David Rosmarin, MD: Major Takeaways Regarding Phase 3 Trials Evaluating Ruxolitinib for Vitiligo


A discussion regarding the main data points from the Phase 3 TRuE-V clinical trial program assessing the use of ruxolitinib cream for nonsegmental vitiligo.

In The New England Journal of Medicine (NEJM) recently, data from the Phase 3 TRuE-V clinical trial program demonstrated the use of ruxolitinib cream (Opzelura) in patients 12 years of age and older with nonsegmental vitiligo.

David Rosmarin, MD, works as a dermatologist and as the Vice Chair of Research and Education, at the Tufts Medical Center Dermatology Department. Rosmarin spoke on the Phase 3 trial results and the major takeaways from the trials.

“The big takeaway from the phase three program of ruxolitinib cream in vitiligo is that patients can read pigment on both the face and the body, about 50% will achieve 75% or more repigmentation on the face, and about half the patients will also achieve 50% or more repigmentation on the body,” Rosmarin explained.

He also described the varying demographic backgrounds of the patients treated with ruxolitinib, as well as some of the more unique facets of the trial data. Rosmarin had previously cited his interest in studies of ruxolitinib that might incorporate a more diverse patient population as well as a longer trial period.

“What's also notable is that, it doesn't matter how long patients have had vitiligo for their race, ethnicity, or the amount of vitiligo they start with, they seem to have similar responses across those different clinical characteristics and baseline demographics,” he said. “What does matter most though, is the anatomical location of the vitiligo.”

Rosmarin went further into depth about some of the more surprising elements of the trial results regarding vitiligo treatment.

“So, the first thing I was surprised with is how consistent the results were between the phase 2 and each of the phase 3 studies,” he said. “The second thing that was surprising is that the clinical characteristics and baseline demographics didn't affect how patients did.”

For more information on the trial results on vitiligo treatment, watch the interview segment above.

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