The European Commission (EC) has approved upadacitinib (RinVoq, AbbVie) 15mg 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.<\/p>\n
With this approval, upadacitinib is now the first and only systemic medication approved in the European Union for NSV. Upadacitinib, a Janus kinase (JAK) inhibitor \u00a0is under regulatory review by the U.S. Food and Drug Administration (FDA)\u00a0for NSV.<\/p>\n
The EC approval of upadacitinib is supported by data from the Phase 3 Viti-Up clinical program, including two replicate, randomized, placebo-controlled, double-blind studies evaluating the efficacy and safety of upadacitinib in adult and adolescent patients with NSV.<\/p>\n
As previously reported in both studies, upadacitinib 15mg met both co-primary endpoints with statistically significant and clinically meaningful improvements in Total Body Vitiligo Area Scoring Index\u00a0 (T-VASI 50) and facial repigmentation (Facial-VASI 75) at Week 48 vs. placebo. Upadacitinib met key ranked secondary endpoints, including stabilization of disease extent as assessed by T-VASI in patients with actively progressing disease at baseline. The safety profile of upadacitinib in both studies was generally consistent with that observed in approved indications, with no new safety signals.<\/p>\n
\u201cGiven 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,\u201d says Diamant Tha\u00e7i, MD, PhD<\/strong>, Professor in the Comprehensive Center for Inflammatory Medicine at the University of L\u00fcbeck in L\u00fcbeck, Germany, and Viti-Up trial investigator. \u201cThe 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.\u201d<\/p>\n Upadacitinib 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\u2019s disease, and giant cell arteritis, and adults and adolescents with severe alopecia areata<\/p>\n
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