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)