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Tolerability and efficacy of abatacept in Japanese patients with rheumatoid arthritis: a phase I study
Modern Rheumatology, 08/01/2012
Clinical Article
Matsubara T et al. – Single and multiple doses of abatacept showed favorable tolerability and efficacy in Japanese patients with rheumatoid arthritis.
Methods- This dose-escalation, single- and multiple-dose, multicenter, open-label study was conducted at nine sites in Japan.
- Seven patients were enrolled at each of three dose levels (2, 8 and 16 mg/kg) and received a single intravenous dose of abatacept on day 1 of the single-dose phase.
- The multiple-dose phase, at the same dose, started once the patients had completed the single-dose phase and when it was confirmed that there were no safety issues.
- Twenty patients started the single-dose phase.
- Single and multiple doses of abatacept were well tolerated, and adverse events were of mild to moderate intensity.
- There were no discontinuations or deaths due to adverse events.
- The pharmacokinetics of abatacept were linear, with no notable accumulation.
- There were no immunogenic effects on the safety, efficacy, or pharmacokinetics of abatacept.
- Multiple doses of abatacept improved individual items of the American College of Rheumatology core set.