Table 16 Summary of findings table for treatment with fremanezumab 675 mg loading dose + 225 mg monthly subcutaneous injection compared with no treatment for prevention of chronic migraine

Reduction of monthly headache days follow up: 3 months

The mean reduction of monthly headache days was −2.5 days#

The mean reduction of monthly headache days in the intervention group was 2.1 days lower (2.6 lower to 1.5 lower)

–

⨁⨁⨁⨁ HIGH

Treatment with Fremanezumab 675/225 mg reduces monthly headache days slightly compared to placebo.

Reduction of monthly acute treatment days follow up: 3 months

The mean reduction of monthly headache days was −4.5 days#

The mean reduction of monthly acute treatment days in the intervention group was 2.4 days lower (3.4 lower to 1.4 lower)

–

⨁⨁⨁⨁ HIGH

Treatment with Fremanezumab 675/225 mg reduces monthly acute treatment days slightly compared to placebo.

Improvement in functional HIT-6 score follow up: 3 months

The mean improvement in functional HIT-6 score was −4.5 points

The mean improvement in functional HIT-6 score in the intervention group was 2.4 days fewer (3.4 fewer to 1.4 fewer)

–

⨁⨁⨁◯ MEDIUM^a

Treatment with fremanezumab 675/225 mg improves functional HIT-6 score slightly compared to placebo.

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

207 per 1000

431 per 1000 (350 to 530)

RR 2.0857 (1.6948 to 2.5667)

⨁⨁⨁⨁ HIGH

Treatment with Fremanezumab 675/225 mg results in at least 50% reduction of monthly headache days compared to placebo.

Serious adverse events follow up: 1 weeks

15 per 1000

13 per 1000 (4 to 38)

RR 0.8516 (0.2884 to 2.5150)

⨁⨁⨁⨁ HIGH

Treatment with Fremanezumab 675/225 mg results in an unimportant reduction of serious adverse event occurrence compared to placebo.

Mortality follow up: 3 months

0 per 1000

0 per 1000 (0 to 0)

not estimable

No deaths were observed with treatment with Fremanezumab 675/225 mg or placebo