Summary of findings 2. Two infusions of natalizumab (300 mg or 3 mg/kg) compared to placebo for induction of remission in Crohn's disease.
| Two infusions of natalizumab (300 mg or 3 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 (300 mg or 3 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 (3 to 4 mg/kg) | |||||
| Failure to induce remission at 6 weeks | 762 per 1,000 | 648 per 1,000 (595 to 709) | RR 0.85 (0.78 to 0.93) | 1034 (2 RCTs) | ⊕⊕⊕⊕ HIGH | |
| Failure to induce remission at 8 weeks | 773 per 1,000 | 657 per 1,000 (588 to 735) | RR 0.85 (0.76 to 0.95) | 1543 (3 RCTs) | ⊕⊕⊕⊝ MODERATE 1 | |
| Failure to induce clinical response at 6 weeks | 512 per 1,000 | 338 per 1,000 (179 to 640) | RR 0.66 (0.35 to 1.25) | 1034 (2 RCTs) | ⊕⊕⊝⊝ LOW 2 | |
| Faliure to induce clinical response at 8 weeks | 571 per 1,000 | 417 per 1,000 (331 to 519) | RR 0.73 (0.58 to 0.91) | 1543 (3 RCTs) | ⊕⊕⊝⊝ LOW 3 | |
| Adverse events up to week 12 | 810 per 1,000 | 866 per 1,000 (745 to 1,000) | RR 1.07 (0.92 to 1.24) | 129 (1 RCT) | ⊕⊕⊕⊝ MODERATE 4 | |
| Withdrawal due to adverse events up to week 12 | 32 per 1,000 | 30 per 1,000 (4 to 209) | RR 0.95 (0.14 to 6.57) | 129 (1 RCT) | ⊕⊕⊝⊝ LOW 5 | |
| Serious adverse events up to week 12 | 111 per 1,000 | 91 per 1,000 (32 to 256) | RR 0.82 (0.29 to 2.30) | 129 (1 RCT) | ⊕⊕⊝⊝ LOW 6 | |
| *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 inconsistency (I2= 53%)
2 Downgraded two levels due to very serious inconsistency (I2= 87%)
3 Downgraded two levels due to very serious inconsistency (I2= 68%)
4 Downgraded one level due to serious imprecision (108 events)
5 Downgraded two levels due to very serious imprecision (4 events)
6 Downgraded two levels due to very serious imprecision (13 events)