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Golimumab for rheumatoid arthritis.
Jasvinder A Singh1, Shahrzad Noorbaloochi, Gurkirpal Singh
1Medicine, Minneapolis VA Medical Center, 1 Veterans Drive, Rheumatology (111R), Minneapolis, Minnesota, USA, 55417.
The Cochrane Database of Systematic Reviews
|January 22, 2010
Summary
Golimumab significantly improves efficacy in Rheumatoid Arthritis (RA) patients when combined with methotrexate, showing higher ACR50 rates and better disease control. Short-term safety is reasonable, with no increased adverse events compared to placebo.
Area of Science:
- Immunology
- Rheumatology
- Clinical Trials
Background:
- Golimumab is a humanized anti-TNF-alpha antibody approved for Rheumatoid Arthritis (RA) treatment.
- Tumor Necrosis Factor-alpha plays a key role in RA pathogenesis.
Purpose of the Study:
- To systematically review and compare the efficacy and safety of golimumab versus placebo in adult RA patients.
- To assess golimumab's effectiveness alone or with DMARDs/biologics against placebo.
Main Methods:
- Systematic review of randomized or quasi-randomized clinical trials.
- Searched six major databases for relevant studies.
- Independent review of studies, data extraction, and risk of bias assessment.
Main Results:
- Four RCTs involving 1,231 golimumab-treated and 483 placebo-treated patients were analyzed.
- Golimumab plus methotrexate significantly increased ACR50 achievement (NNT=5) compared to placebo plus methotrexate.
- Golimumab demonstrated significant improvements in remission, low disease activity, and functional ability without increasing overall adverse events or serious safety concerns.
Conclusions:
- Golimumab, at the FDA-approved dose combined with methotrexate, is significantly more efficacious than placebo for active RA.
- Short-term safety profile is acceptable, with no observed differences in adverse events, serious infections, cancer, or mortality.
- Further long-term surveillance studies are recommended for comprehensive safety assessment.
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