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Table 15 Summary of findings table for treatment with fremanezumab 675 mg quarterly 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 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.
Mortality follow 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
  1. 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