Summary of findings for the main comparison. Methotrexate compared to placebo for maintenance of remission in Crohn's disease.
| Methotrexate compared to placebo for maintenance of remission in Crohn's disease | ||||||
| Patient or population: patients with quiescent Crohn's disease Settings: Outpatient Intervention: Methotrexate 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 | Methotrexate | |||||
| Proportion of patients maintaining clinical remission Follow‐up: 36‐40 weeks | 458 per 10001 | 720 per 1000 (504 to 1000) | RR 1.57 (1.10 to 2.23) | 98 (2 studies) | ⊕⊕⊕⊝ Moderate2 | |
| Proportion of patients maintaining clinical remission (high dose intramuscular methotrexate 15 mg/week) Follow‐up: 40 weeks | 389 per 10001 | 650 per 1000 (408 to 1000) | RR 1.67 (1.05 to 2.67) | 76 (1 study) | ⊕⊕⊕⊝ Moderate3 | |
| Proportion of patients maintaining clinical remission (low dose oral methotrexate 12.5 mg/week) Follow‐up: 36 weeks | 667 per 10001 | 900 per 1000 (574 to 1000) | RR 1.35 (0.86 to 2.12) | 22 (1 study) | ⊕⊕⊝⊝ Low4 | |
| *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 comes from control arm of study 2 Sparse data (57 events) 3 Sparse data (40 events) 4 Very sparse data (17 events)