Prof. Thierry Passeron discusses key data from the upadacitinib Viti-Up studies, the first strong Phase 3 evidence of a systemic treatment for non-segmental vitiligo
In February 2026, AbbVie announced the submission of regulatory applications to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the oral selective Janus kinase (JAK) 1 inhibitor, upadacitinib, for the treatment of adults and adolescents with non-segmental vitiligo (NSV).
The submissions were supported by results from the Phase 3 Viti-Up studies (NCT06118411), which evaluated the efficacy and safety of upadacitinib in NSV.
To gain further insight into the key findings from these studies and their implications for clinical practice, we spoke with Prof. Thierry Passeron (Nice, France), who presented the data during a late-breaking oral session at the 2026 American Academy of Dermatolgy (AAD) Annual Meeting in Denver, CO, USA.
Abstract: Passeron T. Efficacy and Safety of Upadacitinib in Adolescents and Adults for Treatment of Non-Segmental Vitiligo: Results of Two Phase 3 Studies (Viti-Up). S023 Late-Breaking Research: Session 1. AAD 2026, 27-31 March, Denver, CO, USA
TouchDERMATOLOGY coverage from AAD 2026:
What are the limitations of current treatment options for non-segmental vitiligo?
Unfortunately, there are still many unmet needs for patients living with NSV. At present, there are no approved systemic treatments, and the only approved therapy available is topical ruxolitinib cream. For patients with extensive or active vitiligo, there is clearly a need for an effective systemic treatment.
What was the rationale behind investigating upadacitnib in non-segmental vitiligo?
We know that the interferon-gamma pathway plays an important role in vitiligo, and the efficacy of ruxolitinib cream, a JAK1/JAK2 inhibitor, has also highlighted the potential of JAK inhibitors in this setting.
Ruxolitinib is effective, but mainly when vitiligo is localized, as it needs to be applied twice daily. It is also important to remember that treatment for vitiligo often needs to continue for many months, and sometimes for one, two or even three years. When the condition is localized, this approach works well. However, when patients have extensive or active lesions, a systemic treatment is needed.
Upadacitinib, an oral selective JAK1 inhibitor, is already approved for use in atopic dermatitis and alopecia areata, therefore it makes strong sense that we explore its potential in the treatment of NSV.
Could you talk us through the aims, design and eligibility criteria of the Phase 3 Viti-Up studies?
The Viti-Up studies included adults, and adolescents aged 12 years and older, with NSV. To be eligible for enrolment, patients had to have fairly extensive disease affecting both the face and the body. The minimum facial Vitiligo Area Scoring Index (F-VASI) was 0.5, and the minimum total body Vitiligo Area Scoring Index (T-VASI) was 5. Vitiligo could be either active or stable.
These were two identical, prospective, randomized, placebo-controlled Phase 3 studies conducted in parallel over 48 weeks. Patients were randomized in a 2:1 ratio to receive either upadacitinib 15 mg once daily or placebo. The co-primary endpoints, which have already been shown to be meaningful for patients, were achievement of a 50% improvement in T-VASI 50 and a 75% improvement in F-VASI 75, meaning at least 50% repigmentation of the body and at least 75% repigmentation of the face, respectively.
What is also very important is that this was a true monotherapy study. Patients were instructed to protect their skin from the sun, and no other treatments were used in combination.
How well were the primary and secondary efficacy endpoints met?
By week 48, both co-primary endpoints had been met. Approximately 20% of patients achieved T-VASI 50, compared with fewer than 6% in the placebo group, and approximately 25% achieved F-VASI 75, compared with 6–7% in the placebo group. Both results were statistically significant and, interestingly, were very similar across the two studies.
In addition, most of the secondary endpoints were also met, including F-VASI 75 at 6 months. Of particular interest, patient-reported outcomes also favored upadacitinib. In particular, Vitiligo Noticeability Scale (VNS) scores of 4 or 5, indicating that patients felt their NSV was much less noticeable or no longer noticeable, were achieved significantly more often with upadacitinib than with placebo.
What was reported in terms of safety and tolerability?
Upadacitinib showed a very good safety profile. To the best of my knowledge, this is the first study to assess a systemic JAK inhibitor against placebo over 48 weeks in NSV, and no new safety signals were identified.
The most common adverse events were those typically expected with this class of treatment, including pharyngitis, headache and acneiform folliculitis. There were no major adverse cardiovascular events, no venous thromboembolic events and no opportunistic infections, apart from herpes zoster.
Where do you see upadacitinib fitting in the evolving treatment landscape for non-segmental vitiligo?
A recent consensus status statement developed by vitiligo experts together with patient representatives clearly stated that, in NSV, systemic treatment is needed when body surface area involvement exceeds 3%, or whenever the disease is active, regardless of extent. Therefore, any new systemic treatment is welcome.
I hope that, with these efficacy and safety data, upadacitinib will be approved. We are also awaiting data this year on povorcitinib and ritlecitinib, which are being investigated in this setting, so hopefully systemic treatments will soon become available for patients with NSV who clearly need them.
Disclosures: Thierry Passeron has served on advisory boards for, and received honoraria from, Almirall, AbbVie, Amgen, Astellas, Bristol Myers Squibb, Celgene, Galderma, GlaxoSmithKline, Incyte, Janssen, LEO Pharma, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Sanofi-Genzyme, Sun Pharmaceutical Industries, UCB and VYNE Therapeutics. He is also co-founder of NIKIA Pharmaceuticals and founder of SUNLUTION.
This content has been developed independently by Touch Medical Media for touchDERMATOLOGY. It is not affiliated with the American Academy of Dermatology (AAD). Views expressed are the speaker’s own and do not necessarily reflect the views of Touch Medical Media.
Cite: Upadacitinib: Promising phase 3 repigmentation and safety results in non-segmental vitiligo. TouchDERMATOLOGY. 16 April, 2026
Editors: Gina Furnival.
