Skip to main content

Table 10 Summary of findings table for treatment with fremanezumab 675 mg quarterly subcutaneous injection compared with no treatment for prevention of episodic migraine

From: Correction to: European headache federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention

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.
  1. CI: Confidence interval; RR: Risk ratio; RCT: randomized controlled trial; aDowngraded once due to inconsistency.
  2. 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
\