Ritlecitinib in Nonsegmental Vitiligo: A Systematic Review and Comprehensive Program Synthesis of Clinical Efficacy, Safety, and Biomarker Outcomes.

Authors

Aya Mamdouh Fayoud, Eslam Abady, Khloud Shendy, Hanin Abdelhamied Rabea, Alaa A Al-Laithy, Marim A Alnahas, Reem Romaih, Ahmed A Algamal, Asmaa Ahmed Elrashedy, Fawzy Elbarbry

Published in

The Annals of pharmacotherapy. Pages 10600280261493131. Oct 13, 2026. Epub Oct 13, 2026.

Abstract

To evaluate the clinical efficacy and safety of oral ritlecitinib, a selective Janus kinase 3 (JAK3) and tyrosine kinase expressed in hepatocellular carcinoma (TEC) family kinase inhibitor, for the treatment of nonsegmental vitiligo (NSV).
A systematic literature search was conducted across PubMed, Web of Science, Scopus, ClinicalTrials.gov, and the Cochrane Library from inception through August 31, 2026. Search terms included combinations of "ritlecitinib," "JAK inhibitor," and "vitiligo.."
Included studies were clinical trials evaluating ritlecitinib, monotherapy, or with narrowband ultraviolet B (nbUVB), in adults with NSV. Five interrelated studies from the ritlecitinib phase 2b program involving 364 participants were identified for qualitative synthesis. Data extraction included study design, participant demographics, efficacy indices (F-VASI[Facial Vitiligo Area Scoring Index], T-VASI [Total Vitiligo Area Scoring Index], and PGIC-V [Patient Global Impression of Change-Vitiligo]), biomarker changes, and safety outcomes. Quality was assessed using the Cochrane Risk-of-Bias 2 tool.
Ritlecitinib 50 mg daily demonstrated significant facial repigmentation at week 24, achieving a percent change from baseline (%CFB) in F-VASI of -18.5% to -21.2% compared with +2.1% for placebo. Adding nbUVB significantly enhanced efficacy (F-VASI %CFB: -69.6% vs -55.1%; P = .009) and total-body repigmentation. Darker skin phototypes (FST IV-VI) showed earlier and more robust responses (-37.4%) than lighter skin types (FST I-III; -15.2%). Safety outcomes were comparable with placebo, with overall adverse event rates between 60.0% and 86.2% and rare serious adverse events (≤2%). Biomarker analysis confirmed the downregulation of Th1-associated markers (CXCL9 and IFNG) and restoration of melanocyte markers like tyrosinase and Melan-A.Relevance to Patient Care and Clinical Practice in Comparison With Existing Drugs:Ritlecitinib 50 mg daily provides a well-tolerated oral systemic option for active NSV. Efficacy is optimized when combined with nbUVB, and baseline skin phototype is a key predictor of the speed and extent of repigmentation.
Oral ritlecitinib 50 mg daily is an effective systemic treatment for active NSV, demonstrating continuous repigmentation through 48 weeks with a favorable safety profile.

PMID:
42870452
Bibliographic data and abstract were imported from PubMed on 14 Oct 2026.

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