A meta-analysis of the efficacy and safety of using infliximab for the treatment of rheumatoid arthritis

Clin Rheumatol. 2009 Dec;28(12):1365-73. doi: 10.1007/s10067-009-1233-9. Epub 2009 Sep 22.


Infliximab is a chimeric monoclonal antibody. Published studies indicate that its use in patients with rheumatoid arthritis can be efficient in providing long-term benefits. The aim of this study is to evaluate the efficacy and safety of using infliximab for the treatment of rheumatoid arthritis. A systematic review was performed to search for randomized clinical trials that compared intravenous administration of 3 mg/kg body weight infliximab or placebo in patients concomitantly using methotrexate. Only studies of moderate or high quality were included. A meta-analysis was conducted to assess the efficacy (based on changes of American College of Rheumatology (ACR) criteria) and the safety (based on serious adverse events, serious infections, malignancy, and deaths) of infliximab use. Withdrawals due to adverse events or lack of efficacy were also evaluated in both infliximab-treated and control groups. Seven trials met the inclusion criteria, comprising 2,129 patients. In the efficacy meta-analysis, a greater number of infliximab-treated patients relative to those in the placebo group achieved ACR20, ACR50, and ACR70 values from 14 weeks to 2 years of treatment. For safety analysis, there were no statistically significant differences between the groups. Withdrawals due to adverse events were higher in the infliximab group relative to the placebo group, and withdrawals due to lack of efficacy were higher in the placebo group relative to the infliximab-treated group. This meta-analysis shows a higher efficacy of infliximab relative to placebo without significant safety differences between the infliximab-treated and control groups.

Publication types

  • Meta-Analysis
  • Review
  • Systematic Review

MeSH terms

  • Antibodies, Monoclonal / administration & dosage
  • Antibodies, Monoclonal / therapeutic use*
  • Antirheumatic Agents / administration & dosage
  • Antirheumatic Agents / therapeutic use*
  • Arthritis, Rheumatoid / drug therapy*
  • Arthritis, Rheumatoid / physiopathology
  • Humans
  • Infliximab
  • Infusions, Intravenous
  • Randomized Controlled Trials as Topic
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors*


  • Antibodies, Monoclonal
  • Antirheumatic Agents
  • Tumor Necrosis Factor-alpha
  • Infliximab