A couple of weeks ago, Incyte has announced its new FDA-approved topical cream Opzelura (ruxolitinib) for the short-term treatment of the atopic dermatitis. At the recent annual meeting of the European Academy of Dermatology and Venereology, Incyte has presented detailed results from the Phase 3 TRuE-V clinical trial program focused on vitiligo.
Findings revealed that twice-daily treatment with 1.5% ruxolitinib cream resulted in facial repigmentation after 24 weeks: 30% of patients achieved greater than 75% improvement; 50% of patients achieved greater than 50% improvement; and 15% of patients achieved more than 90% improvement. A significant proportion of patients also achieved more than 50% improvement on their body as well. For both areas of the body, no serious treatment-related adverse events were reported, according to the company.
However, this class of drugs recently received a setback with the FDA’s September 1st announcement that it will now require warnings about increased risk of serious heart-related events, blood clots, cancer, and death for skin disease treating JAK inhibitors.
On the heels of promising data from clinical trials and FDA concerns regarding ruxolitinib, HCPLive spoke with Dr. Lawrence Eichenfield and Dr. David Rosmarin. “So, the study that was done in <...> monotherapy, and ruxolitinib alone was able to have a significant impact,” Rosmarin said. “However, perhaps in combination (with phototherapy), it can help patients even more so and do it more rapidly.”
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