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Topical Immune Drug Reverses Skin Disease

Hands with vitiligo

Hands with vitiligo (James Heilman MD, Wikimedia Commons)

18 June 2019. A drug targeting immune system enzymes used as a skin cream is shown in a clinical trial to reverse effects of vitiligo, or loss of skin coloring. Results of the trial were presented on Sunday at the World Congress of Dermatology in Milan, Italy.

Vitiligo is a chronic condition marked by loss of skin color occurring in blotches. While not life-threatening nor contagious, the disorder is very noticeable and stressful, particularly among people with darker skin colors. While the underlying cause is unknown, areas of the skin in people with vitiligo lose functioning melanin-producing cells, causing the skin in those areas to turn white. Vitiligo can also turn hair color white and occur as well inside the mouth.

A team led by dermatologist and medical school professor David Rosmarin at Tufts University in Boston studies a drug known as ruxolitinib, formulated as a skin cream, as a treatment for vitiligo. Ruxolitinib is a Janus kinase, or JAK inhibitor, that regulates enzymes triggered by the immune system, often causing inflammation. Incyte Corp. in Wilmington, Delaware first developed ruxolitinib as a treatment for myelofibrosis, a rare type of bone marrow cancer, marketed under the brand name Jakafi.

However, the underlying JAK-inhibitor mechanism in ruxolitinib makes it a potential treatment for inflammatory skin disorders, including vitiligo. The mid-stage clinical trial is testing Incyte’s ruxolitinib as a topical cream against a placebo cream among 157 participants with vitiligo at 26 sites in the U.S. Participants are randomly assigned to use the ruxolitinib cream or placebo once or twice a day for 52 weeks, with some participants alternating ruxolitinib or the placebo in their twice-a-day routines.

Rosmarin and colleagues are looking primarily for changes in skin color as measured by a standard facial vitiligo area severity index, with a target of at least 50 percent improvement. Their paper at the World Congress of Dermatology reported on results after 24 weeks, with 50 percent of the once-daily ruxolitinib cream users and 45 percent of the twice-daily users hitting that target, compared to 3 percent of those receiving the placebo. In addition, 30 percent of the twice-daily users and 17 percent of the once-a-day users achieved at least 75 percent skin improvement.

The researchers say ruxolitinib cream was generally well tolerated, with mild side effects including redness, skin irritation, and acne.

“Topical ruxolitinib has the potential to change the way vitiligo is treated,” says Rosmarin in a Tufts University statement. “Not only is it effective at repigmenting the skin, but it has an excellent safety profile.”

“The positive 24-week data presented at the World Congress of Dermatology support the potential of ruxolitinib cream to offer a novel treatment option for patients with this chronic autoimmune disease,” adds Steven Stein, Incyte’s chief medical officer in a company statement. “We look forward to advancing ruxolitinib cream into Phase 3 [late-stage] development for vitiligo in the hope that it may become the first approved treatment for what can be a life-altering disease.”

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