Upadacitinib Safe, Effective Over 48 Weeks for Non-Segmental Vitiligo, With Thierry Passeron, MD, PhD

Upadacitinib is both safe and effective over 48 weeks among patients with non-segmental vitiligo, new findings suggest, with no new safety signals or major adverse cardiovascular events (MACE) identified.1

These late-breaking data, the result of the Viti-Up-1 and Viti-Up-2 studies, were released during the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver. The HCPLive editorial team spoke on-site with trial investigator Thierry Passeron, MD, PhD, professor and chair of the Department of Dermatology at the Université Côte d'Azur in Nice, France.

“Unfortunately, so far, there is no systemic treatment approved for vitiligo, and there is still a high unmet need for the patients suffering from vitiligo,” Passeron explained.

Non-segmental vitiligo, an autoimmune inflammatory disease impacting the skin, is characterized by patients’ loss of melanocytes. This can lead to unpredictable skin depigmentation. Passeron stressed the lack of systemic medications approved for the condition, describing additional options as necessary.

Passeron and colleagues reported in this study on the efficacy and safety of upadacitinib, a selective once-daily Janus kinase (JAK) 1 inhibitor, 15 mg in adults and adolescents with non-segmental vitiligo. It was studied across 48 weeks in this pair of identical, pivotal phase 3 analyses.1,2

In his interview, Passeron noted most of the patients were Fitzpatrick skin types 3 and 4, further describing those treated with upadacitinib in the study as being a severe disease population. The subjects were both adults and adolescents aged ≥ 12 years with this skin disease involving the face and body.

They all had a Facial Vitiligo Scoring Index (F-VASI) ≥ 0·5 and a Total Vitiligo Area Scoring Index (T-VASI) ≥ 5. The subjects were randomized 2:1 to be treated either with upadacitinib 15 mg or placebo once daily. There were 614 individuals involved across Viti-Up-1 (n=308) and Viti-Up-2 (n=306) in total.

“Two-thirds of the population were active, and three-fourths had T-VASI above 10…and the mean duration of the vitiligo was about 15 years,” Basseron said. “Most of them had vitiligo that had already been treated by topical treatment of phototherapy.”

In this poster at AAD, the treatment with upadacitinib was described as providing clinically meaningful repigmentation among adult and adolescent patients with non-segmental vitiligo.1 Passeron and coauthors’ safety data through week 48 were described as consistent with the overall profile for upadacitinib.

Specifically, they noted a lack of reports of adjudicated MACE, adjudicated gastrointestinal (GI) perforations, adjudicated venous thromboembolic events (VTE), lymphoma, active tuberculosis, non-melanoma skin cancer, or opportunistic infections outside of herpes zoster in either analysis.1 Among the most often reported TEAEs, examples included acne, upper respiratory infection, nasopharyngitis, and headache. There were 4 serious infections reported among patients in the Viti-Up-1 upadacitinib cohort, though none led to treatment cessation.

For any additional information on the new data from the Viti-Up-1 and 2 trials, view the full video with Passeron posted above.

Passeron is a consultant for AbbVie, Almirall, Amgen, Bristol Myers Squibb, Calypso, Galderma, Incyte Corporation, Janssen, Eli Lilly, Novartis, Pfizer, Roivant, UCB, and VYNE Therapeutics. He has received grants and/or honoraria from AbbVie, ACM Pharma, Almirall, Amgen, Astellas, Bristol Myers Squibb, Calypso, Celgene, Galderma, Genzyme/Sanofi, GlaxoSmithKline, Incyte Corporation, Janssen, LEO Pharma, Eli Lilly, Novartis, Pfizer, Roivant, Sun Pharmaceuticals, Takeda, UCB, and VYNE Therapeutics. He is the cofounder of NIKAIA Pharmaceuticals and founder of SUNLUTION, and has patents on WNT agonists or GSK3b antagonist for repigmentation of vitiligo and the use of CXCR3B blockers in vitiligo.

References

1. Passeron T, Prajapati V, Seneschal J, et al. Efficacy and Safety of Upadacitinib in Adolescents and Adults for Treatment of Non-Segmental Vitiligo: Results of Two Phase 3 Studies (Viti-Up). Presented at: 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO.

2. Smith T. Upadacitinib Regulatory Applications Submitted for Adults, Adolescents with Vitiligo. HCPLive. February 3, 2026. Accessed March 30, 2026. https://www.hcplive.com/view/upadacitinib-regulatory-applications-submitted-adults-adolescents-vitiligo.