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Table 6 Summary of findings table for treatment with eptinezumab 1000 mg single intravenous infusion compared with no treatment for prevention of episodic 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 eptinezumab
Reduction in migraine days follow up: 3 months The mean reduction in migraine days was −4.6 days The mean reduction in migraine days in the intervention group was 1 days fewer (2.1 fewer to 0.2 more) 151 (1 RCT) LOWa Treatment with eptinezumab 1000 mg reduces the number of migraine days slightly compared with placebo.
Reduction in use of acute attack medication follow up: 3 months The mean change in migraines with acute attack medication was +  4.1% The mean reduction in migraines with acute attack medication was 10.4% days fewer (−20.5% fewer to −0.2% fewer) 151 (1 RCT) LOWa Treatment with eptinezumab 1000 mg results in a small possibly unimportant effect in reduction in use of acute attack medication compared with placebo (statistical significance of the differences not tested).
Improvement in function HIT-6 score follow up: 3 months The mean improvement in function HIT-6 score was −7.7 points The mean improvement in function HIT-6 score in the intervention group was 2.4 points lower (5.5 lower to 0.7 higher) 151 (1 RCT) LOWa Treatment with eptinezumab 1000 mg results in a small possibly unimportant effect in improvement in function assessed by means of the HIT-6 score compared with placebo (statistical significance of the differences not tested).
At least 50% reduction in days of migraine follow up: 3 months 667 per 1000 727 per 1000 (584 to 905) RR 1.1597 (0.9407 to 1.4076) 151 (1 RCT) LOWa Treatment with eptinezumab 1000 mg results in a small possibly unimportant effect in at least 50% reduction of days of migraine compared with placebo.
Serious adverse events follow up: 6 months 12 per 1000 24 per 1000 (2 to 264) RR 2.0000 (0.1849 to 21.6193) 163 (1 RCT) LOWa Treatment with eptinezumab 1000 mg results in a small possibly unimportant effect in serious adverse events occurrence compared with placebo.
Mortality follow up: 6 months 0 per 1000 0 per 1000 (0 to 0) Not estimable 163 (1 RCT)   No deaths occurred during the double-blind treatment phase of the trial.
  1. CI Confidence interval, RR Risk ratio, RCT randomized controlled trial; aDowngraded twice due to inconsistency and imprecision
  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