Migraine-Specific Quality-of-Life Questionnaire (MSQ) Version 2.1 Score Improvement in Japanese Patients with Episodic Migraine by Galcanezumab Treatment: Japan Phase 2 Study

Figures & data

Table 1 MSQ Scores at Baseline

	PBO	GMB 120 mg	GMB 240 mg
MSQ-RFR	68.1 (14.5)	66.2 (17.0)	67.6 (13.7)
MSQ-RFP	81.9 (13.7)	82.6 (15.8)	83.5 (12.2)
MSQ-EF	79.8 (17.6)	78.6 (22.5)	82.4 (14.9)
MSQ-Total	74.6 (13.5)	73.5 (16.7)	75.3 (12.0)

Note: Data are mean (SD).

Abbreviations: EF, Emotional Function domain; GMB, galcanezumab; MSQ, Migraine-Specific Quality-of-Life Questionnaire; PBO, placebo; RFP, Role Function-Preventive domain; RFR, Role Function-Restrictive domain; SD, standard deviation.

Figure 1 Monthly LS mean change in MSQ-RFR scores from baseline. Washout period denoted by gray shading. Patients had the option of entering an open-label extension period after Month 6. Number of patients at Month 10 reflects this option: n=98 for PBO, n=51 for GMB 120 mg, and n=51 for GMB 240 mg. *P<0.05 vs PBO (MMRM analysis). The average LS mean change from baseline over Months 4–6 in MSQ-RFR was 10.12±0.72 for PBO, 7.13±1.03 for GMB 120 mg, and 15.91±1.03 for GMB 240 mg.¹⁶ The MMRM model included the fixed categorical effects of treatment, month, and treatment-by-month interaction, the baseline number of monthly migraine headache days (<8, ≥8), and the continuous fixed covariates of baseline value and baseline-by-month interaction.

Abbreviations: GMB, galcanezumab; LS, least squares; MMRM, mixed-model repeated measures; MSQ-RFR, Migraine-Specific Quality-of-Life Questionnaire Role Function-Restrictive domain; PBO, placebo; SE, standard error.

Table 2 MSQ-RFR Responders by Treatment Group

Treatment	n^a	Response Rate (%)	Odds Ratio^b (95% CI)	P-value^c
PBO	228	11.8	-	-
GMB 120 mg	112	25.0	2.86 (1.33–6.17)	0.008
GMB 240 mg	112	25.9	3.91 (1.89–8.10)	<0.001

Notes: ^an = number of intent-to-treat subjects who have non-missing baseline values and ≥1 post-baseline value at Month 4, 5, or 6; ^bVs PBO; ^cP-values from logistic regression: responder indicator = treatment, baseline, and baseline number of monthly migraine headache days (<8, ≥8). Responders were defined as patients whose change from baseline to average of Months 4–6 in the MSQ-RFR domain was ≥25.

Abbreviations: CI, confidence interval; GMB, galcanezumab; MSQ-RFR, Migraine-Specific Quality-of-Life Questionnaire Role Function-Restrictive domain; PBO, placebo.

Figure 2 LS mean changes from baseline in additional MSQ scores. Bar graphs: average LS mean change from baseline over Months 4–6 in (A) MSQ-RFP, (B) MSQ-EF, and (C) MSQ-Total scores. Line graphs: monthly LS mean changes from baseline in (D) MSQ-RFP, (E) MSQ-EF, and (F) MSQ-Total scores. Washout period denoted by gray shading. Patients had the option of entering an open-label extension period after Month 6. Number of patients at Month 10 reflects this option: n=98 for PBO, n=51 for GMB 120 mg, and n=51 for GMB 240 mg. *P<0.05 vs PBO (MMRM analysis). The MMRM model included the fixed categorical effects of treatment, month, and treatment-by-month interaction, the baseline number of monthly migraine headache days (<8, ≥8), and the continuous fixed covariates of baseline value and baseline-by-month interaction.

Abbreviations: EF, Emotional Function domain; GMB, galcanezumab; LS, least squares; MMRM, mixed-model repeated measures; MSQ, Migraine-Specific Quality-of-Life Questionnaire; PBO, placebo; RFP, Role Function-Preventive domain; SE, standard error.

Sakai F, Ozeki A, Skljarevski V. Efficacy and safety of galcanezumab for prevention of migraine headache in Japanese patients with episodic migraine: a phase 2 randomized controlled clinical trial. Cephalalgia Rep. 2020;3:1–10.

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