Key takeaways:
- Upadacitinib met co-primary endpoints in both Phase 3 trials for NSV at week 48.
- Up to 25% of patients achieved ≥75% facial re-pigmentation (F-VASI 75).
- Safety remained consistent with prior indications, with no new concerns.
Upadacitinib achieves 50% reduction in Total Vitiligo Area Scoring Index at 48 weeks
A pair of phase 3 trials showed that AbbVie's daily upadacitinib 15 mg led to a 50% reduction in T-VASI 50 and a 75% reduction in F-VASI 75 at 48 weeks among adolescents 12 years and older.
Upadacitinib achieves 50% reduction in Total Vitiligo Area Scoring Index at 48 weeks | Image Credit: © Liga Cerina - © Liga Cerina - stock.adobe.com.
Upadacitinib (Rinvoq; AbbVie) met co-primary efficacy endpoints from a pair of phase 3 clinical trials among adolescents aged 12 years and older and adults living with non-segmental vitiligo (NSV) who were eligible for systemic therapy, according to a data announcement from AbbVie on October 29, 2025.1
According to results from the replica phase 3 studies (Study 1 and Study 2; NCT06118411), upadacitinib achieved statistically significant improvements versus placebo in both total body and facial re-pigmentation measures. The co-primary endpoints were the proportion of patients achieving at least a 50% reduction in the Total Vitiligo Area Scoring Index (T-VASI 50) and at least a 75% reduction in the Facial Vitiligo Area Scoring Index (F-VASI 75) from baseline at week 48.
Phase 3 data of upadacitinib for v
In Study 1 (n = 206):
- 19.4% of patients achieved T-VASI 50 at week 48 vs 5.9% placebo
- 25.2% of patients achieved F-VASI 75 at week 48 vs 5.9% placebo
- 48.1% of patients achieved F-VASI 50 at week 48 vs 12.7% placebo
In Study 2 (n = 205):
- 21.5% of patients achieved T-VASI 50 at week 48 vs 5.9% of placebo
- 23.4% of patients achieved F-VASI 75 at week 48 vs 6.9% placebo
- 43.4% of patients achieved F-VASI 50 at week 48 vs 12.9% placebo
"For many people living with vitiligo, the journey is marked by uncertainty, frustration and a lack of medicines that can treat the disease systemically," said Thierry Passeron, MD, PhD, professor and chair, Department of Dermatology, Université Côte d'Azur, in a statement. "These positive results indicate that targeting the underlying inflammation may offer a systemic treatment option which could help patients achieve visible results."
Safety of upadacitinib in adolescents and adults with vitiligo
The safety of upadacitinib was consistent with its known profile in other approved indications, with no new safety signals reported. The most common treatment-emergent adverse events included upper respiratory tract infection, acne, and nasopharyngitis. No major cardiovascular events or venous thromboembolism were observed.
“There are no approved systemic medical therapies for achieving re-pigmentation in vitiligo. These results represent a significant step forward in addressing an important unmet need for patients with vitiligo,” said Kori Wallace, MD, PhD, vice president and global head of immunology clinical development at AbbVie.
Upadacitinib phase 3 Up-AA data for alopecia in adolescents
Upadacitinib is also being studied for alopecia areata in patients aged 12 to 64 years. According to phase 3 data published in July 2025, upadacitinib 15 mg and 30 mg demonstrated that 44.6% and 54.3% of patients with severe alopecia areata, respectively, and reached 80% or more scalp hair coverage at week 24.2
Hair coverage was defined by a Severity of Alopecia Tool (SALT) score of 20 or less. At baseline, patients with AA had a mean SALT score of 83.8, which correlated to approximately 16% of scalp hair coverage. The primary endpoint data listed above were compared with 3.4% of placebo-receiving patients who achieved 80% or more scalp hair coverage.
Click here for more on upadacitinib for alopecia areata.
Approved pediatric indications for upadacitinib
- Adults and children 12 years of age and older with moderate to severe atopic dermatitis1
- Children 2 years of age and older with active polyarticular juvenile idiopathic arthritis
- Children 2 to less than 18 years of age with active psoriatic arthritis
References:
- AbbVie Announces Positive Topline Results from Phase 3 Pivotal Studies Evaluating Upadacitinib (RINVOQ) in Adults and Adolescents with Vitiligo. AbbVie. Press release. October 29, 2025. Accessed October 29, 2025. https://news.abbvie.com/2025-10-29-AbbVie-Announces-Positive-Topline-Results-from-Phase-3-Pivotal-Studies-Evaluating-Upadacitinib-RINVOQ-R-in-Adults-and-Adolescents-with-Vitiligo
- Fitch J. Alopecia areata data: Upadacitinib demonstrates improvements in scalp hair coverage. Contemporary Pediatrics. Published July 30, 2025. Accessed October 29, 2025. https://www.contemporarypediatrics.com/view/alopecia-areata-data-upadacitinib-demonstrates-improvements-in-scalp-hair-coverage
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