Summary of findings 1. Tacrolimus compared to placebo for induction of clinical remission in refractory ulcerative colitis.
| Tacrolimus compared to placebo for induction of remission in refractory ulcerative colitis | |||||
| Patient or population: adults with refractory, moderate‐to‐severe ulcerative colitis Settings: multicentre across Japan and Australia Intervention: tacrolimus (oral, rectal) Comparison: placebo (oral, rectal) | |||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Certainty of the evidence (GRADE) | |
| Risk with placebo | Risk with tacrolimus | ||||
| Clinical remission | Study population |
RR 3.76 (1.03 to 13.73) |
148 (3 RCTs) | ⊕⊕⊝⊝ Lowa,b | |
| 16 per 1000 | 62 per 1000 (16 to 220) | ||||
| Clinical improvement | Study population |
RR 4.47 (2.15 to 9.29) |
148 (3 RCTs) | ⊕⊕⊝⊝ Lowa,b | |
| 115 per 1000 | 513 per 1000 (247 to 1000) | ||||
| Serious adverse events | Study population |
RR 2.44 (0.12 to 48.77) |
148 (3 RCTs) |
⊕⊝⊝⊝ Very lowa,d |
|
| 8 per 1000c | 23 per 1000 (1 to 400) | ||||
| Total adverse events | Study population |
RR 1.18 (0.91 to 1.54) |
148 (3 RCTs) |
⊕⊕⊝⊝ Lowa,b |
|
| 476 per 1000 |
561 per 1000 (433 to 733) |
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| *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; RCT: randomised controlled trial; RR: risk ratio. | |||||
| GRADE Working Group grades of evidence High certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: 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 certainty: we are very uncertain about the estimate. | |||||
aDowngraded one level due to imprecision. bDowngraded one level due to risk of bias. cThe risks with placebo were calculated by dividing the number of participants with events to the number of randomised participants. If the total events were zero, as in this case, a token small number was used (i.e. 0.5) so that a range could be calculated. dDowngraded two levels due to imprecision from very sparse data.