Efficacy and Safety of the Oral Janus Kinase 3/Tec Inhibitor Ritlecitinib (PF-06651600) In Adults With Active Non-segmental Vitiligo: Results From a Phase 2b, Randomized, Dose-Ranging Study With an Extension Period
B7981019 was a phase 2b study of ritlecitinib in patients with active non-segmental vitiligo. The study had a double-blind, 24-week dose-ranging period (DR) and a 24-week extension period (EXT). At Week 24, placebo-adjusted percent change from baseline (%CFB [SE]) in centrally-read Facial-Vitiligo Area Scoring Index (crF-VASI; primary endpoint) was −21 (5.8) to −23 (5.6) among the three highest-dose groups (P≤0.001 for each) and the proportion of these patients (90% CI) with ≥75% improvement in crF-VASI (key secondary endpoint) was 8 (3–16) to 12 (7–21)% (P<0.05 for each group). At Week 48, patients who were in the three highest-dose groups of DR and mapped to ritlecitinib monotherapy in EXT had %CFB (SE) in crF-VASI of −60 (11) to −66 (12), with the proportion of patients experiencing TEAEs similar across all treatment sequences. Overall, ritlecitinib monotherapy was effective and well tolerated in patients continuously treated for up to 48 weeks.
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
Khaled Ezzedine declares serving as a consultant for Incyte, La Roche Posay, Pfizer, Pierre Fabre, Sanofi, and Viela Bio.