A Cochrane review [Abstract] 1 included 2 trials with a total of 529 patients. Patients fulfilling the American Rheumatism Association 1987 RA diagnostic criteria were randomized to receive either infliximab 1 mg/kg (with and without methotrexate (MTX)), 3 mg/kg (with and without MTX) , 10 mg/kg of infliximab (with and without MTX) or placebo infusion plus MTX. Infusions were given every 4 or 8 weeks. After 6 months ACR 20, ACR 50 and ACR 70 response rates were significantly improved in all infliximab doses compared to control.
Total withdrawals and withdrawals due to lack of efficacy were lower for all doses of infliximab versus controls. Withdrawals for adverse events and withdrawals for other reasons were not statistically significantly different for those receiving infliximab from control.
Treatment with infliximab for 6 and 12 months significantly reduced RA disease activity and appeared to have an acceptable safety profile in these trials. Total radiographic scores improved, fewer patients showed radiographic progression, and more patients showed radiographic improvement with infliximab treatment at 12 months compared to controls. However, only 2 trials met the inclusion criteria, and these results are largely driven by the largest trial. The available efficacy and toxicity data is relatively short-term (6 - 12 months). In order to detect rare events that may be associated with infliximab, larger and longer term studies are required.
Comment: The quality of evidence is downgraded by study quality (inadequate follow up) and sparse data from mainly one trial.
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