Incyte has announced that data taken from its pivotal phase 3 TRuE-V clinical trial programme assessing Opzelura 1.5% cream (ruxolitinib) in patients 12 years and older with nonsegmental vitiligo has been published in The New England Journal of Medicine (NEJM).

The TRuE-V1 and TRuE-V2 trials showed that application of Opzelura resulted in significant facial and total body repigmentation, compared to vehicle-control as shown by greater proportions of patients reaching the facial and total body Vitiligo Area Scoring Index (F-VASI and T-VASI, respectively) endpoints at week 24 versus vehicle, with a higher proportion of patients responding at week 52.

Results from the phase 3 TRuE-V studies vehicle-controlled period (24 weeks) and week 52 data were featured in an oral presentation at the late-breaking abstract session at the American Academy of Dermatology (AAD) Annual 2022 Meeting. 

The presentation included results at week 24, which had proven consistency across both trials, and showed that approximately 30% of patients treated with Opzelura achieved =75% improvement from baseline in F-VASI (F-VASI75), the primary endpoint.

Around 13% of patients applying vehicle in one study met the primary endpoint. At week 52, approximately 50% of patients who received Opzelura cream from day one achieved F-VASI75.

Additionally, at week 24, more than 15% of patients treated with ruxolitinib cream achieved =90% improvement from baseline in F-VASI (F-VASI90) vs. approximately 2% of patients applying vehicle met F-VASI90. 

At week 52, those treated with Opzelura who achieved F-VASI90 doubled to approximately 30%.