Early onset of efficacy with fremanezumab in patients with episodic and chronic migraine: subanalysis of two phase 2b/3 trials in Japanese and Korean patients

The Journal of Headache and Pain

Takao Takeshima¹  Miki Ishida²  Masami Nakai³  Nobuyuki Koga⁴  Yoshiyuki Shibasaki⁵  Byung-Kun Kim⁶  Xiaoping Ning⁷ 

[1] Headache Center, Department of Neurology, Tominaga Hospital, 1-4-48 Minatomachi Naniwa-ku, Osaka-shi, 556-0017, Osaka, Japan;Headquarters of Clinical Development, Otsuka Pharmaceutical Co., Ltd., 3-2-27 Otedori, Chuo-ku, 540-0021, Osaka, Japan;Medical Affairs, Otsuka Pharmaceutical Co., Ltd., 3-2-27 Otedori, Chuo-ku, 540-0021, Osaka, Japan;Medical Affairs, Otsuka Pharmaceutical Co., Ltd., 463-10 Kagasuno, Kawauchi-cho, 771-0192, Tokushima, Japan;Medical Affairs, Otsuka Pharmaceutical Co., Ltd., Shinagawa Grand Central Tower, 2-16-4 Konan, Minato-ku, 108-8242, Tokyo, Japan;Nowon Eulji Medical Center, Eulji University School of Medicine, 68 Hangeulbiseok-ro, Nowon-gu, 01830, Seoul, Republic of Korea;Speciality Clinical Development, Teva Branded Pharmaceutical Products R&D, Inc., 145 Brandywine Pkwy, 19380, West Chester, PA, USA;

关键词: Calcitonin gene-related peptide;    Chronic migraine;    Episodic migraine;    Fremanezumab;    Japanese;    Korean;    Early onset;   

DOI  :  10.1186/s10194-022-01393-0

来源: Springer

【 摘 要 】

BackgroundEarly onset of action has become recognized as an important efficacy feature of preventive migraine treatment, which can help overcome adherence issues commonly associated with older medications. Preventive treatments that target the calcitonin gene-related peptide (CGRP) or the CGRP receptor have been previously shown to provide early onset of action.MethodsThis subanalysis of primary endpoints of two separate phase 2b/3 studies sought to determine the onset of action of fremanezumab in Japanese and Korean patients with episodic migraine (EM) and chronic migraine (CM).ResultsIn EM patients (n = 357), both fremanezumab quarterly and fremanezumab monthly led to greater reductions in weekly migraine days (days/week) than placebo from the first week after the initial injection and thereafter during the remainder of the study period. Similarly, CM patients (n = 571) had a greater reduction in headache days of at least moderate severity (days/week) with fremanezumab (total) than placebo. The percentage of patients with a migraine day (EM) or headache day at least moderate severity (CM) was lower in those treated with fremanezumab than placebo and this effect was apparent from as early as Day 2 (1 day after first injection).ConclusionsThese results suggest that fremanezumab has an early onset of action, as noted in previous post hoc analyses of anti-CGRP monoclonal antibodies.Trial registrationClinicalTrials.gov. NCT03303092, Registered 5 October 2017, NCT03303079, Registered 5 October 2017.

【 授权许可】

CC BY