Ruxolitinib effective in vitiligo repigmentation
Facial and body repigmentation was significant in patients with vitiligo treated with ruxolitinib cream, according to two phase 3 studies presented at the EADV Congress virtual meeting.
“Currently not a single medication is FDA approved to repigment vitiligo, so we certainly need more options,” David Rosmarin, MD, vice chair of research and education in the department of dermatology at Tufts Medical Center in Boston, and one of the study’s lead investigators, told Healio. “This represents a medication that can work both on the face and the body and gives patients hope for repigmenting if that’s what they would like.”
The phase 3 TRuE-V program is comprised of two identical, multicenter, double-blind, controlled studies: TRuE-V1 and TRuE-V2. Each trial enrolled approximately 300 subjects with vitiligo depigmentation covering 10% or less of the total body surface area, including the face, who were randomly assigned to receive twice daily ruxolitinib cream 1.5% (Opzelura, Incyte) or vehicle cream.
After 24 weeks of treatment, those in the vehicle group could switch to the treatment regimen for a 28-week treatment extension.
An improvement of at least 75% in the facial Vitiligo Area Scoring Index (F-VASI75) was reported in 29.9% of both trials’ treatment groups, compared with 7.5% and 12.9% of the vehicle groups in TRuE-V1 and TRuE-V2, respectively.
A 50% or more improvement from baseline F-VASI was recorded in 51.5% and 51.4% of the two treatment groups, compared with 17.2% of the TRuE-V1 vehicle group and 23.4% of the TRuE-V2 vehicle group.
An improvement of at least 90% from baseline was achieved in more than 15% of subjects.
Total body Vitiligo Scoring Index improvement of at least 50% (T-VASI50) was achieved by 20.6% and 26.1% of patients in the two treatment arms, compared with 4.9% (TRuE-V1) and 11.3% (TRuE-V2) of the vehicle arms, while Vitiligo Noticeability Scale response was also higher in the treatment groups at 24.5% and 21.9%, compared with 3.3% and 6.6%, respectively.
“Ruxolitinib cream is effective at repigmenting patients in both the face and the body and in terms of the safety signals, the medication was well-tolerated with no serious side effects related to the treatment,” Rosmarin said.