Game Changer: Incyte’s Ruxolitinib Reverses Vitiligo

Topical Ruxolitinib is highly effective for skin re-pigmentation in vitiligo.

Topical Ruxolitinib is highly effective for skin re-pigmentation in vitiligo, according to Phase III clinical trial results published in The New England Journal of Medicine.
The study showed better than 75 percent improvement on face and 50 percent improvement on body for half of all patients in study.

“Topical ruxolitinib has the potential to be life-changing for millions of patients with vitiligo and change the standard of care for how physicians approach treating this disease,” said study author David  Rosmarin, MD, a dermatologist and vice chair for education and research in the department of dermatology at Tufts Medical Center in Boston, in a news release. “There is still a lot more work to be done, but it is a milestone step forward to have an effective, accessible re-pigmentation option for this patient population.”

Based on the results from the clinical trial, the U.S, Food and Drug Administration (FDA) granted full approval of Incyte’s ruxolitinib for vitiligo in patients ages 12 and older on July 18, 2022; it is the first-ever FDA-approved topical treatment for skin re-pigmentation in patients with vitiligo.

The one-year, international phase III clinical trial enrolled 343 patients at 70 sites, primarily in North America and Europe. About half of study participants who were randomized to receive topical ruxolitinib experienced at least a 75 percent re-pigmentation improvement on their faces and better than 50 percent re-pigmentation of their bodies. Topical ruxolitinib also showed an excellent safety profile, with only mild side effects in some patients, including redness and irritation at the application site and mild acne.

“It is both satisfying and gratifying to reach this point where people with vitiligo from around the world can access this treatment to re-pigment their skin, if they so choose,” Dr. Rosmarin said. “Alternative therapies can be expensive and burdensome, with limited efficacy. Ruxolitinib is simple to use and effective, and now with FDA-approval, I look forward to it becoming widely available for those who want and need it.”

The study was funded by Incyte Corporation, which produces ruxolitinib.