Written by Dennis Mann
HealthDay reporter
MONDAY, Oct 24, 2022 (HealthDay News) — For the millions of people who suffer from vitiligo, a disease that robs the skin of its natural color, a newly approved cream called ruxolitinib (Opzelura) is fast becoming a game-changer.
The U.S. Food and Drug Administration approved ruxolitinib to treat vitiligo in people 12 years of age and older in July. The drug, which is part of a class known as Janus kinase (JAK) inhibitors, targets JAK, a molecule involved in the development and progression of vitiligo.
The study found that about half of people with vitiligo who used the cream had regained 75% or more of the pigment on the face and 50% or more of the pigment on their entire body after a year of use. More than a third of the adults and more than 50% of the teens in the study said their vitiligo was no longer noticeable or less noticeable after a year.
“This is a major milestone because ruxolitinib cream is the first FDA-approved treatment for re-pigmentation in vitiligo patients,” said study author Dr. Center in Boston.
An autoimmune disease that occurs when the body goes haywire against its own skin cells, vitiligo can be mild or severe and is found anywhere on the body, although it usually affects the face and hands. Vitiligo affects people of all skin types but is often more noticeable in people with darker skin.
Two studies in the new analysis included more than 670 people with vitiligo from 70 centers, primarily in North America and Europe. There were no differences in responses based on race, ethnicity, disease duration, and/or amount of vitiligo, among other factors.
“Even vitiligo patients of over 30 years can still improve with this treatment,” Rosemarin said.
He noted that before approving the new cream, dermatologists used topical steroids, topical calcineurin inhibitors, and phototherapy to treat vitiligo.
“Topical corticosteroids and topical calcineurin inhibitors help some patients, but certainly not everyone.” [it] It can also have side effects. “Corticosteroids can lighten and thin the skin and we should limit their use to sensitive body sites such as the face, genitals and armpits, and calcineurin inhibitors can sting or burn when applied to some patients.”
He added that light therapy includes weekly appointments that are not always geographically convenient.
Topical ruxolitinib caused only mild side effects, including redness and irritation at the application site and mild acne in this study. The drug carries a black box warning from the US Food and Drug Administration (FDA) due to an increased risk of serious infections, major heart problems, clotting, cancer and even death. This warning is based on studies of oral ruxolitinib, which results in much higher blood levels than the cream.
The study was funded by Incyte, which produces ruxolitinib. It was published October 20 in the New England Journal of Medicine.
Vitiligo experts welcome the new drug and are optimistic about the vitiligo treatment pipeline.
Dr. Victor Huang said that vitiligo has traditionally been studied despite its dramatic social and psychological impact. He is director of the Vitiligo Clinic at the University of California, Davis.
“The development of this new drug is exciting to the community for the treatment it offers, the validation of the underlying science for vitiligo that it represents, and for the new treatments it promises,” Huang said.
“This disease can have a significant impact on self-esteem,” he explained. “Half of all patients with vitiligo are diagnosed before the age of 20, and in the pediatric community, harassment, bullying, self-awareness, and embarrassment were issues for patients.”
Huang said there was more, too.
“My patients report the burden of vitiligo that manifests in the time it takes to cover up in the morning, difficulty developing intimate relationships, anxiety about standing still, dealing with strangers who fear that their vitiligo is contagious, and time away from work on follow-up treatments which can include three phototherapy visits times a week,” according to Huang.
Dr. Elft Hamzavi, MD, a dermatologist at Henry Ford Hospital in Detroit, agreed that this new cream is a major problem for people with vitiligo.
“Vitiligo is a major psychosocial disease that has an impact on quality of life similar to chronic asthma, and rates of depression are much higher than in the general population,” Hamza said. “We never know how effective a drug is in a large group and also how safe it is, [and] We have this information now and this is a formidable hurdle to overcome for a disease that has not had approved treatments.”
Dr. Leif Edsmo is Professor of Translational Dermatology and Immunology at the University of Copenhagen in Denmark. I wrote an editorial accompanying the new study. She said the topical treatment targets the affected sites directly and reduces the risk of systemic effects.
“Patients with vitiligo are finally hoping for effective treatments, with several new immune-modifying drugs in various stages of clinical trials,” Edsmo added.
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