Summary of findings 4. Methotrexate + infliximab compared to infliximab alone for induction of remission in refractory Crohn's disease.
| Methotrexate compared with Infliximab for refractory Crohn's disease | ||||||
|
Patient or population: adult patients with refractory Crohn's disease Settings: Outpatient Intervention: Methotrexate + infliximab Comparison: Infliximab | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Infliximab | Methotrexate + infliximab | |||||
|
Failure to enter remission at 14 weeks or 24 weeks (Feagan 2014) |
222 per 10001 | 238 per 1000 (127 to 451) | RR 1.07 (0.57 to 2.03) | 126 (1 study) | ⊕⊕⊝⊝ low2 | |
|
Failure to enter remission at 14 weeks or 24 weeks (Schröder 2006) |
625 per 10001 | 456 per 1000 (194 to 1056) | RR 0.73 (0.31 to 1.69) | 19 (1 study) | ⊕⊝⊝⊝ very low3,4 | |
|
Adverse events (Schröder 2006) |
625 per 10001 | 638 per 1000 (324 to 1281) | RR 1.02 (0.51 to 2.05) | 19 (1 study) | ⊕⊝⊝⊝ very low4,5 | |
|
Serious adverse events (Schröder 2006) |
125 per 10001 | 0per 1000 (1 to 681) | RR 0.25 (0.01 to 5.45) | 19 (1 study) | ⊕⊝⊝⊝ very low4,6 | |
|
Withdrawals due to adverse event (Feagan 2014) |
16 per 10001 | 32 per 1000 (3 to 344) | RR 2.00 (0.19 to 21.50) | 126 (1 study) | ⊕⊕⊝⊝ low7 | |
| *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.Rated down due to very sparse data (29 events)
3.Rated down due to very sparse data (10 events)
4.High risk of bias due to no blinding
5.Rated down due to very sparse data (12 events)
6.Rated down due to very sparse data (1 event)
7.Rated down due to very sparse data (3 events)