New
Incyte has announced positive topline results from its pivotal Phase 3 TRuE-V trial program that evaluated topical ruxolitinib, 1.5% cream in non-segmental vitiligo.
The trials met their primary goals, showing that significantly more patients treated with topical ruxolitinib twice daily achieved a 75% improvement in facial vitiligo, compared to patients treated with control only. The progress was measured by F-VASI75 score from the baseline. The study also track the frequency, duration and severity of adverse events associated with the use of ruxolitinib cream—and so far, no new safety signals were reported.
The company has worked to develop topically delivered ruxolitinib to different skin conditions, like atopic dermatitis and vitiligo, in recent years. Part of the effort has culminated in two Phase 3 trials, TRuE-V1 and TRuE-V2, that each enrolled more than 300 patients aged 12 and above. Details of how many patients met the F-VASI75 score criteria and secondary endpoint remain undisclosed for now. Hopefully, it will be shared at a scientific congress and a medical journal later this year.
However, Incyte shared the overall efficacy and safety profile is consistent with its Phase 2 results. In the earlier trial approximately 30% of patients who used the Phase 3 dose—ruxolitinib cream 1.5% twice daily—experienced a 75% improvement by week 24. The F-VASI75 rate rose to 51% by one year and 66% by two years, although the figure comes from a smaller cohort as some people were lost to follow-up during the course of the study.
An oral JAK1 inhibitor is also in a Phase 2 vitiligo trial, with promising outlook, reflecting Incyte’s belief that more than one drug may be needed to treat the full spectrum of disease severity.
Based on the outcomes, Incyte plans to submit marketing applications for ruxolitinib cream for the treatment of adolescent and adult patients with vitiligo (age 12+ years) to the U.S. FDA and the European Medicines Agency (EMA) in the second half of 2021.
More on ruxolitinib in: JAKs Of All Trades
FAQOther Questions
- Vitiligo and hearing loss: any connection?
Vitiligo is primarily recognized for causing skin discoloration, but it can also impact melanocytes in unexpected areas, such as the inner ear. This raises questions about wheth...
- Белые пятна на теле? Витилиго?
Гид по Витилиго — ваш компас в лабиринте загадочной болезни и непростых решений. Здесь всё по-честному, по делу и на понятном языке. Вы найдёте здесь: Объяснения, что прои...
- I have vitiligo: will my children have vitiligo, too?
If you have vitiligo, you might wonder about the chances of your children developing the condition. While there is a genetic component, vitiligo is not a straightforward heredit...
Though it is not always easy to treat vitiligo, there is much to be gained by clearly understanding the diagnosis, the future implications, treatment options and their outcomes.
Many people deal with vitiligo while remaining in the public eye, maintaining a positive outlook, and having a successful career.
Copyright (C) Bodolóczki JúliaBy taking a little time to fill in the anonymous questionnaire, you can help researchers better understand and fight vitiligo.