AbbVie’s RINVOQ (upadacitinib) has secured approval from the European Commission as the first and only systemic medication in the European Union for adults and adolescents aged 12 and older with non-segmental vitiligo (NSV), the most common form of the chronic autoimmune skin disease.
The approval marks a major shift in the treatment landscape for people living with NSV, who have historically had limited systemic therapy options. The decision is backed by data from AbbVie’s Phase 3 Viti-Up clinical program, where RINVOQ 15 mg once daily demonstrated statistically significant improvements in both total-body and facial repigmentation compared with placebo at week 48.
"The European Commission's approval of RINVOQ as the first and only systemic treatment for non-segmental vitiligo is an advancement for patients living with this chronic autoimmune disease," said Roopal Thakkar, executive vice president, research and development, chief scientific officer, AbbVie.
"People with vitiligo have limited treatment options, and RINVOQ's approval addresses a significant need for patients across Europe."
Vitiligo occurs when the immune system attacks melanocytes, the cells responsible for producing skin pigment, causing irregular white patches to appear. Non-segmental vitiligo accounts for approximately 84% of all vitiligo cases and can have a profound impact beyond visible skin changes, affecting emotional well-being and quality of life.
Unlike conditions that remain stable, vitiligo can be unpredictable, with new lesions appearing or existing patches expanding after periods of inactivity. Patients often face psychological challenges, including increased risks of anxiety and depression.
The European Commission’s decision was supported by the Viti-Up clinical program, which included two randomized, double-blind, placebo-controlled Phase 3 studies evaluating RINVOQ in adults and adolescents with NSV who were candidates for systemic treatment.
The treatment also met key secondary measures, including helping stabilize disease progression in patients whose vitiligo was actively worsening at the start of the studies.
The safety profile observed in the trials was consistent with RINVOQ’s established safety profile across approved indications, with no new safety signals identified.
"Given the immune-mediated and unpredictable nature of non-segmental vitiligo, holistic therapeutic management including early diagnosis, appropriate treatment and precise assessment of disease extent and activity is crucial," said Diamant Thaçi, professor, Comprehensive Center for Inflammatory Medicine, University of Lübeck, and Viti-Up trial investigator.
"The approval of RINVOQ provides an advanced systemic treatment option that targets the immune dysregulation that causes vitiligo and has the potential to stabilize disease while allowing for repigmentation."
With the new approval, RINVOQ is now authorized in the European Union for multiple immune-mediated conditions, including atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease, giant cell arteritis, alopecia areata, and forms of axial spondyloarthritis.
The Viti-Up program involved 614 participants across 90 sites worldwide. Participants received either RINVOQ 15 mg once daily or placebo during the initial 48-week controlled period, with eligible participants continuing into a longer open-label extension.
RINVOQ, discovered and developed by AbbVie scientists, is a selective and reversible Janus kinase (JAK) inhibitor designed to target immune pathways involved in inflammatory diseases.
AbbVie said the medicine continues to be studied in additional Phase 3 programs, including trials for hidradenitis suppurativa, Takayasu arteritis and systemic lupus erythematosus. The use of RINVOQ for non-segmental vitiligo remains under regulatory review by the U.S. Food and Drug Administration.
