Summary of findings 2. Adalimumab compared to active comparator for maintenance of remission in Crohn's disease.
| Adalimumab compared to active comparator for maintenance of remission in Crohn's disease | ||||||
| Patient or population: People with quiescent Crohn's disease (ileocolic resection) Setting: Outpatient Intervention: Adalimumab (40 mg every other week) Comparison: Active comparator ‐ azathioprine (2 mg/kg/day), mesalamine (3 g/day), or 6‐mercaptopurine | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with active comparator | Risk with Adalimumab | |||||
| Failure to maintain clinical remission | Outcome not reported | Outcome not reported | ||||
| Failure to maintain endoscopic remission Follow‐up: 104 weeks |
Study population | RR 0.11 (0.02 to 0.75) | 51 (1 RCT) | ⊕⊝⊝⊝ VERY LOWa,b | Endoscopic remission defined as Rutgeerts score < i2 | |
| 571 per 1000 | 63 per 1000 (11 to 429) | |||||
| Adverse events | Outcome not reported | Outcome not reported | ||||
| Serious adverse events | Outcome not reported | Outcome not reported | ||||
| Withdrawal due to adverse events | Outcome not reported | Outcome not reported | ||||
| Failure to maintain clinical or endoscopic response with prior TNF‐α antagonist exposure | Outcome not reported | Outcome not reported | ||||
| *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 | ||||||
| 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 | ||||||
aDowngraded by one level due to unclear risk of bias. bDowngraded two levels due to very sparse data (21 events).