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The Drug Enforcement Administration (DEA) announced proposed permanent rules for the prescribing of controlled medications through telemedicine with new appropriate safeguards.

In-Person Visits For Some Drug Prescriptions Are Required Over Telehealth Prescriptions

Patients with vitiligo treated with Incyte’s Opzelura (ruxolitinib) largely improved or remained stable in their responses through week 52, according to a pooled analysis of two phase 3 studies. The results were presented during a poster presentation at the annual meeting of the American Academy of Dermatology Association in New Orleans, March 17 to March 20, 2023.

Vitiligo is a disease that causes the loss of skin color. Vitiligo occurs when cells that produce melanin die or stop functioning. Vitiligo affects people of all skin types, but it may be more noticeable in people with darker skin. The exact cause is unknown, but it is believed to be an autoimmune condition.

Worldwide prevalence estimates of vitiligo vary widely, ranging from 0.004% to 2.28%. One study suggests that about 40% of patients with vitiligo may be undiagnosed.

Incyte’s Opzelura is the first FDA-approved treatment for this condition and is the only topical formulation of a Janus kinase (JAK) inhibitor approved in the United States. The approved approved it for this indication in June 2022. For patients over the age of 12. Over-activity of the JAK signaling pathway is believed to drive inflammation involved in vitiligo.

The approval was based on data from the pivotal phase 3 TRuE-V clinical trial program (TRuE-V1 and TRuE-V2), evaluating the safety and efficacy of Opzelura versus vehicle in people with vitiligo at week 24. In the studies, treatment with Opzelura resulted in improvements in Vitiligo Area Severity Index (VASI) scores, which represent improvements in facial and total body repigmentation. At week 24, about 30% of patients treated with Opzelura achieved 75% or more improvement in the facial VASI, the primary endpoint, compared with a non-medicated cream in 8% of patients in the TRuE-V1 study and 13% of patients in the TRuE-V2 study. 

Investigators, led by John E. Harris, M.D., Ph.D., associate professor in the department of Dermatology at the University of Massachusetts Chan Medical School, wanted to evaluate the changes in improvement or stability of facial vitiligo among patients who used Opzelura for 52 weeks.

At week 24, about 30% of patients treated with Opzelura achieved 75% or more improvement in the facial VASI, the primary endpoint, compared with a non-medicated cream in 8% of patients in the TRuE-V1 study and 13% of patients in the TRuE-V2 study. At week 52, about 50% of Opzelura-treated patients achieved 75% or more improvement. Additionally, at week 24, more than 15% of patients treated with Opzelura achieved 90% or more improvement in the facial VASI. At week 52, about 30% of Opzelura-treated patients achieved this improvement.

Opzelura was well-tolerated through 52 weeks of treatment. A total of 58.6% of patients experienced ≥1 treatment-emergent adverse event (AE), most commonly COVID-19 (7.3%), application site acne (6.5%), nasopharyngitis (5.8%), and application site pruritus (5.3%). Application site reactions were the most common treatment-related adverse events; these included acne (5.6%) and pruritus (4.7%), all of which were mild or moderate. No serious adverse events were considered related to treatment. There were no clinically significant changes in hemoglobin or platelet levels.

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Longer-term use of Opzelura was well tolerated, with no serious treatment-related adverse events, according to a poster presented at the annual dermatology meeting.

More Vitiligo Patients Respond with Longer Use of Opzelura

After the FDA approved Opzelura (ruxolitinib) cream as treatment for vitiligo in July 2022, the vitiligo clinic and research center that he directs was flooded with phone calls from patients who wanted the drug, says John E. Harris, M.D., Ph.D., an associated professor at the UMass Chan Medical School in Worcester, Massachusetts.

But the news hadn’t apparently reached some of the people minding the approval processes at health insurers.



“Some of the responses we were getting very early on was this was not approved for vitiligo. We’re like, ‘It is, it is,’” Harris said in an interview with 

Harris says insurance coverage still varies, state-by-state, but that now two-thirds of patients have insurance coverage of Opzelura for vitiligo. He noted that MassHealth, the Massachusetts Medicaid program, has put it on it formulary.

But Harris noted that Opzelura has advantages over prior treatment strategies, which included use of class-one topica steroids, which because of their side effects, have to be use in an alternating pattern with tacrolimus ointment.

