The European Commission approved RINVOQ (upadacitinib) for severe alopecia areata and non-segmental vitiligo based on positive Phase 3 UP-AA and Viti-Up trials showing significant hair regrowth and skin repigmentation.
Written By: Rishabh Sonawane, BPharm
Reviewed By: Pharmacally Editorial Team
The European Commission (EC) has approved RINVOQ® (upadacitinib) for two autoimmune dermatology indications, expanding its use across the European Union. The approvals cover the treatment of adult and adolescent patients aged 12 years and older with severe alopecia areata (AA) and non-segmental vitiligo (NSV) who are candidates for systemic therapy.
The decisions are based on positive findings from AbbVie’s pivotal Phase 3 UP-AA and Viti-Up clinical programs, which demonstrated clinically meaningful hair regrowth in alopecia areata and significant skin repigmentation in vitiligo while maintaining a safety profile consistent with previously approved indications.
RINVOQ Expands Its Role in Immune-Mediated Skin Diseases
RINVOQ (upadacitinib) is an oral, selective, reversible Janus kinase (JAK) inhibitor that preferentially inhibits JAK1-mediated signaling involved in multiple inflammatory pathways. The therapy is already approved in the European Union for several immune-mediated diseases, including atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, Crohn’s disease, ulcerative colitis, giant cell arteritis, and now severe alopecia areata and non-segmental vitiligo.
Both newly approved conditions are chronic autoimmune diseases associated with substantial psychological and social burden that extend beyond visible skin and hair changes.
Phase 3 UP-AA Trial Showed Significant Hair Regrowth
The alopecia areata approval was supported by the ongoing Phase 3 UP-AA (M23-716) clinical program (NCT06012240), comprising two replicates randomized, placebo-controlled, double-blind studies involving 1,399 patients aged 12 to 64 years across 248 global study sites.
Patients received RINVOQ 15 mg, RINVOQ 30 mg, or placebo for 24 weeks during the double-blind period.
Both approved doses met the primary endpoint, with significantly more patients achieving a Severity of Alopecia Tool (SALT) score of 20 or less, corresponding to at least 80% scalp hair coverage, compared with placebo at Week 24.
The studies also met key secondary endpoints, including:
- Complete scalp hair regrowth (SALT = 0) at Week 24
- Significant improvements in eyebrow regrowth
- Significant improvements in eyelash regrowth
According to AbbVie, RINVOQ became the first JAK inhibitor to demonstrate complete scalp hair regrowth versus placebo at Week 24 in this patient population.
The safety profile of both doses remained generally consistent with previous RINVOQ studies, with no unexpected safety findings reported during the placebo-controlled period.
Phase 3 Viti-Up Program Demonstrated Clinically Meaningful Re-pigmentation
The EC also approved RINVOQ 15 mg once daily for adults and adolescents with non-segmental vitiligo based on results from the Phase 3 Viti-Up (M19-044) clinical program (NCT06118411).
The two-replicate randomized, placebo-controlled studies enrolled 614 patients across 90 international sites.
Participants received RINVOQ 15 mg or placebo for 48 weeks before entering a long-term open-label extension.
RINVOQ met both co-primary efficacy endpoints, demonstrating statistically significant improvements over placebo in:
- Total Vitiligo Area Scoring Index (T-VASI 50), representing at least 50% improvement in total body pigmentation
- Facial Vitiligo Area Scoring Index (F-VASI 75), representing at least 75% improvement in facial re-pigmentation
The treatment also achieved key secondary endpoints, including stabilization of disease progression in patients with active vitiligo at baseline.
No new safety signals emerged, and the overall safety profile was consistent with previously approved indications.
With this authorization, RINVOQ becomes the first and only systemic therapy approved in the European Union for non-segmental vitiligo.
Experts Highlight Expanded Treatment Options
AbbVie Chief Scientific Officer Roopal Thakkar, M.D., said the approvals provide important new treatment options for patients with severe alopecia areata and non-segmental vitiligo, diseases that often carry substantial physical and psychological burden despite being frequently underestimated.
Dermatology experts involved in the clinical programs noted that the Phase 3 studies demonstrated clinically meaningful improvements in scalp hair regrowth for alopecia areata and durable facial and body repigmentation for vitiligo, supporting RINVOQ as an important systemic treatment option for these autoimmune disorders.
Regulatory Path
The European approvals further expand RINVOQ’s dermatology portfolio while regulatory reviews continue in the United States. AbbVie confirmed that upadacitinib remains under review by the U.S. Food and Drug Administration for both severe alopecia areata and non-segmental vitiligo.
Beyond dermatology, RINVOQ is also undergoing Phase 3 evaluation in additional immune-mediated diseases, including hidradenitis suppurativa, Takayasu arteritis, and systemic lupus erythematosus, reflecting continued efforts to broaden the therapy’s role across autoimmune conditions.
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About the Writer
Rishabha Sonawane, B.Pharm (LinkedIn) is healthcare writer with a strong interest in medical writing, regulatory affairs, clinical research, and AI-driven drug discovery. He has completed specialized training from the NIH and ICMR in clinical pharmacology, clinical research, and scientific writing. Passionate about evidence-based healthcare communication, he focuses on translating complex scientific research into clear, accurate, and engaging medical content.