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 of monthly headache days follow up: 3 months | The mean reduction of monthly headache days was −2.5 days | The mean reduction of monthly headache days in the intervention group was 1.8 days fewer (2.4 fewer to 1.2 fewer) | – | 746 (1 RCT) | ⨁⨁⨁◯ MEDIUMa | Treatment with Fremanezumab 675 mg reduces monthly headache days slightly compared to placebo. |
Reduction of monthly acute treatment days follow up: 3 months | The mean reduction of monthly acute treatment days was −1.9 days | The mean reduction of monthly acute treatment days in the intervention group was 1.8 days fewer (2.4 fewer to 1.2 fewer) | – | 746 (1 RCT) | ⨁⨁⨁◯ MEDIUMa | Treatment with Fremanezumab 675 mg reduces monthly acute treatment days slightly compared to placebo. |
Improvement in functional HIT-6 score follow up: 3 months | The mean improvement in functional HIT-6 score was −4.5 points | The mean improvement in functional HIT-6 score in the intervention group was 1.9 points fewer (2.9 fewer to 0.9 fewer) | – | 746 (1 RCT) | ⨁⨁⨁◯ MEDIUMa | Treatment with fremanezumab 675 mg improves functional HIT-6 score slightly compared to placebo. |
At least 50% reduction of monthly headache days follow up: 3 months | 181 per 1000 | 376 per 1000 (292 to 484) | RR 2.0820 (1.6167 to 2.6813) | 746 (1 RCT) | ⨁⨁⨁◯ MEDIUMa | Treatment with Fremanezumab 675 mg results in at least 50% reduction of monthly headache days compared to placebo. |
Serious adverse events follow up: 3 months | 16 per 1000 | 8 per 1000 (2 to 32) | RR 0.4987 (0.1256 to 1.9792) | 751 (1 RCT) | ⨁⨁⨁◯ MEDIUMa | Treatment with Fremanezumab 675 mg results in an unimportant reduction of serious adverse event occurrence compared to placebo. |
Mortality follow up: 3 months | 0 per 1000 | < 1 per 1000 | RR 2.9920 (0.1223 to 73.2174) | 751 (1 RCT) | No deaths were observed with treatment with Fremanezumab 675 mg or placebo |