Upadacitinib improves vitiligo among patients without reaching plateau for 1 year
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Key takeaways:
- All patients treated with upadacitinib from week 0 to 24 continually improved through week 52 without reaching plateau.
- No new safety signals emerged.
SAN DIEGO — Patients with nonsegmental vitiligo continually improved with upadacitinib treatment up to 1 year, according to a speaker at the American Academy of Dermatology Annual Meeting.
“There are limited options for widespread vitiligo, which is why advancements in research for this dermatologic immune condition are crucial for fulfilling unmet needs for patients,” Iltefat Hamzavi, MD, FAAD, clinical associate professor at Wayne State University, dermatologist at Henry Ford Hospital and co-founder and past president of the Global Vitiligo Foundation, told Healio.
In this phase 2 study, Hamzavi and colleagues evaluated the efficacy and safety of once-daily upadacitinib for the treatment of nonsegmental vitiligo (NSV) for 52 weeks. The study included 185 patients, 68% of whom had baseline total vitiligo area scoring index (T-VASI) scores of 10 or greater and 71% of whom had active vitiligo.
The study was built upon results from the earlier stages of this trial in which patients were randomly assigned to receive upadacitinib 6 mg (n = 49), 11 mg (n = 47), 22 mg (n = 43) or placebo (n = 46) for 24 weeks. In this extension, upadacitinib-treated patients continued their treatment regimens for up to 52 weeks, whereas placebo patients switched to upadacitinib 11 mg (n = 19) or 22 mg (n = 21).
As the primary endpoint, researchers evaluated skin repigmentation as measured by facial (F)-VASI and T-VASI. Results showed that all patients treated with upadacitinib from week 0 to 24 continually improved to week 52 without reaching plateau.
“Treatment takes time, but patients continue to improve which suggests we are not yet able to assess peak response,” Hamzavi explained.
More specifically, F-VASI 75 and T-VASI 50 were reached, respectively, by 36.8% and 31.6% of the 6 mg group, 63.2% and 39.5% of the 11 mg group, 37.9% and 41.4% of the 22 mg group, 36.8% and 21.1% of the placebo to 11 mg group and 28.6% and 9.5% of the placebo to 22 mg group.
“The most bothersome patches appear on the face, so I am especially excited by the F-VASI data as this is an important measure of clinical improvement for patients and dermatologists,” Hamzavi told Healio.
According to the presentation, no new safety signals as seen in the upadacitinib treatment of atopic dermatitis were reported. However, the number of discontinuations and serious related treatment-emergent adverse events were high in the upadacitinib 22 mg group with eight events, one non-fatal ischemic stroke and one death of unknown cause. The stroke was deemed possibly related to the study drug, whereas the death was not.
“This study marks a positive development for the treatment of vitiligo,” Hamzavi told Healio. “These results are encouraging and provide an important step forward in our work to address the need for additional treatment options.”
References:
Passeron T, et al. Br J Dermatol. 2024;doi:10.1093/bjd/ljad498.066.
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Passeron T, et al. S026 late-breaking research: session 1. Presented at: American Academy of Dermatology Annual Meeting; March 8-13, 2024; San Diego.
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