Summary of findings 3. Two infusions of natalizumab (6 mg/kg) compared to placebo for induction of remission in Crohn's disease.
| Two infusions of natalizumab (6 mg/kg) compared to placebo for induction of remission in Crohn's disease | ||||||
| Patient or population: Participants with active Crohn's disease Setting: Outpatient Intervention: Two infusions of natalizumab (6 mg/kg) Comparison: Placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with two infusions of natalizumab (6 mg/kg) | |||||
| Failure to induce remission at 6 weeks | 730 per 1,000 | 686 per 1,000 (540 to 869) | RR 0.94 (0.74 to 1.19) | 114 (1 RCT) | ⊕⊕⊕⊝ MODERATE 1 | |
| Failure to induce remission at 8 weeks | 841 per 1,000 | 572 per 1,000 (437 to 740) | RR 0.68 (0.52 to 0.88) | 114 (1 RCT) | ⊕⊕⊕⊝ MODERATE 2 | |
| Failure to induce clinical response at 6 weeks | 619 per 1,000 | 433 per 1,000 (297 to 625) | RR 0.70 (0.48 to 1.01) | 114 (1 RCT) | ⊕⊕⊕⊝ MODERATE 3 | |
| Failure to induce clinical response at 8 weeks | 651 per 1,000 | 449 per 1,000 (319 to 644) | RR 0.69 (0.49 to 0.99) | 114 (1 RCT) | ⊕⊕⊕⊝ MODERATE 4 | |
| Adverse events up to week 12 | 810 per 1,000 | 785 per 1,000 (648 to 947) | RR 0.97 (0.80 to 1.17) | 114 (1 RCT) | ⊕⊕⊕⊝ MODERATE 5 | |
| Withdrawal due to adverse events up to week 12 | 32 per 1,000 | 59 per 1,000 (10 to 339) | RR 1.85 (0.32 to 10.67) | 114 (1 RCT) | ⊕⊕⊝⊝ LOW 6 | |
| Serious adverse events up to week 12 | 111 per 1,000 | 118 per 1,000 (42 to 328) | RR 1.06 (0.38 to 2.95) | 114 (1 RCT) | ⊕⊕⊝⊝ LOW 7 | |
| *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 (81 events)
2 Downgraded one level due to serious imprecision (82 events)
3 Downgraded one level due to serious imprecision (61 events)
4 Downgraded one level due to serious imprecision (64 events)
5 Downgraded one level due to serious imprecision (91 events)
6 Downgraded two levels due to very serious imprecision (5 events)
7 Downgraded two levels due to very serious imprecision (13 events)