Harris also noted that the FDA approval is limited only to people age 12 and older, so that he sees parents and children at his clinic who wish Opzelura was approved for children. The FDA approval is also limited to people who have 10% or less of body surface area affecged by vitiligo.

“There are multiple interpretation of that,” Harris. “If somebody has 20% body surface area vitiligo, is it Ok for them to choose 10% and use the cream on 10%. Some payers are saying no, if they have more than 10%, if they have 11% body surface area, we won’t give them the cream at all. But’s very reasonable for patients to say, ‘Look, I’ve got 20% but I want to put it on my face and my hands. That is what really what I care about.’ So. we’re learning on how to talk to payers.” 

The limits of the FDA and insurance company scutiny put a premium on careful documentation, said Harris. "Explaining in your note what type of vitiligo is it, is it segmental or nonsegmental, what's the body surface area — those are important parameters."

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John E. Harris, M.D., Ph.D., of the UMass Chan Medical School in Worcester, Massachusetts, and director of a vitiligo clinic and research center there, discusses some of the insurance issues regarding Opzelura (ruxolitinib) cream.

Opzelura for Vitiligo and Insurance Coverage

Women who are pregnant and who have psoriasis or eczema often have limited options. The evidence about the effect that the systemic medications might have on pregnant women and their fetuses is limited. 

But women deserve more than just topical treatment and moisturizers, and doctors may be more restrictive than necessary,

, M.D., a dermatologist in private practice in Chicago, said during a presentation today at the annual meeting of the American Academy of Dermatology in New Orleans.

“We are more restrictive with both systemics and topical medications in our patients who have atopic dermatitis and psoriasis in a way that is not scientifically backed,” she said. “We may be doing a disservice to patients by being too restrictive in our prescribing patterns. We may have concerns, and there are uncertainties, but these patients deserve to be treated because there's also risk of nontreatment. These patients have a chronic immune-mediated inflammatory disease and they’re pregnant. Having an uncontrolled chronic immune mediated inflammatory disease is also not healthy in pregnancy.”

Inadequate control of disease can lead to flares and infections and even septicemia, Kiracofe said. Additionally, she said, depression is more common in women with psoriasis than in healthy women without psoriasis. And 21% of pregnant women who have psoriasis suffer from depression, compared with 10% of non-psoriasis patients.

In the United States, 4.6% of women have atopic dermatitis, and 3.2% of women have psoriasis. About 75% of women are diagnosed before the age of 40. At the same time, the representation of women in psoriasis studies has decreased. In a recent 

 study, investigators found that clinical studies with least 45% of women in the enrolled population decreased from 87.2% in the 2010 to 2015 timeframe to 29.5% in the 2015 to 2020 timeframe.

Kiracofe acknowledged the treatment choices for pregnant patients with atopic dermatitis are complicated. There are no large clinical studies on the possible effects and side-effect of biologics on conception, pregnancy and lactation.

When treating pregnant women, it’s important to use the science, Kiracofe said. “We can’t just base decisions on just the label; we need to know the pathophysiology, we need to know how the body works. And we need to have a shared decision-making process and talk with our patients because that is a really important conversation.”

An important piece of the puzzle in the use of biologics in psoriasis and atopic dermatitis during pregnancy is the degree of immune suppression the infant experiences within the few first few months of life.

It’s important to think about the impact of using biologics in the second and third trimester. “That’s a really big frameshift when thinking about medication interacting with our patients. We’re taught from medical school to think about the first trimester fetal malformations. But for these type of systemic medications, we actually want to be thinking in the second and third trimester.”

Kiracofe described how  the placental Fc receptor "grabs." The Fc receptor is instrumental in allowing medications to cross the placenta. Cimzia (certolizumab) is the only biologic with a confirmed safety profile during pregnancy and lactation with no increased mortality rate for the fetus, Kiracofe told an audience at the dermatology organization's annual meeting. Cimzia is a TNF-alpha inhibitor that doesn’t bind to the placental Fc receptor.

Cimzia was approved in September 2013 by the FDA as a treatment of active psoriatic arthritis and in May 2018 as a  treatment of moderate-to-severe psoriasis in adults. It is also approved for treating rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, and non-radiographic axial spondyloarthritis.

