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. |