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.
Originalsprache | Englisch |
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Zeitschrift | Journal of the American Academy of Dermatology |
Jahrgang | 88 |
Ausgabenummer | 2 |
Seiten (von - bis) | 395-403 |
Seitenumfang | 9 |
ISSN | 0190-9622 |
DOIs | |
Publikationsstatus | Veröffentlicht - 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
- 2.22-19 Dermatologie
- 2.21-05 Immunologie