Women who are pregnant don’t have to stop all of their treatments during pregnancy. Some can be safely treated for their psoriasis or eczema, according to a presentation today at the annual meeting of the American Academy of Dermatology.

Treatment of Atopic Dermatitis and Psoriasis in People Who Are Pregnant: It’s Complicated

Telehealth has become a routine part of U.S. healthcare, but it seems particularly well suited for dermatology. With relative ease, people can use their phones to take a picture or a short video of a troubling rash or spot and send it to dermatology practice. Real-time consults are also relatively easy. 

Still, there's some uncertainty about how "teledermatology" might be used in the detection and diagnosis of melanoma, the most serious form of skin cancer. The American Cancer Society projects that approximately 98,000 cases of melanoma will be diagnosed in the U.S. this year and just under 8,000 people will die from the disease.

Erik Jaklitsch, a second-year medical school student at the University of Pittsburgh School of Medicine and his colleagues, may have helped filled the gap in understanding of telehealth's role in melanoma care with a presentation of findings from a retrospective study comparing melanoma cases that first presented via a teledermatology visit with those that first presented during an in-person visit. The study included all the melanoma cases identified in the University of Pittsburgh Medical Center system over a two-and-half-year period from 2020 to 2022. 

About 800 melanomas cases first presented in in-person visits, but 35 were initially seen via a teleheath visit. 

"We were able to see that patients seen through teledermatology had significantly shorter time from first-contact, dermatology-seeking consultation to being seen — and, most importantly, to getting biopsied," Jaklitsch said in an interview with 

More specifically, the time to biopsy for the teledermatology group was 13 days compared with 82 days for those seen in-person. 

Jaklitsch said the findings also show that the melanomas in the teledermatology were thicker (higher Breslow thickness) and had other characteristics indicative of higher risk. Becaue it was a retrospective study, the results can't address questions concerning false positives and the number of visits involved, he noted, "but it is saying for 35 high-mortality lesions, we were able to catch them sooner."

The demographic information analyzed by Jaklitsch and his colleagues show that the teledermatology users were younger and included a greater proportion of nonwhite patients. Melanin is protective against melanoma, so the melanoma rates are lower in people with darker skin, noted Jaklitsch. African Americans are, however, at higher risk for acral lentiginous melanoma, which appears on the palms, soles of the feet and nails, he pointed out. For reseachers, the low number of melanoma patients among people with darker skin can mean that it is difficult to conduct studies that produce results that reach the common thresholds for statistical significance.  


The study was funded in part by the Melanoma Research Foundation. 

Erik Jaklitsch of the University of Pittsburgh School of Medicine presented findings today at the annual meeting of the American Academy of Dermatology that suggest that teledermatology might be useful for shortening the time to treatment for melanoma patients. 

Melanoma Diagnosis Via Teledermatology

Wildfires in the United States are increasing in frequency, intensity and size. The smoke from the fires is having widespread health effect on people with and without skin conditions, according to new research presented at the annual meeting of the American Academy of Dermatology Association in New Orleans.

“We found that the air pollution from California wildfire was associated with an increase in patient visits to dermatologists for both eczema and psoriasis,” said 

, M.D., Ph.D., professor of dermatology at the University of California, San Francisco, at a presentation on Friday.

Wei and colleagues conducted a study assessing the short-term dermatological impact of the 2018 Camp Fire in Paradise, Calif. The Camp Fire was one of the deadliest and most destructive wildfires ever in the state. The 17-day fire caused 85 civilian deaths and destroyed more than 18,000 structures over 240 square miles, an area 10 times the area of Manhattan. It only stopped burning after a rainstorm.  

Wei and her colleagues tallied the number of dermatology visits for atopic dermatitis and itch during and after the air pollution spike that resulted from the fire.

The researchers found that the number of visits for atopic dermatitis spiked by 50% during the fire and remained abormally high for four weeks afterwards. In total, there were 66,642 clinic visits, including 6,439 visits for atopic dermatitis and 1,610 for itch. They also saw an 80% increase in the number of itch visits for pediatric patients that also was sustained for four weeks afterwards. There was a similar increase among adult patients.  

Additionally, prescriptions for systemic medications, including prednisone, increased by 50% during this time.

Many of these patients did not have a diagnosis prior to the fire. “We think this means that the wildfire was unmasking previously undiagnosed atopic dermatitis that was irritated by the pollution,” Wei said.

