Summary of findings 5. Methotrexate and azathioprine compared to methotrexate (plus leucovorin) for inclusion body myositis.
| Methotrexate (MTX) and azathioprine (AZA) compared to MTX (plus leucovorin) for inclusion body myositis | ||||||
| Patient or population: people with inclusion body myositis Settings: Intervention: methotrexate and azathioprine (plus leucovorin) Comparison: methotrexate | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Methotrexate | Methotrexate and azathioprine | |||||
| Change in muscle strength at 6 months (%) | Not estimable | Not estimable | Not estimable | 11 (1 study) | See comment | Categorical change in MMT only reported. This study was graded as having a high risk of bias. |
| Change in muscle strength at 12 months (%) (using MMT or QMT) at 12 months ‐ not measured | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| Change in muscle mass at 6 months (%) ‐ not measured | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| Change in handgrip strength at 6 months (%) ‐ not measured | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
|
Change in timed walk at 6 months (%) e.g. 10‐metre or 6‐minute walk test at 6 months ‐ not measured |
‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| Significant adverse events | Not estimable | Not estimable | Not estimable | 11 (1 study) | See comment | Leff 1993: Combined AZA and MTX = 3 withdrawals; MTX (plus leucovorin) = 0 withdrawals |
| *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; MMT: manual muscle testing; QMT: quantitative muscle testing | ||||||
| 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. | ||||||