Treatment Satisfaction of Galcanezumab in Japanese Patients with Episodic Migraine: A Phase2 Randomized Controlled Study.

Abstract

IntroductionThis analysis evaluated the treatment satisfaction of Japanese patients receiving galcanezumab (GMB) as a preventive medication for episodic migraine (4–14 monthly migraine headache days).MethodsThis 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.ResultsAverage 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]).ConclusionJapanese patients with episodic migraine receiving preventive treatment with GMB are significantly more satisfied than those receiving PBO.Trial RegistrationClinicalTrials.gov, NCT02959177 (registered November 7, 2016).Graphical Plain Language Summary Supplementary InformationThe online version contains supplementary material available at 10.1007/s40120-021-00236-5.