Cochrane · systematic review · CD012609

Infliximab for maintenance of medically‐induced remission in Crohn's disease

Gordon, M, Sinopoulou, V, Akobeng, AK, et al. · Cochrane Database of Systematic Reviews · 2024 · Cochrane Library

GutAMSTAR 2: not assessed

SoF tableOnly the outcomes this review put in its Summary of Findings table are listed (the Cochrane Handbook caps them at about seven per comparison). Its other analyses are not shown here.

Questions

current version

GRADE rated

No studies

Included studies

No studies 6 · 25%Ungraded 0 · 0%Very low 12 · 50%Low 4 · 16.7%Moderate 2 · 8.3%High 0 · 0%

Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.

Questions and results

Infliximab compared to placebo

Population: patients with Crohn's disease (mixed disease activity population with clinical response at baseline)

4 questions

Outcome	Effect	Evidence	Status / GRADE
Clinical relapse (at 30‐32 weeks, CDAI > 150) Infliximab vs placebo	RR 0.73 [0.63, 0.84]	2 studies · 408 participants	Moderate Downgraded: risk of bias
Loss of clinical response (at 32 weeks, less than 70 points in CDAI change) Infliximab vs placebo	RR 0.59 [0.37, 0.96]	1 study · 73 participants	Very low Downgraded: risk of bias, imprecision
Withdrawal due to adverse events (at 32‐54 weeks) Infliximab vs placebo	RR 0.66 [0.37, 1.19]	2 studies · 355 participants	Very low Downgraded: risk of bias, imprecision
Serious adverse events (at 54 weeks) Infliximab vs placebo	RR 0.6 [0.36, 1]	1 study · 282 participants	Very low Downgraded: risk of bias, imprecision

Infliximab combined with purine analogues compared to purine analogues

Population: Crohn's disease patients (in remission at baseline)

4 questions

Outcome	Effect	Evidence	Status / GRADE
Clinical relapse (at 48 weeks, CDAI of 150 or greater together with an increase in CDAImore than 70 points above baseline over 2 consecutive weeks or definitive clinical relapse requiring immediate intervention, as judged by the treating physician) Infliximab combined with purine analogues vs purine analogues	RR 0.2 [0.1, 0.42]	1 study · 115 participants	Moderate Downgraded: risk of bias
Loss of clinical response Infliximab combined with purine analogues vs purine analogues	no estimate extracted	NR	No studies
Withdrawal due to adverse events (at 48 weeks) Infliximab combined with purine analogues vs purine analogues	RR 0.47 [0.15, 1.49]	1 study · 115 participants	Very low Downgraded: risk of bias, imprecision
Serious adverse events (at 48 weeks to 2 years) Infliximab combined with purine analogues vs purine analogues	RR 1.19 [0.54, 2.64]	2 studies · 257 participants	Very low Downgraded: risk of bias, imprecision

Infliximab compared to purine analogues

Population: Crohn's disease patients (in remission at baseline)

4 questions

Outcome	Effect	Evidence	Status / GRADE
Clinical relapse Infliximab vs purine analogues	no estimate extracted	NR	No studies
Loss of clinical response Infliximab vs purine analogues	no estimate extracted	NR	No studies
Withdrawal due to adverse events Infliximab vs purine analogues	no estimate extracted	NR	No studies
Serious adverse events (at 2 years) Infliximab vs purine analogues	RR 0.79 [0.37, 1.68]	1 study · 140 participants	Very low Downgraded: risk of bias, imprecision

Infliximab compared to biosimilar

Population: patients with Crohn's disease (with mixed/low disease activity at baseline)

4 questions

Outcome	Effect	Evidence	Status / GRADE
Clinical relapse (at 52 weeks, HBI > 4) Infliximab vs biosimilar	RR 1.18 [0.82, 1.69]	1 study · 155 participants	Low Downgraded: imprecision
Loss of clinical response (at 52 weeks, HBI change from baseline of less than 4 points and a total score of less than 7 points) Infliximab vs biosimilar	RR 1.5 [1.01, 2.23]	1 study · 155 participants	Low Downgraded: imprecision
Withdrawal due to adverse events (at 52 weeks) Infliximab vs biosimilar	RR 20.73 [2.86, 150.33]	1 study · 155 participants	Low Downgraded: imprecision
Serious adverse events (at 52 weeks) Infliximab vs biosimilar	RR 0.99 [0.39, 2.5]	1 study · 155 participants	Low Downgraded: imprecision

Subcutaneous CT‐P13 and purine analogues compared to intravenous CT‐P13 and purine analogues

Population: patients with Crohn's disease (active disease population with clinical response at baseline)

4 questions

Outcome	Effect	Evidence	Status / GRADE
Clinical relapse (at 22 weeks, CDAI > 150) Subcutaneous CT‐P13 and purine analogues vs intravenous CT‐P13 and purine analogues	RR 1.01 [0.65, 1.57]	1 study · 53 participants	Very low Downgraded: risk of bias, imprecision
Loss of clinical response (at 22 weeks, less than 100 points in CDAI change) Subcutaneous CT‐P13 and purine analogues vs intravenous CT‐P13 and purine analogues	RR 0.94 [0.7, 1.25]	1 study · 53 participants	Very low Downgraded: risk of bias, imprecision
Withdrawal due to adverse events (at 30 weeks) Subcutaneous CT‐P13 and purine analogues vs intravenous CT‐P13 and purine analogues	RR 0.77 [0.3, 1.97]	1 study · 53 participants	Very low Downgraded: risk of bias, imprecision
Serious adverse events Subcutaneous CT‐P13 and purine analogues vs intravenous CT‐P13 and purine analogues	no estimate extracted	NR	No studies

Infliximab compared to adalimumab

Population: patients with Crohn's disease (active disease population with clinical response at baseline)

4 questions

Outcome	Effect	Evidence	Status / GRADE
Clinical relapse Infliximab vs adalimumab	no estimate extracted	NR	No studies
Loss of clinical response (at 56 weeks, less than 100 points in CDAI change) Infliximab vs adalimumab	RR 0.68 [0.29, 1.59]	1 study · 73 participants	Very low Downgraded: risk of bias, imprecision
Withdrawal due to adverse events (at 56 weeks) Infliximab vs adalimumab	RR 0.1 [0.01, 0.72]	1 study · 73 participants	Very low Downgraded: risk of bias, imprecision
Serious adverse events (at 56 weeks) Infliximab vs adalimumab	RR 0.09 [0.01, 1.54]	1 study · 73 participants	Very low Downgraded: risk of bias, imprecision