On 4 February 2026, AbbVie announced the submission of regulatory applications to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) seeking approval of upadacitinib (Rinvoq; 15 mg once daily) for the treatment of adult and adolescent patients with non-segmental vitiligo (NSV). The submissions are supported by previously reported results from the Viti-Up studies which evaluated the safety and efficacy of upadacitinib in patients with NSV.1
About the Viti-UP studies
Upadacitinib M19-044 was conducted under a single protocol comprising two replicate phase III studies (Study 1 and Study 2; NCT06118411). The trials enrolled adults and adolescents aged 12 years and older with non-segmental vitiligo who were eligible for systemic therapy. Participants were randomised in a 2:1 ratio to receive upadacitinib 15 mg once daily or placebo for 48 weeks, followed by a 112-week open-label extension in which all patients received active treatment, resulting in a total study duration of 160 weeks.
Key efficacy results
Across Study 1 and Study 2, 614 patients were randomised at 90 sites worldwide. Both trials met their co-primary endpoints at week 48, demonstrating statistically significant improvements with upadacitinib compared with placebo. In Study 1, T-VASI50 responses were achieved by 19.4% of patients receiving upadacitinib versus 5.9% with placebo, while F-VASI75 responses were observed in 25.2% and 5.9% of patients, respectively. Comparable results were reported in Study 2, with T-VASI50 responses in 21.5% of patients treated with upadacitinib compared with 5.9% with placebo, and F-VASI75 responses in 23.4% versus 6.9%, respectively.2
Secondary endpoints further supported the efficacy of upadacitinib, with higher rates of F-VASI50 at week 48 observed in both studies. Nearly half of patients in Study 1 (48.1%) and 43.4% in Study 2 achieved at least a 50% improvement in facial vitiligo with upadacitinib, compared with 12.7% and 12.9% in the corresponding placebo groups.
Safety findings
The safety profile of upadacitinib was consistent with that seen in approved indications, with no new safety signals identified. The most common treatment-emergent adverse events were upper respiratory tract infection, acne and nasopharyngitis, while serious adverse events occurred at low and comparable rates between treatment and placebo groups. No adjudicated major cardiovascular events or venous thromboembolic events were reported, and no deaths occurred in patients treated with upadacitinib.2
“Many patients experience ongoing frustration due to the unpredictability of non-segmental vitiligo spread and the lack of systemic treatment options that can stabilize disease progression and achieve skin re-pigmentation,” said Kori Wallace, M.D., Ph.D., Vice President, Global Head of Immunology Clinical Development, AbbVie. “The Viti-Up clinical studies explored these treatment gaps in vitiligo care and reinforced AbbVie’s dedication to providing the first systemic treatment for patients, aiming to evolve the vitiligo treatment landscape.“1
References
- AbbVie. AbbVie submits regulatory applications to FDA and EMA for upadacitinib (RINVOQ®) in adults and adolescents with vitiligo. Press release. AbbVie; 3 Feb 2026. Available at: https://news.abbvie.com/2026-02-03-AbbVie-Submits-Regulatory-Applications-to-FDA-and-EMA-for-Upadacitinib-RINVOQ-R-in-Adults-and-Adolescents-With-Vitiligo (accessed Feb 2026).
- AbbVie. AbbVie announces positive topline results from phase 3 pivotal studies evaluating upadacitinib (RINVOQ®) in adults and adolescents with vitiligo. Press release. AbbVie; 29 Oct 2025. Available at: https://news.abbvie.com/2025-10-29-AbbVie-Announces-Positive-Topline-Results-from-Phase-3-Pivotal-Studies-Evaluating-Upadacitinib-RINVOQ-R-in-Adults-and-Adolescents-with-Vitiligo (accessed Feb 2026).
Citation: Upadacitinib moves closer to approval for non-segmental vitiligo. TouchDERMATOLOGY. 04 Feb, 2026
Disclosure: This article was created by the touchDERMATOLOGY team utilizing AI as an editorial tool (ChatGPT (GPT-4o) [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.
More content in pigmentary disorders
Related content
What had us talking in 2025: 8 defining developments in dermatology
Upadacitinib in a phase 2 study of adults with non-segmental vitiligo
Advancing care for patient with infantile haemangiomas: Timing is key
SIGN UP to TouchDERMATOLOGY!
Join our global community today for access to thousands of peer-reviewed articles, expert insights, and learn-on-the-go education across 150+ specialties, plus concise email updates and newsletters so you never miss out.
