More than half of patients in Viti-Up-1 who stayed on upadacitinib (Rinvoq) 15 mg daily attained at least 75% facial repigmentation by the 76-week mark, up from about one-third at Week 48, in long-term phase 3 data for non-segmental vitiligo presented by AbbVie in a late-breaking oral session at the 2026 European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria.¹
The presentation also featured Week 28 results from a substudy pairing the oral Janus kinase (JAK) inhibitor with narrowband ultraviolet B (NB-UVB) phototherapy. Response rates ran higher in the combination arms than with upadacitinib alone, although the company did not report statistical comparisons.¹
How Did Repigmentation Change Between Weeks 48 and 76?
The replicate Viti-Up-1 and Viti-Up-2 trials (NCT06118411) randomized 614 patients aged 12 years and older across 90 sites in a 2:1 ratio to upadacitinib 15 mg once daily or placebo for 48 weeks. After this period, participants could move into a 112-week open-label extension on upadacitinib or, if eligible, into the phototherapy substudy.¹˒²
In Viti-Up-1, the share of patients achieving a 75% or greater improvement in the Facial Vitiligo Area Scoring Index (F-VASI 75) rose from 33.1% at Week 48 (n = 130) to 55.1% at Week 76 (n = 127). Over the same interval, a 50% or greater improvement in the Total Vitiligo Area Scoring Index (T-VASI 50) climbed from 29.2% to 42.5%.¹
Viti-Up-2 followed a parallel course, with F-VASI 75 rising from 27.6% (n = 145) to 47.4% (n = 137) and T-VASI 50 from 26.2% to 40.1%. Both analyses used observed case data.¹
Does Adding Phototherapy Improve Response to Upadacitinib?
The substudy enrolled 84 adults who had not reached T-VASI 90 by Week 48. Investigators rerandomized them to upadacitinib 15 mg daily with or without whole-body NB-UVB twice weekly for 28 weeks, analyzing outcomes with nonresponder imputation.¹
Among patients previously treated with upadacitinib, combination therapy yielded F-VASI 75 in 59.3% versus 37.0% with monotherapy, and T-VASI 50 in 63.0% versus 33.3% (n = 27 per arm). The gap was narrower for patients switched from placebo, with F-VASI 75 at 46.7% versus 40.0% and T-VASI 50 at 33.3% versus 20.0% (n = 15 per arm).¹
Julien Seneschal, MD, PhD, of the National Reference Center for Rare Skin Diseases at the University of Bordeaux, France, said the substudy offers the earliest evidence pairing NB-UVB with a JAK inhibitor holding systemic approval. In his view, the data add to what clinicians know about repigmentation over prolonged treatment and give researchers a starting point for testing combination strategies.¹
What Do the Safety Data and Regulatory Status Show?
Safety findings through Week 76 in the main trials, and through Week 28 in the substudy, aligned with the established upadacitinib profile and with results from the 48-week placebo-controlled phase. AbbVie identified no new safety concerns.¹
The European Commission approved upadacitinib in July 2026 for adults and adolescents aged 12 years and older with non-segmental vitiligo who are candidates for systemic therapy, making it the first systemic agent cleared for this indication in the European Union. The approval drew on Week 48 Viti-Up results, and a US Food and Drug Administration (FDA) review is ongoing.¹
Kori Wallace, MD, PhD, AbbVie's global head of immunology clinical development, framed the findings as support for durable, body-wide repigmentation with upadacitinib. Wallace added the phototherapy results give the company an initial basis for further work on combination use.¹
Interpretation of the substudy is limited by small arm sizes and the absence of reported significance testing.
Editor's Note: This summary has been edited for grammar and clarity using artificial intelligence tools.
References
A study to assess upadacitinib in adult and adolescent participants with non-segmental vitiligo (Viti-Up). ClinicalTrials.gov identifier: NCT06118411. Accessed October 1, 2026. https://clinicaltrials.gov/study/NCT06118411.