of the right hand corresponded to areas subjected to significant pressure during the described activity. Consequently, a diagnosis of lichen simplex chronicus (LSC) secondary to mechanical rubbing, along with associated pachydermodactyly on the fingers of the right hand, was established.

Lichen simplex chronicus and pachydermodactyly are both attributed to microtrauma inflicted upon the skin. Lichen simplex chronicus often constitutes a diagnosis of exclusion and is characterized by repetitive trauma-induced keratinocyte proliferation and melanocyte activation, resulting in hyperpigmentation and skin thickening. Although typically observed in women between the fourth and fifth decades of life, LSC is rarely reported in children. In adults, LSC-related rubbing or scratching frequently arises from chronic pruritic dermatitis such as eczema or psoriasis, neurodermatitis from dysesthesia, or habitual movements, as exhibited by this young patient. While generally benign, LSC may become infected. In rare instances, malignant transformation may occur.

The association with pachydermodactyly implicates microtrauma, necessitating careful observation and questioning to elucidate the cause, as demonstrated in this case. Lesions are typically hyperpigmented, though cases of associated hypopigmentation or depigmentation have been documented. Affected areas typically fall within the patient’s hand and finger reach, with lesion improvement over several months achievable through trigger avoidance.
 

Pachydermodactyly, a rare but benign fibromatosis around the proximal interphalangeal joints, is often misdiagnosed as juvenile idiopathic arthritis, potentially leading to unnecessary treatments and patient anxiety. Microtrauma history due to digit manipulation is prevalent among affected individuals, with most also exhibiting neuropsychiatric disorders. Histological examination of pachydermodactyly reveals hypergranulosis and dermal thickening, accompanied by increased fibroblasts and collagen types I, III, and V, differing from the epidermal changes seen in LSC.

The differential diagnosis also included phytophotodermatitis, a phototoxic dermatologic reaction following exposure to ultraviolet light subsequent to contact with furocoumarin-containing plant chemicals. However, the persistence of the patient’s lesions for over a year precluded this diagnosis. Secondary hyperpigmentation was also contemplated but excluded due to the absence of preceding inflammatory dermatitis.

Treatment of LSC primarily involves identifying and addressing any underlying conditions, repairing the skin barrier, reducing inflammation, and modifying behaviors contributing to chronic microtrauma, as observed in this patient. Topical corticosteroids may aid in decreasing epidermal thickening and discoloration, though lesion resolution necessitates behavior cessation.

It’s important to identify these types of skin changes in children to avoid unnecessary medical treatments for these benign conditions.
 

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.

Suggested Reading

Seier JA, Dissemond J. Lichen Simplex Chronicus Due to Mechanical Irritation. Dtsch Arztebl Int. 2022 Nov 18;119(46):802. doi: 10.3238/arztebl.m2022.0213.

Small S et al. A 12-Year-Old Boy Presenting With Unilateral Proximal Interphalangeal Joint Swelling. BMJ Case Rep. 2011 Apr 13:2011:bcr0120113719. doi: 10.1136/bcr.01.2011.3719.

Voicu C et al Lichen Simplex Chronicus as an Essential Part of the Dermatologic Masquerade. Open Access Maced J Med Sci. 2017 Jul 24;5(4):556-557. doi: 10.3889/oamjms.2017.133.

Ashley Winter, MD, remembers the first time she Googled the skin condition lichen sclerosus. Most of the websites listed the autoimmune condition as a rare disease.

In the realm of genital health, some conditions remain shrouded in silence and consequently are more likely to go undercounted and underdiagnosed, said Dr. Winter, a urologist based in Los Angeles.

“I truly believe that we just miss the diagnosis a vast majority of the time because there isn’t enough training on [detecting] it,” said Dr. Winter.

Lichen sclerosus primarily affects the skin in the genital and anal regions. Estimates of the disease range between 1 in 300 and 1 in 1000 people, according to the US National Institutes of Health. The condition also more commonly occurs among women, and symptoms include hypopigmentation, itching, pain, changes in skin appearance, and skin atrophy.

“Most cases [affect the] genital [area] only, so often patients don’t bring it up because they don’t want to be examined,” said Sarah Lonowski, MD, assistant professor of dermatology and codirector of the Multidisciplinary Autoimmune Skin Disease/Derm-Rheum Program at the University of Nebraska–Lincoln. “It’s a sensitive area, it’s an uncomfortable area to have examined, so it comes with a lot of emotional burden,” for patients, Dr. Lonowski said.

Receiving a lichen sclerosis diagnosis can take 5 years or longer, in part because the condition’s symptoms can lead clinicians to first make a diagnosis of a yeast infection or bacterial vaginosis, according to Christina Kraus, MD, assistant professor of dermatology at UCI Health in Irvine, California.

“There is still limited information on this condition in medical education, and it is not uncommon for clinicians who are not in dermatology or gynecology to be unfamiliar with this diagnosis,” Dr. Kraus said.

Because no medical tests are available to confirm lichen sclerosus, clinicians diagnose the condition based on the skin’s appearance and symptoms. In some cases, a skin biopsy may help differentiate it from similar rashes that occur in the genital area.

Prepubescent children and postmenopausal women are most likely to develop genital lichen sclerosis, so pediatricians and primary care physicians may be the first to see possible cases, Dr. Lonowski said.

Patients “may not mention it unless they’re asked,” Dr. Lonowski said, adding clinicians can inquire with patients about genital health, examine bothersome areas, “and refer if you’re not sure.”

Clinicians may also miss the condition during physical exams if they do not examine the vulvar skin, she said. The exact cause also remains elusive, but researchers believe genetic and hormonal factors, as well as an overactive immune response, may contribute to development of the condition.
 

Watch Out for Presentation

While lichen sclerosus more frequently occurs in women, men are also affected by the condition. Benjamin N. Breyer, MD, professor and chair of urology at the University of California San Francisco, said lichen sclerosus is one of the most common skin conditions he treats in his male patients.

“Advanced cases can cause urethral narrowing, which is a condition I treat commonly,” said Dr. Breyer. “Lichen sclerosus is often an underrecognized cause of pain or tearing with erections and sex in men.”

Similar to women, lichen sclerosus presents as white color changes on the skin. For men, the condition can also result in fusion of the shaft skin to the head of the penis and burying or concealment of the penis, Dr. Breyer said.

“This leads to challenges with intimacy and urination and can have extensive impacts on quality of life,” said Dr. Breyer.

For women, the skin changes often extend to the perianal area and can cause scarring, said Dr. Kraus.

“Early scarring may present as adherence of the labia minora to the labia majora or inability to fully retract the clitoral hood from the clitoris,” said Dr. Kraus.

In both men and women, lichen sclerosus and another autoimmune condition known as morphea, characterized by skin hardening and discoloration, often present together, said Dr. Lonowski.

“If you have a patient with known morphea, it’s important to ask about genital symptoms,” said Dr. Lonowski. “The association between the two is fairly strong.”

Circumcision is often the first step to help prevent chronic inflammation among male patients, said Dr. Breyer. Because lichen sclerosus is associated with an increased risk for penile cancer, “it is important to biopsy suspicious lesions,” Dr. Breyer added.

Increasing awareness of lichen sclerosus is crucial for early detection and timely intervention, said Dr. Lonowski. The first-line treatment of genital lichen sclerosus is strong topical steroid ointments to reduce inflammation. Clinicians might prescribe this treatment for use twice daily for 2-3 months and then assesses the patient on their response.

“It is fairly responsive to treatment in most cases,” said Dr. Lonowski.

Once symptoms have improved, Dr. Lonowski transitions patients to a maintenance regimen, which might include using the same steroid but only three times a week, switching to a topical with a less potent steroid dosage, or using a combination of a topical steroid and a nonsteroidal anti-inflammatory cream. Despite the prolonged use of the drug, she said patients with lichen sclerosus usually do not present with side effects like discoloration or thinning of skin.

“You may achieve control or remission, but we don’t stop treatment completely because we know the natural history of the disease is to have flares and recurrence.”

If left untreated, the condition can lead to atrophy, scarring, and distortion of the genital anatomy and, in some cases, develop into squamous cell carcinoma.

“The fact that you can do a topical cream intervention and prevent cancer is huge,” said Dr. Winter.

She said open discussions surrounding genital health led by primary care providers can destigmatize conditions like lichen sclerosus and promote early detection and management.

“We need to foster an environment where individuals feel comfortable discussing their symptoms openly,” Dr. Winter said. “Increased awareness can pave the way for early detection, which is crucial for managing the condition effectively.”

The experts included in the story reported no relevant disclosures.
 

A version of this article appeared on Medscape.com.

Ashley Winter, MD, remembers the first time she Googled the skin condition lichen sclerosus. Most of the websites listed the autoimmune condition as a rare disease.

In the realm of genital health, some conditions remain shrouded in silence and consequently are more likely to go undercounted and underdiagnosed, said Dr. Winter, a urologist based in Los Angeles.

“I truly believe that we just miss the diagnosis a vast majority of the time because there isn’t enough training on [detecting] it,” said Dr. Winter.

Lichen sclerosus primarily affects the skin in the genital and anal regions. Estimates of the disease range between 1 in 300 and 1 in 1000 people, according to the US National Institutes of Health. The condition also more commonly occurs among women, and symptoms include hypopigmentation, itching, pain, changes in skin appearance, and skin atrophy.

“Most cases [affect the] genital [area] only, so often patients don’t bring it up because they don’t want to be examined,” said Sarah Lonowski, MD, assistant professor of dermatology and codirector of the Multidisciplinary Autoimmune Skin Disease/Derm-Rheum Program at the University of Nebraska–Lincoln. “It’s a sensitive area, it’s an uncomfortable area to have examined, so it comes with a lot of emotional burden,” for patients, Dr. Lonowski said.

Receiving a lichen sclerosis diagnosis can take 5 years or longer, in part because the condition’s symptoms can lead clinicians to first make a diagnosis of a yeast infection or bacterial vaginosis, according to Christina Kraus, MD, assistant professor of dermatology at UCI Health in Irvine, California.

“There is still limited information on this condition in medical education, and it is not uncommon for clinicians who are not in dermatology or gynecology to be unfamiliar with this diagnosis,” Dr. Kraus said.

Because no medical tests are available to confirm lichen sclerosus, clinicians diagnose the condition based on the skin’s appearance and symptoms. In some cases, a skin biopsy may help differentiate it from similar rashes that occur in the genital area.

Prepubescent children and postmenopausal women are most likely to develop genital lichen sclerosis, so pediatricians and primary care physicians may be the first to see possible cases, Dr. Lonowski said.

Patients “may not mention it unless they’re asked,” Dr. Lonowski said, adding clinicians can inquire with patients about genital health, examine bothersome areas, “and refer if you’re not sure.”

Clinicians may also miss the condition during physical exams if they do not examine the vulvar skin, she said. The exact cause also remains elusive, but researchers believe genetic and hormonal factors, as well as an overactive immune response, may contribute to development of the condition.
 

Watch Out for Presentation

While lichen sclerosus more frequently occurs in women, men are also affected by the condition. Benjamin N. Breyer, MD, professor and chair of urology at the University of California San Francisco, said lichen sclerosus is one of the most common skin conditions he treats in his male patients.

“Advanced cases can cause urethral narrowing, which is a condition I treat commonly,” said Dr. Breyer. “Lichen sclerosus is often an underrecognized cause of pain or tearing with erections and sex in men.”

Similar to women, lichen sclerosus presents as white color changes on the skin. For men, the condition can also result in fusion of the shaft skin to the head of the penis and burying or concealment of the penis, Dr. Breyer said.

“This leads to challenges with intimacy and urination and can have extensive impacts on quality of life,” said Dr. Breyer.

For women, the skin changes often extend to the perianal area and can cause scarring, said Dr. Kraus.

“Early scarring may present as adherence of the labia minora to the labia majora or inability to fully retract the clitoral hood from the clitoris,” said Dr. Kraus.

In both men and women, lichen sclerosus and another autoimmune condition known as morphea, characterized by skin hardening and discoloration, often present together, said Dr. Lonowski.

“If you have a patient with known morphea, it’s important to ask about genital symptoms,” said Dr. Lonowski. “The association between the two is fairly strong.”

Circumcision is often the first step to help prevent chronic inflammation among male patients, said Dr. Breyer. Because lichen sclerosus is associated with an increased risk for penile cancer, “it is important to biopsy suspicious lesions,” Dr. Breyer added.

Increasing awareness of lichen sclerosus is crucial for early detection and timely intervention, said Dr. Lonowski. The first-line treatment of genital lichen sclerosus is strong topical steroid ointments to reduce inflammation. Clinicians might prescribe this treatment for use twice daily for 2-3 months and then assesses the patient on their response.

“It is fairly responsive to treatment in most cases,” said Dr. Lonowski.

Once symptoms have improved, Dr. Lonowski transitions patients to a maintenance regimen, which might include using the same steroid but only three times a week, switching to a topical with a less potent steroid dosage, or using a combination of a topical steroid and a nonsteroidal anti-inflammatory cream. Despite the prolonged use of the drug, she said patients with lichen sclerosus usually do not present with side effects like discoloration or thinning of skin.

“You may achieve control or remission, but we don’t stop treatment completely because we know the natural history of the disease is to have flares and recurrence.”

If left untreated, the condition can lead to atrophy, scarring, and distortion of the genital anatomy and, in some cases, develop into squamous cell carcinoma.

“The fact that you can do a topical cream intervention and prevent cancer is huge,” said Dr. Winter.

She said open discussions surrounding genital health led by primary care providers can destigmatize conditions like lichen sclerosus and promote early detection and management.

“We need to foster an environment where individuals feel comfortable discussing their symptoms openly,” Dr. Winter said. “Increased awareness can pave the way for early detection, which is crucial for managing the condition effectively.”

The experts included in the story reported no relevant disclosures.
 

A version of this article appeared on Medscape.com.

Ashley Winter, MD, remembers the first time she Googled the skin condition lichen sclerosus. Most of the websites listed the autoimmune condition as a rare disease.

In the realm of genital health, some conditions remain shrouded in silence and consequently are more likely to go undercounted and underdiagnosed, said Dr. Winter, a urologist based in Los Angeles.

“I truly believe that we just miss the diagnosis a vast majority of the time because there isn’t enough training on [detecting] it,” said Dr. Winter.

Lichen sclerosus primarily affects the skin in the genital and anal regions. Estimates of the disease range between 1 in 300 and 1 in 1000 people, according to the US National Institutes of Health. The condition also more commonly occurs among women, and symptoms include hypopigmentation, itching, pain, changes in skin appearance, and skin atrophy.

