Fourteen RCTs were included in the review of efficacy (n=3,955). Twenty-one RCTs were included in the review of safety (n=5356). All 21 trials had a Jadad score greater than 3.
Luminal Crohn's disease: Anti-TNF therapy was associated with greater rates of induction of remission at week four compared with placebo (MD 11%, 95% CI 6% to 16%, p<0.001; 10 RCTs). In open label induction trials anti-TNF therapy was also associated with greater maintenance of remission than placebo (four RCTs) at weeks 20 to 30 (MD 23%, 95% CI 18% to 28%, p<0.001) and weeks 48 to 52 (MD 23%, 95% CI 18% to 29%, p<0.001). In both long- and short-term trials trials in which patients were randomised before induction (three RCTs) anti-TNF therapy was associated with more effective maintenance of remission at weeks 20-30 (MD 8%, 95% CI 3% to 12%, p<0.001). Anti-TNF therapy was also more effective in maintaining steroid-free remission at weeks 48 to 52 than placebo (MD 15%, 95% CI 5% to 25%, p<0.0046; two RCTs).
Fistulising Crohn's disease: No significant differences were detected between anti-TNF agent and placebo for at least 50% or complete fistula closure in the short-term trials, or in short- and long-term trials overall. In the maintenance trials (three RCTs) anti-TNF therapy was significantly more effective than placebo for complete fistula closure (MD 16%, 95% CI 8% to 25%, p<0.001).
There was no evidence of statistical heterogeneity or publication bias in these analyses.
There was no evidence of differences in the frequency of deaths, malignancies and serious infections between anti-TNF therapy and placebo.