AbbVie, which trades on the NYSE under the ticker ABBV, has announced encouraging top-line results from two Phase 3 trials looking at the safety and effectiveness of upadacitinib, marketed as RINVOQ, at a dose of 15 mg once a day. These studies focused on adults and adolescents with non-segmental vitiligo, or NSV, which is the most common form of the condition, making up over 90% of all cases. NSV is marked by symmetrical white patches appearing on both sides of the body.
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Kori Wallace, M.D., Ph.D., AbbVie’s vice president and global head of immunology clinical development, said that vitiligo goes beyond appearance. She explained it’s a long-term autoimmune disease that can influence a person’s self-esteem, sense of identity, and everyday life. Wallace highlighted that there are currently no approved treatments for re-pigmentation and called the Phase 3 results a major step forward for AbbVie in helping patients and broadening its immunology treatments.
The studies used the Total Vitiligo Area Scoring Index, or T-VASI, to measure the amount of depigmentation across the body and the Facial Vitiligo Area Scoring Index, or F-VASI, to assess depigmentation on the face, which is especially noticeable and has a strong effect on emotional well-being. About 70% of participants in both studies had T-VASI scores above 10 at the start. Upadacitinib met the main goals of the study, showing at least a 50% reduction in total body depigmentation and a 75% reduction in facial depigmentation after 48 weeks compared to a placebo. It also showed significant improvements in other secondary measures, including a 50% reduction in facial depigmentation at week 48.
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Thierry Passeron, M.D., Ph.D., professor and head of the Department of Dermatology at Université Côte d’Azur, said living with vitiligo can be tough because there are few systemic treatment options. He pointed out that these results suggest targeting the underlying inflammation could offer patients a real systemic treatment that leads to visible re-pigmentation.
The safety of upadacitinib in both studies was similar to what’s been seen in other approved uses. No new safety problems were found. Common side effects included upper respiratory infections, acne, and colds. Serious side effects occurred in 3.9% and 4% of patients in the first study and 2% and 1% in the second study, in the upadacitinib and placebo groups, respectively. No serious heart problems or blood clots were reported. Three cases of cancer were noted, including one genital tumor in the upadacitinib group. No deaths were reported among those taking upadacitinib, while one death was recorded in a placebo-treated patient in the second study. Upadacitinib is not yet approved for NSV, and its safety and effectiveness for this condition have not been reviewed by regulatory agencies.
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