Summary of findings 1. Adalimumab compared to placebo for maintenance of remission in Crohn's disease.
| Adalimumab compared to placebo for maintenance of remission in Crohn's disease | ||||||
| Patient or population: People with quiescent Crohn's disease Setting: Outpatient Intervention: Adalimumab (40 mg/week or 40 mg every other week) 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 Adalimumab | |||||
| Failure to maintain clinical remission Follow‐up: 52 to 56 weeks |
Study population | RR 0.70 (0.64 to 0.77) | 683 (3 RCTs) | ⊕⊕⊕⊕ HIGH | Clinical remission defined as a CDAI < 150 | |
| 858 per 1000 | 600 per 1000 (549 to 660) | |||||
| Failure to maintain clinical remission Follow‐up: 24 to 26 weeks |
Study population | RR 0.66 (0.52 to 0.83) | 554 (2 RCTs) | ⊕⊕⊕⊝ MODERATEa | Clinical remission defined as a CDAI < 150 | |
| 793 per 1000 | 523 per 1000 (412 to 658) | |||||
| Failure to maintain endoscopic remission Follow‐up: 52 weeks |
969 per 1000 | 717 per 1000 (611 to 843) |
RR 0.74 (0.63 to 0.87) |
129 (1 RCT) |
⊕⊕⊕⊝ MODERATEb | Endoscopic remission defined as an absence of mucosal ulceration |
| Adverse events Follow‐up: 52 to 56 weeks |
Study population | RR 1.01 (0.94 to 1.09) | 1012 (4 RCTs) | ⊕⊕⊕⊕ HIGH | Commonly‐reported adverse events included CD aggravation, arthralgia, nasopharyngitis, urinary tract infections, headache, nausea, fatigue and abdominal pain | |
| 854 per 1000 | 862 per 1000 (802 to 930) | |||||
| Serious adverse events Follow‐up: 52 to 56 weeks |
Study population | RR 0.56 (0.39 to 0.80) | 1012 (4 RCTs) | ⊕⊕⊕⊝ MODERATEc | Reported serious adverse events included infectious complications including tuberculosis, abscess formation and wound infections, multiple sclerosis, pulmonary embolism | |
| 144 per 1000 | 80 per 1000 (56 to 115) | |||||
| Withdrawals due to adverse events Follow‐up: 52 to 56 weeks |
Study population | RR 0.59 (0.38 to 0.91) | 1012 (4 RCTs) | ⊕⊕⊕⊝ MODERATEd | Adverse events leading to withdrawal included flare of CD, infectious complications | |
| 130 per 1000 | 77 per 1000 (49 to 118) | |||||
| Failure to maintain clinical or endoscopic response with prior TNF‐α antagonist exposure Follow‐up: 52 to 56 weeks |
Study population | RR 0.76 (0.68 to 0.85) | 302 (2 RCTs) | ⊕⊕⊕⊝ MODERATEe | Clinical response defined as decrease in baseline CDAI score of ≥ 100. Endoscopic response defined as mucosal healing seen at time of endoscopy | |
| 931 per 1000 | 708 per 1000 (633 to 791) | |||||
| *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 serious inconsistency (I2 = 55%). bDowngraded by one level due to sparse data (109 events). cDowngraded by one level due to sparse data (105 events). dDowngraded by one level due to sparse data (93 events). eDowngraded by one level due to sparse data (237 events).