Efficacy and safety of erenumab in women with a history of menstrual migraine

Table 2 Efficacy over months 4–6 of the double-blind treatment phase

	Placebo N = 83	Erenumab 70 mg N = 68	Erenumab 140 mg N = 81
Migraine days per month
N	83	68	81
Change from baseline, LSM (95% CI)	− 1.4 (− 2.2, − 0.7)	−3.2 (− 4.0, − 2.4)	−3.5 (− 4.3, − 2.8)
Difference from placebo, LSM (95% CI)		−1.8 (− 2.9, − 0.7) P = 0.001	−2.1 (− 3.1, − 1.1) P < 0.001
Acute MSMD per month among patients taking acute migraine-specific medications at baseline
N	48	38	51
Change from baseline, LSM (95% CI)	−0.4 (−1.1, 0.3)	−2.0 (− 2.8, − 1.2)	−2.8 (− 3.5, − 2.1)
Difference from placebo, LSM (95% CI)		−1.6 (− 2.6, − 0.6) P = 0.002	−2.4 (− 3.4, − 1.4) P < 0.001
Patients with ≥ 50% reduction from baseline in migraine days per month (≥ 50% response)
N	83	68	81
n (%)	21 (25.3)	29 (42.6)	40 (49.4)
OR^a (95% CI)		2.2 (1.1, 4.4) P = 0.024	2.8 (1.5, 5.5) P = 0.002

The analysis included randomized patients who received ≥ 1 dose of investigational product and had ≥ 1 postbaseline measurement during the double-blind treatment phase. Change from baseline in MMD and monthly acute MSMD was analyzed using a generalized linear mixed effects model, which included treatment, visit, treatment by visit interaction, stratification factors (North America/other and naïve/prior use/concomitant use), and baseline value as covariates and assumed a first-order autoregressive covariance structure; missing data were not imputed. The proportion of responders was analyzed using a stratified Cochran-Mantel-Haenszel test after imputation of missing data as nonresponse
Abbreviations: CI confidence interval, LSM least squares mean, MSMD migraine-specific medication days, OR odds ratio
^aThe common ORs and P values were obtained from a Cochran-Mantel-Haenszel test, stratified by prior/current treatment with migraine-preventive medication and region

ISSN: 1129-2377