Peficitinib, a JAK Inhibitor, in the Treatment of Moderate‐to‐Severe Rheumatoid Arthritis in Patients With an Inadequate Response to Methotrexate

Abstract

Objective. To evaluate efficacy and safety of orally administered once-daily peficitinib in combination with methotrexate (MTX) in patients with moderate-to-severe rheumatoid arthritis (RA) who had an inadequate response to MTX. Methods. In this multinational, phase IIb, randomized, double-blind, placebo-controlled, dose-ranging trial, patients with RA (N=378) were treated with peficitinib 25 mg, 50 mg, 100 mg, 150 mg + MTX, or matching placebo + MTX once daily for 12 weeks (NCT01554696). Primary endpoint was the percentage of patients achieving an American College of Rheumatology (ACR) 20% response at Week 12. Results. ACR20 response rates at Week 12 were 43.9%, 61.5% (PPPConclusion. ACR20 response with peficitinib 50 mg + MTX was significantly different compared with placebo, but there were no apparent dose-dependent responses and the placebo response rate was high. Peficitinib + MTX in patients with moderate-to-severe RA was well tolerated with limited safety signals emerging.