“Most cases [affect the] genital [area] only, so often patients don’t bring it up because they don’t want to be examined,” said Sarah Lonowski, MD, assistant professor of dermatology and codirector of the Multidisciplinary Autoimmune Skin Disease/Derm-Rheum Program at the University of Nebraska–Lincoln. “It’s a sensitive area, it’s an uncomfortable area to have examined, so it comes with a lot of emotional burden,” for patients, Dr. Lonowski said.

Receiving a lichen sclerosis diagnosis can take 5 years or longer, in part because the condition’s symptoms can lead clinicians to first make a diagnosis of a yeast infection or bacterial vaginosis, according to Christina Kraus, MD, assistant professor of dermatology at UCI Health in Irvine, California.

“There is still limited information on this condition in medical education, and it is not uncommon for clinicians who are not in dermatology or gynecology to be unfamiliar with this diagnosis,” Dr. Kraus said.

Because no medical tests are available to confirm lichen sclerosus, clinicians diagnose the condition based on the skin’s appearance and symptoms. In some cases, a skin biopsy may help differentiate it from similar rashes that occur in the genital area.

Prepubescent children and postmenopausal women are most likely to develop genital lichen sclerosis, so pediatricians and primary care physicians may be the first to see possible cases, Dr. Lonowski said.

Patients “may not mention it unless they’re asked,” Dr. Lonowski said, adding clinicians can inquire with patients about genital health, examine bothersome areas, “and refer if you’re not sure.”

Clinicians may also miss the condition during physical exams if they do not examine the vulvar skin, she said. The exact cause also remains elusive, but researchers believe genetic and hormonal factors, as well as an overactive immune response, may contribute to development of the condition.
 

Watch Out for Presentation

While lichen sclerosus more frequently occurs in women, men are also affected by the condition. Benjamin N. Breyer, MD, professor and chair of urology at the University of California San Francisco, said lichen sclerosus is one of the most common skin conditions he treats in his male patients.

“Advanced cases can cause urethral narrowing, which is a condition I treat commonly,” said Dr. Breyer. “Lichen sclerosus is often an underrecognized cause of pain or tearing with erections and sex in men.”

Similar to women, lichen sclerosus presents as white color changes on the skin. For men, the condition can also result in fusion of the shaft skin to the head of the penis and burying or concealment of the penis, Dr. Breyer said.

“This leads to challenges with intimacy and urination and can have extensive impacts on quality of life,” said Dr. Breyer.

For women, the skin changes often extend to the perianal area and can cause scarring, said Dr. Kraus.

“Early scarring may present as adherence of the labia minora to the labia majora or inability to fully retract the clitoral hood from the clitoris,” said Dr. Kraus.

In both men and women, lichen sclerosus and another autoimmune condition known as morphea, characterized by skin hardening and discoloration, often present together, said Dr. Lonowski.

“If you have a patient with known morphea, it’s important to ask about genital symptoms,” said Dr. Lonowski. “The association between the two is fairly strong.”

Circumcision is often the first step to help prevent chronic inflammation among male patients, said Dr. Breyer. Because lichen sclerosus is associated with an increased risk for penile cancer, “it is important to biopsy suspicious lesions,” Dr. Breyer added.

Increasing awareness of lichen sclerosus is crucial for early detection and timely intervention, said Dr. Lonowski. The first-line treatment of genital lichen sclerosus is strong topical steroid ointments to reduce inflammation. Clinicians might prescribe this treatment for use twice daily for 2-3 months and then assesses the patient on their response.

“It is fairly responsive to treatment in most cases,” said Dr. Lonowski.

Once symptoms have improved, Dr. Lonowski transitions patients to a maintenance regimen, which might include using the same steroid but only three times a week, switching to a topical with a less potent steroid dosage, or using a combination of a topical steroid and a nonsteroidal anti-inflammatory cream. Despite the prolonged use of the drug, she said patients with lichen sclerosus usually do not present with side effects like discoloration or thinning of skin.

“You may achieve control or remission, but we don’t stop treatment completely because we know the natural history of the disease is to have flares and recurrence.”

If left untreated, the condition can lead to atrophy, scarring, and distortion of the genital anatomy and, in some cases, develop into squamous cell carcinoma.

“The fact that you can do a topical cream intervention and prevent cancer is huge,” said Dr. Winter.

She said open discussions surrounding genital health led by primary care providers can destigmatize conditions like lichen sclerosus and promote early detection and management.

“We need to foster an environment where individuals feel comfortable discussing their symptoms openly,” Dr. Winter said. “Increased awareness can pave the way for early detection, which is crucial for managing the condition effectively.”

The experts included in the story reported no relevant disclosures.
 

A version of this article appeared on Medscape.com.

Localized melanoma of the skin is highly curable with surgery, especially when the malignancy is in its early stages. Yet many patients with successfully resected cutaneous melanoma may live in fear of recurrence and feel highly anxious about the prospect that their next skin examination may reveal a new lesion or metastasis.

These findings come from a study of 51 patients who were treated for stage 0 (melanoma in situ) to stage IIA (Breslow thickness 1.01-2.0 mm without lymph node invasion or metastasis) disease, and who were interviewed about their experiences as survivors and their fear of recurrence.

“Consistent themes and subthemes brought up by participants included anxiety associated with follow-up skin examinations, frequent biopsy procedures attributable to screening intensity, fear of the sun, changes in sun exposure behavior, and increasing thoughts about death. Many of these experiences profoundly affected participants’ lives, despite the favorable prognosis for this group,” wrote Ayisha N. Mahama, MD, MPH, from the Dell Medical School at the University of Texas at Austin, and colleagues, in an article published online in JAMA Dermatology.
 

Interviews and Inventory

The investigators sought to characterize the psychological well-being of localized melanoma survivors who were treated in their practice. Participants took part in a semistructured interview and the Fear of Cancer Recurrence Inventory short form, with a score of 13 or greater indicating potential cases of clinically significant fear of recurrence.

The mean patient age was 48.5 years, and there were twice as many women as men (34 and 17, respectively). In all, 17 of the patients were treated for stage 0 melanoma, and the remainder were treated for stage I-IIA disease.

The interviews and survey revealed four main “themes” among the patients: anxiety surrounding follow-up appointments and relief after a normal examination; concerns about intensity of melanoma surveillance, including anxiety or reassurance about frequent biopsies and worries regarding familial melanoma risk; lifestyle changes related to sun exposure, such as limiting time outdoors, using sunscreen, and wearing protective clothing; and thoughts about life and death.

On the Fear of Cancer Recurrence Inventory short form, 38 of the 51 participants (75%) had a score of 13 or more points, indicating clinically significant fear of cancer recurrence, and when a higher threshold of 16 or more points were was applied, 34 participants (67%) still met the definition for clinically significant fear of recurrence.
 

Inform, Reassure, Counsel

“Given the crucial role that dermatologists play in diagnosing melanomas, there may be an opportunity to provide reassurance and support for patients to mitigate the psychological consequences of the diagnosis, by emphasizing the excellent life expectancy at a localized stage, particularly at stage 0. In addition, a referral to a mental health practitioner could be placed for patients with higher levels of anxiety and fear of recurrence,” Dr. Mahama and her coauthors wrote.

They also noted that their findings suggest that some individuals who undergo screening for melanoma might experience “psychological harms” from receiving a melanoma diagnosis “particularly given that many or most screening-detected early-stage melanomas will not progress.”

In an interview seeking objective commentary, a surgical oncologist who was not involved in the study said that anxiety about recurrence is common among patients with melanoma, many of whom may be unfamiliar with significant recent advances such as immunotherapy in the care of patients with more advanced disease.

“Often what we will do in addition to just sharing statistics, which are historical and don’t even necessarily reflect how much better we can do for patients now if the melanoma does recur or metastasize, is recommend close surveillance by their dermatologist,” said Sonia Cohen, MD, PhD, from the Mass General Cancer Center in Boston.

“The earlier we capture a recurrence the better we can help the patients. So that’s something we’ll recommend for patients to help give them a sense of control, and that they’re doing everything they can to capture current or new skin cancers,” she said.

Dr. Cohen and colleagues also instruct patients how to look for potential signs of recurrence, such as swollen lymph nodes or suspicious lesions. Patients who express extreme anxiety may also be referred to an oncology social worker or other support services, she said.

Also asked to comment on the results, Allison Dibiaso MSW, LICSW, a social worker at Dana-Farber Cancer Institute, Boston, Massachusetts, who specializes in melanoma, said that she often sees patients who have been successfully treated for early localized malignant melanoma who experience a fear of recurrence. “These patients frequently express feelings of uncertainty and worry, with the fear of another occurrence always on their mind. Managing this fear on a day-to-day basis can be challenging,” she told this news organization.

Moreover, patients with previous treatment for melanoma often experience significant anxiety before skin exams. “Some may feel anxious and worried a few days or weeks before their appointment wondering if something will reoccur and be discovered during the examination,” she said. “While some individuals develop coping skills to manage their anxiety beforehand, many still feel anxious about the possibility of recurrence until after the exam is over and results are confirmed.”

At Dana-Farber, patients with completely resected lesions are provided with individual counseling and have access to support groups specifically designed for patients with melanoma. In addition, a caregiver group is also available for those supporting patients with melanoma, and, “if needed, we provide referrals to therapists in their local community,” Ms. Dibiaso said.

The study was supported by awards/grants to senior author Adewole S. Adamson, MD, MPP from the Robert Wood Johnson Foundation, Dermatology Foundation, National Institutes of Health, and the American Cancer Society. All authors reported having no conflicts of interest. Dr. Cohen had no relevant conflicts of interest to disclose. Ms. Dibiaso had no relevant conflicts to disclose.

Localized melanoma of the skin is highly curable with surgery, especially when the malignancy is in its early stages. Yet many patients with successfully resected cutaneous melanoma may live in fear of recurrence and feel highly anxious about the prospect that their next skin examination may reveal a new lesion or metastasis.

These findings come from a study of 51 patients who were treated for stage 0 (melanoma in situ) to stage IIA (Breslow thickness 1.01-2.0 mm without lymph node invasion or metastasis) disease, and who were interviewed about their experiences as survivors and their fear of recurrence.

“Consistent themes and subthemes brought up by participants included anxiety associated with follow-up skin examinations, frequent biopsy procedures attributable to screening intensity, fear of the sun, changes in sun exposure behavior, and increasing thoughts about death. Many of these experiences profoundly affected participants’ lives, despite the favorable prognosis for this group,” wrote Ayisha N. Mahama, MD, MPH, from the Dell Medical School at the University of Texas at Austin, and colleagues, in an article published online in JAMA Dermatology.
 

Interviews and Inventory

The investigators sought to characterize the psychological well-being of localized melanoma survivors who were treated in their practice. Participants took part in a semistructured interview and the Fear of Cancer Recurrence Inventory short form, with a score of 13 or greater indicating potential cases of clinically significant fear of recurrence.

The mean patient age was 48.5 years, and there were twice as many women as men (34 and 17, respectively). In all, 17 of the patients were treated for stage 0 melanoma, and the remainder were treated for stage I-IIA disease.

The interviews and survey revealed four main “themes” among the patients: anxiety surrounding follow-up appointments and relief after a normal examination; concerns about intensity of melanoma surveillance, including anxiety or reassurance about frequent biopsies and worries regarding familial melanoma risk; lifestyle changes related to sun exposure, such as limiting time outdoors, using sunscreen, and wearing protective clothing; and thoughts about life and death.

On the Fear of Cancer Recurrence Inventory short form, 38 of the 51 participants (75%) had a score of 13 or more points, indicating clinically significant fear of cancer recurrence, and when a higher threshold of 16 or more points were was applied, 34 participants (67%) still met the definition for clinically significant fear of recurrence.
 

Inform, Reassure, Counsel

“Given the crucial role that dermatologists play in diagnosing melanomas, there may be an opportunity to provide reassurance and support for patients to mitigate the psychological consequences of the diagnosis, by emphasizing the excellent life expectancy at a localized stage, particularly at stage 0. In addition, a referral to a mental health practitioner could be placed for patients with higher levels of anxiety and fear of recurrence,” Dr. Mahama and her coauthors wrote.

They also noted that their findings suggest that some individuals who undergo screening for melanoma might experience “psychological harms” from receiving a melanoma diagnosis “particularly given that many or most screening-detected early-stage melanomas will not progress.”

In an interview seeking objective commentary, a surgical oncologist who was not involved in the study said that anxiety about recurrence is common among patients with melanoma, many of whom may be unfamiliar with significant recent advances such as immunotherapy in the care of patients with more advanced disease.

“Often what we will do in addition to just sharing statistics, which are historical and don’t even necessarily reflect how much better we can do for patients now if the melanoma does recur or metastasize, is recommend close surveillance by their dermatologist,” said Sonia Cohen, MD, PhD, from the Mass General Cancer Center in Boston.

“The earlier we capture a recurrence the better we can help the patients. So that’s something we’ll recommend for patients to help give them a sense of control, and that they’re doing everything they can to capture current or new skin cancers,” she said.

Dr. Cohen and colleagues also instruct patients how to look for potential signs of recurrence, such as swollen lymph nodes or suspicious lesions. Patients who express extreme anxiety may also be referred to an oncology social worker or other support services, she said.

Also asked to comment on the results, Allison Dibiaso MSW, LICSW, a social worker at Dana-Farber Cancer Institute, Boston, Massachusetts, who specializes in melanoma, said that she often sees patients who have been successfully treated for early localized malignant melanoma who experience a fear of recurrence. “These patients frequently express feelings of uncertainty and worry, with the fear of another occurrence always on their mind. Managing this fear on a day-to-day basis can be challenging,” she told this news organization.

Moreover, patients with previous treatment for melanoma often experience significant anxiety before skin exams. “Some may feel anxious and worried a few days or weeks before their appointment wondering if something will reoccur and be discovered during the examination,” she said. “While some individuals develop coping skills to manage their anxiety beforehand, many still feel anxious about the possibility of recurrence until after the exam is over and results are confirmed.”

At Dana-Farber, patients with completely resected lesions are provided with individual counseling and have access to support groups specifically designed for patients with melanoma. In addition, a caregiver group is also available for those supporting patients with melanoma, and, “if needed, we provide referrals to therapists in their local community,” Ms. Dibiaso said.

The study was supported by awards/grants to senior author Adewole S. Adamson, MD, MPP from the Robert Wood Johnson Foundation, Dermatology Foundation, National Institutes of Health, and the American Cancer Society. All authors reported having no conflicts of interest. Dr. Cohen had no relevant conflicts of interest to disclose. Ms. Dibiaso had no relevant conflicts to disclose.

