Efficacy and safety of oral ritlecitinib for the treatment of active nonsegmental vitiligo: A randomized phase 2b clinical trial

Khaled Ezzedine*, Elena Peeva, Yuji Yamaguchi, Lori Ann Cox, Anindita Banerjee, George Han, Iltefat Hamzavi, Anand K. Ganesan, Mauro Picardo, Diamant Thaçi, John E. Harris, Jung Min Bae, Katsuhiko Tsukamoto, Rodney Sinclair, Amit G. Pandya, Abigail Sloan, Dahong Yu, Kavita Gandhi, Michael S. Vincent, Brett King

*Korrespondierende/r Autor/-in für diese Arbeit
19 Zitate (Scopus)

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.

OriginalspracheEnglisch
ZeitschriftJournal of the American Academy of Dermatology
Jahrgang88
Ausgabenummer2
Seiten (von - bis)395-403
Seitenumfang9
ISSN0190-9622
DOIs
PublikationsstatusVeröffentlicht - 02.2023

Strategische Forschungsbereiche und Zentren

  • Forschungsschwerpunkt: Infektion und Entzündung - Zentrum für Infektions- und Entzündungsforschung Lübeck (ZIEL)
  • Zentren: Center for Research on Inflammation of the Skin (CRIS)

DFG-Fachsystematik

  • 205-19 Dermatologie
  • 204-05 Immunologie

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