Facial and total body repigmentation with upadacitinib kept rising through Week 76 in Viti-Up, with higher responses when NB-UVB was added.
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
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
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
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
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
