AbbVie Announces Positive Phase IIb Results for Upadacitinib in Non-Segmental Vitiligo

On October 12, AbbVie announced that the Phase IIb study of upadacitinib for the treatment of non-segmental vitiligo (NSV) met its primary endpoint, showing a significant improvement in the Facial Vitiligo Area Scoring Index (F-VASI) at week 24 for both the 11mg and 22mg dose groups compared to the placebo group. The F-VASI improvement was greater at week 52 than at week 24 across all dose groups. No new safety signals were identified beyond the known safety profile. Based on these data, AbbVie plans to advance the clinical program of upadacitinib for vitiligo into Phase III.

Upadacitinib is a selective JAK inhibitor currently under investigation for various immune-mediated diseases. Enzyme and cell assay results show that upadacitinib has greater inhibitory potency against JAK1 than JAK2, JAK3, and TYK2. In August 2019, the product received its first FDA approval and became the world’s first approved JAK1 inhibitor.

This Phase IIb study showed that at Week 24, both the 11mg and 22mg doses of upadacitinib achieved the primary endpoint of a significant reduction in the percentage change from baseline in F-VASI (%CFB) compared to placebo. In secondary endpoints, higher response rates were also observed with upadacitinib versus placebo, including F-VASI 75 (a ≥75% reduction from baseline in F-VASI) for both the 11mg and 22mg doses at Week 24, and T-VASI 50 (defined as a ≥50% reduction from baseline in T-VASI) for the 22mg dose at Week 24.

For all upadacitinib dose groups, the mean percentage reduction in F-VASI from baseline at Week 52 was numerically greater than the results at Week 24; the response rates for F-VASI 75 and T-VASI 50 observed at Week 52 were also numerically higher than the data at Week 24.

Roopal Thakkar, M.D., Senior Vice President of Development and Regulatory Affairs and Chief Medical Officer at AbbVie, stated: "There is a significant unmet need in vitiligo, with no systemic treatments currently approved, leaving patients frustrated in their search for options to restore skin pigmentation. We will continue to leverage our extensive experience to advance research and innovation in the treatment of immune-mediated diseases, including vitiligo, where the burden on patients remains high and needs are not adequately addressed."

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