Peficitinib, a JAK Inhibitor, in Combination with Limited Conventional Synthetic DMARDs in the Treatment of Moderate-to-severe Rheumatoid Arthritis
Arthritis Rheumatol DOI 10.1002/art.40054. Accepted article.In this Phase 2b study in patients with moderate to severe RA, once-daily peficitinib in combination with limited csDMARDs reduced the symptoms of RA, demonstrated adose-dependent ACR20 response rate over 12 weeks, and showed acceptable tolerability. This 12-week study included patients who had an inadequate response or intolerance to csDMARDs (N=289). Patients were randomised 1:1:1:1:1 to peficitinib 25-, 50-, 100, 150 mg or matching placebo. Statistically significant differences in the ACR20 r...
Peficitinib, a JAK Inhibitor, in the Treatment of Moderate-to-severe Rheumatoid Arthritis in Methotrexate-inadequate Responders
Arthritis & Rheum 2016; ePub ahead of printThis Phase 2b study of peficitinib (ASP015K), an orally administered once-daily JAK inhibitor, plus MTX, demonstrated efficacy across multiple secondary endpoints with higher peficitinib doses. Peficitinib in combination with MTX was well tolerated with a safety profile that was consistent with previous studies.A high placebo response rate was seen in both Latin and North America, when patient data were stratified. This high placebo rate is problematic for the accurate interpretation of peficit...