Localized melanoma of the skin is highly curable with surgery, especially when the malignancy is in its early stages. Yet many patients with successfully resected cutaneous melanoma may live in fear of recurrence and feel highly anxious about the prospect that their next skin examination may reveal a new lesion or metastasis.

These findings come from a study of 51 patients who were treated for stage 0 (melanoma in situ) to stage IIA (Breslow thickness 1.01-2.0 mm without lymph node invasion or metastasis) disease, and who were interviewed about their experiences as survivors and their fear of recurrence.

“Consistent themes and subthemes brought up by participants included anxiety associated with follow-up skin examinations, frequent biopsy procedures attributable to screening intensity, fear of the sun, changes in sun exposure behavior, and increasing thoughts about death. Many of these experiences profoundly affected participants’ lives, despite the favorable prognosis for this group,” wrote Ayisha N. Mahama, MD, MPH, from the Dell Medical School at the University of Texas at Austin, and colleagues, in an article published online in JAMA Dermatology.
 

Interviews and Inventory

The investigators sought to characterize the psychological well-being of localized melanoma survivors who were treated in their practice. Participants took part in a semistructured interview and the Fear of Cancer Recurrence Inventory short form, with a score of 13 or greater indicating potential cases of clinically significant fear of recurrence.

The mean patient age was 48.5 years, and there were twice as many women as men (34 and 17, respectively). In all, 17 of the patients were treated for stage 0 melanoma, and the remainder were treated for stage I-IIA disease.

The interviews and survey revealed four main “themes” among the patients: anxiety surrounding follow-up appointments and relief after a normal examination; concerns about intensity of melanoma surveillance, including anxiety or reassurance about frequent biopsies and worries regarding familial melanoma risk; lifestyle changes related to sun exposure, such as limiting time outdoors, using sunscreen, and wearing protective clothing; and thoughts about life and death.

On the Fear of Cancer Recurrence Inventory short form, 38 of the 51 participants (75%) had a score of 13 or more points, indicating clinically significant fear of cancer recurrence, and when a higher threshold of 16 or more points were was applied, 34 participants (67%) still met the definition for clinically significant fear of recurrence.
 

Inform, Reassure, Counsel

“Given the crucial role that dermatologists play in diagnosing melanomas, there may be an opportunity to provide reassurance and support for patients to mitigate the psychological consequences of the diagnosis, by emphasizing the excellent life expectancy at a localized stage, particularly at stage 0. In addition, a referral to a mental health practitioner could be placed for patients with higher levels of anxiety and fear of recurrence,” Dr. Mahama and her coauthors wrote.

They also noted that their findings suggest that some individuals who undergo screening for melanoma might experience “psychological harms” from receiving a melanoma diagnosis “particularly given that many or most screening-detected early-stage melanomas will not progress.”

In an interview seeking objective commentary, a surgical oncologist who was not involved in the study said that anxiety about recurrence is common among patients with melanoma, many of whom may be unfamiliar with significant recent advances such as immunotherapy in the care of patients with more advanced disease.

“Often what we will do in addition to just sharing statistics, which are historical and don’t even necessarily reflect how much better we can do for patients now if the melanoma does recur or metastasize, is recommend close surveillance by their dermatologist,” said Sonia Cohen, MD, PhD, from the Mass General Cancer Center in Boston.

“The earlier we capture a recurrence the better we can help the patients. So that’s something we’ll recommend for patients to help give them a sense of control, and that they’re doing everything they can to capture current or new skin cancers,” she said.

Dr. Cohen and colleagues also instruct patients how to look for potential signs of recurrence, such as swollen lymph nodes or suspicious lesions. Patients who express extreme anxiety may also be referred to an oncology social worker or other support services, she said.

Also asked to comment on the results, Allison Dibiaso MSW, LICSW, a social worker at Dana-Farber Cancer Institute, Boston, Massachusetts, who specializes in melanoma, said that she often sees patients who have been successfully treated for early localized malignant melanoma who experience a fear of recurrence. “These patients frequently express feelings of uncertainty and worry, with the fear of another occurrence always on their mind. Managing this fear on a day-to-day basis can be challenging,” she told this news organization.

Moreover, patients with previous treatment for melanoma often experience significant anxiety before skin exams. “Some may feel anxious and worried a few days or weeks before their appointment wondering if something will reoccur and be discovered during the examination,” she said. “While some individuals develop coping skills to manage their anxiety beforehand, many still feel anxious about the possibility of recurrence until after the exam is over and results are confirmed.”

At Dana-Farber, patients with completely resected lesions are provided with individual counseling and have access to support groups specifically designed for patients with melanoma. In addition, a caregiver group is also available for those supporting patients with melanoma, and, “if needed, we provide referrals to therapists in their local community,” Ms. Dibiaso said.

The study was supported by awards/grants to senior author Adewole S. Adamson, MD, MPP from the Robert Wood Johnson Foundation, Dermatology Foundation, National Institutes of Health, and the American Cancer Society. All authors reported having no conflicts of interest. Dr. Cohen had no relevant conflicts of interest to disclose. Ms. Dibiaso had no relevant conflicts to disclose.

Pretreatment testing of patients starting systemic immunomodulatory therapies for chronic skin diseases fell short of recommendations, based on an analysis of more than 120,000 individuals in a national commercial insurance claims database.

Because of concerns for the potential reactivation of tuberculosis or hepatitis B or C, or for an increased risk for infections, myelosuppression, and hepatoxicity in the wake of immunomodulator use, some medical societies recommend screening patients for hepatitis B, hepatitis C, and tuberculosis before starting these medications, wrote Maria C. Schneeweiss, MD, of Brigham and Women’s Hospital, Boston, Massachusetts, and colleagues.

“Conducting this study was crucial because of the increasing use of systemic immunomodulatory agents for chronic inflammatory skin diseases and the recognized need for pretreatment testing to prevent complications,” coauthor Denys Shay, a PhD candidate in population health sciences at Harvard University, Cambridge, Massachusetts, said in an interview.

“Despite recommendations from professional societies, there was a lack of clarity on how consistently these guidelines were being followed in the United States. This study aimed to fill that gap in knowledge, providing a comprehensive view of current practices and highlighting areas for improvement,” he said.

In the study, published online in JAMA Dermatology, he and his coauthors identified 122,308 adults in the United States with psoriasis, hidradenitis suppurativa, or atopic dermatitis who started an immunomodulatory agent, including methotrexate (28,684 patients), tumor necrosis factor (TNF)–alpha inhibitors (40,965), ustekinumab (12,841), interleukin (IL)-23 inhibitors (6116), IL-17A inhibitors (9799), dupilumab (7787), and apremilast (16,116). The data were from a commercial insurance claims database from December 31, 2002, to December 31, 2020.

The primary outcome was the proportion of patients who underwent recommended screening lab tests including tuberculosis, hepatitis, liver function, complete blood cell counts (CBCs), and lipid panels within 6 months before treatment initiation and during the first 2 years of treatment. The median age of the study population was 49 years, and 52.1% were male.

A CBC was the most common pretreatment test across treatments, performed in 41%-69% of patients before starting treatment. Tuberculosis screening occurred in 11%-59% of patients within 6 months of initiating treatment, and 3%-26% had updated tests after 1 year. Similarly, 13%-41% of patients underwent hepatitis screening prior to treatment.

The highest levels of pretreatment testing occurred for TNF-alpha inhibitors, ustekinumab, IL-17A inhibitors, and IL-23 inhibitors, with similar patterns, while the lowest levels of testing occurred with apremilast and dupilumab.

Testing prevalence before starting apremilast and after a year of treatment was 15%-45% and 9%-36%, respectively. Testing before initiation and a year into treatment with dupilumab was 11%-41% and 3%-25%, respectively.

The findings were limited by several factors including the descriptive design, which does not allow for evaluation of the testing practices, the researchers said.

However, the results show the extent of patients with chronic inflammatory skin diseases (CISDs) who do not undergo pretreatment testing, and research is needed to create testing practices on the basis of recommendations for each agent and incorporating each patient’s history and clinical profile, they concluded.

“The finding that less than 60% of patients received recommended pretreatment testing was initially somewhat surprising,” Shay said in the interview. “However, the context provided by higher rates of baseline testing within the 6-12 months before treatment initiation and the potential for additional testing not captured by the dataset — such as hospital stays — suggests that the gap may not be as large as this estimate,” he said.

“The key message for clinicians is that there are considerable variations in laboratory testing practices with regard to the initiation of systemic immunomodulatory agents in patients with CISDs,” Shay said. “This represents a divergence from existing testing guidelines.”

“Further research is needed to understand the reasons for the variations in pretreatment testing practices and whether this heterogeneity affects patient outcomes,” he added.

Resist Routine Testing

The study findings represent a call to action in the form of ongoing assessment of the safety, clinical utility, and cost-effectiveness of pretreatment testing, wrote Clinton W. Enos, MD, Ana Ormaza Vera, MD, and Abby S. Van Voorhees, MD, of the Department of Dermatology, Eastern Virginia Medical School, Norfolk, Virginia, in an accompanying editorial.

The data in the current study suggesting less frequent laboratory testing compared with current guidelines could stem from a high comfort level with many of the therapies that have been available and in use for many years, they noted. Clinicians’ lack of knowledge of the laboratory screening and monitoring guidelines also may play a role, they said.

However, the authors cautioned against routine checking of laboratory results “without purpose” and without attention to their clinical utility and cost. “A thorough medical history is essential and can serve as a sensitive indicator of which patients are more at risk for diseases such as TB or hepatitis, thereby allowing for more meaningful laboratory screening use,” they said.

Evidence supporting prescreening labs for the spectrum of systemic agents used in dermatology varies considerably, “some trapped in time and carried forward for decades until finally questioned, others rooted in treatment mechanism and clinical data,” Adam Friedman, MD, professor and chief of dermatology at George Washington University, Washington, DC, said in an interview.

The study elucidated the current state of clinical practice, said Friedman, who was not involved with the study. This includes screening even if the label says it is not necessary and letting screening slide when guidelines say otherwise — even if the guidelines are outdated and insurance requires certain metrics prior to approval, he said.

Looking ahead, “we need better consensus and even better communication/education on said guidance,” Dr. Friedman said. “Clear, concise, evidenced-based, and expert-validated guidance to ensure we are meaningfully using medical resources” is what is needed, he added. “It will certainly take a village, and close collaboration between the industry and practitioners is key to success.”

The study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Shay had no financial conflicts to disclose. Lead author Dr. Schneeweiss disclosed grants from UCB Pharma and AbbVie to Brigham and Women’s Hospital outside the submitted work. Other authors disclosed receiving personal fees from Aetion and grants from UCB Pharma and Takeda outside the submitted work; grants from Amarin, Kowa, Novartis, and Pfizer outside the submitted work; and personal fees from Hims & Hers, AbbVie, Sun Pharmaceuticals, Pfizer, Digital Diagnostics, Lilly, Equillium, ASLAN, Boehringer Ingelheim, ACOM, Olaplex, and Legacy Healthcare during the study. No other disclosures were reported.

Editorial author Dr. Enos disclosed serving as an investigator for Amgen and Castle Biosciences and receiving grants from Arcutis Biotherapeutics outside the submitted work. Dr. Van Voorhees disclosed an honorarium outside the submitted work.

Dr. Friedman had no relevant financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Pretreatment testing of patients starting systemic immunomodulatory therapies for chronic skin diseases fell short of recommendations, based on an analysis of more than 120,000 individuals in a national commercial insurance claims database.

Because of concerns for the potential reactivation of tuberculosis or hepatitis B or C, or for an increased risk for infections, myelosuppression, and hepatoxicity in the wake of immunomodulator use, some medical societies recommend screening patients for hepatitis B, hepatitis C, and tuberculosis before starting these medications, wrote Maria C. Schneeweiss, MD, of Brigham and Women’s Hospital, Boston, Massachusetts, and colleagues.

“Conducting this study was crucial because of the increasing use of systemic immunomodulatory agents for chronic inflammatory skin diseases and the recognized need for pretreatment testing to prevent complications,” coauthor Denys Shay, a PhD candidate in population health sciences at Harvard University, Cambridge, Massachusetts, said in an interview.

“Despite recommendations from professional societies, there was a lack of clarity on how consistently these guidelines were being followed in the United States. This study aimed to fill that gap in knowledge, providing a comprehensive view of current practices and highlighting areas for improvement,” he said.

In the study, published online in JAMA Dermatology, he and his coauthors identified 122,308 adults in the United States with psoriasis, hidradenitis suppurativa, or atopic dermatitis who started an immunomodulatory agent, including methotrexate (28,684 patients), tumor necrosis factor (TNF)–alpha inhibitors (40,965), ustekinumab (12,841), interleukin (IL)-23 inhibitors (6116), IL-17A inhibitors (9799), dupilumab (7787), and apremilast (16,116). The data were from a commercial insurance claims database from December 31, 2002, to December 31, 2020.

The primary outcome was the proportion of patients who underwent recommended screening lab tests including tuberculosis, hepatitis, liver function, complete blood cell counts (CBCs), and lipid panels within 6 months before treatment initiation and during the first 2 years of treatment. The median age of the study population was 49 years, and 52.1% were male.

A CBC was the most common pretreatment test across treatments, performed in 41%-69% of patients before starting treatment. Tuberculosis screening occurred in 11%-59% of patients within 6 months of initiating treatment, and 3%-26% had updated tests after 1 year. Similarly, 13%-41% of patients underwent hepatitis screening prior to treatment.

The highest levels of pretreatment testing occurred for TNF-alpha inhibitors, ustekinumab, IL-17A inhibitors, and IL-23 inhibitors, with similar patterns, while the lowest levels of testing occurred with apremilast and dupilumab.

Testing prevalence before starting apremilast and after a year of treatment was 15%-45% and 9%-36%, respectively. Testing before initiation and a year into treatment with dupilumab was 11%-41% and 3%-25%, respectively.

The findings were limited by several factors including the descriptive design, which does not allow for evaluation of the testing practices, the researchers said.

However, the results show the extent of patients with chronic inflammatory skin diseases (CISDs) who do not undergo pretreatment testing, and research is needed to create testing practices on the basis of recommendations for each agent and incorporating each patient’s history and clinical profile, they concluded.

“The finding that less than 60% of patients received recommended pretreatment testing was initially somewhat surprising,” Shay said in the interview. “However, the context provided by higher rates of baseline testing within the 6-12 months before treatment initiation and the potential for additional testing not captured by the dataset — such as hospital stays — suggests that the gap may not be as large as this estimate,” he said.

