|The following article is part of conference coverage from the 2018 American College of Rheumatology and Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in Chicago, Illinois. Rheumatology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in rheumatology. Check back for the latest news from ACR/ARHP 2018 .|
CHICAGO — Peficitinib significantly reduced symptoms in patients with rheumatoid arthritis (RA) and demonstrated tolerability and safety. This research was recently presented at the 2018 ACR/ARHP Annual Meeting, held October 19-24 in Chicago, Illinois.
This double-blind, parallel-group, placebo-controlled study included 507 patients, 104 of whom were randomly assigned to peficitinib 100 mg/d, 102 of whom were assigned to peficitinib 150 mg/d, 200 of whom were assigned to etanercept, and 101 of whom were assigned to placebo. A 20% response to ACR criteria (ACR20) at 12 weeks was defined as the primary variable. Both doses of peficitinib were associated with achieving ACR20, ACR50, and 28-joint Disease Activity Score based on C-reactive protein (DAS28-CRP) less than 2.6, and 150 mg/d was associated with achieving ACR70. Differences were also observed in the change in DAS28-CRP from baseline to 12 weeks. The treatment groups all showed similar safety profiles up to 12 weeks, with serious adverse events more common among the placebo group and no deaths occurring among any groups. Serious infections occurred at a higher rate with peficitinib than placebo.
Participants were studied at multiple centers in Japan, Taiwan, and Korea. RA was diagnosed in accordance with criteria set forth by the 1987 ACR or the 2010 ACR/European League Against Rheumatism. Active RA was defined as at least 6 tender joints, at least 6 swollen joints, and CRP greater than 0.50 mg/dL. Those with active RA and poor disease-modifying antirheumatic drug (DMARD) response were randomly assigned to the study groups for 1 year of treatment. At the 12-week mark, those given placebo were blindly switched to one of the peficitinib treatment groups. DMARDs were permitted in accompanying doses.
The study researchers conclude that “in patients with RA who had an inadequate response to DMARDs, 100 mg/day and 150 mg/day peficitinib doses significantly reduced RA symptoms according to clinical and patient assessment scores.”
All authors disclose a relationship with Astellas Pharma, Inc.
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Tanaka Y, Takeuchi T, Tanaka S, et al. Efficacy and safety of the novel oral Janus kinase (JAK) inhibitor, peficitinib (ASP015K), in a phase 3, double-blind, placebo-controlled, randomized study of patients with RA who had an inadequate response to Dmards. Presented at: 2018 ACR/ARHP Annual Meeting; October 19-24, 2018; Chicago, IL. Abstract 887.
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