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Clinical Trial
. 2025 Apr;92(4):781-789.
doi: 10.1016/j.jaad.2024.11.064. Epub 2024 Dec 19.

Response to ritlecitinib with or without narrow-band ultraviolet B add-on therapy in patients with active nonsegmental vitiligo: Results from a phase 2b extension study

Yuji Yamaguchi  1 , Elena Peeva  2 , Roni Adiri  3 , Pranab Ghosh  2 , Lynne Napatalung  4 , Iltefat Hamzavi  5 , Amit G Pandya  6 , Ronald N Shore  7 , Khaled Ezzedine  8 , Emma Guttman-Yassky  9
Affiliations
Free article
Clinical Trial

Response to ritlecitinib with or without narrow-band ultraviolet B add-on therapy in patients with active nonsegmental vitiligo: Results from a phase 2b extension study

Yuji Yamaguchi et al. J Am Acad Dermatol. 2025 Apr.
Free article

Abstract

Background: Ritlecitinib demonstrated efficacy in a phase 2b trial of nonsegmental vitiligo.

Objective: To evaluate the efficacy and tolerability of ritlecitinib with add-on narrow-band ultraviolet B (nbUVB) phototherapy in patients with nonsegmental vitiligo.

Methods: Following a 24-week, placebo-controlled, dose-ranging period, patients received ritlecitinib 200 mg for 4 weeks then 50 mg for 20 weeks, with or without nbUVB phototherapy 2x/week. Missing data were handled using last observation carried forward and observed case (OC).

Results: Forty-three patients received ritlecitinib + nbUVB and 187 received ritlecitinib-monotherapy. Nine patients receiving ritlecitinib + nbUVB discontinued due to nbUVB group-specific efficacy criteria requiring >10% improvement in % change from baseline (% change from baseline) in Total-Vitiligo Area Scoring Index at week 12. At week 24, mean % change from baseline in Facial-VASI score was -57.0 vs -51.5 (last observation carried forward; P = .158) and -69.6 vs -55.1 (OC; P = .009), for ritlecitinib + nbUVB vs ritlecitinib-monotherapy, respectively. Mean % change from baseline in Total-Vitiligo Area Scoring Index at week 24 was -29.4 vs -21.2 (last observation carried forward; P = .043) and -46.8 vs -24.5 (OC; P < .001), respectively. nbUVB addition to ritlecitinib was well tolerated with no new safety signals.

Limitations: Exploratory analysis; discontinuation criterion applied only to the ritlecitinib + nbUVB group; small sample size.

Conclusion: Ritlecitinib alone and with nbUVB therapy improved facial and total body repigmentation and was well tolerated. Adding nbUVB may improve ritlecitinib efficacy.

Keywords: JAK inhibitor; TEC inhibitor; VASI; clinical trial; nonsegmental vitiligo; ritlecitinib; skin depigmentation; vitiligo.

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Conflict of interest statement

Conflicts of interest Drs Yamaguchi, Peeva, Adiri, Ghosh, and Napatalung are employees of, and may hold stock or stock options in, Pfizer Inc. Dr Hamzavi is a consultant to AbbVie, Pfizer, Incyte, UCB, Boehringer Ingelheim, Sonoma, Union Therapeutics, Novartis, Janssen, Avita, Galderma, Vimela, and Almirall; an investigator for Lenicura, Pfizer, Incyte, Avita, L’Oréal/LaRoche-Posay, ITN, and AbbVie; and a board member and past president of the Hidradenitis Suppurativa and Global Vitiligo Foundations. Dr Pandya was an investigator for Incyte; is a consultant for AbbVie, Avita Medical, Immune Tolerance Network, Incyte, Pfizer, Thalocan, Trifecta, TWi, Viela Bio, Vyne, and Villaris; and holds stock options in Tara Medical and Zerigo Health. Dr Shore has served as an investigator and consultant for Pfizer and as a consultant and advisor for 20/20 GeneSystems. Dr Ezzedine is a consultant for AbbVie, Incyte, LaRoche-Posay, Pfizer, Pierre Fabre, Sanofi, Almirall, and Merck Sharp & Dohme. Dr Guttman-Yassky is an advisory board member for Pfizer, Asana Biosciences, Celgene, Dermira, Galderma, Glenmark, MedImmune, Novartis, Regeneron, Sanofi, Stiefel/GlaxoSmithKline, and Vitae (honorarium); a consultant for Pfizer, AbbVie, Almirall, Anacor, Asana Biosciences, Celgene, Dermira, Galderma, Eli Lilly, Glenmark, Kyowa Kirin, LEO Pharma, MedImmune, Mitsubishi Tanabe, Novartis, Regeneron, Sanofi, Stiefel/GlaxoSmithKline, and Vitae (honorarium); and an investigator for Celgene, Eli Lilly, LEO Pharma, MedImmune, and Regeneron (grants to institution).

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