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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

From: 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 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.
Mortality follow 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
  1. #The risk is from a single study; CI: Confidence interval; RR: Risk ratio; RCT: randomized controlled trial; aDowngraded once due to inconsistency
  2. GRADE Working Group grades of evidence
  3. High certainty: We are very confident that the true effect lies close to that of the estimate of the effect
  4. 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
  5. Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
  6. 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