TABLE 2.
Summary of primary and secondary efficacy endpoints
| Fremanezumab | Placebo (n = 116) | ||
|---|---|---|---|
| Monthly (n = 121) | Quarterly (n = 117) | ||
| Primary endpoint | |||
| Average number of migraine days per month, mean ± SD | 4.9 ± 3.0 | 5.0 ± 3.3 | 8.2 ± 3.7 |
| Mean change from baseline during 12‐week period ± SE | −4.0 ± 0.4 | −4.0 ± 0.4 | −1.0 ± 0.4 |
| Difference versus placebo (95% CI, p)a | −3.0 ± 0.4 (−3.74, −2.23; p < 0.0001) | −3.0 ± 0.4 (−3.76, −2.24; p < 0.0001) | |
| Secondary endpoints | |||
| Proportion of patients reaching ≥50% reduction in the average number of migraine days per month from baseline during the 12‐week period after the first dose of study medication | |||
| Number of patients with reduction (%) | 50 (41.3) | 53 (45.3) | 13 (11.2) |
| Difference versus placebo, % (95% CI, p)b | 30.1 (19.6, 40.6; p < 0.0001) | 34.1 (23.4, 44.7; p < 0.0001) | |
| Average number of days with use of any acute headache medications per month | |||
| Mean change from baseline during 12‐week period ± SE | −3.3 ± 0.3 | −3.3 ± 0.4 | −0.5 ± 0.4 |
| Difference ± SE versus placebo (95% CI, p)a | −2.8 ± 0.4 (−3.55, −2.14; p < 0.0001) | −2.8 ± 0.4 (−3.54, −2.12; p < 0.0001) | |
| Average number of migraine days in patients not receiving concomitant migraine‐preventive medications per month | |||
| Number of patients evaluated | 97 | 94 | 94 |
| Mean change from baseline during 12‐week period ± SE | −4.4 ± 0.4 | −4.2 ± 0.4 | −1.4 ± 0.4 |
| Difference ± SE versus placebo (95% CI, p)a | −3.0 ± 0.4 (−3.82, −2.21; p < 0.0001) | −2.8 ± 0.4 (−3.62, −2.01; p < 0.0001) | |
| MIDAS score | |||
| Number of patients evaluated | 118 | 113 | 112 |
| Mean change from baseline at 4 weeks after third (final) injection ± SE | −12.6 ± 1.4 | −12.6 ± 1.5 | −7.4 ± 1.5 |
| Difference ± SE versus placebo (95% CI, p)a | −5.2 ± 1.5 (−8.14, −2.33; p < 0.001) | −5.1 ± 1.5 (−8.09, −2.20; p < 0.001) | |
a
ANCOVA model for change from baseline includes treatment, sex, country, and baseline preventive medication use (yes/no) as fixed effects and baseline value and years since onset of migraine as covariates.
b
Comparisons conducted using Mantel–Haenszel test stratified by baseline preventive medication use (yes/no).