Wei and her colleagues also noted that people with eczema were more likely to visit a dermatologist during the wildfire, while those with psoriasis were more likely to seek care five to nine weeks after the fire started. “This difference in timing may suggest that there are differences in how air pollution triggers flares for eczema compared with psoriasis,” she said.

Wei and her colleagues also reviewed web searches during the 2022 Lightning Complex fire that burned through 192,000 acres across the wine country area in Northern California and destroyed nearly 1,500 structures. They found searches for skin conditions increased at a time when the air pollution was high. “This suggests that as wildfires increase, we might see an influx in the number of people seeking care for pollution-related skin conditions.”

Research shows that short-term exposure to wildfire air pollution can affect the skin and cause flares of certain skin conditions.

Visits to Dermatologists Increased After California Wildfires 

Eva R. Parker, MD, associate professor of dermatology at Vanderbilt University Medical Center and president of the Nashville Dermatologic Society addressed how climate change, such as heat and humidity, can increase the incidence of skin infections during the annual American Academy of Dermatology meeting today in New Orleans. 

Parker said she sees more staph infections in summer months than winter months because the heat from hot weather increases chances of bacteria growth.

Eva R. Parker, MD, associate professor of dermatology at Vanderbilt University Medical Center and president of the Nashville Dermatologic Society, addressed how climate change is already increasing the incidence of some skin-related  conditions at the annual meeting of the American Academy of Dermatology in New Orleans.

Eva Parker, M.D. , of Vanderbilt Talks Effects of Climate Change on Skin Infections

Emma Guttman-Yassky, M.D., Ph.D. of Icahn School of Medicine at Mount Sinai, New York discussed developments in atopic dermatitis treatment, more specifically with therapies like rocatinlimab and other anti-OX4 agents today at the annual American Academy of Dermatology meeting in New Orleans.

Emma Guttman-Yassky of Icahn School of Medicine Talks Developments in Atopic Dermatitis Treatment

(ruxolitinib) cream was able to control symptoms of atopic dermatitis with an as-needed use after initial treatment, according to a pooled analysis of long-term safety periods in two phase 3 studies. The results of the long-term analysis were presented during a poster presentation at the annual meeting of the American Academy of Dermatology Association in New Orleans, March 17 to March 20, 2023.

Atopic dermatitis is a chronic skin disease affecting more than 21 million people aged 12 years and older in the United States. Quality of life in patients with atopic dermatitis can be reduced because of inflammation and itch.

Incyte’s Opzelura is a topical formulation of ruxolitinib, an inhibitor of JAK1 and JAK2. The FDA approved the treatment in September 2021 to treat mild-to-moderate atopic dermatitis in patients 12 years of age and older. The FDA approval was based on data from two phase 3 studies (TRuE-AD1 and TRuE-AD 2) evaluating the safety and efficacy of Opzelura in more than 1,200 adolescents and adults. Results from the studies showed patients experienced significantly clearer skin and itch reduction when treated with Opzelura cream 1.5% twice daily, compared with a non-medicated cream. Significantly more patients treated with Opzelura experienced a clinically meaningful reduction in itch from baseline at Week 8.

Led by Andrew Blauvelt, M.D., MBA, a board-certified dermatologist and investigator at Oregon Medical Research Center, investigators wanted to evaluate long-term maintenance of disease and symptom control when using ruxolitinib cream as needed. They conducted an analysis of the long-term safety extension from the two phase 3 studies. Patients initially randomized to Opzelura cream remained on their regimen for the 44-week long-term safety period.

Of 1,249 randomized patients, 1,072 (85.8%) continued into the long-term safety period; 837 (67.0%) who applied ruxolitinib cream since day 1 were evaluated for disease and symptom control in the long-term safety period. A majority completed the long-term safety period, with 11 (1.3%) discontinuing due to adverse events and 15 (1.8%) discontinuing due to lack of efficacy.

The majority of patients maintained or demonstrated improvements in symptom control of itch between assessments. The mean cumulative number of days with no treatment due to lesion clearance was 116.5 and 133.8 days with 0.75% ruxolitinib cream and 1.5% ruxolitinib cream, respectively

The majority of patients maintained or demonstrated improvements in sleep between assessments. Sleep disturbance for 0 days in the past week was reported by 64.9% applying the 0.75% ruxolitinib cream at week 8 and 74.5% at week 52. Of patients using the 1.5 ruxolitinib, 71.8% reported no days of sleep disturbance at week 8 and in 74.5% at week 52. Ruxolitinib cream was well-tolerated during 52-week study.

