Safety and effectiveness of peficitinib (ASP015K) in patients with rheumatoid arthritis: interim data (22.7 months mean peficitinib treatment) from a long-term, open-label extension study in Japan, Korea, and Taiwan

Abstract

Background: Peficitinib (ASP015K), a novel oral Janus kinase inhibitor, has demonstrated efficacy and safety for the treatment of rheumatoid arthritis (RA) in randomized, controlled trials of up to 52 weeks' duration. However, safety and effectiveness after long-term treatment have not been assessed. Methods: This was an interim analysis of an ongoing open-label, multicenter extension study in RA patients who completed phase 2b (RAJ1; 12 weeks) and phase 3 (RAJ3 and RAJ4; 52 weeks) peficitinib studies in Asia (mainly Japan). Eligible patients (n = 843) received oral peficitinib once daily (100 mg, or 50 mg for patients transferring from RAJ1). The peficitinib dose could be increased (up to 150 mg) or reduced (to 50 mg) at the discretion of the investigator. Efficacy variables assessed included American College of Rheumatology (ACR) response rates, ACR components, and disease activity score in 28 joints based on C-reactive protein (DAS28-CRP).

Efficacy and safety of peficitinib in rheumatoid arthritis

“…Notably, 5 of the 90 patients switched from the placebo to peficitinib developed herpes zoster after the treatment change. In the Phase 3 RAJ4 study [21], the incidence of adverse events during the 12 weeks of double-blinded phase was 49.4% in the placebo group and 55.5% in the peficitinib 100 mg and 150 mg groups. During the 52-week study period, herpes zoster was documented in 12 patients in the peficitinib group, and in 2 of the 148 patients switched from placebo to peficitinib post switching.…”

“…To date, results from five randomized, placebo-controlled trials and two long-term extension studies have been reported [15][16][17][18][19][20][21]. Among the five randomized, placebo-controlled trials, two were Phase 2b trials conducted as global studies, one was a Phase 2b trial and one a Phase 3 trial both conducted in Japan, and one was a Phase 3 trial conducted in Japan, Korea, and Taiwan.…”

“…The incidence of total adverse events and adverse events of interest in the five randomized, placebo-controlled trials are summarized in Table 2 [17][18][19][20][21].…”

A pooled safety analysis of peficitinib (ASP015K) in Asian patients with rheumatoid arthritis treated over a median of 2 years

“…Inhibition of these JAKs offers an alternative treatment approach for RA, principally for those failing initial treatment with methotrexate (MTX) or other csDMARDs [7]. Peficitinib (ASP015K) is an oral pan-JAK inhibitor, which has demonstrated efficacy in Phase 2b and Phase 3 studies, and in a long-term extension (LTE) study, by reducing symptoms of RA and suppressing joint destruction in Asian patients with active RA, at doses up to 150 mg/day [8][9][10][11]. It has also been shown to have an acceptable safety profile for a period of up to 6 years [8][9][10][11].…”

Correction to: Safety and effectiveness of peficitinib (ASP015K) in patients with rheumatoid arthritis: interim data (22.7 months mean peficitinib treatment) from a long-term, open-label extension study in Japan, Korea, and Taiwan

“…Correction to: Safety and effectiveness of peficitinib (ASP015K) in patients with rheumatoid arthritis: interim data (22.7 months mean peficitinib treatment) from a long-term, open-label extension study in Japan, Korea, and Taiwan Following publication of the original article [1], the authors identified an error in the 95% CI bars plotted on the graphs of Fig. 6a, b, and c. The CI numbers in the table below the graph are correct, but the upper and lower limit bars plotted on the graph are incorrect.…”