Treatment Satisfaction of Galcanezumab in Japanese Patients with Episodic Migraine: A Phase 2 Randomized Controlled Study

Abstract

Introduction: This analysis evaluated the treatment satisfaction of Japanese patients receiving galcanezumab (GMB) as a preventive medication for episodic migraine (4-14 monthly migraine headache days).

Methods: This phase 2, randomized, double-blind, placebo-controlled study enrolled patients aged 18-65 years at 40 centers in Japan. Patients were randomized 2:1:1 to receive monthly subcutaneous injections of placebo (PBO, n = 230), GMB 120 mg (n = 115), or GMB 240 mg (n = 114) for 6 months. Patients' experience with treatment was measured using the Patient Global Impression of Severity (PGI-S), Patient Global Impression of Improvement (PGI-I), and Patient Satisfaction with Medication Questionnaire-Modified (PSMQ-M) scales. PGI-S was administered at baseline and months 1-6, PGI-I at months 1-6, and PSMQ-M at months 1 and 6. Prespecified analyses were differences between GMB and PBO in PGI-I and the change from baseline in PGI-S, and evaluating positive responses for the PGI-I and PSMQ-M.

Results: Average change ± SE from baseline across months 1-6 was - 0.09 ± 0.05 (PBO), - 0.17 ± 0.07 (GMB 120 mg, p = 0.33), and - 0.30 ± 0.07 (GMB 240 mg, p = 0.013) for PGI-S. Average PGI-I across months 1-6 was 3.39 ± 0.05 (PBO), 2.55 ± 0.07 (GMB 120 mg, p < 0.05), and 2.71 ± 0.07 (GMB 240 mg, p < 0.05). Reductions of 2.8-3.0 monthly migraine headache days corresponded to 25-31% higher positive PGI-I response rates with GMB compared with PBO. Positive PSMQ-M response rates for satisfaction and preference were statistically significantly higher for GMB compared with PBO (odds ratio [95% confidence interval], all p < 0.05 vs. PBO): satisfaction GMB 120 mg (3.142 [1.936-5.098]) and GMB 240 mg (3.924 [2.417-6.369]), and preference GMB 120 mg (3.691 [2.265-6.017]) and GMB 240 mg (3.510 [2.180-5.652]).

Conclusion: Japanese patients with episodic migraine receiving preventive treatment with GMB are significantly more satisfied than those receiving PBO.

Trial registration: ClinicalTrials.gov, NCT02959177 (registered November 7, 2016).

Keywords: CGRP; Episodic migraine; Galcanezumab; Japan; Migraine; PGI-I; PGI-S; PSMQ-M; Patient satisfaction; Preventive therapy.

Figures

Fig. 1

LS mean change from baseline in overall PGI-S rating (average of months 1–6). More negative scores indicate a greater improvement from baseline (score range 1–7). GMB galcanezumab, LS least squares, MMRM mixed-model repeated measures, PBO placebo, PGI-S Patient Global Impression of Severity. *p = 0.013 vs. PBO (MMRM analysis). The MMRM analysis included fixed categorical effects (treatment, month, the baseline number of monthly migraine headache days [< 8, ≥ 8], and treatment-by-month interaction) and continuous fixed covariates (baseline value and baseline-by-month interaction)

Fig. 2

Effect of GMB treatment on PGI-I score. Lower scores indicate greater improvement (score range 1–7). a Overall average (over months 1–6). b Monthly PGI-I score. GMB galcanezumab, LS least squares, MMRM mixed-model repeated measures, PBO placebo, PGI-I Patient Global Impression of Improvement, PGI-S Patient Global Impression of Severity, SE standard error. *p < 0.05 vs. PBO (MMRM analysis). The MMRM analysis included fixed categorical effects (treatment, month, the baseline number of monthly migraine headache days [< 8, ≥ 8], and treatment-by-month interaction), with PGI-S baseline value and PGI-S baseline-by-month interaction included as continuous fixed covariates