Summary of findings for the main comparison. Briakinumab compared to placebo for induction of remission in Crohn's disease.
| Briakinumab compared to placebo for induction of remission in Crohn's disease | ||||||
| Patient or population: induction of remission in Crohn's disease Settings: Intervention: Briakinumab Comparison: placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| placebo | Briakinumab | |||||
|
Failure to induce clinical remission (Mannon 2004) CDAI (≤150 points) Follow‐up: 9 weeks |
812 per 10001 | 699 per 1000 (528 to 926) | RR 0.86 (0.65 to 1.14) | 79 (1 study) | ⊕⊕⊝⊝ low2,3 | |
|
Failure to induce clinical remission (Panaccione 2010) CDAI (≤150 points) Follow‐up: 6 weeks |
913 per 10001 |
840 per 1000 (758 to 940) |
RR 0.92 (0.83 to 1.03) |
230 (1 study) |
⊕⊕⊝⊝ low3,4 | |
|
Failure to induce clinical response
(Mannon 2004) CDAI ‐ (≥100 point reduction) Follow‐up: 9 weeks |
688 per 10001 | 447 per 1000 (289 to 681) | RR 0.65 (0.42 to 0.99) | 79 (1 study) | ⊕⊕⊝⊝ low5 | |
|
Failure to induce clinical response
(Panaccione 2010) CDAI ‐ (≥100 point reduction) Follow‐up: 6 weeks |
783 per 10001 |
642 per 1000 (525 to 775) |
RR 0.82 (0.67 to 0.99) |
230 (1 study) |
⊕⊕⊕⊝ moderate6 | |
|
Adverse events (Panaccione 2010) Follow‐up: 12 weeks |
783 per 10001 |
705 per 1000 (587 to 838) |
RR 0.90 (0.75 to 1.07) |
230 (1 study) |
⊕⊕⊕⊝ moderate7 | |
|
Serious adverse events (Panaccione 2010) Follow‐up: 12 weeks |
87 per 10001 | 45 per 1000 (15 to 140) | RR 0.52 (0.17 to 1.61) | 246 (1 study) | ⊕⊕⊝⊝ low8 | |
|
Withdrawals due to adverse event** (Pannaccione 2010) Follow‐up: 12 weeks |
44 per 10001 | 30 per 1000 (6 to 146) | RR 0.69 (0.14 to 3.31) | 246 (1 study) | ⊕⊕⊝⊝ low9 | |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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). **Subject numbers are higher than those reported for the efficacy analyses of the individual studies due to the 200 mg, i.v. experimental group discontinuing enrolment during the induction phase due to poor patient enrolment (Panaccione, 2010). These patients were not included in the efficacy analyses, but were included in the safety analyses. CI: confidence interval; RR: risk ratio. | ||||||
| GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||
1 Control group risk estimates come from control arm of meta‐analysis, based on included trials 2 Downgraded one level due to sparse data (57 events) 3 Downgraded on level because the 95% CI around the effect estimate includes both benefit and no effect 4 Downgraded one level due to sparse data (196 events) 5 Downgraded two levels due to very sparse data (39 events) 6 Downgraded one level due to sparse data (153 events) 7 Downgraded one level due to sparse data (177 events) 8 Downgraded two levels due to very sparse data (13 events) 9 Downgraded two levels due to very sparse data (8 events)