title: Tolerability and efficacy of abatacept in Japanese patients with rheumatoid arthritis: a phase I study.
abstract: OBJECTIVE
  The primary objective of this study was to evaluate the tolerability of single and multiple doses of abatacept in Japanese patients with rheumatoid arthritis. Secondary objectives included evaluating its pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy.
  
  
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Single and multiple doses of abatacept showed favorable tolerability and efficacy in Japanese patients with rheumatoid arthritis.
authors: Department of Orthopedics, Matsubara Mayflower Hospital, 944-25 Fujita, Kato, Hyogo 673-1462, Japan. mats@mayflower-hp.jp
authors: Tsukasa
authors: T
authors: Matsubara
authors: Seizo
authors: S
authors: Yamana
authors: Shigeto
authors: S
authors: Tohma
authors: Tsutomu
authors: T
authors: Takeuchi
authors: Hirobumi
authors: H
authors: Kondo
authors: Hitoshi
authors: H
authors: Kohsaka
authors: Shoichi
authors: S
authors: Ozaki
authors: Hiroshi
authors: H
authors: Hashimoto
authors: Nobuyuki
authors: N
authors: Miyasaka
authors: Ami
authors: A
authors: Yamamoto
authors: Masaki
authors: M
authors: Hiraoka
authors: Tohru
authors: T
authors: Abe
mesh_terms: D000069594:Abatacept; D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D018796:Immunoconjugates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007564:Japan; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D018796:Immunoconjugates; D000069594:Abatacept