Extension Study Showed Continued Strong Results for Ruxolitinib in Vitiligo Patients

Article

Late-breaking data showed strong results for ruxolitinib cream as a treatment for vitiligo in the long-term extension of the TRuE-V1 and TRuE-V2 studies.

David Rosmarin, MD

David Rosmarin, MD

The TRuE-V long-term extension study data showed that ruxolitinib treatment continued to show improvements in facial/total Vitiligo Area Scoring Index (F-VASI/T-VASI) responses from weeks 52 through 104.1

The research was authored by David Rosmarin, MD, dermatologist and Vice Chair of Research and Education at Tufts Medical Center’s dermatology department.

The long-term extension study was conducted to assess the effects of open-label ruxolitinib cream on F-VASI/T-VASI responses for an additional 52 weeks following the TRuE-V1 and TRuE-V2 trials.2

The study included participants aged 12 or above with nonsegmental vitiligo who did not get a minimum of 90% improvement in F-VASI at 52 weeks in the 2 trials.

Over this period, the investigators found that 66.1% of study participants achieved F-VASI75 and 63.8% of patients achieved T-VASI50 with continued use of ruxolitinib cream.

The study included participants aged 12 or above with nonsegmental vitiligo who did not get a minimum of 90% improvement in F-VASI at 52 weeks in the 2 trials.

In the original 2 randomized, controlled studies (TRuE-V1/TRuE-V2), the investigators had found that the use of ruxolitinib cream showed significant improvement in facial and total body repigmentation over 52 weeks.

The subsequent long-term extension study followed 222 study participants who had been initially treated with ruxolitinib, and they observed that 66.1% of participants ended up achieving F-VASI75 and 63.8% achieved T-VASI50 by the end of the study at 104 weeks.

Additionally, the investigators noted that 30.9% of patients attained F-VASI90 at 104 weeks.

They further added that at 80 weeks, a substantial portion of the study participants showed stable or improved F-VASI and T-VASI responses and similar trends were observed by 104 weeks.

Ruxolitinib is the only drug currently approved by the US Food and Drug Administration (FDA) for treatment of vitiligo.

This long-term extension study confirms that ruxolitinib cream was well-tolerated among vitiligo patients over the course of 104 weeks.

References

  1. Rosmarin D, et al. Facial and Total Vitiligo Area Scoring Index Response Shift During 104 Weeks of Ruxolitinib Cream Treatment for Vitiligo: Res ults From the Open-Label Arm of the TRuE-V Long-Term Extension Phase 3 Study. Paper presented at: American Academy of Dermatology 2023 Annual Meeting; March 17-21, 2023. New Orleans, LA. Accessed March 18, 2023.
  2. Rosmarin D, Passeron T, Pandya AG, et al. Two Phase 3, Randomized, Controlled Trials of Ruxolitinib Cream for Vitiligo. N Engl J Med. 2022 Oct 20;387(16):1445-1455. doi: 10.1056/NEJMoa2118828. PMID: 36260792.
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