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Table 13 Summary of findings table for treatment with erenumab 70 mg monthly subcutaneous injection 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 erenumab

Reduction of monthly migraine days follow up: 3 months

The mean reduction of monthly migraine days was −4.2  days

The mean reduction of monthly migraine days in the intervention group was 2.5 days fewer (3.5 lower to 1.4 fewer)

469 (1 RCT)

MEDIUMa

Treatment with Erenumab 70 mg reduces monthly migraine days slightly compared to placebo.

Reduction of monthly acute treatment days follow up: 3 months

The mean reduction of monthly acute treatment days was −1.6 days

The mean reduction of monthly acute treatment days in the intervention group was 1.9 days fewer (2.6 fewer to 1.1 fewer)

469 (1 RCT)

MEDIUMa

Treatment with Erenumab 70 mg reduces monthly acute treatment days slightly compared to placebo.

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

235 per 1000

399 per 1000 (303 to 525)

RR 1.6985 (1.2908 to 2.2349)

469 (1 RCT)

MEDIUMa

Treatment with Erenumab 70 mg results in at least 50% reduction of monthly migraine days compared to placebo.

Serious adverse events follow up: 3 months

25 per 1000

31 per 1000 (11 to 92)

RR 1.2722 (0.4340 to 3.7268)

471 (1 RCT)

MEDIUMa

Treatment with Erenumab 70 mg results in a small unimportant increase of serious adverse event occurrence compared to placebo.

Mortality follow up: 3 months

0 per 1000

0 per 1000 (0 to 0)

not estimable

471 (1 RCT)

 

No deaths were observed with treatment with Erenumab 70 mg or placebo

  1. CI Confidence interval, RR Risk ratio, RCT Randomized controlled trial; aDowngraded once due to inconsistency. a. Downgraded once due to imprecision: phase II study
  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