AbbVie Achieves 76-Week Repigmentation Data for Upadacitinib in Non-Segmental Vitiligo

With RINVOQ (upadacitinib) already holding the first-and-only EU systemic approval for non-segmental vitiligo, AbbVie's 76-week Phase 3 dataset presented at EADV 2026 extends the clinical dossier that manufacturing and regulatory teams will need to support as the commercial programme matures.

The ongoing Viti-Up-1 and Viti-Up-2 studies enrolled patients through a 48-week placebo-controlled period, after which continuing participants entered an open-label extension on upadacitinib 15 mg once daily. In Viti-Up-1, the proportion achieving F-VASI 75 (≥75% reduction in Facial Vitiligo Area Scoring Index) rose from 33.1% at week 48 to 55.1% at week 76; T-VASI 50 moved from 29.2% to 42.5%. Viti-Up-2 showed a comparable trajectory: F-VASI 75 from 27.6% to 47.4%, T-VASI 50 from 26.2% to 40.1%. The consistent directional improvement across both studies strengthens the long-term benefit-risk profile regulators will scrutinise in any label variation submissions.

A phototherapy substudy enrolled 84 adults who had not achieved T-VASI 90 at week 48 and re-randomised them to upadacitinib monotherapy or upadacitinib plus whole-body narrowband ultraviolet B (NB-UVB) phototherapy twice weekly. At week 28, the combination arm in patients previously on RINVOQ reached F-VASI 75 in 59.3% and T-VASI 50 in 63.0%, against 37.0% and 33.3% respectively for monotherapy. The substudy is exploratory and numerically driven; it does not yet constitute a registrational package for a combination regimen, but it does signal a potential line extension that would carry its own CMC and process validation considerations if a fixed or co-administered protocol advances.

For QA and regulatory leads tracking the JAK inhibitor portfolio, the 76-week data arrive as upadacitinib production lines already support approved indications across rheumatoid arthritis, atopic dermatitis, and Crohn's disease. Each new indication approval under 21 CFR Part 211 and the EU GMP framework requires a documented assessment of whether existing validated processes and annual product review cycles adequately cover the incremental demand and any formulation or packaging changes tied to the new patient population.

The data were presented as a late-breaking oral at the 2026 European Academy of Dermatology and Venereology Congress in Vienna; the phototherapy substudy findings represent week-28 interim results from a programme that continues to enrol.

Source: AbbVie News Center via PR Newswire, 1 October 2026.