Extension study demonstrates stable long-term safety, efficacy profiles for peficitinib
medwireNews: The Janus kinase (JAK) inhibitor peficitinib has demonstrated a consistent safety and efficacy profile over 2 years of follow-up among Japanese patients with rheumatoid arthritis (RA), researchers report.
The open-label extension study involved 611 people who participated in one of two phase II trials, in which peficitinib or placebo was given either with or without methotrexate for 12 weeks, followed by 2 years of treatment with open-label peficitinib 100 mg/day for all participants.
Mark Genovese (Stanford University, Palo Alto, California, USA) and co-investigators report in Rheumatology and Therapy that 36.3% of patients experienced treatment-related adverse events (AEs) over the study period, most commonly upper respiratory tract infections (6.7%), while 13.0% experienced serious AEs. Cases of pulmonary embolism and chest pain, pulmonary thrombosis and thrombosis, and deep vein thrombosis, each occurring in one patient, were not considered to be drug related.
The JAK inhibitor also demonstrated sustained efficacy in an exploratory analysis, with ACR20 response rates of 49.4% at the 12-week follow-up and 44.0% at 2 years.
The researchers note that the extension study had a “low completion rate,” at 52.2%, which they attribute mainly to patient withdrawals following protocol amendments according to ACR and EULAR guidelines.
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