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Table 11 Summary of findings table for treatment with galcanezumab 240 mg loading dose + 120 mg monthly subcutaneous injection 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 galcanezumab
Reduction in migraine days follow up: 6 months The mean reduction in migraine days was −2.8 days The mean reduction in migraine days in the intervention group was 1.9 days fewer (2.5 fewer to 1.4 fewer) 646 (1 RCT) MEDIUMa Treatment with galcanezumab 120 mg results in reduction in migraine days compared with placebo.
Reduction in use of acute attack medication follow up: 6 months The mean reduction in use of acute attack medication was −2.2 days The mean reduction in use of acute attack medication in the intervention group was 1.8 days fewer (2.3 fewer to 1.3 fewer) 646 (1 RCT) MEDIUMa Treatment with galcanezumab 120 mg results in reduction in use of acute attack medication compared with placebo.
Improvement in functional MSQ RFR score follow up: 6 months The mean improvement in functional MSQ RFR score was 24.7 points The mean improvement in functional MSQ RFR score in the intervention group was 7.7 points higher (5.2 higher to 10.3 higher) 646 (1 RCT) MEDIUMa Treatment with galcanezumab 120 mg results in improvement in functional MSQ RFR score compared with placebo.
At least 50% reduction in days of migraine follow up: 6 months 386 per 1000 623 per 1000 (533 to 731) RR 1.6190 (1.3823 to 1.8962) 646 (1 RCT) MEDIUMa Treatment with galcanezumab 120 mg results in at least 50% reduction of days of migraine compared with placebo.
Serious adverse events follow up: 12–6 months 12 per 1000 28 per 1000 (9 to 91) RR 2.4394 (0.7530 to 7.9028) 646 (1 RCTs) MEDIUMa Treatment with galcanezumab 120 mg results a small possibly unimportant effect in serious adverse events occurrence compared with placebo
Mortality follow up: 3–6 months 0 per 1000 0 per 1000 (0 to 0) not estimable 646 (1 RCTs)   No deaths occurred during the double-blind treatment phase of the trial.
  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