Phase II dose-response study of abatacept in Japanese patients with active rheumatoid arthritis with an inadequate response to methotrexate

Tsutomu Takeuchi, Tsukasa Matsubara, Taisuke Nitobe, Eiichi Suematsu, Syuji Ohta, Shigeru Honjo, Tohru Abe, Ami Yamamoto, Nobuyuki Miyasaka

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

Objective: The objective of this study was to assess the response to abatacept at doses of 2 mg/kg and 10 mg/kg compared to placebo in patients with active rheumatoid arthritis (RA) with an inadequate clinical response to methotrexate (MTX). Methods: In this multicenter, placebo-controlled, doubleblind, parallel-group, dose-response study, 195 Japanese patients with active RA with an inadequate response to MTX were randomized 1:1:1 to receive 10 mg/kg or 2 mg/ kg abatacept plus MTX, or placebo plus MTX, for 24 weeks. Results: Abatacept demonstrated a dose-response relationship when given at 2 and 10 mg/kg. Based on the American College of Rheumatology criteria (20, 50, and 70 %), the responses to 10 mg/kg abatacept were significantly greater than those to placebo at week 24 (p<0.001). Smaller yet statistically significant responses were also seen in the 2 mg/kg abatacept group. Overall rates of adverse events, serious adverse events, and treatment discontinuations because of adverse events were comparable in all three groups. Conclusions: Abatacept (2 mg/kg and 10 mg/kg) showed a dose-response relationship in Japanese patients with active RA with an inadequate clinical response to MTX. Administration of abatacept in combination with MTX for 24 weeks was well tolerated.

Original languageEnglish
Pages (from-to)226-235
Number of pages10
JournalModern rheumatology
Volume23
Issue number2
DOIs
Publication statusPublished - 2013 Mar 1
Externally publishedYes

Keywords

  • Abatacept
  • Active rheumatoid arthritis
  • Clinical response
  • Japan
  • Methotrexate

ASJC Scopus subject areas

  • Rheumatology

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