Early Onset and Maintenance Effect of Galcanezumab in Japanese Patients with Episodic Migraine

Hisaka Igarashi,1 Mamoru Shibata,2 Akichika Ozeki,3 Kathleen Ann Day,4 Taka Matsumura3 1Department of Internal Medicine, Fujitsu Clinic, Kawasaki, Japan; 2Department of Neurology, Tokyo Dental College Ichikawa General Hospital, Ichikawa, Japan; 3Eli Lilly Japan K.K., Kobe, Japan; 4Eli Lilly and Company, Indianapolis, IN, USACorrespondence: Taka MatsumuraMedical Science, Medicines Development Unit Japan, Eli Lilly Japan K.K., 4-15-1 Akasaka, Akasaka Garden City 13F, Minato-ku, Tokyo, 107-0052, JapanTel +81 3 5574 9169Fax +81 3 5574 9979Email matsumura_taka@lilly.comPurpose: This study aimed to extensively evaluate the onset and maintenance effect of galcanezumab compared with placebo for the prevention of episodic migraine in Japanese patients.Patients and Methods: This was a post-hoc analysis of a Phase 2, multicenter, randomized, double-blind, placebo-controlled study conducted between December 2016 and January 2019 (ClinicalTrials.gov: NCT02959177). Patients aged between 18 and 65 years with episodic migraine were randomized to receive a monthly injection of galcanezumab (120 mg: N = 115, 240 mg: N = 114) or placebo (N = 230) for 6 months. Outcome measures included onset of effect at weekly and daily intervals—assessed by change from baseline in the number of migraine headache days and the proportion of patients with migraine headache—with galcanezumab versus placebo. To further confirm the onset and maintenance effect, the 50% response rate was also evaluated.Results: The mean change from baseline in weekly migraine headache days was significantly reduced with galcanezumab (– 0.97 days) compared with placebo (– 0.10 days) at week 1 (p ≤ 0.0001), which was maintained at all subsequent weeks up to week 4 (all p ≤ 0.0001 vs placebo). A significantly smaller proportion of galcanezumab-treated patients had migraine headache compared with placebo-treated patients at day 1 after the first injection (13.6% vs 31.4%, respectively; p ≤ 0.0001), which was also maintained at all subsequent days during the first week after the first injection. Furthermore, the 50% response rate was significantly higher with galcanezumab compared with placebo from week 1 through month 6.Conclusion: The onset of the migraine preventive effect of galcanezumab was rapid compared with placebo, starting from day 1 after the first injection in Japanese patients with episodic migraine. The effect was maintained during the first week and first month, and throughout 6 months of monthly injections of galcanezumab. Galcanezumab is a promising preventive treatment in Japanese patients with episodic migraine.Keywords: calcitonin gene-related peptide, galcanezumab, Japan, migraine disorders, onset of effect, maintenance effect