Skip to main content

Table 17 Summary of findings table for treatment with galcanezumab 120 mg compared with no treatment for prevention of chronic 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 galcanezumab
Reduction of monthly migraine days follow up: 3 months The mean reduction of monthly headache days was −2.7 days The mean reduction of monthly headache days in the intervention group was 2.1 days lower (2.9 lower to 1.3 lower) 836(1 RCT) MEDIUMa Treatment with Galcanezumab 120 mg reduces monthly migraine days slightly compared to placebo.
Reduction of monthly acute treatment days follow up: 3 months The mean reduction of monthly headache days was −2.2 days The mean reduction of monthly acute treatment days in the intervention group was 2.5 days lower (3.3 lower to 1.8 lower)b 836(1 RCT) MEDIUMa Treatment with Galcanezumab 120 mg reduces monthly acute treatment days slightly compared to placebo.
Improvement in functional MIDAS score follow up: 3 months The mean improvement in functional MIDAS score was −11.5 points The mean improvement in functional MIDAS score in the intervention group was 8.7 points lower (16.4 lower to 1.1 lower) 836(1 RCT) MEDIUMa Treatment with Galcanezumab 120 mg improves functional MIDAS score compared to placebo.
At least 50% reduction of monthly migraine days follow up: 3 months 149 per 1000 284 per 1000(215 to 375) RR 1.9112(1.4477 to 2.5232) 836(1 RCT) MEDIUMa Treatment with Galcanezumab 120 mg mg results in at least 50% reduction of monthly headache days compared to placebo.
Serious adverse events follow up: 3 months 7 per 1000 4 per 1000(0 to 34) RR 0.5288(0.0594 to 4.7092) 836(1 RCT) MEDIUMa Treatment with Galcanezumab 120 mg mg results in a possibly unimportant effect on serious adverse event occurrence compared to placebo.
Mortalityfollow up: 3 months 0 per 1000 0 per 1000(0 to 0) not estimable 836(1 RCT)   No deaths were observed with treatment with Galcanezumab 120 mg or placebo
  1. CI: Confidence interval; RR: Risk ratio; RCT: randomized controlled trial; aDowngraded once due to inconsistency; bnominall significance, non-significant after multiplicity adjustments
  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
\