“The key message for clinicians is that there are considerable variations in laboratory testing practices with regard to the initiation of systemic immunomodulatory agents in patients with CISDs,” Shay said. “This represents a divergence from existing testing guidelines.”

“Further research is needed to understand the reasons for the variations in pretreatment testing practices and whether this heterogeneity affects patient outcomes,” he added.

Resist Routine Testing

The study findings represent a call to action in the form of ongoing assessment of the safety, clinical utility, and cost-effectiveness of pretreatment testing, wrote Clinton W. Enos, MD, Ana Ormaza Vera, MD, and Abby S. Van Voorhees, MD, of the Department of Dermatology, Eastern Virginia Medical School, Norfolk, Virginia, in an accompanying editorial.

The data in the current study suggesting less frequent laboratory testing compared with current guidelines could stem from a high comfort level with many of the therapies that have been available and in use for many years, they noted. Clinicians’ lack of knowledge of the laboratory screening and monitoring guidelines also may play a role, they said.

However, the authors cautioned against routine checking of laboratory results “without purpose” and without attention to their clinical utility and cost. “A thorough medical history is essential and can serve as a sensitive indicator of which patients are more at risk for diseases such as TB or hepatitis, thereby allowing for more meaningful laboratory screening use,” they said.

Evidence supporting prescreening labs for the spectrum of systemic agents used in dermatology varies considerably, “some trapped in time and carried forward for decades until finally questioned, others rooted in treatment mechanism and clinical data,” Adam Friedman, MD, professor and chief of dermatology at George Washington University, Washington, DC, said in an interview.

The study elucidated the current state of clinical practice, said Friedman, who was not involved with the study. This includes screening even if the label says it is not necessary and letting screening slide when guidelines say otherwise — even if the guidelines are outdated and insurance requires certain metrics prior to approval, he said.

Looking ahead, “we need better consensus and even better communication/education on said guidance,” Dr. Friedman said. “Clear, concise, evidenced-based, and expert-validated guidance to ensure we are meaningfully using medical resources” is what is needed, he added. “It will certainly take a village, and close collaboration between the industry and practitioners is key to success.”

The study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Shay had no financial conflicts to disclose. Lead author Dr. Schneeweiss disclosed grants from UCB Pharma and AbbVie to Brigham and Women’s Hospital outside the submitted work. Other authors disclosed receiving personal fees from Aetion and grants from UCB Pharma and Takeda outside the submitted work; grants from Amarin, Kowa, Novartis, and Pfizer outside the submitted work; and personal fees from Hims & Hers, AbbVie, Sun Pharmaceuticals, Pfizer, Digital Diagnostics, Lilly, Equillium, ASLAN, Boehringer Ingelheim, ACOM, Olaplex, and Legacy Healthcare during the study. No other disclosures were reported.

Editorial author Dr. Enos disclosed serving as an investigator for Amgen and Castle Biosciences and receiving grants from Arcutis Biotherapeutics outside the submitted work. Dr. Van Voorhees disclosed an honorarium outside the submitted work.

Dr. Friedman had no relevant financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Pretreatment testing of patients starting systemic immunomodulatory therapies for chronic skin diseases fell short of recommendations, based on an analysis of more than 120,000 individuals in a national commercial insurance claims database.

Because of concerns for the potential reactivation of tuberculosis or hepatitis B or C, or for an increased risk for infections, myelosuppression, and hepatoxicity in the wake of immunomodulator use, some medical societies recommend screening patients for hepatitis B, hepatitis C, and tuberculosis before starting these medications, wrote Maria C. Schneeweiss, MD, of Brigham and Women’s Hospital, Boston, Massachusetts, and colleagues.

“Conducting this study was crucial because of the increasing use of systemic immunomodulatory agents for chronic inflammatory skin diseases and the recognized need for pretreatment testing to prevent complications,” coauthor Denys Shay, a PhD candidate in population health sciences at Harvard University, Cambridge, Massachusetts, said in an interview.

“Despite recommendations from professional societies, there was a lack of clarity on how consistently these guidelines were being followed in the United States. This study aimed to fill that gap in knowledge, providing a comprehensive view of current practices and highlighting areas for improvement,” he said.

In the study, published online in JAMA Dermatology, he and his coauthors identified 122,308 adults in the United States with psoriasis, hidradenitis suppurativa, or atopic dermatitis who started an immunomodulatory agent, including methotrexate (28,684 patients), tumor necrosis factor (TNF)–alpha inhibitors (40,965), ustekinumab (12,841), interleukin (IL)-23 inhibitors (6116), IL-17A inhibitors (9799), dupilumab (7787), and apremilast (16,116). The data were from a commercial insurance claims database from December 31, 2002, to December 31, 2020.

The primary outcome was the proportion of patients who underwent recommended screening lab tests including tuberculosis, hepatitis, liver function, complete blood cell counts (CBCs), and lipid panels within 6 months before treatment initiation and during the first 2 years of treatment. The median age of the study population was 49 years, and 52.1% were male.

A CBC was the most common pretreatment test across treatments, performed in 41%-69% of patients before starting treatment. Tuberculosis screening occurred in 11%-59% of patients within 6 months of initiating treatment, and 3%-26% had updated tests after 1 year. Similarly, 13%-41% of patients underwent hepatitis screening prior to treatment.

The highest levels of pretreatment testing occurred for TNF-alpha inhibitors, ustekinumab, IL-17A inhibitors, and IL-23 inhibitors, with similar patterns, while the lowest levels of testing occurred with apremilast and dupilumab.

Testing prevalence before starting apremilast and after a year of treatment was 15%-45% and 9%-36%, respectively. Testing before initiation and a year into treatment with dupilumab was 11%-41% and 3%-25%, respectively.

The findings were limited by several factors including the descriptive design, which does not allow for evaluation of the testing practices, the researchers said.

However, the results show the extent of patients with chronic inflammatory skin diseases (CISDs) who do not undergo pretreatment testing, and research is needed to create testing practices on the basis of recommendations for each agent and incorporating each patient’s history and clinical profile, they concluded.

“The finding that less than 60% of patients received recommended pretreatment testing was initially somewhat surprising,” Shay said in the interview. “However, the context provided by higher rates of baseline testing within the 6-12 months before treatment initiation and the potential for additional testing not captured by the dataset — such as hospital stays — suggests that the gap may not be as large as this estimate,” he said.

“The key message for clinicians is that there are considerable variations in laboratory testing practices with regard to the initiation of systemic immunomodulatory agents in patients with CISDs,” Shay said. “This represents a divergence from existing testing guidelines.”

“Further research is needed to understand the reasons for the variations in pretreatment testing practices and whether this heterogeneity affects patient outcomes,” he added.

Resist Routine Testing

The study findings represent a call to action in the form of ongoing assessment of the safety, clinical utility, and cost-effectiveness of pretreatment testing, wrote Clinton W. Enos, MD, Ana Ormaza Vera, MD, and Abby S. Van Voorhees, MD, of the Department of Dermatology, Eastern Virginia Medical School, Norfolk, Virginia, in an accompanying editorial.

The data in the current study suggesting less frequent laboratory testing compared with current guidelines could stem from a high comfort level with many of the therapies that have been available and in use for many years, they noted. Clinicians’ lack of knowledge of the laboratory screening and monitoring guidelines also may play a role, they said.

However, the authors cautioned against routine checking of laboratory results “without purpose” and without attention to their clinical utility and cost. “A thorough medical history is essential and can serve as a sensitive indicator of which patients are more at risk for diseases such as TB or hepatitis, thereby allowing for more meaningful laboratory screening use,” they said.

Evidence supporting prescreening labs for the spectrum of systemic agents used in dermatology varies considerably, “some trapped in time and carried forward for decades until finally questioned, others rooted in treatment mechanism and clinical data,” Adam Friedman, MD, professor and chief of dermatology at George Washington University, Washington, DC, said in an interview.

The study elucidated the current state of clinical practice, said Friedman, who was not involved with the study. This includes screening even if the label says it is not necessary and letting screening slide when guidelines say otherwise — even if the guidelines are outdated and insurance requires certain metrics prior to approval, he said.

Looking ahead, “we need better consensus and even better communication/education on said guidance,” Dr. Friedman said. “Clear, concise, evidenced-based, and expert-validated guidance to ensure we are meaningfully using medical resources” is what is needed, he added. “It will certainly take a village, and close collaboration between the industry and practitioners is key to success.”

The study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Shay had no financial conflicts to disclose. Lead author Dr. Schneeweiss disclosed grants from UCB Pharma and AbbVie to Brigham and Women’s Hospital outside the submitted work. Other authors disclosed receiving personal fees from Aetion and grants from UCB Pharma and Takeda outside the submitted work; grants from Amarin, Kowa, Novartis, and Pfizer outside the submitted work; and personal fees from Hims & Hers, AbbVie, Sun Pharmaceuticals, Pfizer, Digital Diagnostics, Lilly, Equillium, ASLAN, Boehringer Ingelheim, ACOM, Olaplex, and Legacy Healthcare during the study. No other disclosures were reported.

Editorial author Dr. Enos disclosed serving as an investigator for Amgen and Castle Biosciences and receiving grants from Arcutis Biotherapeutics outside the submitted work. Dr. Van Voorhees disclosed an honorarium outside the submitted work.

Dr. Friedman had no relevant financial conflicts to disclose.

A version of this article appeared on Medscape.com.

On February 14, Dermavant Sciences announced that the company had submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration for tapinarof cream, 1%, for treating atopic dermatitis (AD) in adults and children 2 years of age and older.

Tapinarof cream, 1%, is an aryl hydrocarbon receptor agonist marketed under the brand name VTAMA that was approved in 2022 for treating plaque psoriasis in adults.

According to a Dermavant press release, the sNDA is based on positive data from the phase 3 ADORING 1 and ADORING 2 pivotal trials and interim results from the phase 3 ADORING 3 open-label, long-term extension 48-week trial. In ADORING 1 and ADORING 2, tapinarof cream demonstrated statistically significant improvements in the primary endpoint of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) treatment success, defined as a vIGA-AD score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline; demonstrated treatment success over vehicle at week 8; and met all key secondary endpoints with statistical significance, according to the company.

The most common adverse reactions in patients treated with VTAMA cream include folliculitis, nasopharyngitis, contact dermatitis, headache, and pruritus.

On February 14, Dermavant Sciences announced that the company had submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration for tapinarof cream, 1%, for treating atopic dermatitis (AD) in adults and children 2 years of age and older.

Tapinarof cream, 1%, is an aryl hydrocarbon receptor agonist marketed under the brand name VTAMA that was approved in 2022 for treating plaque psoriasis in adults.

According to a Dermavant press release, the sNDA is based on positive data from the phase 3 ADORING 1 and ADORING 2 pivotal trials and interim results from the phase 3 ADORING 3 open-label, long-term extension 48-week trial. In ADORING 1 and ADORING 2, tapinarof cream demonstrated statistically significant improvements in the primary endpoint of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) treatment success, defined as a vIGA-AD score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline; demonstrated treatment success over vehicle at week 8; and met all key secondary endpoints with statistical significance, according to the company.

The most common adverse reactions in patients treated with VTAMA cream include folliculitis, nasopharyngitis, contact dermatitis, headache, and pruritus.

On February 14, Dermavant Sciences announced that the company had submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration for tapinarof cream, 1%, for treating atopic dermatitis (AD) in adults and children 2 years of age and older.

Tapinarof cream, 1%, is an aryl hydrocarbon receptor agonist marketed under the brand name VTAMA that was approved in 2022 for treating plaque psoriasis in adults.

According to a Dermavant press release, the sNDA is based on positive data from the phase 3 ADORING 1 and ADORING 2 pivotal trials and interim results from the phase 3 ADORING 3 open-label, long-term extension 48-week trial. In ADORING 1 and ADORING 2, tapinarof cream demonstrated statistically significant improvements in the primary endpoint of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) treatment success, defined as a vIGA-AD score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline; demonstrated treatment success over vehicle at week 8; and met all key secondary endpoints with statistical significance, according to the company.

The most common adverse reactions in patients treated with VTAMA cream include folliculitis, nasopharyngitis, contact dermatitis, headache, and pruritus.

TOPLINE:

Tinea capitis management varies among US-based pediatric dermatologists, a national survey found.

METHODOLOGY:

• The fungal scalp infection tinea capitis affects an estimated 3%-13% of children.
• While international guidelines exist for the treatment of tinea capitis in infants and children, no such document has been developed in the United States.
• Researchers distributed a survey by email to dermatologists through the  and the Society for Pediatric Dermatology in the United States, asking about how they treated and managed pediatric patients with tinea capitis; 56 dermatologists participated.

TAKEAWAY:

• Most respondents (88.2%) said they felt comfortable prescribing oral medications prior to confirmation for those aged 2-18 years ( was the most common choice in 60.4% of cases), compared with 81.6% for those aged 2 months to 2 years ( was the most common treatment choice in 41.5% of cases), and 48.7% for those aged 0-2 months ( was the most common choice in 28.6% of cases).
• When asked what topical medication they would start prior to confirmation, most respondents said  shampoo (62.3% for those aged 0-2 months and 75.5% each for those aged 2 months to 2 years and those aged 2-18 years), yet between 11.3% and 13% said they would use none.
• The most common form of confirmatory testing was , followed by potassium hydroxide preparation, trichoscopy, and Wood’s lamp.
• More than half of survey respondents would alter their choice of oral medication based on culture results, but most would not change their topical medication preference.

IN PRACTICE:

“The management of tinea capitis in the United States is currently variable, particularly with the introduction of newer antifungals,” the authors wrote. “Future steps involve establishing evidence-based clinical practice guidelines that consider drug efficacy, safety profiles, and costs.”

SOURCE:

Bernard Cohen, MD, of the Departments of Pediatrics and Dermatology at Johns Hopkins University, Baltimore, Maryland, led the research, which was published in Pediatric Dermatology.

LIMITATIONS:

Lower response rates associated with online surveys and predefined age groups restrict the granularity of responses.

DISCLOSURES:

The authors reported having no financial disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Tinea capitis management varies among US-based pediatric dermatologists, a national survey found.

METHODOLOGY:

• The fungal scalp infection tinea capitis affects an estimated 3%-13% of children.
• While international guidelines exist for the treatment of tinea capitis in infants and children, no such document has been developed in the United States.
• Researchers distributed a survey by email to dermatologists through the  and the Society for Pediatric Dermatology in the United States, asking about how they treated and managed pediatric patients with tinea capitis; 56 dermatologists participated.

