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Table 12 Summary of findings table for treatment with galcanezumab 240 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 (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 1.8 days fewer (2.3 fewer to 1.2 fewer)

633 (1 RCT)

MEDIUMa

Treatment with galcanezumab 240 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 1.6 days fewer (2.1 fewer to 1.1 fewer)

633 (1 RCT)

MEDIUMa

Treatment with galcanezumab 240 mg results in reduction in use of 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 7.4 points higher (4.8 higher to 10 higher)

561 (1 RCT)

MEDIUMa

Treatment with galcanezumab 240 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

609 per 1000 (128 to 288)

RR 2.1508 (1.4247 to 3.2469)

633 (1 RCT)

MEDIUMa

Treatment with galcanezumab 240 mg results in at least 50% reduction of days of migraine compared with placebo.

Serious adverse events follow up: 6 months

12 per 1000

2 per 1000 (0 to 39)

RR 0.1633 (0.0091 to 2.9414)

652 (1 RCT)

MEDIUMa

Treatment with galcanezumab 240 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

652 (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 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.