Summary of findings 5. Three infusions of natalizumab (300 mg) and two infusions of infliximab (5 mg/kg) compared to placebo and two infusions of infliximab for induction of remission in Crohn's disease.
Three infusions of natalizumab (300 mg) and two infusions of infliximab compared to placebo and two infusions of infliximab for induction of remission in Crohn's disease | ||||||
Patient or population: Participants with active Crohn's disease despite current treatment with infliximab Setting: Outpatient Intervention: Three infusions of natalizumab (300 mg) and two infusions of infliximab Comparison: Placebo and two infusions of infliximab | ||||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
Risk with placebo and two infusions of infliximab (5 mg/kg) | Risk with three infusions of natalizumab (300 mg) and two infusions of infliximab | |||||
Failure to induce clinical remission at week 10 | 704 per 1,000 | 633 per 1,000 (457 to 873) | RR 0.90 (0.65 to 1.24) | 79 (1 RCT) | ⊕⊕⊕⊝ MODERATE 1 | |
Failure to induce clinical response at 10 weeks | Not reported | This outcome was not reported | ||||
Adverse events up to week 10 | 1,000 per 1,000 | 930 per 1,000 (850 to 1,000) | RR 0.93 (0.85 to 1.03) | 79 (1 RCT) | ⊕⊕⊕⊝ MODERATE 2 | |
Withdrawal due to adverse events up to week 10 | 37 per 1,000 | 7 per 1,000 (0 to 155) | RR 0.18 (0.01 to 4.18) | 79 (1 RCT) | ⊕⊕⊝⊝ LOW 3 | |
Serious adverse events up to week 10 | 37 per 1,000 | 19 per 1,000 (1 to 296) | RR 0.52 (0.03 to 7.98) | 79 (1 RCT) | ⊕⊕⊝⊝ LOW 4 | |
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; OR: Odds ratio; | ||||||
GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect |
1 Downgraded one level due to serious imprecision (52 events)
2 Downgraded one level due to serious imprecision (75 events)
3 Downgraded two levels due to very serious imprecision (1 event)
4 Downgraded two levels due to very serious imprecision (2 events)