AbbVie reported that two replicate Phase 3 studies of its JAK‑inhibitor RINVOQ met co‑primary endpoints in adults and adolescents with non‑segmental vitiligo.
In the studies, 19.4% of RINVOQ patients achieved a ≥50% reduction in total body vitiligo area (T‑VASI 50) at week 48 compared with 5.9% of placebo patients. A further 25.2% of RINVOQ patients achieved a ≥75% reduction in facial vitiligo area (F‑VASI 75) at week 48 versus 5.9% of placebo patients. The trials enrolled 614 participants across 90 sites worldwide and were designated M19‑044.
Safety data showed no new signals. RINVOQ is already approved for rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, non‑radiographic axial spondyloarthritis, juvenile idiopathic arthritis, and giant cell arteritis.
Non‑segmental vitiligo affects approximately 1–2% of the global population, and no approved systemic therapies exist for repigmentation. The positive results support a regulatory filing for a new indication that could add a significant revenue stream to AbbVie’s immunology portfolio, especially as the company seeks to offset the loss of Humira exclusivity.
AbbVie has been raising its long‑term revenue outlook for RINVOQ and Skyrizi, underscoring the importance of these products to the company’s growth strategy. The JAK‑inhibitor class continues to expand, and RINVOQ’s success in vitiligo positions AbbVie as a leader in systemic treatments for this chronic autoimmune disease.
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