Associations Between Clinical Response and Patient-Reported Outcomes in Patients with Nonsegmental Vitiligo Treated with Upadacitinib: Results from Phase 3 Trials

Presenter: Seemal R Desai

Nonsegmental vitiligo (NSV) is an autoimmune condition characterized by progressive skin depigmentation. The condition can significantly impact quality of life (QoL), making patient-reported outcomes (PROs) an important measure of treatment benefit alongside repigmentation. This post hoc analysis of Phase 3 Viti-Up trials assessed associations between clinical response and PROs at Week 48 in 614 patients aged ≥12 years randomised to upadacitinib (UPA) or placebo (PBO). Clinical responders achieving Total Vitiligo Area Scoring Index (T-VASI) 50 or Facial VASI (F-VASI) 75 had greater Vitiligo-Specific Quality of Life Instrument (VitiQoL) improvement than nonresponders (mean differences: 6.75 and 7.01, respectively). Patient Global Impression of Change in Vitiligo (PaGIC-V) responses were also more frequent among responders, with risk differences of 31.58 for T-VASI 50 and 32.39 for F-VASI 75 (both p<0.001). VitiQoL improvement increased with greater repigmentation, while PaGIC-V response rates rose from 35.8% in patients with T-VASI improvement ≤10% to 83.3% in those with improvement >75% (p<0.0001). Compared with PBO, UPA was associated with higher rates of VitiQoL response (adjusted hazard ratio [aHR] 1.44, 95% confidence interval [CI] 1.22–1.69) and PaGIC-V response (aHR 3.28, 95% CI 2.81–3.82; both p<0.001). These findings indicate that incremental repigmentation in NSV is associated with meaningful improvements in patient-reported outcomes and quality of life, highlighting the clinical value of achieving even partial repigmentation.

Efficacy of Upadacitinib in Adults and Adolescents for Treatment of Nonsegmental Vitiligo in Six Body Regions Across 48 Weeks of Treatment from Two Phase 3 Studies (Viti-Up)

Presenter: Vimal H. Prajapati

Nonsegmental vitiligo (NSV) is an autoimmune inflammatory condition characterised by skin depigmentation resulting from melanocyte loss. It can affect multiple body regions, including the face, hands, and feet, which may be particularly challenging to treat. A post hoc analysis of two Phase 3 Viti-Up studies assessed regional repigmentation with upadacitinib 15 mg (UPA15) versus placebo over 48 weeks in adults and adolescents with NSV. Analyses evaluated six anatomical regions and included only patients with non-zero baseline regional Vitiligo Area Scoring Index (VASI) scores, using non-responder imputation. At Week 48, higher proportion of patients receiving UPA15 achieved VASI 50 across all body regions compared with placebo (nominal p≤0.001): head/neck (43.3% vs 13.9%), upper extremities (27.6% vs 7.5%), hands (24.6% vs 7.3%), trunk/genitalia (23.5% vs 8.6%), lower extremities (22.4% vs 9.1%), and feet (12.7% vs 3.9%). ; all nominal p-values were ≤0.001. The greatest response occurred in the head/neck region. This post-hoc analysis demonstrated that upadacitinib was associated with substantial repigmentation across all body regions in adults and adolescents with NSV, including frequently affected, socially sensitive, and treatment-resistant areas such as the face, hands, and feet.

Efficacy of Upadacitinib in Adults with Extensive Non-Segmental Vitiligo: Analysis of Stabilization Endpoints Through 48 Weeks in Viti-Up

Presenter: Nanja van Geel

Nonsegmental vitiligo (NSV) is an autoimmune skin disorder characterised by melanocyte loss and subsequent depigmentation. A key treatment goal is to stabilise the disease and prevent further spread of depigmented lesions. A post hoc analysis of Study 2 of the Phase 3 Viti-Up programme examined changes in disease activity and improvement with upadacitinib 15 mg once daily (UPA15) versus placebo (PBO) at Weeks 12, 24, and 48. The Vitiligo Disease Activity Score (VDAS) and Vitiligo Disease Improvement Score (VDIS) assess disease progression and improvement, respectively, capturing changes in vitiligo activity and repigmentation over time. Among patients with active disease progression at Week 12 (VDAS >0), a greater proportion receiving UPA15 achieved reduced disease activity at Weeks 24 and 48 compared with PBO [50% (3/6) vs 0%], respectively. Stabilisation of vitiligo (VDAS = 0) was achieved by more patients receiving UPA15 than PBO at Week 12 (20% vs 10%) and Week 24 (25% vs 0%). At Week 48, stabilisation was observed in 23.5% (4/17) of UPA15-treated patients and 33.3% (1/3) receiving PBO. Achievement of both repigmentation (VDIS >0) and disease stabilisation (VDAS = 0) was higher with UPA15 than PBO at Week 12 (15% vs 10%), Week 24 (25% vs 0%), and Week 48 (23.5% vs 0%). UPA15 was associated with greater stabilisation of NSV disease activity over time compared with placebo. A higher proportion of patients receiving UPA15 achieved both disease inactivity and clinical improvement, observed through Week 48.

EADV Congress 2026, 30 SEP - 03 OCT 26, Vienna