Efficacy and safety of the human anti-IL-1beta monoclonal antibody canakinumab in rheumatoid arthritis: results of a 12-week, phase II, dose-finding study
2011

Canakinumab for Rheumatoid Arthritis Treatment

Sample size: 274 publication 10 minutes Evidence: moderate

Author Information

Author(s): Rieke Alten, Juan Gomez-Reino, Patrick Durez, Andre Beaulieu, Anthony Sebba, Gerhard Krammer, Ralph Preiss, Udayasankar Arulmani, Albert Widmer, Xavier Gitton, Herbert Kellner

Primary Institution: Schlosspark-Klinik Teaching Hospital of the Charité, University Medicine Berlin

Hypothesis

Canakinumab is effective in improving symptoms of rheumatoid arthritis in patients already on methotrexate.

Conclusion

Canakinumab 150 mg SC every 4 weeks significantly improves therapeutic responses in patients with active rheumatoid arthritis despite stable methotrexate treatment.

Supporting Evidence

  • Canakinumab 150 mg SC every 4 weeks resulted in a 26.5% response rate compared to 11.4% for placebo.
  • No safety concerns were raised with canakinumab therapy, particularly regarding infections.
  • The study was conducted at 56 centers in Europe and North America.

Takeaway

This study shows that a medicine called canakinumab can help people with rheumatoid arthritis feel better, even if they are already taking another medicine called methotrexate.

Methodology

This was a phase II, 12-week, randomized, double-blind, placebo-controlled study involving patients with active rheumatoid arthritis receiving methotrexate.

Potential Biases

No significant bias risks were reported.

Limitations

The study had a relatively small sample size and short duration of treatment.

Participant Demographics

{"age_mean":57.1,"female_percentage":81.2}

Statistical Information

P-Value

0.028

Confidence Interval

95% CI not specified

Statistical Significance

p = 0.028

Digital Object Identifier (DOI)

10.1186/1471-2474-12-153

Want to read the original?

Access the complete publication on the publisher's website

View Original Publication