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

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, double-blind, 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.

• Authors: Tsutomu Takeuchi, Tsukasa Matsubara, Taisuke Nitobe, Eiichi Suematsu, Syuji Ohta, Shigeru Honjo, Tohru Abe, Ami Yamamoto, Nobuyuki Miyasaka, Japan Abatacept Study Group
• Journal: Modern rheumatology (Mod Rheumatol) Vol. 23 Issue 2 Pg. 226-35 (Mar 2013) ISSN: 1439-7609 [Electronic] England
• PMID: 22684431 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antirheumatic Agents
• Immunoconjugates
• Abatacept
• Methotrexate

Topics

• Abatacept
• Antirheumatic Agents (administration & dosage, therapeutic use)
• Arthritis, Rheumatoid (drug therapy)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Humans
• Immunoconjugates (administration & dosage, therapeutic use)
• Japan
• Methotrexate (administration & dosage, therapeutic use)
• Retreatment
• Treatment Outcome