After initial treatment, Opzelura used on an as-needed basis was able to control symptoms of atopic dermatitis and helped patients sleep, according to a poster presented at the annual dermatology meeting.

As-Needed Use of Opzelura Can Control Atopic Dermatitis 

Haley Naik, M.D., associate professor of dermatology at the University of California, San Francisco, School of Medicine, led a discussion about hidradenitis suppurativa today at the annual American Academy of Dermatology meeting in New Orleans.

Naik says the growing prevalence of the disease is likely the result of increased diagnosis and public awareness and not a population increase in the condition.

Although studies have shown an association between hidradenitis suppurativa and metabolic disorders, Naik said the evidence does not point toward a causal relationship and that weight loss.

Humira (adalimumab) is approved as a treatment for hidradentis suppurativa. Naik, who said it may be time for clinicians to consider using biologics earlier in the course of hidradenitis suppurativa, said the launching of biosimilars to Humira this year may improves access to treatment for the condition.

Haley Naik, M.D., associate professor of dermatology at the University of California, San Francisco, School of Medicine, led a discussion about  hidradenitis suppurativa today at the annual American Academy of Dermatology meeting in New Orleans. 


Haley Naik, M.D., Discusses Hidradenitis Suppurativa at Annual AAD Meeting

About 10% of people in the United States will receive a medical implant sometime in their lives, and increasingly dermatologists are seeing patients who have a skin reaction associated with the metals used in those implants, according to a presentation today at the annual meeting of the American Academy of Dermatology Association in New Orleans.

Golara Honari, M.D., make a presentation on the cutaneous side effects of metal implants today at the annual meeting of the American Academy of Dermatology.

The metals used, particularly nickel, are the most common culprits of allergic contact dermatitis, said presenter 

, M.D, clinical associate professor of dermatology at Stanford School of Medicine. “Cases in which patients are inquiring about a metal allergy as it relates to their metal implants — including joint replacements, rods, pins, screws, plates, and certain neurological and cardiac devices such as pacemakers, and dental devices — are becoming more prevalent as medical implants become more common.” Honari said that it is not clear what proportion of patients develop these reactions, although they are relatively uncommon.

“Cutaneous reactions can be localized. Occasionally, they can be systemic, and they also can have other morphologies,” she noted.

The use of metal implants is growing. The U.S. medical device market was $177.06 billion in 2021 and is projected to be $255.14 billion in 2029, Honari said in her presentation. Joint replacement surgeries continue to grow about 5% annually with a market value of $19 billion in 2021. In the United States, there are about 450,000 hip replacements annually, and this is projected to increase to 572,000 a year by 2030. There are about 790,000 knee replacements annually in the United States and this is expected to grow to 3.48 million 2030. Additionally, more than 2 million vascular stents are implanted in the United States.

Implanted devices can sometimes corrode, and chemicals can leak into the body. This can cause an immune response, but interactions between the materials and the body are complex, Honari said. Reactions can include hypersensitivity, chronic inflammation, immune suppression, immunostimulation and autoimmunity. 

For hip and knee replacements, cutaneous and systemic reactions can occur within weeks to months of the implantation. Most common are localized reactions that present as dermatitis affecting the skin over the site of the implant.

Nickel is the most common contact allergen, and the incidence, especially among children tested in the United States, has almost quadrupled over the last three decades. Chromium is the third most common allergen in the population. Titanium is generally considered biocompatible but can cause a rare reaction. Honari said that she has seen allergic reactions to the bone cement that sometimes used in surgeries.

Honari recommends that patients who have a history of metal allergies consider patch testing prior to surgery. After surgery, she recommends ruling out inflammation if a patient presents with an allergic reaction. “However, if an allergic reaction is suspected, the first line of treatment may be topical and/or oral medications, like anti-inflammatories, which can relieve pain, reduce inflammation, and bring down a high temperature,” she said.

Although not a common complication of hip, knee and other metal implants, the number of allergic reactions is growing, partly the number of joint replacements is growing, according to a presentation at the annual meeting of the American Academy of Dermatology. Nickel is the most common contact allergen.