Abstract

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.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.ACR20 response rates at Week 12 were 43.9%, 61.5% (P<0.05), 46.4%, 57.7%, and 44.4% in the peficitinib 25 mg, 50 mg, 100 mg, 150 mg, and placebo groups, respectively. Significant decreases in DAS28-CRP levels were seen in peficitinib 50 mg (P<0.05) and 150 mg (P<0.01) groups compared with placebo. Overall, the incidence of adverse events (AEs) were similar between peficitinib and placebo. The most common AEs were urinary tract infection (22 [6%]), upper respiratory tract infection (16 [4%]), and diarrhea (16 [4%]). There were three cases of herpes zoster (peficitinib 100 mg [n=2] and 150 mg [n=1]) and two cases of serious infection (peficitinib 100 mg [viral infection] and 150 mg [erysipelas]).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. This article is protected by copyright. All rights reserved.

View details for DOI 10.1002/art.39955

View details for PubMedID 27748083