AbbVie announced positive topline results from two pivotal, replicate Phase 3 clinical studies evaluating the safety and efficacy of upadacitinib (RINVOQ; 15 mg, once daily) in adults and adolescents with non-segmental vitiligo (NSV), the most common form of the disease.

Both studies met their co-primary endpoints, demonstrating that treatment with upadacitinib achieved a 50 per cent reduction in Total Vitiligo Area Scoring Index (T-VASI 50) and a 75 per cent reduction in Facial Vitiligo Area Scoring Index (F-VASI 75) from baseline at week 48, compared with placebo. The studies also met key ranked secondary endpoints, including significant improvements in F-VASI 50 at week 48.

“Vitiligo is more than a skin condition – it’s a chronic autoimmune disease that can deeply affect a person’s confidence, identity, and daily life,” said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development at AbbVie. “There are currently no approved systemic medical therapies that can achieve repigmentation in vitiligo. These Phase 3 results mark an important milestone in our commitment to advancing care and expanding our immunology portfolio to deliver meaningful innovations for patients.”

Vitiligo, affecting over 90 per cent of patients in its non-segmental form, is characterized by symmetrical white patches on both sides of the body. T-VASI measures depigmentation across the entire body, while F-VASI assesses facial depigmentation—an area with profound psychosocial impact. Across both studies, approximately 70 per cent of participants had a baseline T-VASI score greater than 10.

“For many people living with vitiligo, the journey is marked by uncertainty, frustration, and a lack of effective systemic therapies,” said Thierry Passeron, M.D., Ph.D., professor and chair of the Department of Dermatology at Université Côte d’Azur. “These results suggest that targeting the underlying inflammation may provide a systemic treatment option that helps patients achieve visible repigmentation.”

The safety profile of upadacitinib was consistent with its established safety data across approved indications. No new safety signals were identified. The most common treatment-emergent adverse events were upper respiratory tract infection, acne, and nasopharyngitis. Serious adverse events occurred in 3.9 per cent and 4 per cent of patients in the upadacitinib and placebo groups, respectively, in the first study, and in 2 per cent and 1 per cent of patients in the upadacitinib and placebo groups, respectively, in the second study. There were no reported cases of major adverse cardiovascular events (MACE) or venous thromboembolism (VTE). Three malignancy events were observed—one in each placebo group and one in the upadacitinib group. No deaths occurred among upadacitinib-treated participants; one death was reported in the placebo group in the second study.

These positive results reinforce AbbVie’s ongoing efforts to advance research and develop innovative treatment options for immune-mediated diseases, addressing critical unmet needs for patients around the world.