Summary of findings 1. Alemtuzumab 12 mg compared to interferon beta‐1a for multiple sclerosis.
| Alemtuzumab 12 mg compared to interferon beta‐1a for multiple sclerosis | ||||||
| Patient or population: adults with relapsing–remitting multiple sclerosis Settings: outpatients Intervention: alemtuzumab 12 mg Comparison: interferon beta‐1a | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Interferon beta‐1a | Alemtuzumab 12 mg | |||||
|
Relapse‐free survival Follow‐up: 36 months |
10 per 100a |
49 per 100 (30 to 66) |
HR 0.31 (0.18 to 0.53) |
221 (1 study) | ⊕⊕⊝⊝ Lowb | Alemtuzumab may increase relapse‐free survival at 36 months. |
|
Sustained disease progression‐free survival Follow‐up: 36 months |
75 per 100a |
93 per 100 (85 to 97) |
HR 0.25 (0.11 to 0.56) |
223 (1 study) | ⊕⊕⊝⊝ Lowb | Alemtuzumab may increase sustained disease progression‐free survival at 36 months. |
|
Adverse events, including serious events Assessed by: number of participants with ≥ 1 event Follow‐up: 36 months |
100 per 100 |
100 per 100 (98 to 100) |
RR 1.00 (0.98 to 1.02) | 224 (1 study) |
⊕⊕⊝⊝ Lowc | Alemtuzumab may result in little to no difference in the proportion of participants with ≥ 1 adverse event at 36 months. |
|
Change in disability
Assessed by: EDSS Follow‐up: 36 months |
The mean EDSS score in the control group was 0.38 | The mean change in EDSS in the intervention groups was 0.70 lower (1.04 lower to 0.36 lower) | — | 223 (1 study) | ⊕⊕⊝⊝ Lowb | Alemtuzumab may result in a slight reduction in disability at 36 months. |
|
New or enlarging T2‐hyperintense lesions Assessed by: number of participants with new or enlarging T2‐hyperintense lesions Follow‐up: 36 months |
— | — | — | — | — | — |
|
Dropouts Assessed by: number of participants who dropped out Follow‐up: 36 months |
41 per 100 |
33 per 100 (23 to 46) |
RR 0.81 (0.57 to 1.14) | 224 (1 study) |
⊕⊝⊝⊝ Very lowc,d | We are very uncertain about the effects of alemtuzumab for dropouts at 36 months. |
| *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; EDSS: Expanded Disability Status Scale; HR: hazard ratio; 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. | ||||||
a Control group risk was derived from Kaplan‐Meier curves from the included study (CAMMS223). b Risk of bias. Participants and personnel were not blinded and this outcome could have been affected by this. There was high risk of attrition bias. Downgraded two levels. c Risk of bias. Participants and personnel were not blinded and this is a patient‐reported outcome. There was high risk of attrition bias. Downgraded two levels. d Imprecision. Wide CI, including null effect, and both clinical benefit and harm.