Summary of findings for the main comparison. Etrolizumab versus placebo for induction of remission in ulcerative colitis.
| Etrolizumab versus placebo for induction of remission in ulcerative colitis | ||||||
| Patient or population: patients with induction of remission in ulcerative colitis Settings: Intervention: Etrolizumab versus 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 | |||||
| Control | Etrolizumab versus placebo | |||||
| Failure to enter clinical remission at week 10 | 1000 per 10001 | 860 per 1000 (770 to 950) | RR 0.86 (0.77 to 0.95) | 119 (1 study) | ⊕⊕⊕⊝ moderate2 | |
| Failure to enter clinical remission at week 10 ‐ 100 mg | 1000 per 10001 | 810 per 1000 (680 to 960) | RR 0.81 (0.68 to 0.96) | 59 (1 study) | ⊕⊕⊕⊝ moderate3 | |
| Failure to respond at week 10 | 707 per 10001 | 679 per 1000 (530 to 870) | RR 0.96 (0.75 to 1.23) | 119 (1 study) | ⊕⊕⊕⊝ moderate4 | |
| Failure to enter endoscopic remission at week 6 | 976 per 10001 | 956 per 1000 (878 to 1000) | RR 0.98 (0.9 to 1.06) | 119 (1 study) | ⊕⊕⊕⊝ moderate5 | |
| Failure to enter endoscopic remission at week 10 | 1000 per 10001 | 920 per 1000 (850 to 1000) | RR 0.92 (0.85 to 1) | 119 (1 study) | ⊕⊕⊕⊝ moderate6 | |
| Adverse events | 721 per 10001 | 541 per 1000 (411 to 714) | RR 0.75 (0.57 to 0.99) | 124 (1 study) | ⊕⊕⊕⊝ moderate7 | |
| Serious adverse events | 122 per 10001 | 113 per 1000 (44 to 287) | RR 0.92 (0.36 to 2.34) | 165 (2 studies) | ⊕⊕⊝⊝ low8 | |
| *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). 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 (107 events).
3 Downgraded one level due to sparse data (51 events).
4 Downgraded one level due to sparse data (82 events).
5 Downgraded one level due to sparse data (114 events).
6 Downgraded one level due to sparse data (112 events).
7Downgraded one level due to sparse data (75 events).
8 Downgraded two levels due to very sparse data (20 events).