欧盟批准艾伯维RINVOQ用于非节段型白癜风治疗

NORTH CHICAGO, Ill., July 29, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Commission (EC) has approved RINVOQ® (upadacitinib; 15 mg, once daily) for the treatment of adult and adolescent patients 12 years and older with non-segmental vitiligo (NSV) who are candidates for systemic therapy.1 With this approval, RINVOQ is now the first and only systemic medication approved in the European Union for NSV, the most common form of vitiligo.2
"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, M.D., 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 is a chronic autoimmune disease characterized by irregular white patches on the skin, resulting from the selective destruction of melanocytes – the cells responsible for skin pigmentation. Non-segmental vitiligo (NSV) is the most common type, accounting for 84% of all vitiligo cases.2-4 Vitiligo should not be dismissed as a cosmetic disease, as its effects can be psychologically devastating, often posing a considerable burden on patients' quality of life and resulting in high rates of depression and anxiety.5,6 The unpredictable course of vitiligo, which might progress at any time, and the associated fear of having new and/or expanding vitiligo lesions even after long periods of stability, contribute to the burden of patients living with the disease.2,7
Data Supporting the EC Approval
The EC approval of RINVOQ is supported by data from the Phase 3 Viti-Up clinical program (M19-044), including two replicate, randomized, placebo-controlled, double-blind studies evaluating the efficacy and safety of RINVOQ in adult and adolescent patients with NSV.1 As previously reported in both studies, RINVOQ 15 mg met both co-primary endpoints with statistically significant and clinically meaningful improvements in total body (T-VASI 50) and facial repigmentation (F-VASI 75) at week 48 versus placebo.1 RINVOQ met key ranked secondary endpoints, including stabilization of disease extent as assessed by T-VASI in patients with actively progressing disease at baseline.1 The safety profile of RINVOQ in both studies was generally consistent with that observed in approved indications, with no new safety signals.1
"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, M.D., Ph.D., 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."
RINVOQ is also approved in the European Union for the treatment of adults and adolescents with atopic dermatitis, and adults with radiographic axial spondylarthritis, non-radiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and giant cell arteritis, and adults and adolescents with severe alopecia areata.1
About Viti-Up Clinical Trials
Upadacitinib M19-044 was conducted under a single protocol encompassing two replicate Phase 3 studies (Study 1 and Study 2) with independent randomization, investigative sites, data collection, analysis and reporting for each study. The trials were designed to evaluate the efficacy, safety and tolerability of upadacitinib in adult and adolescent patients (ages 12 and older) living with non-segmental vitiligo (NSV) who were eligible for systemic therapy. In Period A of both studies, participants were randomized in a 2:1 ratio to receive either upadacitinib 15 mg once daily or placebo for 48 weeks. Participants who completed Period A were eligible to enter Period B, a 112-week open-label extension in which all patients received upadacitinib 15 mg once daily. In total, Study 1 and Study 2 Periods A and B span 160 weeks. The two trials randomized 614 participants with NSV across 90 sites worldwide. More information on these trials can be found at www.clinicaltrials.gov (NCT06118411).
The co-primary endpoints were based on the achievement of Total Vitiligo Area Scoring Index (T-VASI) 50, defined as at least 50% reduction in T-VASI from baseline, at week 48, and the achievement of Facial Vitiligo Area Scoring Index (F-VASI) 75, defined as at least 75% reduction in F-VASI from baseline, at week 48 with the treatment of upadacitinib 15 mg compared with placebo in adults and adolescents with NSV.
The ranked secondary endpoints include the achievement of F-VASI 50, defined as at least a 50% reduction in F-VASI from baseline, at week 48, the achievement of F-VASI 75, defined as at least a 75% reduction in facial vitiligo area from baseline, at week 24, and, in actively progressing patients, no increase in disease extent based on the achievement of no increase from baseline in T-VASI at week 8 and 12. These endpoints were designed to assess the degree and timing of re-pigmentation on the face, an area among the most visible and psychosocially impactful for people living with NSV, as well as the potential to stabilize disease extent in actively progressing patients.
About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.1,8 In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK 1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.1
Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for hidradenitis suppurativa, Takayasu arteritis and systemic lupus erythematosus. The use of upadacitinib in non-segmental vitiligo is under regulatory review by the U.S. FDA.
EU Indications and Important Safety Information about RINVOQ® (upadacitinib)1
Indications
Rheumatoid arthritis
RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.
Psoriatic arthritis
RINVOQ is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to, one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.
Axial spondyloarthritis
Non-radiographic axial spondyloarthritis (nr-axSpA)
RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).
Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.
Giant cell arteritis
RINVOQ is indicated for the treatment of giant cell arteritis (GCA) in adult patients.
Atopic dermatitis
RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy.
Alopecia areata
RINVOQ is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older.
Vitiligo
RINVOQ is indicated for the treatment of non-segmental vitili