Efficacy and safety of tregalizumab in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase IIb, randomised, placebo-controlled trial

Ronald F van Vollenhoven, Edward Clark Keystone, Vibeke Strand, Cesar Pacheco-Tena, Jiří Vencovský, Frank Behrens, Arthur Racewicz, Daniela Zipp, Faiza Rharbaoui, Ralf Wolter, Luise Knierim, Rainer Schmeidl (+4 others)
2018 Annals of the Rheumatic Diseases  
Objectives To investigate the efficacy and safety of peficitinib, an oral Janus kinase inhibitor, in patients with rheumatoid arthritis (Ra). Methods in this double-blind phase iii study, patients with Ra and an inadequate response to prior diseasemodifying anti-rheumatic drugs (DMaRDs) were randomised to peficitinib 100 mg once daily, peficitinib 150 mg once daily, placebo or open-label etanercept for 52 weeks' treatment; placebo-treated patients were switched at week 12 to peficitinib 100 or
more » ... peficitinib 100 or 150 mg once daily. The primary endpoint was american College of Rheumatology (aCR)20 response at week 12/ early termination (eT). secondary endpoints (assessed throughout) included aCR20, aCR50 and aCR70 response, changes from baseline in disease activity scores (Das)28 and aCR core parameters, adverse events (aes) and changes in clinical or laboratory measurements. Results in total, 507 patients received treatment. aCR20 response rates at week 12/eT were significantly higher in the peficitinib 100 mg (57.7%) and 150 mg (74.5%) groups versus placebo (30.7%) (p<0.001). aCR50/70 response rates were also higher for both peficitinib doses versus placebo. improvements in aCR response were maintained until week 52. Changes from baseline in Das28-C-reactive protein/ erythrocyte sedimentation rate and the aCR core set were significantly greater for both peficitinib doses versus placebo at week 12/eT (p<0.001). ae incidence was similar across treatment arms. incidence of serious infection and herpes zoster-related disease was higher with peficitinib versus placebo, but with no clear dosedependent increase. Conclusions in patients with Ra and inadequate response to DMaRDs, peficitinib 100 mg once daily or 150 mg once daily was efficacious in reducing Ra symptoms and was well tolerated compared with placebo. ResulTs Patient demographics, baseline characteristics and treatment compliance Of 724 patients screened, 509 were randomised: 102, 104, 102 and 201 to the placebo, peficitinib 100 mg, peficitinib 150 mg and etanercept groups, respectively. Of the randomised patients, on March 18, 2020 by guest. Protected by copyright.
doi:10.1136/annrheumdis-2017-212478 pmid:29343509 fatcat:kptl2lb6hbhcpapc72tyigdeky