The Overview
AbbVie announced late-breaking results from the ongoing Phase 3 Viti-Up-1 and Viti-Up-2 studies of RINVOQ (upadacitinib; 15 mg once daily) in non-segmental vitiligo (NSV). The data, presented at the 2026 European Academy of Dermatology and Venereology (EADV) Congress, showed continued facial (F-VASI 75) and total body (T-VASI 50) repigmentation through week 76 in patients continuing RINVOQ. Additionally, a phototherapy substudy at week 28 indicated numerically higher repigmentation responses when RINVOQ was combined with narrowband ultraviolet B (NB-UVB) phototherapy compared to RINVOQ alone. These findings support RINVOQ's long-term efficacy and suggest potential benefits of combination therapy for NSV patients.
Knolens Analysis
At a Glance
| Indication | Non-segmental vitiligo |
| Drug | Upadacitinib |
| Mechanism of Action | Selective and reversible JAK inhibitor |
| Company | AbbVie |
| Trial Phase | Phase 3 |
| Trial Acronym | Viti-Up-1, Viti-Up-2 |
| NCT ID | NCT06118411 |
| Category | Clinical Trial Event |
| Sub Category | Topline Results Positive |
| Therapeutic Area | Immunology |
| Conference Name | 2026 European Academy of Dermatology and Venereology (EADV) Congress |
| Location | Vienna, Austria |
| Dosage | 15 mg once daily |
| Follow-up Duration | 76 weeks, 28 weeks |
| Endpoints Measured | F-VASI 75, T-VASI 50 |
| Combination Partner | Narrowband ultraviolet B (NB-UVB) phototherapy |
| Patient Population Size | 614 (Viti-Up studies), 84 (phototherapy substudy) |
| Approved Region | European Union |
| Regulatory Review Status | Under review by U.S. FDA |
AbbVie's RINVOQ Shows Continued Repigmentation in Vitiligo Through 76 Weeks
AbbVie announced late-breaking results from the ongoing Phase 3 Viti-Up-1 and Viti-Up-2 studies of RINVOQ (upadacitinib; 15 mg once daily) in non-segmental vitiligo (NSV). The data, presented at the 2026 European Academy of Dermatology and Venereology (EADV) Congress, showed continued facial (F-VASI 75) and total body (T-VASI 50) repigmentation through week 76 in patients continuing RINVOQ. Additionally, a phototherapy substudy at week 28 indicated numerically higher repigmentation responses when RINVOQ was combined with narrowband ultraviolet B (NB-UVB) phototherapy compared to RINVOQ alone. These findings support RINVOQ's long-term efficacy and suggest potential benefits of combination therapy for NSV patients.
- Long-Term Efficacy of RINVOQ Monotherapy: In the open-label extension of the Viti-Up-1 and Viti-Up-2 studies, patients continuing on RINVOQ 15 mg once daily demonstrated sustained and increasing repigmentation. For Viti-Up-1, F-VASI 75 improved from 33.1% at Week 48 to 55.1% at Week 76, and T-VASI 50 increased from 29.2% to 42.5%. Similarly, for Viti-Up-2, F-VASI 75 rose from 27.6% to 47.4%, and T-VASI 50 from 26.2% to 40.1%, highlighting the drug's continued benefit over an extended period.
- Benefits of Combination Therapy with NB-UVB: A 28-week phototherapy substudy explored RINVOQ 15 mg once daily in combination with whole-body NB-UVB phototherapy twice weekly. Results showed numerically higher repigmentation responses in combination groups compared to RINVOQ monotherapy. For instance, in patients who previously received RINVOQ in Period A, F-VASI 75 reached 59.3% with combination therapy versus 37.0% with monotherapy, and T-VASI 50 was 63.0% versus 33.3%, suggesting an enhanced effect.
- Safety Profile Consistency and Regulatory Status: The safety results through week 76 for the main studies and week 28 for the phototherapy substudy were consistent with the known safety profile of upadacitinib, with no new safety signals reported. RINVOQ is already approved in the European Union for non-segmental vitiligo in adults and adolescents 12 years and older, based on 48-week Phase 3 data, and is currently under regulatory review by the U.S. FDA for the same indication.
Frequently Asked Questions
What are the treatment options for non-segmental vitiligo?
Treatment options for non-segmental vitiligo primarily include topical corticosteroids or calcineurin inhibitors for localized disease, and narrowband ultraviolet B (NB-UVB) phototherapy for more widespread involvement. Systemic corticosteroids may be used for rapidly progressing cases. Newer targeted therapies, such as topical and systemic Janus kinase (JAK) inhibitors, are also available or in development, with ruxolitinib cream being an approved option. Surgical interventions like melanocyte transplantation may be considered for stable, refractory lesions.
Can you use Rinvoq for vitiligo?
Rinvoq (upadacitinib) is not currently approved by regulatory bodies such as the FDA or EMA for the treatment of vitiligo. Its approved indications include various inflammatory conditions like rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, and inflammatory bowel diseases. While other JAK inhibitors are approved for vitiligo, upadacitinib lacks an official indication for this condition.
Does non-segmental vitiligo ever stop spreading?
Non-segmental vitiligo is a chronic, progressive autoimmune disease characterized by unpredictable periods of depigmentation. While its course can involve periods of stability or even spontaneous, partial repigmentation, the disease typically continues to spread over time. Complete and permanent cessation of spreading without therapeutic intervention is uncommon, as the underlying autoimmune process persists.
What are the newest treatment options for vitiligo in 2026?
By 2026, new treatment options for vitiligo are anticipated to primarily include additional oral Janus kinase (JAK) inhibitors. Following the approval of topical ruxolitinib, systemic JAK inhibitors like baricitinib, currently in late-stage development, are expected to gain regulatory approval, offering broader therapeutic options for patients with extensive disease. Further advancements may involve other targeted small molecules or biologics progressing through clinical trials.
Can non-segmental vitiligo be cured?
Non-segmental vitiligo is a chronic autoimmune condition for which there is currently no definitive cure. While various treatments can induce significant repigmentation and achieve long-term disease control, they do not eliminate the underlying autoimmune process or guarantee permanent prevention of recurrence. Management focuses on halting disease progression and restoring pigmentation.
What is the newest treatment for vitiligo?
Ruxolitinib cream (Opzelura) is the newest FDA-approved treatment for vitiligo, specifically for nonsegmental vitiligo in adults and pediatric patients 12 years and older. Approved in July 2022, it is the first and only topical Janus kinase (JAK) inhibitor indicated for repigmentation in vitiligo. This targeted therapy works by inhibiting JAK pathways implicated in the pathogenesis of vitiligo, offering a novel mechanism for restoring melanocyte function.
What is the newest breakthrough in vitiligo treatment?
The newest breakthrough in vitiligo treatment is the FDA approval of ruxolitinib cream (Opzelura) in July 2022. This topical Janus kinase (JAK) inhibitor is the first and only FDA-approved treatment for repigmentation in nonsegmental vitiligo for patients 12 years and older. Its approval represents a significant advancement, offering a targeted therapeutic option to restore melanocyte function.
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