Photo Credit: Andre Onegin
Phase 2 trial results show that upadacitinib led to fast improvement in repigmentation in patients with non-segmental vitiligo.
In a phase 2 trial, the JAK1 inhibitor upadacitinib led to a fast improvement in repigmentation in patients with non-segmental vitiligo. After the 24-week, double-blind phase, participants showed continuous further pigmentation on the face and body.
Previous research has shown that disrupting IFN-γ signaling by inhibiting the JAK/STAT pathway is an attractive therapeutic target for vitiligo. Therefore, the objective of the current phase 2 dose-ranging study was to evaluate the efficacy and safety of the JAK1 inhibitor upadacitinib for the treatment of adults with non-segmental vitiligo, a disease with limited treatment options.1 Thierry Passeron, MD, PhD, presented the results at the AAD 2024 Annual Meeting.
The researchers randomized 184 participants to placebo or upadacitinib at 6 mg, 11 mg, or 22 mg once daily for 24 weeks. The primary endpoint was the percentage change from baseline in the Facial Vitiligo Area Scoring Index (F-VASI) at week 24. After the double-blind period at week 24, the researchers switched participants from placebo to 11 mg or 22 mg upadacitinib and continuously treated them until week 52.
The study met its primary endpoint with a significantly greater percentage change in the 2 highest upadacitinib doses (i.e. 11 mg and 22 mg). F-VASI was reduced by -34% in the 22 mg group (P≤0.05 vs placebo) and -35.6% in the 11 mg (P≤ 0.01 vs placebo) compared with -14.4 % in the placebo group. Significant reductions were also noted for the change in total VASI (T-VASI).
Moreover, participants treated with upadacitinib experienced continued improvement in F-VASI through week 52. At this time, participants achieved an approximately 60% to 65% reduction in F-VASI with 11 mg and 22 mg upadacitinib, respectively. Similar improvements in F-VASI were observed in participants who switched at week 24 from placebo to upadacitinib 11 mg or 22 mg. T-VASI values also improved up to week 52.
The safety assessment disclosed similar treatment-emergent adverse events (TEAE) rates between upadacitinib and placebo groups, with the most frequently reported TEAEs being a COVID-19 infection, acne, headache, and nasopharyngitis.
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