Summary of findings 2. Briakinumab compared to placebo for maintenance of remission in Crohn's disease.
| Briakinumab compared to placebo for maintenance of remission in Crohn's disease | ||||||
| Patient or population: people with moderate to severe Crohn's disease in remission Setting: outpatient Intervention: briakinumab Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | No. of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with briakinumab | |||||
|
Failure to maintain clinical remission Follow‐up: 24 weeks |
611 per 1000 |
513 per 1000 (354 to 733) |
RR 0.84 (0.58 to 1.20) |
99 (1 RCT) |
⊕⊕⊝⊝ low1 | Clinical remission was defined as a CDAI score < 150 points. |
|
Failure to maintain clinical response Follow‐up: 24 weeks |
528 per 1000 |
338 per 1000 (211 to 538) |
RR 0.64 (0.40 to 1.02) |
99 (1 RCT) |
⊕⊕⊝⊝ low2 | Clinical response was defined as a decrease in CDAI score ≥ 100 points compared with week 0. |
|
Adverse events Follow‐up: 24 weeks |
643 per 1000 |
656 per 1000 (431 to 996) |
RR 1.02 (0.67 to 1.55) |
104 (1 RCT) |
⊕⊕⊝⊝ low3 | Common adverse events included upper respiratory tract infection, nausea, abdominal pain, and headache. |
|
Serious adverse events Follow‐up: 24 weeks |
71 per 1000 |
22 per 1000 (2 to 229) |
RR 0.31 (0.03 to 3.21) |
104 (1 RCT) |
⊕⊕⊝⊝ low4 | Serious adverse events included small bowel obstruction, deep vein thrombosis, and respiratory distress. |
|
Withdrawals due to adverse events Follow‐up: 24 weeks |
0 per 1000 |
0 per 1000 (0 to 0) |
RR 0.82 (0.04 to 16.34) |
104 (1 RCT) |
⊕⊕⊝⊝ low5 | We were unable to calculate absolute effects. 2% of briakinumab participants withdrew due to an adverse event compared to none of the placebo participants. Adverse events leading to withdrawal were 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). CDAI: Crohn's Disease Activity Index; CI: confidence interval; RCT: randomized controlled trial; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: 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 quality: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low quality: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | ||||||
1Downgraded two levels due to sparse data (54 events) and very wide confidence interval. 2Downgraded two levels due to very sparse data (40 events). 3Downgraded two levels due to sparse data (68 events) and very wide confidence interval. 4Downgraded two levels due to very sparse data (3 events). 5Downgraded two levels due to very sparse data (2 events).