The United States Food and Drug Administration approved the first topical JAK (Janus kinase) inhibitor cream, Opzelura, to treat people aged 12 and older with vitiligo.
Vitiligo is an autoimmune disorder caused by antibodies that attack a person’s pigment-producing cells. Research published in the journal JAMA estimated that about 1.9-2.8 million adults in the United States suffer from vitiligo.
The new vitiligo treatment cream, Opzelura, was developed by Incyte. “There’s a large unmet medical need here in vitiligo,” Dr. Steven Stein, Chief Medical Officer at Incyte, said.
Vitiligo causes discoloration of the skin, and the skin turns white. The discoloration does not necessarily pose a medical risk, but it may result in some physical complications like hearing problems, eye issues, and severe sunburn, as reported by ABC News.
Experts said that vitiligo could not be cured. Oral and topical steroids were the common treatment for vitiligo before the FDA’s approval of Opzelura.
Long-term steroid usage has several side effects. Thus, dermatologists always look for non-steroid methods to cure vitiligo, said Dr. Mansha Sethi, a board-certified dermatologist in Houston, who was not involved in the study.
Some doctors also try phototherapy, which includes cells to make skin pigment. However, this phototherapy method is difficult to implement as it is very expensive.
With FDA’s approval, insurance companies would soon start covering this on prescription. Dr. Stein said that Incyte would provide co-pay cards that would limit the out-of-pocket cost to patients to as little as $10 or less.
According to Dr. David Rosmarin, director of the Clinical Trials Unit at Tufts and the principal investigator for the vitiligo clinical trials, he started searching for better treatments in 2013.
The researchers realized that the immune system was too active in destroying pigment cells. Dr. Rosmarin wondered if Opzelura would work in stopping the immune system from attacking the pigment. Later, it worked as JAK1/JAK2 inhibitor.
Two Phase 3 trials were conducted for Opzelura on over six hundred people aged 12 and above. The trial results showed that adolescents and adult patients with vitiligo got significant facial and total body re-pigmentation within 24 to 52 weeks under therapy.
About half of the total participants had a 75 percent improvement in their facial vitiligo after using the study’s measurements of re-pigmentation for more than one year. Additionally, the side effects were well tolerated by the participants.
Dr. Rosmarin said that about 6 percent of patients would have an application site reaction, and about 6 percent would get some acne. The medication would require a prescription, and it would be applied as a cream to clear the skin infected by vitiligo.
