A Cochrane review [Abstract] 1 included 4 studies with a total of 1 714 subjects; 1 231 patients were treated with golimumab and 483 with placebo. Of these, 436 were treated with the FDA-approved dose of golimumab 50 mg every four weeks. Compared to patients treated with placebo+methotrexate, patients treated with golimumab 50 mg every four weeks+methotrexate were 2.6 times more likely to reach the American College of Rheumatolofy criteria, ACR50 (95% CI 1.3 to 4.9; NNT= 5, 95% CI 2 to 20), no more likely to have any adverse event (RR 1.1, 95% Cl 0.9 to 1.2), and 0.5 times as likely to have overall withdrawals (95% Cl 0.3 to 0.8) after treatment for 14-24 weeks. Golimumab-treated patients were significantly more likely to achieve remission, low disease activity and improvement in functional ability compared to placebo (all statistically significant). No radiographic data were reported.
No significant differences were noted between golimumab and placebo regarding serious adverse events, infections, serious infections, lung infections, tuberculosis, cancer, withdrawals due to adverse events and inefficacy and deaths. None of the studies had safety as the primary outcome and all were of short duration. Therefore, adverse events that are uncommon and/or occur with long-term treatment with golimumab are unknown at this time.
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