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Table 18 Summary of findings table for treatment with galcanezumab 240 mg 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 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 1.9 days lower (2.7 lower to 1.1 lower)

835 (1 RCT)

MEDIUMa

Treatment with Galcanezumab 240 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 2.0 days lower (2.8 lower to 1.3 lower)

835 (1 RCT)

MEDIUMa

Treatment with Galcanezumab 240 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 5.5 points lower (13.1 lower to 2.1 higher)

835 (1 RCT)

MEDIUMa

Treatment with Galcanezumab 240 mg does not improve functional MIDAS score significantly compared to placebo.

At least 50% reduction of monthly migraine days follow up: 3 months

149 per 1000

285 per 1000 (216 to 377)

RR 1.9181 (1.4531 to 2.5321)

835 (1 RCT)

MEDIUMa

Treatment with Galcanezumab 240 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

19 per 1000 (5 to 70)

RR 2.6534 (0.7181 to 9.8049)

835 (1 RCT)

MEDIUMa

Treatment with Galcanezumab 240 mg mg results in a possibly unimportant effect on serious adverse event occurrence compared to placebo.

Mortality follow up: 3 months

0 per 1000

0 per 1000 (0 to 0)

not estimable

835 (1 RCT)

 

No deaths were observed with treatment with Galcanezumab 240 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