Table 15.
Summary of findings table for treatment with fremanezumab 675 mg quarterly 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 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. |
| Mortalityfollow 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 | |
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