AbbVie’s Rinvoq has been approved by the European Commission (EC) to treat adults and adolescents 12 years and older with non-segmental vitiligo (NSV) who are candidates for systemic therapy.
Rinvoq is now the first and only systemic medication approved in the EU for NSV, the most common form of vitiligo, accounting for 84% of all cases.
Roopal Thakkar, executive vice president, research and development, chief scientific officer at AbbVie, commented: “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 characterised by irregular white patches on the skin, resulting from the selective destruction of melanocytes – the cells responsible for skin pigmentation.
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. 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.
The EC approval of Rinvoq is supported by data from the phase 3 Viti-Up clinical programme (M19-044), including two replicate, randomised, placebo-controlled, double-blind studies evaluating the efficacy and safety of Rinvoq in adult and adolescent patients with NSV.
“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 stabilise disease while allowing for repigmentation.”
Rinvoq is also approved in the EU to treat 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.