NORTH CHICAGO, Ill., October 29, 2025 — AbbVie Inc. (NYSE: ABBV) announced positive topline results from two replicate Phase 3 pivotal studies of RINVOQ® (upadacitinib 15 mg once daily) in adults and adolescents with non-segmental vitiligo (NSV).1 In both trials, RINVOQ achieved the co-primary endpoints of at least 50 % reduction in Total Vitiligo Area Scoring Index (T-VASI 50) and at least 75 % reduction in Facial Vitiligo Area Scoring Index (F-VASI 75) at Week 48 compared with placebo.2
Science Significance
Vitiligo—affecting approximately 0.5 % to 2.3 % of the global population—is a chronic autoimmune condition marked by the destruction of pigment-producing melanocytes, leaving white patches on skin.3 In the two trials (each randomised ~2:1 RINVOQ vs placebo), RINVOQ achieved T-VASI 50 of 19.4 % and 21.5 % vs 5.9 % in placebo; F-VASI 75 of 25.2 % and 23.4 % vs ~6 % in placebo.4 Key secondary endpoints (e.g., F-VASI 50 at Week 48) were also met.5 The safety profile of RINVOQ in this indication remained consistent with its known profile—no new safety signals emerged.4 These results mark a scientific milestone, highlighting the potential for systemic therapy to drive repigmentation in vitiligo, shifting it from a cosmetic concern to a treatable autoimmune condition.
Regulatory Significance
Before these data, no approved systemic therapies existed for vitiligo that provide meaningful repigmentation.6 The positive topline results pave the way for AbbVie to prepare regulatory submissions (e.g., U.S. FDA, EMA) in 2026 for the indication extension of RINVOQ. The robust Phase 3 dataset—including two large replicate trials across 90 global sites and 614 patients—provides a strong foundation for regulatory review and potential label expansion.7 From a regulatory standpoint, this represents a major step in recognising vitiligo as an immunologic disease amenable to targeted JAK-inhibition intervention.
Business Significance
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For AbbVie, RINVOQ is a core growth driver within its immunology franchise. Adding vitiligo to the list of indications (which already includes rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis) could unlock a multi-billion-dollar expansion opportunity given the lack of existing systemic therapies for vitiligo.8 The successful Phase 3 results strengthen AbbVie’s competitive positioning and support its strategic shift away from legacy products toward high-growth biologics and small-molecule immunology assets. This development may also help reinforce RINVOQ’s long-term revenue horizon as part of AbbVie’s broader portfolio strategy.
Patients’ Significance
For patients with vitiligo—particularly those with visible facial patches and bilateral involvement—the psychological, social and quality-of-life burden is substantial.9 The ability of RINVOQ to achieve visible repigmentation (≥ 75 % reduction in facial depigmented area) means real potential for restoring appearance and confidence. The reported safety consistency further supports optimism in treatment access. Patients and dermatologists now have evidence of a systemic modality that may offer meaningful repigmentation—rather than only topical or cosmetic approaches.
Policy Significance
These findings arrive at a time when dermatologic autoimmune diseases are increasingly recognised in health-policy frameworks. The success of RINVOQ in vitiligo may influence future treatment guidelines, reimbursement policy and regulatory classifications of vitiligo as a treatable autoimmune disorder rather than a cosmetic condition. Funding agencies and payers may now treat vitiligo interventions with greater priority, opening access and coverage pathways for systemic therapies in this historically underserved area.
Transaction Highlights
AbbVie’s two replicate Phase 3 studies (Study 1 and Study 2 of the M19-044 protocol) randomised 614 adult and adolescent patients (ages 12 +) with non-segmental vitiligo across 90 sites worldwide to receive RINVOQ® 15 mg once daily or placebo. At Week 48, RINVOQ achieved the co-primary endpoints of T-VASI 50 and F-VASI 75 versus placebo. Key ranked secondary endpoints (including F-VASI 50) were also met. The safety profile remained consistent with prior RINVOQ indications—no new safety signals were observed. Following the positive topline data, AbbVie is preparing regulatory submission efforts toward vitiligo indication expansion and plans to share detailed results at upcoming dermatology congresses. This development strengthens RINVOQ’s growth trajectory within AbbVie’s immunology portfolio and marks a significant advancement for systemic vitiligo treatment.
Source: AbbVie Inc. Press Release