TAKEAWAY:

• Most respondents (88.2%) said they felt comfortable prescribing oral medications prior to confirmation for those aged 2-18 years ( was the most common choice in 60.4% of cases), compared with 81.6% for those aged 2 months to 2 years ( was the most common treatment choice in 41.5% of cases), and 48.7% for those aged 0-2 months ( was the most common choice in 28.6% of cases).
• When asked what topical medication they would start prior to confirmation, most respondents said  shampoo (62.3% for those aged 0-2 months and 75.5% each for those aged 2 months to 2 years and those aged 2-18 years), yet between 11.3% and 13% said they would use none.
• The most common form of confirmatory testing was , followed by potassium hydroxide preparation, trichoscopy, and Wood’s lamp.
• More than half of survey respondents would alter their choice of oral medication based on culture results, but most would not change their topical medication preference.

IN PRACTICE:

“The management of tinea capitis in the United States is currently variable, particularly with the introduction of newer antifungals,” the authors wrote. “Future steps involve establishing evidence-based clinical practice guidelines that consider drug efficacy, safety profiles, and costs.”

SOURCE:

Bernard Cohen, MD, of the Departments of Pediatrics and Dermatology at Johns Hopkins University, Baltimore, Maryland, led the research, which was published in Pediatric Dermatology.

LIMITATIONS:

Lower response rates associated with online surveys and predefined age groups restrict the granularity of responses.

DISCLOSURES:

The authors reported having no financial disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Tinea capitis management varies among US-based pediatric dermatologists, a national survey found.

METHODOLOGY:

• The fungal scalp infection tinea capitis affects an estimated 3%-13% of children.
• While international guidelines exist for the treatment of tinea capitis in infants and children, no such document has been developed in the United States.
• Researchers distributed a survey by email to dermatologists through the  and the Society for Pediatric Dermatology in the United States, asking about how they treated and managed pediatric patients with tinea capitis; 56 dermatologists participated.

TAKEAWAY:

• Most respondents (88.2%) said they felt comfortable prescribing oral medications prior to confirmation for those aged 2-18 years ( was the most common choice in 60.4% of cases), compared with 81.6% for those aged 2 months to 2 years ( was the most common treatment choice in 41.5% of cases), and 48.7% for those aged 0-2 months ( was the most common choice in 28.6% of cases).
• When asked what topical medication they would start prior to confirmation, most respondents said  shampoo (62.3% for those aged 0-2 months and 75.5% each for those aged 2 months to 2 years and those aged 2-18 years), yet between 11.3% and 13% said they would use none.
• The most common form of confirmatory testing was , followed by potassium hydroxide preparation, trichoscopy, and Wood’s lamp.
• More than half of survey respondents would alter their choice of oral medication based on culture results, but most would not change their topical medication preference.

IN PRACTICE:

“The management of tinea capitis in the United States is currently variable, particularly with the introduction of newer antifungals,” the authors wrote. “Future steps involve establishing evidence-based clinical practice guidelines that consider drug efficacy, safety profiles, and costs.”

SOURCE:

Bernard Cohen, MD, of the Departments of Pediatrics and Dermatology at Johns Hopkins University, Baltimore, Maryland, led the research, which was published in Pediatric Dermatology.

LIMITATIONS:

Lower response rates associated with online surveys and predefined age groups restrict the granularity of responses.

DISCLOSURES:

The authors reported having no financial disclosures.

A version of this article appeared on Medscape.com.

SAN DIEGO – Soon after Brett M. Coldiron, MD, launched his Cincinnati-based dermatology and Mohs surgery practice more than 20 years ago, he reported his first three cases of thin melanomas to the Ohio Department of Health, as mandated by state law.

“I got sent reams of paperwork to fill out that I did not understand,” Dr. Coldiron, a past president of the American College of Mohs Surgery and the American Academy of Dermatology, recalled at the annual Cutaneous Malignancy Update. “Then, I got chewed out for not reporting sooner and threatened with thousands of dollars in fines if I did not promptly report the forms in the future. It was an obnoxious experience.”

About 15 years later, while testifying at the Ohio Legislature on medical reasons to restrict the use of tanning beds, a lobbyist for the tanning bed industry told him that the melanoma rates had been stable in Ohio for the previous 5 years. “It turns out they were cherry picking certain segments of data to fit their narrative,” Dr. Coldiron said. “I was stunned and it kind of deflated me. I thought about this for a long time, and thought, ‘how do we solve this issue of reporting melanoma cases without adding work to existing staff if you’re a small practice and without spending significant amounts of money? Let’s make this easier.’ ”

In addition to reducing the use of tanning beds, proper reporting of melanoma cases is important for reasons that include efforts to increase sunscreen use and to be counted in ongoing research efforts to obtain a realistic snapshot of melanoma prevalence and incidence, he said.

Quality of melanoma case reporting relies on the Centers for Disease Control and Prevention’s National Program of Cancer Registries (NPCR), and the National Cancer Institute’s Surveillance Epidemiology and End Results (SEER) Program, which collects data on the incidence, treatment, staging, and survival for 28% of the US population. All 50 states and US territories require melanoma to be reported to the NPCR, but while most hospital systems have reporting protocols and dedicated data registrars, private practices may not.

Also, many dermatopathology practices operate independently and do not have dedicated registrars and may not report cases. “Melanoma is unique in that it is often completely managed in outpatient settings and these melanomas may never be reported,” said Dr. Coldiron, current president of the Ohio Dermatological Foundation. “That’s the practice gap.” One study published in 2018 found that only 49% of dermatologists knew that melanoma was a reportable disease and only 34% routinely reported newly diagnosed cases to their state’s cancer registry. He characterized melanoma reporting as an unfunded mandate.

“Hospitals are doing the most of them, because they have a registrar,” he said. “Small practices have to assign someone to do this, and it can be difficult to train that person. It’s time consuming. The first time we did it, it took an hour,” but, he said, taking a 2-hour tutorial from the Ohio Department of Health helped.

He noted that there is a lack of awareness and clinicians think it’s the dermatopathologist’s job to report cases, “while the dermatopathologist thinks it’s the clinician’s job,” and many of the entry fields are not applicable to thinner melanomas.

There is also a “patchwork” of ways that state departments of health accept the information, not all electronically, he continued. For example, those in Arizona, Montana, West Virginia, Delaware, Vermont, and Maine accept paper copies only, “meaning you have to download a PDF, fill it out, and fax it back to them,” Dr. Coldiron said at the meeting, which was hosted by Scripps Cancer Center.

To facilitate reporting in Ohio, Dr. Coldiron and two of his dermatology fellows, Matthew DaCunha, MD, and Michael Tassavor, MD, partnered with a local melanoma support group – Melanoma Know More — to assist with collection data in the reporting of thin melanomas, training volunteers from the group for the task. “We have them sign a HIPAA form and take the two-hour online tutorial,” he said. They download data that Ohio dermatologists have faxed to a dedicated secure HIPAA-compliant cloud-based fax line that Dr. Coldiron has set up, and the cases are then sent to the Ohio Department of Health.

Dr. Coldiron and colleagues have also partnered with the University of Cincinnati Clermont, which offers a National Cancer Registries Association–accredited certificate program — one of several nationwide. Students in this program are trained to become cancer registrars. “The university staff are gung-ho about it because they are looking for easy cases to train the students on. Also, the Ohio Department of Health staff are keen to help train the students and even help them find jobs or hire them after they complete the degree. Staff from the department of health and college faculty are fully engaged and supervising. It’s a win-win for all.”

According to Dr. Coldiron, in 2023, 8 Ohio dermatology practices were sending their reports to the fax line he set up and 7 more have signed up in recent months, making 15 practices to date. “It’s self-perpetuating at this point,” he said. “The Ohio Department of Health and the University of Cincinnati are invested in this program long-term.” The fax service costs Dr. Coldiron $42 per month — a small price to pay, he said, for being a clearinghouse for private Ohio dermatology practices looking for a practical way to report their melanoma cases. The model has increased melanoma reporting in Ohio by 2.8% in the last 2 years, “which doesn’t seem like that many, but if there are 6500 cases of melanoma, and you can increase reporting by a couple hundred cases, that’s a lot,” he said.

His goal is to expand this model to more states. “Dermatologists, surgical oncologists, and cancer center administrators should embrace this opportunity to make their practices a clearinghouse for their state,” he said. “This is an opportunity to improve state health, quality improvement projects, help providers, and gain recognition as a center of excellence. The increase in incidence of melanoma will lend great clout to public and legislative requests for prevention, treatment, and research dollars.”

In an interview, Hugh Greenway, MD, the head of Mohs and dermatologic surgery at Scripps Clinic in San Diego, also noted that cutaneous melanoma is significantly underreported in spite of individual state requirements. “As Dr. Coldiron reminds us, the main reason is that in many cases the pathology diagnosis and report come from the dermatologist’s/dermatopathologist’s office,” Dr. Greenway said. “With no hospital or large multispecialty laboratory involved, the reporting may be incomplete or not done. This is not the case with almost all other cancers where a hospital laboratory is involved.”

If widespread adoption of Dr. Coldiron’s model can occur, he added, “then we will have much better melanoma reporting data on which to both help our patients and specialty. He is to be applauded for producing a workable solution to the problem of underreporting.”

Dr. Coldiron reported having no relevant disclosures. Dr. Greenway reported that he conducts research for Castle Biosciences. He is also course director of the annual Cutaneous Malignancy Update.

SAN DIEGO – Soon after Brett M. Coldiron, MD, launched his Cincinnati-based dermatology and Mohs surgery practice more than 20 years ago, he reported his first three cases of thin melanomas to the Ohio Department of Health, as mandated by state law.

“I got sent reams of paperwork to fill out that I did not understand,” Dr. Coldiron, a past president of the American College of Mohs Surgery and the American Academy of Dermatology, recalled at the annual Cutaneous Malignancy Update. “Then, I got chewed out for not reporting sooner and threatened with thousands of dollars in fines if I did not promptly report the forms in the future. It was an obnoxious experience.”

About 15 years later, while testifying at the Ohio Legislature on medical reasons to restrict the use of tanning beds, a lobbyist for the tanning bed industry told him that the melanoma rates had been stable in Ohio for the previous 5 years. “It turns out they were cherry picking certain segments of data to fit their narrative,” Dr. Coldiron said. “I was stunned and it kind of deflated me. I thought about this for a long time, and thought, ‘how do we solve this issue of reporting melanoma cases without adding work to existing staff if you’re a small practice and without spending significant amounts of money? Let’s make this easier.’ ”

In addition to reducing the use of tanning beds, proper reporting of melanoma cases is important for reasons that include efforts to increase sunscreen use and to be counted in ongoing research efforts to obtain a realistic snapshot of melanoma prevalence and incidence, he said.

Quality of melanoma case reporting relies on the Centers for Disease Control and Prevention’s National Program of Cancer Registries (NPCR), and the National Cancer Institute’s Surveillance Epidemiology and End Results (SEER) Program, which collects data on the incidence, treatment, staging, and survival for 28% of the US population. All 50 states and US territories require melanoma to be reported to the NPCR, but while most hospital systems have reporting protocols and dedicated data registrars, private practices may not.

Also, many dermatopathology practices operate independently and do not have dedicated registrars and may not report cases. “Melanoma is unique in that it is often completely managed in outpatient settings and these melanomas may never be reported,” said Dr. Coldiron, current president of the Ohio Dermatological Foundation. “That’s the practice gap.” One study published in 2018 found that only 49% of dermatologists knew that melanoma was a reportable disease and only 34% routinely reported newly diagnosed cases to their state’s cancer registry. He characterized melanoma reporting as an unfunded mandate.

“Hospitals are doing the most of them, because they have a registrar,” he said. “Small practices have to assign someone to do this, and it can be difficult to train that person. It’s time consuming. The first time we did it, it took an hour,” but, he said, taking a 2-hour tutorial from the Ohio Department of Health helped.

He noted that there is a lack of awareness and clinicians think it’s the dermatopathologist’s job to report cases, “while the dermatopathologist thinks it’s the clinician’s job,” and many of the entry fields are not applicable to thinner melanomas.

There is also a “patchwork” of ways that state departments of health accept the information, not all electronically, he continued. For example, those in Arizona, Montana, West Virginia, Delaware, Vermont, and Maine accept paper copies only, “meaning you have to download a PDF, fill it out, and fax it back to them,” Dr. Coldiron said at the meeting, which was hosted by Scripps Cancer Center.

To facilitate reporting in Ohio, Dr. Coldiron and two of his dermatology fellows, Matthew DaCunha, MD, and Michael Tassavor, MD, partnered with a local melanoma support group – Melanoma Know More — to assist with collection data in the reporting of thin melanomas, training volunteers from the group for the task. “We have them sign a HIPAA form and take the two-hour online tutorial,” he said. They download data that Ohio dermatologists have faxed to a dedicated secure HIPAA-compliant cloud-based fax line that Dr. Coldiron has set up, and the cases are then sent to the Ohio Department of Health.

Dr. Coldiron and colleagues have also partnered with the University of Cincinnati Clermont, which offers a National Cancer Registries Association–accredited certificate program — one of several nationwide. Students in this program are trained to become cancer registrars. “The university staff are gung-ho about it because they are looking for easy cases to train the students on. Also, the Ohio Department of Health staff are keen to help train the students and even help them find jobs or hire them after they complete the degree. Staff from the department of health and college faculty are fully engaged and supervising. It’s a win-win for all.”

According to Dr. Coldiron, in 2023, 8 Ohio dermatology practices were sending their reports to the fax line he set up and 7 more have signed up in recent months, making 15 practices to date. “It’s self-perpetuating at this point,” he said. “The Ohio Department of Health and the University of Cincinnati are invested in this program long-term.” The fax service costs Dr. Coldiron $42 per month — a small price to pay, he said, for being a clearinghouse for private Ohio dermatology practices looking for a practical way to report their melanoma cases. The model has increased melanoma reporting in Ohio by 2.8% in the last 2 years, “which doesn’t seem like that many, but if there are 6500 cases of melanoma, and you can increase reporting by a couple hundred cases, that’s a lot,” he said.

His goal is to expand this model to more states. “Dermatologists, surgical oncologists, and cancer center administrators should embrace this opportunity to make their practices a clearinghouse for their state,” he said. “This is an opportunity to improve state health, quality improvement projects, help providers, and gain recognition as a center of excellence. The increase in incidence of melanoma will lend great clout to public and legislative requests for prevention, treatment, and research dollars.”

