Ruxolitinib cream associated with higher repigmentation of vitiligo lesions, study says
USA: Results from two phase 3 trials published in the New England Journal of Medicine showed that the application of ruxolitinib cream led to a greater repigmentation of vitiligo lesions compared to the vehicle control through 52 weeks. However, ruxolitinib cream was associated with acne and pruritus at the application site.
Vitiligo is a chronic autoimmune disease that leads to skin depigmentation and reduces the quality of life. The state is characterized by white patches correlating with a loss of melanocyte function in the epidermis. The high prevalence of coexisting psychosocial conditions among vitiligo patients affects the quality-of-life burden.
Some research has provided evidence for repigmentation in vitiligo patients after treatment with JAK inhibitors. A cream formulation of an inhibitor of Janus kinase 1 and 2, ruxolitinib, resulted in repigmentation in a phase 2 trial comprising adults with vitiligo.
David Rosmarin and the team conducted two phase 3, double-blind, vehicle-controlled trials -- Topical Ruxolitinib Evaluation in Vitiligo Study 1 [TRuE-V1] and 2 [TRuE-V2] in Europe and North America. The tests comprised patients 12 years or older with nonsegmental vitiligo with depigmentation covering 10% or less of the total body-surface area. Patients were randomly assigned in a ratio of 2:1 to apply 1.5% ruxolitinib cream or vehicle control twice daily for 24 weeks to all vitiligo areas on the face and body, following which all patients could apply 1.5% ruxolitinib cream through week 52.
An improvement of at least 75% from baseline in the facial Vitiligo Area Scoring Index (F-VASI; range, 0 to 3, higher scores indicate a greater area of facial depigmentation) was the primary endpoint or F-VASI75 response at week 24. Five critical secondary endpoints were improved responses on the Vitiligo Noticeability Scale.
The study demonstrated the following findings:
· 674 patients were enrolled, 330 in TRuE-V1 and 344 in TRuE-V2.
· In TRuE-V1, the percentage of patients with an F-VASI75 response at week 24 was 29.8% in the ruxolitinib-cream group and 7.4% in the vehicle group (relative risk, 4.0). TRuE-V2's percentages were 30.9% and 11.4%, respectively (relative risk, 2.7).
· The results for key secondary endpoints showed the superiority of ruxolitinib cream over vehicle control.
· Among patients who applied ruxolitinib cream throughout 52 weeks, adverse events occurred in 54.8% in TRuE-V1 and 62.3% in TRuE-V2; the most common adverse events were application-site acne (6.3% and 6.6%, respectively), nasopharyngitis (5.4% and 6.1%), and application-site pruritus (5.4% and 5.3%).
"There is a need for larger and longer trials to determine the effect and safety of ruxolitinib cream in vitiligo patients," the researchers wrote in their study.
Reference:
The study, "Two Phase 3, Randomized, Controlled Trials of Ruxolitinib Cream for Vitiligo," was published in the New England Journal of Medicine.
DOI: 10.1056/NEJMoa2118828
