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

Table 3 Change From Baseline in Mean Monthly Migraine Days by Hormonal Contraception Status

	Received Hormonal Contraception			Did Not Receive Hormonal Contraception
	Placebo N = 20	Erenumab 70 mg N = 18	Erenumab 140 mg N = 27	Placebo N = 63	Erenumab 70 mg N = 50	Erenumab 140 mg N = 54
Monthly migraine days at baseline, mean (SD)	9.5 (3.0)	8.5 (2.7)	8.9 (2.2)	8.3 (2.8)	8.2 (2.3)	8.2 (2.4)
Change from baseline over months 4–6, LSM (95% CI)	−1.6 (− 3.4, 0.25)	− 2.9 (− 4.8, − 1.0)	− 3.9 (− 5.5, − 2.4)	− 1.4 (− 2.2, − 0.6)	−3.3 (− 4.2, − 2.4)	−3.4 (− 4.2, − 2.5)
Difference from placebo		−1.3 (− 3.9, 1.2) P = 0.3	− 2.4 (− 4.7, − 0.1) P = 0.045		−2.0 (− 3.1, − 0.8) P = 0.001	−2.0 (− 3.1, − 0.8) P < 0.001
Treatment by subgroup interaction P value over months 4–6	0.76

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. P values for pairwise comparisons are nominal P values without multiplicity adjustment
Abbreviations: CI confidence interval, LSM least squares mean

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