In an interview, Hugh Greenway, MD, the head of Mohs and dermatologic surgery at Scripps Clinic in San Diego, also noted that cutaneous melanoma is significantly underreported in spite of individual state requirements. “As Dr. Coldiron reminds us, the main reason is that in many cases the pathology diagnosis and report come from the dermatologist’s/dermatopathologist’s office,” Dr. Greenway said. “With no hospital or large multispecialty laboratory involved, the reporting may be incomplete or not done. This is not the case with almost all other cancers where a hospital laboratory is involved.”

If widespread adoption of Dr. Coldiron’s model can occur, he added, “then we will have much better melanoma reporting data on which to both help our patients and specialty. He is to be applauded for producing a workable solution to the problem of underreporting.”

Dr. Coldiron reported having no relevant disclosures. Dr. Greenway reported that he conducts research for Castle Biosciences. He is also course director of the annual Cutaneous Malignancy Update.

SAN DIEGO – Soon after Brett M. Coldiron, MD, launched his Cincinnati-based dermatology and Mohs surgery practice more than 20 years ago, he reported his first three cases of thin melanomas to the Ohio Department of Health, as mandated by state law.

“I got sent reams of paperwork to fill out that I did not understand,” Dr. Coldiron, a past president of the American College of Mohs Surgery and the American Academy of Dermatology, recalled at the annual Cutaneous Malignancy Update. “Then, I got chewed out for not reporting sooner and threatened with thousands of dollars in fines if I did not promptly report the forms in the future. It was an obnoxious experience.”

About 15 years later, while testifying at the Ohio Legislature on medical reasons to restrict the use of tanning beds, a lobbyist for the tanning bed industry told him that the melanoma rates had been stable in Ohio for the previous 5 years. “It turns out they were cherry picking certain segments of data to fit their narrative,” Dr. Coldiron said. “I was stunned and it kind of deflated me. I thought about this for a long time, and thought, ‘how do we solve this issue of reporting melanoma cases without adding work to existing staff if you’re a small practice and without spending significant amounts of money? Let’s make this easier.’ ”

In addition to reducing the use of tanning beds, proper reporting of melanoma cases is important for reasons that include efforts to increase sunscreen use and to be counted in ongoing research efforts to obtain a realistic snapshot of melanoma prevalence and incidence, he said.

Quality of melanoma case reporting relies on the Centers for Disease Control and Prevention’s National Program of Cancer Registries (NPCR), and the National Cancer Institute’s Surveillance Epidemiology and End Results (SEER) Program, which collects data on the incidence, treatment, staging, and survival for 28% of the US population. All 50 states and US territories require melanoma to be reported to the NPCR, but while most hospital systems have reporting protocols and dedicated data registrars, private practices may not.

Also, many dermatopathology practices operate independently and do not have dedicated registrars and may not report cases. “Melanoma is unique in that it is often completely managed in outpatient settings and these melanomas may never be reported,” said Dr. Coldiron, current president of the Ohio Dermatological Foundation. “That’s the practice gap.” One study published in 2018 found that only 49% of dermatologists knew that melanoma was a reportable disease and only 34% routinely reported newly diagnosed cases to their state’s cancer registry. He characterized melanoma reporting as an unfunded mandate.

“Hospitals are doing the most of them, because they have a registrar,” he said. “Small practices have to assign someone to do this, and it can be difficult to train that person. It’s time consuming. The first time we did it, it took an hour,” but, he said, taking a 2-hour tutorial from the Ohio Department of Health helped.

He noted that there is a lack of awareness and clinicians think it’s the dermatopathologist’s job to report cases, “while the dermatopathologist thinks it’s the clinician’s job,” and many of the entry fields are not applicable to thinner melanomas.

There is also a “patchwork” of ways that state departments of health accept the information, not all electronically, he continued. For example, those in Arizona, Montana, West Virginia, Delaware, Vermont, and Maine accept paper copies only, “meaning you have to download a PDF, fill it out, and fax it back to them,” Dr. Coldiron said at the meeting, which was hosted by Scripps Cancer Center.

To facilitate reporting in Ohio, Dr. Coldiron and two of his dermatology fellows, Matthew DaCunha, MD, and Michael Tassavor, MD, partnered with a local melanoma support group – Melanoma Know More — to assist with collection data in the reporting of thin melanomas, training volunteers from the group for the task. “We have them sign a HIPAA form and take the two-hour online tutorial,” he said. They download data that Ohio dermatologists have faxed to a dedicated secure HIPAA-compliant cloud-based fax line that Dr. Coldiron has set up, and the cases are then sent to the Ohio Department of Health.

Dr. Coldiron and colleagues have also partnered with the University of Cincinnati Clermont, which offers a National Cancer Registries Association–accredited certificate program — one of several nationwide. Students in this program are trained to become cancer registrars. “The university staff are gung-ho about it because they are looking for easy cases to train the students on. Also, the Ohio Department of Health staff are keen to help train the students and even help them find jobs or hire them after they complete the degree. Staff from the department of health and college faculty are fully engaged and supervising. It’s a win-win for all.”

According to Dr. Coldiron, in 2023, 8 Ohio dermatology practices were sending their reports to the fax line he set up and 7 more have signed up in recent months, making 15 practices to date. “It’s self-perpetuating at this point,” he said. “The Ohio Department of Health and the University of Cincinnati are invested in this program long-term.” The fax service costs Dr. Coldiron $42 per month — a small price to pay, he said, for being a clearinghouse for private Ohio dermatology practices looking for a practical way to report their melanoma cases. The model has increased melanoma reporting in Ohio by 2.8% in the last 2 years, “which doesn’t seem like that many, but if there are 6500 cases of melanoma, and you can increase reporting by a couple hundred cases, that’s a lot,” he said.

His goal is to expand this model to more states. “Dermatologists, surgical oncologists, and cancer center administrators should embrace this opportunity to make their practices a clearinghouse for their state,” he said. “This is an opportunity to improve state health, quality improvement projects, help providers, and gain recognition as a center of excellence. The increase in incidence of melanoma will lend great clout to public and legislative requests for prevention, treatment, and research dollars.”

In an interview, Hugh Greenway, MD, the head of Mohs and dermatologic surgery at Scripps Clinic in San Diego, also noted that cutaneous melanoma is significantly underreported in spite of individual state requirements. “As Dr. Coldiron reminds us, the main reason is that in many cases the pathology diagnosis and report come from the dermatologist’s/dermatopathologist’s office,” Dr. Greenway said. “With no hospital or large multispecialty laboratory involved, the reporting may be incomplete or not done. This is not the case with almost all other cancers where a hospital laboratory is involved.”

If widespread adoption of Dr. Coldiron’s model can occur, he added, “then we will have much better melanoma reporting data on which to both help our patients and specialty. He is to be applauded for producing a workable solution to the problem of underreporting.”

Dr. Coldiron reported having no relevant disclosures. Dr. Greenway reported that he conducts research for Castle Biosciences. He is also course director of the annual Cutaneous Malignancy Update.

TOPLINE:

Allergens were present in more than half of evaluable over-the-counter (OTC) topical scar products, study finds. 

METHODOLOGY:

• OTC topical scar treatments have the potential to cause an allergic reaction, but the prevalence of North American Contact Dermatitis Group (NACDG) core allergens in these products is unclear.
• Researchers used the word scar in a query of Amazon.com and four other retail websites to identify topical scar products for consumers and noted the list of ingredients.
• The investigators also surveyed the American Contact Dermatitis Society’s Contact Allergen Management Program (CAMP), a resource that helps patients with allergies find personal care products that are safe to use, for pertinent products.

TAKEAWAY: 

• The search query identified 156 products. Of these, 119 (76.2%) were gels, creams, or oils and 37 (23.7%) were sheets, strips, or tape.
• Of the 125 products that had a list of ingredients, 69 (55.2%) contained at least one NACDG allergen and 45 (36%) contained more than one.
• The top six most common allergens listed in the ingredients were fragrance (16.8%), phenoxyethanol (16.8%), parabens (14.4%), panthenol (12.8%), sodium benzoate (9.60%), and ethylhexylglycerin (8%).
• Analysis of CAMP revealed that the program only had five unique scar products in its list, suggesting that CAMP might not be a reliable source of scar product information for patients with known allergies to pertinent NACDG allergens.

IN PRACTICE:

“Patients can consider trying a ‘use test’ on the inner forearm before applying to the surgical site,” the authors wrote. “It may reveal they are sensitive or sensitized by a product. 

SOURCE:

First author Meera Kattapuram, MD, of the Department of Internal Medicine at Mount Sinai Hospital, New York, led the study, published in the February issue of Dermatologic Surgery.  

LIMITATIONS:

Limitations include the selection of five retailers and the top 100 products from each website and the potential for ingredient list inaccuracies. 

DISCLOSURES:

The authors reported having no financial conflicts of interest. The research was supported by a grant from the National Institutes of Health/National Cancer Institute. 

A version of this article appeared on Medscape.com.

TOPLINE:

Allergens were present in more than half of evaluable over-the-counter (OTC) topical scar products, study finds. 

METHODOLOGY:

• OTC topical scar treatments have the potential to cause an allergic reaction, but the prevalence of North American Contact Dermatitis Group (NACDG) core allergens in these products is unclear.
• Researchers used the word scar in a query of Amazon.com and four other retail websites to identify topical scar products for consumers and noted the list of ingredients.
• The investigators also surveyed the American Contact Dermatitis Society’s Contact Allergen Management Program (CAMP), a resource that helps patients with allergies find personal care products that are safe to use, for pertinent products.

TAKEAWAY: 

• The search query identified 156 products. Of these, 119 (76.2%) were gels, creams, or oils and 37 (23.7%) were sheets, strips, or tape.
• Of the 125 products that had a list of ingredients, 69 (55.2%) contained at least one NACDG allergen and 45 (36%) contained more than one.
• The top six most common allergens listed in the ingredients were fragrance (16.8%), phenoxyethanol (16.8%), parabens (14.4%), panthenol (12.8%), sodium benzoate (9.60%), and ethylhexylglycerin (8%).
• Analysis of CAMP revealed that the program only had five unique scar products in its list, suggesting that CAMP might not be a reliable source of scar product information for patients with known allergies to pertinent NACDG allergens.

IN PRACTICE:

“Patients can consider trying a ‘use test’ on the inner forearm before applying to the surgical site,” the authors wrote. “It may reveal they are sensitive or sensitized by a product. 

SOURCE:

First author Meera Kattapuram, MD, of the Department of Internal Medicine at Mount Sinai Hospital, New York, led the study, published in the February issue of Dermatologic Surgery.  

LIMITATIONS:

Limitations include the selection of five retailers and the top 100 products from each website and the potential for ingredient list inaccuracies. 

DISCLOSURES:

The authors reported having no financial conflicts of interest. The research was supported by a grant from the National Institutes of Health/National Cancer Institute. 

A version of this article appeared on Medscape.com.

TOPLINE:

Allergens were present in more than half of evaluable over-the-counter (OTC) topical scar products, study finds. 

METHODOLOGY:

• OTC topical scar treatments have the potential to cause an allergic reaction, but the prevalence of North American Contact Dermatitis Group (NACDG) core allergens in these products is unclear.
• Researchers used the word scar in a query of Amazon.com and four other retail websites to identify topical scar products for consumers and noted the list of ingredients.
• The investigators also surveyed the American Contact Dermatitis Society’s Contact Allergen Management Program (CAMP), a resource that helps patients with allergies find personal care products that are safe to use, for pertinent products.

TAKEAWAY: 

• The search query identified 156 products. Of these, 119 (76.2%) were gels, creams, or oils and 37 (23.7%) were sheets, strips, or tape.
• Of the 125 products that had a list of ingredients, 69 (55.2%) contained at least one NACDG allergen and 45 (36%) contained more than one.
• The top six most common allergens listed in the ingredients were fragrance (16.8%), phenoxyethanol (16.8%), parabens (14.4%), panthenol (12.8%), sodium benzoate (9.60%), and ethylhexylglycerin (8%).
• Analysis of CAMP revealed that the program only had five unique scar products in its list, suggesting that CAMP might not be a reliable source of scar product information for patients with known allergies to pertinent NACDG allergens.

IN PRACTICE:

“Patients can consider trying a ‘use test’ on the inner forearm before applying to the surgical site,” the authors wrote. “It may reveal they are sensitive or sensitized by a product. 

SOURCE:

First author Meera Kattapuram, MD, of the Department of Internal Medicine at Mount Sinai Hospital, New York, led the study, published in the February issue of Dermatologic Surgery.  

LIMITATIONS:

Limitations include the selection of five retailers and the top 100 products from each website and the potential for ingredient list inaccuracies. 

DISCLOSURES:

The authors reported having no financial conflicts of interest. The research was supported by a grant from the National Institutes of Health/National Cancer Institute. 

A version of this article appeared on Medscape.com.

This patient showed no evidence of recurrence in the scar where the melanoma was excised, and had no enlarged lymph nodes on palpation. His complete blood count and liver function tests were normal. A positron emission tomography (PET) scan was ordered by Dr. Nasser that revealed hypermetabolic right paratracheal, right hilar, and subcarinal lymph nodes, highly suspicious for malignant lymph nodes. The patient was referred to oncology for metastatic melanoma treatment and has been doing well on ipilimumab and nivolumab.

Courtesy Lucas Shapiro and Dr. Natalie Y. Nasser

Vitiligo is an autoimmune condition characterized by the progressive destruction of melanocytes resulting in hypopigmentation or depigmentation of the skin. Vitiligo has been associated with cutaneous melanoma. Patients with melanoma can present with hypopigmentation around the primary lesion and/or bilateral symmetrical lesions similar to vitiligo. Melanoma-associated leukoderma occurs in a portion of patients with melanoma and is correlated with a favorable prognosis. Additionally, leukoderma has been described as a side effect of melanoma treatment itself. However, cases such as this one have also been reported of vitiligo-like depigmentation presenting prior to the diagnosis of metastatic melanoma.

Melanoma, like vitiligo, is considered highly immunogenic, and cytotoxic T lymphocytes (CTLs) can recognize antigens in melanoma. Furthermore, studies have shown a vitiligo-like halo around melanoma tumors, likely caused by T-cell recruitment, and this may lead to tumor destruction, but rarely total clearance. It seems that the CTL infiltrate in both diseases is similar, but regulatory T cells are decreased in vitiligo, whereas they are present in melanomas and may contribute to the immunosuppressive tumor microenvironment found at the margin of these lesions.

