Repigmentation With Upadacitinib Continues Through Week 76 in Non-Segmental Vitiligo

AbbVie recently announced late-breaking phase 3 data showing continued facial and total body repigmentation through week 76 with upadacitinib 15 mg once daily (Rinvoq; AbbVie) in patients with non-segmental vitiligo (NSV). Results from the Viti-Up-1 and Viti-Up-2 studies were presented in a late-breaking oral session at the 2026 European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria. The data also include week-28 findings from a phototherapy substudy.¹

Upadacitinib, a Janus kinase (JAK) inhibitor, is the first and only systemic medication approved in the European Union for adults and adolescents 12 years and older with NSV who are candidates for systemic therapy, according to AbbVie. The approval was based on week-48 placebo-controlled results from the Viti-Up program. Use of upadacitinib in NSV remains under review by the US FDA.¹

Viti-Up consists of 2 replicate phase 3 studies conducted under a single protocol, with independent randomization, sites, data collection, and analysis for each. The studies randomized 614 participants with NSV across 90 sites worldwide in a 2:1 ratio to upadacitinib 15 mg once daily or placebo for 48 weeks (Period A).¹

After Period A, patients entered either a 112-week open-label extension (OLE), in which all patients received upadacitinib 15 mg once daily, or a phototherapy substudy. Together, Periods A and B span 160 weeks.¹

In patients continuing upadacitinib in the OLE, response rates continued to rise from week 48 through week 76 on both measures. F-VASI 75 denotes a 75% or greater reduction from baseline in the Facial Vitiligo Area Scoring Index, and T-VASI 50 denotes a 50% or greater reduction in the Total Vitiligo Area Scoring Index.¹

In Viti-Up-1, F-VASI 75 rose from 33.1% (N=130) at week 48 to 55.1% (N=127) at week 76, and T-VASI 50 rose from 29.2% to 42.5%.¹

In Viti-Up-2, F-VASI 75 rose from 27.6% (N=145) to 47.4% (N=137), and T-VASI 50 rose from 26.2% to 40.1%. These were observed-case analyses, and the release did not report P values.¹

Upadacitinib Plus NB-UVB Phototherapy Substudy Results and Safety Profile

Following Period A, 84 adults who did not achieve T-VASI 90 at week 48 and met additional eligibility criteria were re-randomized. They received upadacitinib 15 mg once daily alone or in combination with whole-body narrowband ultraviolet B (NB-UVB) phototherapy twice weekly for 28 weeks. All groups improved from baseline, with numerically higher response rates in the combination groups.¹

Among patients who received placebo in Period A, week-28 F-VASI 75 was 46.7% (N=15) with upadacitinib plus NB-UVB vs 40.0% (N=15) with upadacitinib alone.¹

T-VASI 50 in this group was 33.3% vs 20.0%. Among patients who received upadacitinib in Period A, F-VASI 75 was 59.3% (N=27) with the combination vs 37.0% (N=27) with upadacitinib alone, and T-VASI 50 was 63.0% vs 33.3%.¹

Responses were analyzed with non-responder imputation, and each substudy arm enrolled 15 to 27 patients. No statistical comparisons between arms were reported in the release.¹

According to AbbVie, safety results through week 76 in Viti-Up-1 and Viti-Up-2 and through week 28 in the phototherapy substudy were consistent with the known safety profile of upadacitinib and with Period A. No new safety signals were reported. The release did not detail specific adverse events or discontinuation rates.¹

Julien Seneschal, MD, PhD, professor of dermatology at the National Reference Center for Rare Skin Diseases, University of Bordeaux, France, said, "These findings are important for physicians treating people with vitiligo because they extend our understanding of repigmentation with continued RINVOQ treatment and provide the first data on combining NB-UVB with an approved systemic JAK inhibitor. This research opens an important path for further investigation into how combination approaches could evolve to support patient care in non-segmental vitiligo."¹

Upadacitinib is a selective and reversible JAK inhibitor, preferentially inhibiting signaling by JAK1 or JAK1/3 in human cellular assays, according to AbbVie. Viti-Up remains ongoing and is registered on ClinicalTrials.gov under NCT06118411.²

References

1. AbbVie presents long-term RINVOQ (upadacitinib) data showing continued repigmentation in non-segmental vitiligo. News release. AbbVie. October 1, 2026. Accessed October 1, 2026. https://news.abbvie.com/2026-10-01-AbbVie-Presents-Long-Term-RINVOQ-R-upadacitinib-Data-Showing-Continued-Repigmentation-in-Non-Segmental-Vitiligo
2. A study to assess adverse events and effectiveness of upadacitinib oral tablets in adult and adolescent participants with vitiligo (Viti-Up). ClinicalTrials.gov identifier: NCT06118411. Accessed October 1, 2026. https://clinicaltrials.gov/study/NCT06118411?term=NCT06118411&viewType=Card&rank=1