Table 8.
Summary of findings table for treatment with erenumab 140 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: 6 months | The mean reduction in migraine days was −1.8 days | The mean reduction in migraine days in the intervention group was 1.9 days fewer (2.3 fewer to 1.4 fewer) | – | 634(1 RCT) | ⨁⨁⨁◯MEDIUMa | Treatment with erenumab 140 mg results in reduction in migraine days compared with placebo. |
| Reduction in use of acute attack medicationfollow up: 6 months | The mean reduction in use of acute attack medication was − 0.2 days | The mean reduction in use of acute attack medication in the intervention group was 1.4 days fewer (1.7 fewer to 1.1 fewer) | – | 634(1 RCT) | ⨁⨁⨁◯MEDIUMa | Treatment with erenumab 140 mg results in reduction in number of days of use of acute attack medication compared with placebo. |
|
Improvement in functional MPFID everyday-activities follow up: 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 2.6 points lower (3.6 fewer to 1.5 fewer) | – | 634(1 RCT) | ⨁⨁⨁◯MEDIUMa | Treatment with erenumab 140 mg results in improvement in functional MPFID everyday-activities score compared with placebo. |
| At least 50% reduction in days of migraine follow up: 6 months | 266 per 1000 | 494 per 1000(353 to 690) | RR 1.8810(1.5191 to 2.3290) | 634(1 RCT) | ⨁⨁⨁◯MEDIUMa | Treatment with erenumab 140 mg results in at least 50% reduction of days of migraine compared with placebo. |
|
Serious adverse events follow up: 6 months |
22 per 1000 | 19 per 1000(6 to 55) | RR 1.0871(0.2913 to 2.5224) | 638(1 RCT) | ⨁⨁⨁◯MEDIUMa | Treatment with erenumab 140 mg results in a small possibly unimportant effect in serious adverse events occurrence compared with placebo. |
| Mortality follow up: 6 months | 0 per 1000 |
0 per 1000 (0 to 0) |
Not estimable | 638(1 RCT) | No deaths occurred during the double-blind treatment phase of the trial. | |
CI: Confidence interval; RR: Risk ratio; RCT: randomized controlled trial; 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