Leukoderma is also associated with melanoma immunotherapy which may be described as drug-induced leukoderma. Additionally, the frequency of recognition of melanoma cells by CTLs leading to hypopigmentation appears to be higher in those with metastatic disease. High immune infiltrate with CTLs and interferon-gamma (IFN-gamma) expression by type 1 T helper cells is associated with favorable prognosis. Immunotherapy with checkpoint inhibitors has shown promise in treatment augmentation for melanoma, but not all patients fully respond to therapy. Nonetheless, development of leukoderma with these treatments has been significantly associated with good therapeutic response. Depigmentation of hair and retinal epithelium has also been reported. However, drug-induced leukoderma and vitiligo seem to have clinical and biological differences, including family history of disease and serum chemokine levels. Vaccines are in production to aid in the treatment of melanoma, but researchers must first identify the appropriate antigen(s) to include.

Conversely, vitiligo-like depigmentation has been reported as a harbinger of metastatic melanoma. Patients with previous excision of primary melanoma have presented months or years later with depigmentation and, upon further evaluation, have been diagnosed with metastatic melanoma. The prevalence of depigmentation in melanoma patients is about 3%-6%, and is estimated to be 7-10 times more common in those with melanoma than in the general population. In most cases, hypopigmentation follows the diagnosis of melanoma, with an average of 4.8 years after the initial diagnosis and 1-2 years after lymph node or distant metastases. It is unclear whether hypopigmentation occurs before or after the growth of metastatic lesions, but this clinical finding in a patient with previous melanoma may serve as an important clue to conduct further investigation for metastasis.

This case and the photos were submitted by Lucas Shapiro, BS, of Nova Southeastern University College of Osteopathic Medicine, Fort Lauderdale, Florida, and Natalie Y. Nasser, MD, Kaiser Permanente Riverside Medical Center; Riverside, California. The column was edited by Donna Bilu Martin, MD.
 

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Florida More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].

References

Cerci FB et al. Cutis. 2017 Jun;99(6):E1-E2. PMID: 28686764.

Cho EA et al. Ann Dermatol. 2009 May;21(2):178-181.

Failla CM et al. Int J Mol Sci. 2019 Nov 15;20(22):5731.

This patient showed no evidence of recurrence in the scar where the melanoma was excised, and had no enlarged lymph nodes on palpation. His complete blood count and liver function tests were normal. A positron emission tomography (PET) scan was ordered by Dr. Nasser that revealed hypermetabolic right paratracheal, right hilar, and subcarinal lymph nodes, highly suspicious for malignant lymph nodes. The patient was referred to oncology for metastatic melanoma treatment and has been doing well on ipilimumab and nivolumab.

Courtesy Lucas Shapiro and Dr. Natalie Y. Nasser

Vitiligo is an autoimmune condition characterized by the progressive destruction of melanocytes resulting in hypopigmentation or depigmentation of the skin. Vitiligo has been associated with cutaneous melanoma. Patients with melanoma can present with hypopigmentation around the primary lesion and/or bilateral symmetrical lesions similar to vitiligo. Melanoma-associated leukoderma occurs in a portion of patients with melanoma and is correlated with a favorable prognosis. Additionally, leukoderma has been described as a side effect of melanoma treatment itself. However, cases such as this one have also been reported of vitiligo-like depigmentation presenting prior to the diagnosis of metastatic melanoma.

Melanoma, like vitiligo, is considered highly immunogenic, and cytotoxic T lymphocytes (CTLs) can recognize antigens in melanoma. Furthermore, studies have shown a vitiligo-like halo around melanoma tumors, likely caused by T-cell recruitment, and this may lead to tumor destruction, but rarely total clearance. It seems that the CTL infiltrate in both diseases is similar, but regulatory T cells are decreased in vitiligo, whereas they are present in melanomas and may contribute to the immunosuppressive tumor microenvironment found at the margin of these lesions.

Leukoderma is also associated with melanoma immunotherapy which may be described as drug-induced leukoderma. Additionally, the frequency of recognition of melanoma cells by CTLs leading to hypopigmentation appears to be higher in those with metastatic disease. High immune infiltrate with CTLs and interferon-gamma (IFN-gamma) expression by type 1 T helper cells is associated with favorable prognosis. Immunotherapy with checkpoint inhibitors has shown promise in treatment augmentation for melanoma, but not all patients fully respond to therapy. Nonetheless, development of leukoderma with these treatments has been significantly associated with good therapeutic response. Depigmentation of hair and retinal epithelium has also been reported. However, drug-induced leukoderma and vitiligo seem to have clinical and biological differences, including family history of disease and serum chemokine levels. Vaccines are in production to aid in the treatment of melanoma, but researchers must first identify the appropriate antigen(s) to include.

Conversely, vitiligo-like depigmentation has been reported as a harbinger of metastatic melanoma. Patients with previous excision of primary melanoma have presented months or years later with depigmentation and, upon further evaluation, have been diagnosed with metastatic melanoma. The prevalence of depigmentation in melanoma patients is about 3%-6%, and is estimated to be 7-10 times more common in those with melanoma than in the general population. In most cases, hypopigmentation follows the diagnosis of melanoma, with an average of 4.8 years after the initial diagnosis and 1-2 years after lymph node or distant metastases. It is unclear whether hypopigmentation occurs before or after the growth of metastatic lesions, but this clinical finding in a patient with previous melanoma may serve as an important clue to conduct further investigation for metastasis.

This case and the photos were submitted by Lucas Shapiro, BS, of Nova Southeastern University College of Osteopathic Medicine, Fort Lauderdale, Florida, and Natalie Y. Nasser, MD, Kaiser Permanente Riverside Medical Center; Riverside, California. The column was edited by Donna Bilu Martin, MD.
 

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Florida More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].

References

Cerci FB et al. Cutis. 2017 Jun;99(6):E1-E2. PMID: 28686764.

Cho EA et al. Ann Dermatol. 2009 May;21(2):178-181.

Failla CM et al. Int J Mol Sci. 2019 Nov 15;20(22):5731.

This patient showed no evidence of recurrence in the scar where the melanoma was excised, and had no enlarged lymph nodes on palpation. His complete blood count and liver function tests were normal. A positron emission tomography (PET) scan was ordered by Dr. Nasser that revealed hypermetabolic right paratracheal, right hilar, and subcarinal lymph nodes, highly suspicious for malignant lymph nodes. The patient was referred to oncology for metastatic melanoma treatment and has been doing well on ipilimumab and nivolumab.

Courtesy Lucas Shapiro and Dr. Natalie Y. Nasser

Vitiligo is an autoimmune condition characterized by the progressive destruction of melanocytes resulting in hypopigmentation or depigmentation of the skin. Vitiligo has been associated with cutaneous melanoma. Patients with melanoma can present with hypopigmentation around the primary lesion and/or bilateral symmetrical lesions similar to vitiligo. Melanoma-associated leukoderma occurs in a portion of patients with melanoma and is correlated with a favorable prognosis. Additionally, leukoderma has been described as a side effect of melanoma treatment itself. However, cases such as this one have also been reported of vitiligo-like depigmentation presenting prior to the diagnosis of metastatic melanoma.

Melanoma, like vitiligo, is considered highly immunogenic, and cytotoxic T lymphocytes (CTLs) can recognize antigens in melanoma. Furthermore, studies have shown a vitiligo-like halo around melanoma tumors, likely caused by T-cell recruitment, and this may lead to tumor destruction, but rarely total clearance. It seems that the CTL infiltrate in both diseases is similar, but regulatory T cells are decreased in vitiligo, whereas they are present in melanomas and may contribute to the immunosuppressive tumor microenvironment found at the margin of these lesions.

Leukoderma is also associated with melanoma immunotherapy which may be described as drug-induced leukoderma. Additionally, the frequency of recognition of melanoma cells by CTLs leading to hypopigmentation appears to be higher in those with metastatic disease. High immune infiltrate with CTLs and interferon-gamma (IFN-gamma) expression by type 1 T helper cells is associated with favorable prognosis. Immunotherapy with checkpoint inhibitors has shown promise in treatment augmentation for melanoma, but not all patients fully respond to therapy. Nonetheless, development of leukoderma with these treatments has been significantly associated with good therapeutic response. Depigmentation of hair and retinal epithelium has also been reported. However, drug-induced leukoderma and vitiligo seem to have clinical and biological differences, including family history of disease and serum chemokine levels. Vaccines are in production to aid in the treatment of melanoma, but researchers must first identify the appropriate antigen(s) to include.

Conversely, vitiligo-like depigmentation has been reported as a harbinger of metastatic melanoma. Patients with previous excision of primary melanoma have presented months or years later with depigmentation and, upon further evaluation, have been diagnosed with metastatic melanoma. The prevalence of depigmentation in melanoma patients is about 3%-6%, and is estimated to be 7-10 times more common in those with melanoma than in the general population. In most cases, hypopigmentation follows the diagnosis of melanoma, with an average of 4.8 years after the initial diagnosis and 1-2 years after lymph node or distant metastases. It is unclear whether hypopigmentation occurs before or after the growth of metastatic lesions, but this clinical finding in a patient with previous melanoma may serve as an important clue to conduct further investigation for metastasis.

This case and the photos were submitted by Lucas Shapiro, BS, of Nova Southeastern University College of Osteopathic Medicine, Fort Lauderdale, Florida, and Natalie Y. Nasser, MD, Kaiser Permanente Riverside Medical Center; Riverside, California. The column was edited by Donna Bilu Martin, MD.
 

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Florida More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].

References

Cerci FB et al. Cutis. 2017 Jun;99(6):E1-E2. PMID: 28686764.

Cho EA et al. Ann Dermatol. 2009 May;21(2):178-181.

Failla CM et al. Int J Mol Sci. 2019 Nov 15;20(22):5731.

A novel oral drug for plaque psoriasis that targets the same inflammatory pathway as currently available parenteral therapies showed promise for treating moderate to severe disease in a phase 2 dose-finding trial.

Among 255 patients with plaque psoriasis randomly assigned to receive either placebo or an oral interleukin (IL)–23 receptor antagonist peptide dubbed JNJ-77242113 (Janssen), 79% of those who were assigned to the oral agent at the highest dose of 100 mg twice daily had a reduction in the Psoriasis Area and Severity Index (PASI) score at week 16 of at least 75% (PASI 75) compared with 9% of patients assigned to placebo, reported Robert Bissonnette, MD, from Innovaderm Research in Montreal, Quebec, Canada, and colleagues.

“The level of reduction of psoriasis that was observed with higher doses of JNJ-77242113 at week 16 was similar in magnitude to the responses seen with several of the injectable biologics that are currently approved for psoriasis,” investigators in the FRONTIER 1 trial wrote in The New England Journal of Medicine.

The investigators noted that among patients assigned to the 100-mg dose of the active drug, 60% had a PASI 90 response, which compares favorably with that seen in phase 3 trials of two other orally available therapies for psoriasis, deucravacitinib (Sotyktu) and apremilast (Otezla). They cautioned, however, against drawing any further inferences from these data, because these agents have not been tested head-to-head against JNJ-77242113 in comparison trials.
 

Targets IL-23 and IL-17

The investigational agent is an oral IL-23 receptor antagonist peptide that selectively blocks IL-23 proximal signaling as well as the production of downstream inflammatory cytokines such as IL-17, according to the authors.

“Modulation of the interleukin-23 pathway with the use of monoclonal antibodies has shown efficacy in the treatment of psoriasis and is considered to be associated with a more favorable safety profile than older oral therapies (eg, cyclosporine, acitretin, methotrexate, and dimethyl fumarate),” the investigators wrote.

Currently available biologic agents targeting IL-23 include guselkumab (Tremfya), risankizumab (Skyrizi) and tildrakizumab (Ilumya). These agents require intravenous or subcutaneous administration, whereas JNJ-77242113 is taken orally, giving it a theoretical advantage in terms of patient preference.

The novel drug must be taken twice daily on an empty stomach at least 2 hours before food or drink, and those who take it must wait an additional 30 minutes to eat or drink after taking the drug. (This news organization has learned that in planned phase 3 studies, patients will be instructed to take a double daily dose on awakening and then wait 30 minutes for eating or drinking.)

‘Profoundly Effective’

The results of this study have convinced at least one former skeptic of the efficacy of the novel agent.

“They asked me to do the trial, and I turned it down, because I didn’t believe it would work,” said Mark G. Lebwohl, MD, dean for Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai and professor and chairman emeritus of the Department of Dermatology at Mount Sinai Medicine in New York, NY.

In an interview with this news organization, Dr. Lebwohl said that he was initially dubious that a peptide, a short chain of amino acids directed against a receptor, could be effective because it would likely be digested in the intestinal tract.

“Indeed, more than 99% of it is digested, but the data show that the tiny amount that gets through is profoundly effective,” he said.

“I would never have believed that this was going to work – and it did,” Dr. Lebwohl added.

He has signed on as an investigator in the currently recruiting phase 3 ICONIC-LEAD trial, in which JNJ-77242113 will be tested against placebo in adolescents and adults with moderate to severe plaque psoriasis. 

In an editorial accompanying the study in the NEJM, Joel M. Gelfand, MD, MSCE, vice chair of clinical research and medical director of the Dermatology Clinical Studies Unit at the University of Pennsylvania in Philadelphia, noted that if confirmed in larger studies, the PASI 90 rate at the highest dose “would be similar to the most effective injectable biologics,” with no evidence of increased adverse events at higher doses.

“However, two occurrences of infection (COVID-19 and an infected cyst) and a suicide attempt were reported as serious adverse events; larger trials will be needed to determine whether such events are attributable to chance, psoriasis itself, or inhibition of interleukin-23 signaling,” cautioned Dr. Gelfand, director of the psoriasis and phototherapy treatment center at the University of Pennsylvania.

In an interview, Dr. Lebwohl said that currently available IL-23 signaling inhibitors have an excellent safety profile and that the investigational oral agent also appears to be very safe. “It’s seeing a target whose effects are known, and the effects are all good and not bad,” he said.
 

FRONTIER-1 Details

The investigators enrolled eligible adults aged 18 years or older who had moderate to severe plaque psoriasis as defined by an Investigator’s Global Assessment score ≥ 3, a total body-surface area of psoriasis involvement of at least 10%, and a PASI score ≥ 12 who had received their diagnosis of plaque psoriasis at least 6 months before starting the trial. The participants had to be candidates for phototherapy or systemic psoriasis therapy.

Patients were randomly assigned to the active agent at doses of 25 mg once or twice daily, 50 mg once daily, or 100 mg once or twice daily for 16 weeks. 

There was a clear dose response, with 37% of patients assigned to 25-mg once-daily dose meeting the primary endpoint of a PASI 75 response at week 16 compared with 51% of those assigned to the 25-mg twice-daily dose, 58% assigned to 50-mg once-daily dose, 65% assigned to 100-mg once-daily dose, and 79% assigned to 100-mg twice-daily dose (P for dose response < .001).

As noted previously, 9% of patients in the placebo group had a PASI 75 response at week 16.

After a mean duration of 15.9 weeks, adverse events after the first dose of JNJ-77242113 (all dose groups were pooled for the safety analysis) were reported in 47% of patients on the 25-mg once-daily dose, 49% on 25-mg twice-daily dose, 60% on 50-mg once-daily dose, 44% on 100-mg once-daily dose, and 62% on 100-mg twice-daily dose. Adverse events after the first dose occurred in 51% of patients assigned to placebo.

The incidence of adverse events did not increase significantly with successively higher dose levels.

As noted by Dr. Gelfand in his editorial, there were three serious adverse events, all occurring in patients on the active drug: a case of COVID-19 in one patient and a suicide attempt in one patient, both in the 100-mg once-daily dose group, and an infected cyst in the 50-mg once-daily group. All three events were determined by the principal investigator and the sponsor to be unrelated to JNJ-77242113. 

There were no reports of deaths, major adverse cardiovascular events, or incident cancers during the trial.

The study was supported by Janssen Research and Development. Dr. Bissonnette disclosed institutional research funding and advisory board participation and honoraria with Janssen. Dr. Gelfand disclosed consulting for Janssen Biotech. Dr. Lebwohl disclosed institutional research funding from Janssen but no personal fees.

A version of this article first appeared on Medscape.com.

A novel oral drug for plaque psoriasis that targets the same inflammatory pathway as currently available parenteral therapies showed promise for treating moderate to severe disease in a phase 2 dose-finding trial.

Among 255 patients with plaque psoriasis randomly assigned to receive either placebo or an oral interleukin (IL)–23 receptor antagonist peptide dubbed JNJ-77242113 (Janssen), 79% of those who were assigned to the oral agent at the highest dose of 100 mg twice daily had a reduction in the Psoriasis Area and Severity Index (PASI) score at week 16 of at least 75% (PASI 75) compared with 9% of patients assigned to placebo, reported Robert Bissonnette, MD, from Innovaderm Research in Montreal, Quebec, Canada, and colleagues.

“The level of reduction of psoriasis that was observed with higher doses of JNJ-77242113 at week 16 was similar in magnitude to the responses seen with several of the injectable biologics that are currently approved for psoriasis,” investigators in the FRONTIER 1 trial wrote in The New England Journal of Medicine.

The investigators noted that among patients assigned to the 100-mg dose of the active drug, 60% had a PASI 90 response, which compares favorably with that seen in phase 3 trials of two other orally available therapies for psoriasis, deucravacitinib (Sotyktu) and apremilast (Otezla). They cautioned, however, against drawing any further inferences from these data, because these agents have not been tested head-to-head against JNJ-77242113 in comparison trials.
 

Targets IL-23 and IL-17

The investigational agent is an oral IL-23 receptor antagonist peptide that selectively blocks IL-23 proximal signaling as well as the production of downstream inflammatory cytokines such as IL-17, according to the authors.

“Modulation of the interleukin-23 pathway with the use of monoclonal antibodies has shown efficacy in the treatment of psoriasis and is considered to be associated with a more favorable safety profile than older oral therapies (eg, cyclosporine, acitretin, methotrexate, and dimethyl fumarate),” the investigators wrote.

Currently available biologic agents targeting IL-23 include guselkumab (Tremfya), risankizumab (Skyrizi) and tildrakizumab (Ilumya). These agents require intravenous or subcutaneous administration, whereas JNJ-77242113 is taken orally, giving it a theoretical advantage in terms of patient preference.

The novel drug must be taken twice daily on an empty stomach at least 2 hours before food or drink, and those who take it must wait an additional 30 minutes to eat or drink after taking the drug. (This news organization has learned that in planned phase 3 studies, patients will be instructed to take a double daily dose on awakening and then wait 30 minutes for eating or drinking.)

‘Profoundly Effective’

The results of this study have convinced at least one former skeptic of the efficacy of the novel agent.

“They asked me to do the trial, and I turned it down, because I didn’t believe it would work,” said Mark G. Lebwohl, MD, dean for Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai and professor and chairman emeritus of the Department of Dermatology at Mount Sinai Medicine in New York, NY.

In an interview with this news organization, Dr. Lebwohl said that he was initially dubious that a peptide, a short chain of amino acids directed against a receptor, could be effective because it would likely be digested in the intestinal tract.

“Indeed, more than 99% of it is digested, but the data show that the tiny amount that gets through is profoundly effective,” he said.

“I would never have believed that this was going to work – and it did,” Dr. Lebwohl added.

He has signed on as an investigator in the currently recruiting phase 3 ICONIC-LEAD trial, in which JNJ-77242113 will be tested against placebo in adolescents and adults with moderate to severe plaque psoriasis. 

In an editorial accompanying the study in the NEJM, Joel M. Gelfand, MD, MSCE, vice chair of clinical research and medical director of the Dermatology Clinical Studies Unit at the University of Pennsylvania in Philadelphia, noted that if confirmed in larger studies, the PASI 90 rate at the highest dose “would be similar to the most effective injectable biologics,” with no evidence of increased adverse events at higher doses.

“However, two occurrences of infection (COVID-19 and an infected cyst) and a suicide attempt were reported as serious adverse events; larger trials will be needed to determine whether such events are attributable to chance, psoriasis itself, or inhibition of interleukin-23 signaling,” cautioned Dr. Gelfand, director of the psoriasis and phototherapy treatment center at the University of Pennsylvania.

In an interview, Dr. Lebwohl said that currently available IL-23 signaling inhibitors have an excellent safety profile and that the investigational oral agent also appears to be very safe. “It’s seeing a target whose effects are known, and the effects are all good and not bad,” he said.
 

FRONTIER-1 Details

The investigators enrolled eligible adults aged 18 years or older who had moderate to severe plaque psoriasis as defined by an Investigator’s Global Assessment score ≥ 3, a total body-surface area of psoriasis involvement of at least 10%, and a PASI score ≥ 12 who had received their diagnosis of plaque psoriasis at least 6 months before starting the trial. The participants had to be candidates for phototherapy or systemic psoriasis therapy.

Patients were randomly assigned to the active agent at doses of 25 mg once or twice daily, 50 mg once daily, or 100 mg once or twice daily for 16 weeks. 

There was a clear dose response, with 37% of patients assigned to 25-mg once-daily dose meeting the primary endpoint of a PASI 75 response at week 16 compared with 51% of those assigned to the 25-mg twice-daily dose, 58% assigned to 50-mg once-daily dose, 65% assigned to 100-mg once-daily dose, and 79% assigned to 100-mg twice-daily dose (P for dose response < .001).

As noted previously, 9% of patients in the placebo group had a PASI 75 response at week 16.

After a mean duration of 15.9 weeks, adverse events after the first dose of JNJ-77242113 (all dose groups were pooled for the safety analysis) were reported in 47% of patients on the 25-mg once-daily dose, 49% on 25-mg twice-daily dose, 60% on 50-mg once-daily dose, 44% on 100-mg once-daily dose, and 62% on 100-mg twice-daily dose. Adverse events after the first dose occurred in 51% of patients assigned to placebo.

The incidence of adverse events did not increase significantly with successively higher dose levels.

As noted by Dr. Gelfand in his editorial, there were three serious adverse events, all occurring in patients on the active drug: a case of COVID-19 in one patient and a suicide attempt in one patient, both in the 100-mg once-daily dose group, and an infected cyst in the 50-mg once-daily group. All three events were determined by the principal investigator and the sponsor to be unrelated to JNJ-77242113. 

There were no reports of deaths, major adverse cardiovascular events, or incident cancers during the trial.

The study was supported by Janssen Research and Development. Dr. Bissonnette disclosed institutional research funding and advisory board participation and honoraria with Janssen. Dr. Gelfand disclosed consulting for Janssen Biotech. Dr. Lebwohl disclosed institutional research funding from Janssen but no personal fees.

A version of this article first appeared on Medscape.com.

A novel oral drug for plaque psoriasis that targets the same inflammatory pathway as currently available parenteral therapies showed promise for treating moderate to severe disease in a phase 2 dose-finding trial.

Among 255 patients with plaque psoriasis randomly assigned to receive either placebo or an oral interleukin (IL)–23 receptor antagonist peptide dubbed JNJ-77242113 (Janssen), 79% of those who were assigned to the oral agent at the highest dose of 100 mg twice daily had a reduction in the Psoriasis Area and Severity Index (PASI) score at week 16 of at least 75% (PASI 75) compared with 9% of patients assigned to placebo, reported Robert Bissonnette, MD, from Innovaderm Research in Montreal, Quebec, Canada, and colleagues.

“The level of reduction of psoriasis that was observed with higher doses of JNJ-77242113 at week 16 was similar in magnitude to the responses seen with several of the injectable biologics that are currently approved for psoriasis,” investigators in the FRONTIER 1 trial wrote in The New England Journal of Medicine.

The investigators noted that among patients assigned to the 100-mg dose of the active drug, 60% had a PASI 90 response, which compares favorably with that seen in phase 3 trials of two other orally available therapies for psoriasis, deucravacitinib (Sotyktu) and apremilast (Otezla). They cautioned, however, against drawing any further inferences from these data, because these agents have not been tested head-to-head against JNJ-77242113 in comparison trials.
 

Targets IL-23 and IL-17

The investigational agent is an oral IL-23 receptor antagonist peptide that selectively blocks IL-23 proximal signaling as well as the production of downstream inflammatory cytokines such as IL-17, according to the authors.

“Modulation of the interleukin-23 pathway with the use of monoclonal antibodies has shown efficacy in the treatment of psoriasis and is considered to be associated with a more favorable safety profile than older oral therapies (eg, cyclosporine, acitretin, methotrexate, and dimethyl fumarate),” the investigators wrote.

Currently available biologic agents targeting IL-23 include guselkumab (Tremfya), risankizumab (Skyrizi) and tildrakizumab (Ilumya). These agents require intravenous or subcutaneous administration, whereas JNJ-77242113 is taken orally, giving it a theoretical advantage in terms of patient preference.

The novel drug must be taken twice daily on an empty stomach at least 2 hours before food or drink, and those who take it must wait an additional 30 minutes to eat or drink after taking the drug. (This news organization has learned that in planned phase 3 studies, patients will be instructed to take a double daily dose on awakening and then wait 30 minutes for eating or drinking.)

‘Profoundly Effective’

The results of this study have convinced at least one former skeptic of the efficacy of the novel agent.

“They asked me to do the trial, and I turned it down, because I didn’t believe it would work,” said Mark G. Lebwohl, MD, dean for Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai and professor and chairman emeritus of the Department of Dermatology at Mount Sinai Medicine in New York, NY.

In an interview with this news organization, Dr. Lebwohl said that he was initially dubious that a peptide, a short chain of amino acids directed against a receptor, could be effective because it would likely be digested in the intestinal tract.

“Indeed, more than 99% of it is digested, but the data show that the tiny amount that gets through is profoundly effective,” he said.

“I would never have believed that this was going to work – and it did,” Dr. Lebwohl added.

He has signed on as an investigator in the currently recruiting phase 3 ICONIC-LEAD trial, in which JNJ-77242113 will be tested against placebo in adolescents and adults with moderate to severe plaque psoriasis. 

In an editorial accompanying the study in the NEJM, Joel M. Gelfand, MD, MSCE, vice chair of clinical research and medical director of the Dermatology Clinical Studies Unit at the University of Pennsylvania in Philadelphia, noted that if confirmed in larger studies, the PASI 90 rate at the highest dose “would be similar to the most effective injectable biologics,” with no evidence of increased adverse events at higher doses.

“However, two occurrences of infection (COVID-19 and an infected cyst) and a suicide attempt were reported as serious adverse events; larger trials will be needed to determine whether such events are attributable to chance, psoriasis itself, or inhibition of interleukin-23 signaling,” cautioned Dr. Gelfand, director of the psoriasis and phototherapy treatment center at the University of Pennsylvania.

In an interview, Dr. Lebwohl said that currently available IL-23 signaling inhibitors have an excellent safety profile and that the investigational oral agent also appears to be very safe. “It’s seeing a target whose effects are known, and the effects are all good and not bad,” he said.
 

FRONTIER-1 Details

The investigators enrolled eligible adults aged 18 years or older who had moderate to severe plaque psoriasis as defined by an Investigator’s Global Assessment score ≥ 3, a total body-surface area of psoriasis involvement of at least 10%, and a PASI score ≥ 12 who had received their diagnosis of plaque psoriasis at least 6 months before starting the trial. The participants had to be candidates for phototherapy or systemic psoriasis therapy.

Patients were randomly assigned to the active agent at doses of 25 mg once or twice daily, 50 mg once daily, or 100 mg once or twice daily for 16 weeks. 

There was a clear dose response, with 37% of patients assigned to 25-mg once-daily dose meeting the primary endpoint of a PASI 75 response at week 16 compared with 51% of those assigned to the 25-mg twice-daily dose, 58% assigned to 50-mg once-daily dose, 65% assigned to 100-mg once-daily dose, and 79% assigned to 100-mg twice-daily dose (P for dose response < .001).

As noted previously, 9% of patients in the placebo group had a PASI 75 response at week 16.

After a mean duration of 15.9 weeks, adverse events after the first dose of JNJ-77242113 (all dose groups were pooled for the safety analysis) were reported in 47% of patients on the 25-mg once-daily dose, 49% on 25-mg twice-daily dose, 60% on 50-mg once-daily dose, 44% on 100-mg once-daily dose, and 62% on 100-mg twice-daily dose. Adverse events after the first dose occurred in 51% of patients assigned to placebo.

The incidence of adverse events did not increase significantly with successively higher dose levels.

As noted by Dr. Gelfand in his editorial, there were three serious adverse events, all occurring in patients on the active drug: a case of COVID-19 in one patient and a suicide attempt in one patient, both in the 100-mg once-daily dose group, and an infected cyst in the 50-mg once-daily group. All three events were determined by the principal investigator and the sponsor to be unrelated to JNJ-77242113. 

There were no reports of deaths, major adverse cardiovascular events, or incident cancers during the trial.

The study was supported by Janssen Research and Development. Dr. Bissonnette disclosed institutional research funding and advisory board participation and honoraria with Janssen. Dr. Gelfand disclosed consulting for Janssen Biotech. Dr. Lebwohl disclosed institutional research funding from Janssen but no personal fees.

A version of this article first appeared on Medscape.com.