Infliximab for medical induction of remission in Crohn's disease.
Level 1 - systematic review of randomized trials
Systematic review and meta-analysis of randomized controlled trials
PubMed 37982428 · doi:10.1002/14651858.CD012623.pub2
What was done
Authors conducted a Cochrane systematic review searching CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, and WHO ICTRP through March 2023. They included randomized controlled trials comparing infliximab alone or combined with another agent against placebo or active medical therapies for inducing remission in adults aged 26 to 65 with active Crohn's disease. Dual independent review, risk of bias assessment, and GRADE evaluation were conducted. Primary outcomes were clinical remission, clinical response, and withdrawals due to adverse events.
What was found
Ten RCTs with 1,101 participants were included. - Infliximab (5–10 mg/kg) versus placebo at week 4: higher clinical remission (30/55 vs 3/25; RR 4.55, 95% CI 1.53 to 13.50; NNTB 3) and response (36/55 vs 4/25; RR 4.09, 95% CI 1.63 to 10.25; NNTB 3; low certainty). - Infliximab plus purine analogues versus purines alone at weeks 24–26: higher clinical remission (182/301 vs 95/302; RR 1.92, 95% CI 1.59 to 2.32; NNTB 4; 4 studies; moderate certainty) and response at week 26 (107/177 vs 66/178; RR 1.64, 95% CI 1.31 to 2.05; NNTB 5; 2 studies; moderate certainty), with no clear difference in adverse event withdrawals (62/302 vs 53/301; RR 0.87, 95% CI 0.63 to 1.21; 4 studies; low certainty). - Infliximab alone versus purines alone at week 26: higher clinical remission (85/177 vs 57/178; RR 1.50, 95% CI 1.15 to 1.95; NNTB 7; 2 studies; low certainty) and response (94/177 vs 66/178; RR 1.44, 95% CI 1.13 to 1.82; low certainty). - Infliximab versus CT-P13 biosimilar at week 6: little to no difference in remission (47/109 vs 49/111; RR 0.98, 95% CI 0.72 to 1.32; low certainty) or adverse event withdrawals (21/109 vs 17/111; RR 1.26, 95% CI 0.70 to 2.25; low certainty). - Dose comparisons (5, 10, and 20 mg/kg) and outcomes in exclusively fistulating populations were based on very low certainty evidence.
Why it matters
This review shows that combining infliximab with purine analogues is more effective for induction of remission in active Crohn's disease than purine monotherapy, supporting combination regimens.
Limits
Most individual comparisons relied on single trials with small sample sizes and wide confidence intervals. All but one included trial were industry-funded with author conflicts of interest. Evidence remains very low certainty for optimal dosing, fistulating disease, and several adverse event outcomes.
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