The Food and Drug Administration (FDA) has recently authorized the first at-home treatment for skin repigmentation for vitiligo patients.
Based on data from two identical Phase 3 clinical trials revealed that 30% of patients using the cream regained at least 50% of skin repigmentation on their body and roughly 20% of patients regained at least 50% of repigmentation on their face after 24 weeks, the FDA announced the approval of Incyte’s ruxolitinib cream on July 18.
Background
Before the approval of ruxolitinib, whose brand name is Opzelura, Jim Lee, vice president of Incyte’s head inflammation and autoimmune department, stated that the only treatment options available to people with vitiligo were light therapy carried out in a doctor’s office. They may now apply the cream at home.
Disease or circumstance
The most prevalent kind of vitiligo is nonsegmental vitiligo. Depigmentation, or loss of pigment, occurs in regions of the skin as a result of the disorder. Depigmentation may appear on the hands, arms, face, neck, scalp, and places that frequently come into contact with objects or are rubbed, such as the lips and genitals.
It is thought that vitiligo is an autoimmune condition. The immune system seems to be attacking the skin’s pigment cells (melanocytes) in vitiligo patients. Numerous people who have vitiligo also have at least one additional autoimmune condition.
Effectiveness
Opzelura has been proven to be safe and effective in two clinical studies (NCT04052425 and NCT04057573). In both studies, nonsegmental vitiligo patients were randomized to receive Opzelura or a placebo twice daily for 24 weeks, with an additional 28 weeks of Opzelura therapy for all participants. Compared to 10% of placebo patients, 30% of Opzelura patients achieved at least a 75% improvement in the face Vitiligo Area Scoring Index after the 24-week treatment period.
Information on Safety
The most frequent side effects of Opzelura are acne, itching, and fever at the application site, as well as the common cold, headache, and urinary tract infection.
Opzelura shouldn’t be used alongside therapeutic biologics, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine.
Patients using JAK inhibitor therapy for inflammatory disorders are at an increased risk of serious infections, death, cancer, significant adverse cardiovascular events, and thrombosis.
