Thirty-four studies (n=896) were included in the review.
Overall, short-term response and remission with infliximab therapy were 68% (95% CI: 65, 71) and 40% (95% CI: 36, 44), respectively. The corresponding estimates in the long-term follow-up were 53% (95% CI: 49, 56) and 39% (95% CI: 35, 42).
Infliximab versus placebo (5 studies).
All studies comparing infliximab and placebo were high-quality double-blinded RCTs. Compared with placebo, treatment with infliximab achieved more often a short-term response(OR 3.6, 95% CI: 2.67, 4.95, p<0.001; 4 datasets) and a short-term remission (OR 4.56, 95% CI: 1.98, 10.5, p<0.001; 2 datasets). The NNTs were 3 (95% CI: 3, 4) and 4 (95% CI: 3, 6), respectively. There was statistical heterogeneity for the outcome short-term remission (p=0.09; I-squared 66%). In the long-term follow-up, infliximab was associated with higher response rates (OR 3.4, 95% CI: 2.52, 4.59; p<0.001; 3 datasets) and remission rates (OR 2.72, 95% CI: 1.92, 3.83, p<0.001; 2 datasets), without significant heterogeneity. The NNTs were 3 (95% CI: 3, 4) and 5 (95% CI: 4, 7), respectively.
Infliximab versus steroids (2 studies).
Two open-label RCTs with quality scores of 2 and 3, respectively, compared infliximab versus steroids and showed similar short-term and long-term responses for both treatments. Short-term remission was also comparable in one of the studies, while the second trial found remission rates of 70% and 80% among patients treated with infliximab and steroids, respectively.
Adverse events.
The frequency of adverse events was higher with infliximab (OR 1.52, 95% CI: 1.03, 2.24, p=0.04).