Table 7.
Summary of findings table for treatment with erenumab 70 mg monthly subcutaneous injection compared with no treatment for prevention of episodic migraine
| Outcomes | Anticipated absolute effects*(95% CI) | Relative effect (95% CI) |
№ of participants (studies) |
Certainty of the evidence (GRADE) |
Comments | |
|---|---|---|---|---|---|---|
| Risk with placebo | Risk with erenumab | |||||
|
Reduction in migraine days follow up: 3–6 months |
The mean reduction in migraine days was − 1.9 days | The mean reduction in migraine days in the intervention group was 1.2 days fewer (1.8 fewer to 0.5 fewer) | – |
1455 (3 RCTs) |
⨁⨁⨁⨁ HIGH |
Treatment with erenumab 70 mg results in reduction in migraine days compared with placebo. |
|
Reduction in use of acute attack medication follow up: 3–6 months |
The mean reduction in use of acute attack medication was − 0.6 days | The mean reduction in use of acute attack medication in the intervention group was 0.8 days fewer (1.3 fewer to 0.4 fewer) | – |
1455 (3 RCTs) |
⨁⨁⨁⨁ HIGH |
Treatment with erenumab 70 mg results in reduction in use of acute attack medication compared with placebo. |
| Improvement in functional MPFID everyday-activities follow up: 3–6 months | The mean improvement in functional MPFID everyday-activities was −3.3 points | The mean improvement in functional MPFID everyday-activities in the intervention group was 2.2 points lower (3.3 fewer to 1.2 fewer) | – | 628(1 RCT) | ⨁⨁⨁◯MEDIUMa | Treatment with erenumab 70 mg results in improvement in functional MPFID everyday-activities score compared with placebo. |
| At least 50% reduction in days of migraine follow up: 3–6 months | 283 per 1000 |
422 per 1000 (366 to 488) |
RR 1.4918 (1.2925 to 1.7217) |
1441 (3 RCTs) |
⨁⨁⨁⨁ HIGH |
Treatment with erenumab 70 mg results in at least 50% reduction of days of migraine compared with placebo. |
| Serious adverse events follow up: 3–6 months | 17 per 1000 |
17 per 1000 (8 to 37) |
RR 0.9992 (0.4590 to 2.1752) |
1464 (3 RCTs) |
⨁⨁⨁⨁ HIGH |
Treatment with erenumab 70 mg results in a small possibly unimportant effect in serious adverse events occurrence compared with placebo. |
| Mortality follow up: 3–6 months | 0 per 1000 | 0 per 1000 (0 to 0) | Not estimable |
1464 (3 RCTs) |
No deaths occurred during the double-blind treatment phase of the trial. | |
*The risk in the intervention group (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. aDowngraded once due to inconsistency.
GRADE Working Group grades of evidenceHigh certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect