Tumor necrosis factor‐alpha antibody for maintenance of remission in Crohn's disease

Background Crohn's disease may be refractory to conventional treatments including corticosteroids and immunosuppressives. Recent studies suggest TNF‐α blocking agents may be effective in maintaining remission in Crohn's disease. Objectives To conduct a systematic review of the evidence for the effectiveness of TNF‐α blocking agents in the maintenance of remission in patients with Crohn's disease. Search methods MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and the IBD/FBD Review Group Specialized Trials Register were searched for relevant studies published between 1966‐2007. Manual searches of references from potentially relevant papers were performed to identify additional studies. Experts in the field and study authors were contacted to identify unpublished data. Selection criteria Randomized controlled trials involving patients > 18 years with Crohn's disease who had a clinical response or clinical remission with a TNF‐α blocking agent, or patients with Crohn's disease in remission but unable to wean corticosteroids, who were then randomized to maintenance of remission with a TNF‐α blocking agent or placebo Data collection and analysis Two independent authors performed data extraction and assessment of the methodological quality of each trial. Outcome measures reported in the primary studies included clinical remission, clinical response, and steroid‐sparing effects. Main results Nine studies met all inclusion criteria. Four different anti‐TNF‐α agents were evaluated (infliximab in 3 studies, CDP571 in 3 studies, adalimumab in 2 studies, and certolizumab in 1 study). There is evidence from three randomized controlled trials that infliximab maintains clinical remission (RR 2.50; 95% CI 1.64 to 3.80), maintains clinical response (RR 1.66; 95% CI 1.00 to 2.76), has corticosteroid‐sparing effects (RR 3.13; 95% CI 1.25 to 7.81), and maintains fistula healing (RR 1.87; 95% CI 1.15 to 3.04) in patients with Crohn's disease with a response to infliximab induction therapy. There were no significant differences in remission rates between infliximab doses of 5 mg/kg or 10 mg/kg. There is evidence that adalimumab maintains clinical remission, clinical response, and has corticosteroid‐sparing effects in patients with Crohn's disease who have responded or entered remission with adalimumab induction therapy. There were no significant differences in remission rates between adalimumab 40 mg weekly or every other week. There is evidence from one ran