Table 10.
Summary of findings table for treatment with fremanezumab 675 mg quarterly 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 fremanezumab | |||||
| Reduction in migraine days follow up: 3 months | The mean reduction in migraine days was − 2.2 days | The mean reduction in migraine days in the intervention group was 1.3 days fewer (1.8 fewer to 0.7 fewer) | – | 578(1 RCT) | ⨁⨁⨁◯MEDIUMa | Treatment with fremanezumab 675 mg results in reduction in migraine days compared with placebo. |
| Reduction in use of acute attack medication follow up: 3 months | The mean reduction in use of acute attack medication was − 1.6 days | The mean reduction in use of acute attack medication in the intervention group was 1.3 days fewer (1.8 fewer to 0.8 fewer) | – | 578(1 RCT) | ⨁⨁⨁◯MEDIUMa | Treatment with fremanezumab 675 mg results in reduction in use of acute attack medication compared with placebo. |
| Improvement in functional MIDAS score follow up: 3 months | The mean improvement in functional MIDAS score was − 17.5 points | The mean improvement in functional MIDAS score in the intervention group was 5.4 points lower (8.9 lower to 1.9 lower) | – | 578(1 RCT) | ⨁⨁⨁◯MEDIUMa | Treatment with fremanezumab 675 mg results in improvement in functional MIDAS score compared with placebo. |
| At least 50% reduction in migraine days follow up: 3 months | 279 per 1000 | 444 per 1000(355 to 557) |
RR 1.5912 (1.2700 to 1.9937) |
578(1 RCT) | ⨁⨁⨁◯MEDIUMa | Treatment with fremanezumab 675 mg results in at least 50% reduction of days of migraine compared with placebo. |
| Serious adverse events follow up: 3 months | 24 per 1000 | 10 per 1000(3 to 39) | RR 0.4330(0.1131 to 1.6582) | 584(1 RCT) | ⨁⨁⨁◯MEDIUMa | Treatment with fremanezumab 675 mg results in small possibly unimportant effect in serious adverse events occurrence compared with placebo. |
| Mortality follow up: 3 months | 0 per 1000 | < 1 per 1000(0 to 1) | RR 3.0308(0.1240 to 74.0995) | 584(1 RCT) | ⨁⨁⨁◯MEDIUMa | One death occurred in fremanezumab 675 mg group, and no deaths occurred in the placebo group during the double-blind treatment phase of the trials. Treatment with fremanezumab 675 mg results in small possibly unimportant effect in mortality compared with placebo. |
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