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Table 9 Summary of findings table for treatment with fremanezumab 225 mg monthly 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 1.7 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.
  1. #The risk is from a single study; CI: Confidence interval; RR: Risk ratio; RCT: randomized controlled trial
  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