Table 16.
Summary of findings table for treatment with fremanezumab 675 mg loading dose + 225 mg monthly subcutaneous injection compared with no treatment for prevention of chronic 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 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 2.1 days lower (2.6 lower to 1.5 lower) | – | 922(2 RCTs) | ⨁⨁⨁⨁HIGH | Treatment with Fremanezumab 675/225 mg reduces monthly headache days slightly compared to placebo. |
| Reduction of monthly acute treatment days follow up: 3 months | The mean reduction of monthly headache days was −4.5 days# | The mean reduction of monthly acute treatment days in the intervention group was 2.4 days lower (3.4 lower to 1.4 lower) | – | 922(2 RCTs) | ⨁⨁⨁⨁HIGH | Treatment with Fremanezumab 675/225 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 2.4 days fewer (3.4 fewer to 1.4 fewer) | – | 746(1 RCT) | ⨁⨁⨁◯MEDIUMa | Treatment with fremanezumab 675/225 mg improves functional HIT-6 score slightly compared to placebo. |
| At least 50% reduction of monthly headache days follow up: 3 months | 207 per 1000 |
431 per 1000 (350 to 530) |
RR 2.0857 (1.6948 to 2.5667) |
922(2 RCTs) | ⨁⨁⨁⨁HIGH | Treatment with Fremanezumab 675/225 mg results in at least 50% reduction of monthly headache days compared to placebo. |
| Serious adverse events follow up: 1 weeks | 15 per 1000 | 13 per 1000(4 to 38) | RR 0.8516(0.2884 to 2.5150) | 928(2 RCTs) | ⨁⨁⨁⨁HIGH | Treatment with Fremanezumab 675/225 mg results in an unimportant reduction of serious adverse event occurrence compared to placebo. |
| Mortalityfollow up: 3 months | 0 per 1000 | 0 per 1000(0 to 0) | not estimable | 928(2 RCTs) | No deaths were observed with treatment with Fremanezumab 675/225 mg or placebo | |
#The risk is from a single study; 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