Efficacy and safety of oral ritlecitinib for the treatment of active nonsegmental vitiligo: A randomized phase 2b clinical trial
- PMID: 36370907
- DOI: 10.1016/j.jaad.2022.11.005
Efficacy and safety of oral ritlecitinib for the treatment of active nonsegmental vitiligo: A randomized phase 2b clinical trial
Erratum in
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Correction.J Am Acad Dermatol. 2023 Sep;89(3):639. doi: 10.1016/j.jaad.2023.04.001. Epub 2023 Apr 6. J Am Acad Dermatol. 2023. PMID: 37086233 No abstract available.
Abstract
Background: Vitiligo is a chronic autoimmune disorder characterized by depigmented patches of the skin.
Objective: To evaluate the efficacy and safety of ritlecitinib, an oral JAK3 (Janus kinase)/TEC (tyrosine kinase expressed in hepatocelluar carcinoma) inhibitor, in patients with active nonsegmental vitiligo in a phase 2b trial (NCT03715829).
Methods: Patients were randomized to once-daily oral ritlecitinib ± 4-week loading dose (200/50 mg, 100/50 mg, 30 mg, or 10 mg) or placebo for 24 weeks (dose-ranging period). Patients subsequently received ritlecitinib 200/50 mg daily in a 24-week extension period. The primary efficacy endpoint was percent change from baseline in Facial-Vitiligo Area Scoring Index at week 24.
Results: A total of 364 patients were treated in the dose-ranging period. Significant differences from placebo in percent change from baseline in Facial-Vitiligo Area Scoring Index were observed for the ritlecitinib 50 mg groups with (-21.2 vs 2.1; P < .001) or without (-18.5 vs 2.1; P < .001) a loading dose and ritlecitinib 30 mg group (-14.6 vs 2.1; P = .01). Accelerated improvement was observed after treatment with ritlecitinib 200/50 mg in the extension period (n = 187). No dose-dependent trends in treatment-emergent or serious adverse events were observed across the 48-week treatment.
Limitations: Patients with stable vitiligo only were excluded.
Conclusions: Oral ritlecitinib was effective and well tolerated over 48 weeks in patients with active nonsegmental vitiligo.
Keywords: JAK inhibitor; JAK/STAT signaling; TEC inhibitor; VASI; randomized clinical trial; ritlecitinib; skin depigmentation; vitiligo.
Copyright © 2022 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Conflicts of interest KE declares acting as a consultant for Incyte, La Roche Posay, Pfizer, Pierre Fabre, Sanofi, and Viela Bio. EP, YY, LAC, AB, AS, DY, and MSV are employees of Pfizer and hold stock and/or stock options with Pfizer. KG was an employee of Pfizer at the time of the study and held stock and/or stock options with Pfizer. GH declares being an investigator for Amgen, Athenex, Boehringer Ingelheim, Bond Avillion, Bristol Myers Squibb, Celgene, Eli Lilly, Novartis, Janssen, MC2, PellePharm, Pfizer, and UCB; and a consultant, advisor, or speaker for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Castle Biosciences, Dermavant, Dermtech, Eli Lilly, Janssen, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi Genzyme, SUN Pharmaceuticals, and UCB. IH declares being a consultant for Galderma Laboratories and UCB; an investigator for Arcutis, Avita, Bayer, Lenicura, L’Oréal, and Unigen; and a consultant and investigator for Incyte and Pfizer; serving on scientific advisory boards for AbbVie; and being co-chair of Global Vitiligo Foundation in a non-funded capacity. AKG declares being a consultant for AbbVie, Allergan Aesthetics, and Viela Bio. MP declares being a consultant, advisor, or speaker for Incyte, Pfizer, Pierre Fabre, and PPM. DT declares being a consultant, investigator, speaker, and participating in scientific advisory boards for AbbVie, Almirall, Amgen, Biogen Idec, BMS, Janssen-Cilag, LEO Pharma, Eli Lilly, Novartis, Pfizer, Regeneron, Samsung, Sanofi, and UCB; and research/educational grants from AbbVie, LEO Pharma, and Novartis. JEH declares acting as a consultant and investigator for Pfizer, Genzyme/Sanofi, Incyte, Rheos Medicines, Sun Pharmaceuticals, Leo Pharma, Villaris Therapeutics, Dermavant, and TeVido BioDevices; and a consultant for Temprian Therapeutics, AbbVie, Inc, Janssen, Almirall, Methuselah Health, Pandion, AnaptysBio, Avita, NIRA Biosciences, Admirx, Granular Therapeutics, Platelet BioGenesis, Inc; he has equity in TeVido Biodevices, Rheos, Villaris Therapeutics, Inc, and NIRA Biosciences; and is a founder of Villaris Therapeutics, Inc, and NIRA Biosciences. JMB declares acting as a consultant for Pfizer, AbbVie, LaserOptek, and Ilooda. KT declares being a speaker for AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi, and UCB. RS declares providing professional services to Amgen, Bayer, Boehringer Ingelheim, Celgene, Coherus Biosciences, Cutanea, Eli Lilly, GlaxoSmithKline, Janssen, LEO Pharma, MedImmune, Merck & Co, MSD, Novartis, Oncobiologics, Pfizer, Regeneron, Roche, Samson Clinical, and Sun Pharma. AGP declares acting as a consultant for AbbVie, Arcutis, Avita, Chromaderm, Immune Tolerance Network, Incyte, Pfizer, TWi, Viela Bio, and Villaris, and holds stock options with Tara Medical and Zerigo Health. BK declares receiving honoraria and/or consultation fees from Aclaris Therapeutics, Arena Therapeutics, Bristol-Myers Squibb, Concert Pharmaceuticals, Dermavant Sciences, Eli Lilly, Pfizer, Regeneron, and Viela Bio, and serving on a speakers bureau for Pfizer. The other authors have no conflicts of interest to declare.
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