Galcanezumab in patients with episodic migraine: results from the open-label period of the phase 3 PERSIST study

Table 2 Efficacy and quality of life endpoints

Endpoint	Time	Change from baseline^a
		GMB/GMB	PBO/GMB	LS Mean (95% CI)^b	p-value
		LS Mean (SE)	LS Mean (SE)	LS Mean (95% CI)^b	p-value
Monthly MHDs	Month 3	-4.01 (0.26)	-2.31 (0.27)	-1.70 (-2.34, -1.06)	< 0.0001
Monthly MHDs	Month 6	-4.62 (0.27)	-4.56 (0.27)	-0.06 (-0.72, 0.60)	0.8607
≥ 50% response rate	Month 3	59.7 (3.1)^c	35.9 (3.1)^c	2.64 (1.83, 3.80)	< 0.0001
≥ 50% response rate	Month 6	70.9 (3.0)^c	67.2 (3.1)^c	1.19 (0.80, 1.76)	0.3906
≥ 75% response rate	Month 3	28.3 (2.9)^c	18.4 (2.5)^c	1.75 (1.14, 2.70)	0.0108
≥ 75% response rate	Month 6	46.1 (3.3)^c	47.1 (3.3)^c	0.96 (0.67, 1.38)	0.8177
100% response rate	Month 3	13.4 (2.3)^c	6.2 (1.6)^c	2.34 (1.21, 4.52)	0.0114
100% response rate	Month 6	21.5 (2.7)^c	23.1 (2.8)^c	0.91 (0.59, 1.41)	0.6815
Monthly MHDs treated with acute medication	Month 3	-2.64 (0.25)	-0.77 (0.25)	-1.86 (-2.46, -1.27)	< 0.0001
Monthly MHDs treated with acute medication	Month 6	-2.82 (0.24)	-2.40 (0.24)	-0.43 (-0.99, 0.13)	0.1330
MSQ-RFR	Month 3	20.71 (0.99)	15.27 (1.01)	5.44 (3.03, 7.86)	< 0.0001
MSQ-RFR	Month 6	23.72 (1.02)	24.92 (1.04)	-1.20 (-3.70, 1.31)	0.3473
PGI-S	Month 3	-0.90 (0.09)	-0.70 (0.09)	-0.20 (-0.41, 0.01)	0.0559
PGI-S	Month 6	-1.18 (0.10)	-1.09 (0.10)	-0.09 (-0.32, 0.15)	0.4701
MIDAS Total Score	Month 3	-23.09 (2.72)	-11.12 (2.80)	-11.97 (-18.53, -5.42)	0.0004
MIDAS Total Score	Month 6	-27.77 (2.39)	-27.24 (2.48)	-0.54 (-5.97, 4.90)	0.8459

^aAll values reported as change from baseline with the exception of response rates, which are absolute values at the timepoint indicated
^bAll values reported as LS square mean difference, with the exception of response rates, which are reported as odds ratios
^cModel estimated rate
CI Confidence interval, GMB Galcanezumab, LS Least squares, MHD Migraine headache day, MIDAS Migraine Disability Assessment, MSQ-RFR Migraine Specific Quality of Life Questionnaire Role Function-Restrictive, NA Not applicable, PBO Placebo, PGI-S Patient Global Impression of Severity, SE Standard error

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