Back to Search
Start Over
Efficacy and safety of oral ritlecitinib for the treatment of active nonsegmental vitiligo: A randomized phase 2b clinical trial.
- Source :
- Journal of the American Academy of Dermatology; Feb2023, Vol. 88 Issue 2, p395-403, 9p
- Publication Year :
- 2023
-
Abstract
- <bold>Background: </bold>Vitiligo is a chronic autoimmune disorder characterized by depigmented patches of the skin.<bold>Objective: </bold>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).<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Limitations: </bold>Patients with stable vitiligo only were excluded.<bold>Conclusions: </bold>Oral ritlecitinib was effective and well tolerated over 48 weeks in patients with active nonsegmental vitiligo. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 01909622
- Volume :
- 88
- Issue :
- 2
- Database :
- Supplemental Index
- Journal :
- Journal of the American Academy of Dermatology
- Publication Type :
- Academic Journal
- Accession number :
- 161281822
- Full Text :
- https://doi.org/10.1016/j.jaad.2022.11.005