Following the success of a nearly complete re-pigmentation status in vitiligo on ruxolitinib cream, more than one-third of the patients who withdrew from the active therapy were able to maintain 75 or more facial vitiligo area scoring index (F-VASI) for more than 1 more year. Of those who relapsed, in about 15 weeks, 68.8% regained an F-VASI90 or greater response.
In one cohort of the long-term extension study of the phase 3 TRuE-V1and the TRuE-V2 trials, 116 patients who had achieved a re-pigmentation of at least 90%, were re-randomized to either continue on twice-daily ruxolitinib cream 1.5% or withdraw from active treatment by switching to a vehicle. John E. Harris, MD, conducted maintenance analysis aimed to investigate the time span to relapse of vitiligo and the duration of maintenance.1 Dr. Harris presented his findings at the 2023 American Academy of Dermatology annual meeting.
Participants with a F-VASI90 or greater had a median age of 42, more than half were women, and 31.9%, 30.2%, and 25.0% had the Fitzpatrick skin types 2, 3, and 4, respectively. In 70.7%, stable disease was present, while the rest presented with progressive vitiligo.
After withdrawal, 39.3% of the participants retained a F-VASI75 or greater response after 1 year; 28.6% experienced a relapse defined as F-VASI75 or less. In half of the cases, the relapses occurred within the first 4 months. Surprisingly, 21.4% of participants on vehicle and 61.8% of those on ruxolitinib cream had a sustained F-VASI90 or greater response over 1 year, with a median duration of F-VASI90 or greater response of 195 days on vehicle only.
In the withdrawal group, after restarting the active treatment in case of a relapse, 75% had a response of F-VASI75 or greater over a median of 12 weeks. After a median of 15 weeks, 68.8% of participants regained an F-VASI90 or greater response.
Overall, ruxolitinib cream was well tolerated with only mild and moderate treatment-related adverse events. There were no reported cases of application-site acne or pruritus.
“There is a population that really maintains response. If patients lose pigment put them back on and they will regain it in most cases,” Dr. Harris said..
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