Table 9.
Summary of findings table for treatment with fremanezumab 225 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 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 1.7 days fewer (2.6 fewer to 0.8 fewer) | – | 776(2 RCT) | ⨁⨁⨁⨁HIGH | Treatment with fremanezumab 225 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 1.5 days fewer (2.3 fewer to 0.6 fewer) | – | 776(2 RCT) | ⨁⨁⨁⨁HIGH | Treatment with fremanezumab 225 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 7.6 points lower (14.1 lower to 1.0 lower) | – | 776(2 RCT) | ⨁⨁⨁⨁HIGH | Treatment with fremanezumab 225 mg results in improvement in functional MIDAS score compared with placebo. |
| At least 50% reduction in days of migraine follow up: 3 months | 269 per 1000 | 474 per 1000(324 to 693) | RR 1.7594(1.2019 to 2.5754) | 776(2 RCT) | ⨁⨁⨁⨁HIGH | Treatment with fremanezumab 225 mg results in at least 50% reduction of days of migraine compared with placebo. |
| Serious adverse events follow up: 3 months | 18 per 1000 | 13 per 1000(4 to 40) | RR 0.7346(0.2352 to 2.2949) | 783(2 RCT) | ⨁⨁⨁⨁HIGH | Treatment with fremanezumab 225 mg results in small possibly unimportant effect in serious adverse events occurrence compared with placebo. |
| Mortality follow up: 3 months | 0 per 1000 | 0 per 1000(0 to 0) | not estimable | 783(2 RCTs) | No deaths occurred during the double-blind treatment phase of the trials. | |
#The risk is from a single study; CI: Confidence interval; RR: Risk ratio; RCT: randomized controlled trial
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