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. 2023 May 18:16:1673-1682.
doi: 10.2147/JPR.S393896. eCollection 2023.

Fremanezumab for Episodic Migraine Prevention in Japanese Patients: Subgroup Analysis from Two International Trials

Kazumasa Saigoh  1 , Takao Takeshima  2 , Masami Nakai  3 , Yoshiyuki Shibasaki  4 , Miki Ishida  5 , Xiaoping Ning  6 , Steve Barash  6 , Yuki Isogai  4 , Nobuyuki Koga  7
Affiliations

Fremanezumab for Episodic Migraine Prevention in Japanese Patients: Subgroup Analysis from Two International Trials

Kazumasa Saigoh et al. J Pain Res. .

Abstract

Purpose: The monoclonal antibody fremanezumab has been shown effective and well tolerated in numerous Phase 2 and Phase 3 trials. This subgroup analysis of the international HALO episodic migraine (EM; [NCT02629861]) trial and a similarly designed phase 2b/3 trial in Japanese and Korean patients (NCT03303092) sought to evaluate the efficacy and safety of fremanezumab in Japanese patients with EM.

Patients and methods: In both trials, eligible patients were randomly assigned at baseline to receive subcutaneous monthly fremanezumab, quarterly fremanezumab, or placebo in a 1:1:1 ratio. The primary endpoint was the mean change from baseline in the monthly (28-day) average number of migraine days during the 12-week period after the first dose of fremanezumab or placebo. Secondary endpoints assessed other aspects of efficacy, including disability and medication use.

Results: A total of 301 patients in the Japanese and Korean phase 2b/3 trial and 75 patients in the HALO EM trial were Japanese with baseline and treatment characteristics similar between treatment groups. According to ANCOVA analysis of the primary endpoint, both fremanezumab quarterly and monthly led to greater reductions in the monthly (28-day) average number of migraine days than placebo. This was supported by MMRM analysis of the primary endpoint over the initial 4 weeks, highlighting the rapid onset of action of fremanezumab. Results of secondary endpoint analysis supported the primary endpoint analyses. Fremanezumab was well tolerated with no new safety signals seen in this population of Japanese patients.

Conclusion: Fremanezumab appears to be an effective and well-tolerated preventive medication for Japanese patients with EM.

Keywords: Japanese; calcitonin gene-related peptide; episodic migraine; fremanezumab.

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Conflict of interest statement

KS has received grants from Sumitomo Pharma Co., Ltd.; consulting fees from Takeda Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Co., Ltd.; payment for lectures from AMGEN Inc., Daiichi Sankyo Company, Eisai Co., Ltd., Eli Lilly Japan, Otsuka Pharmaceutical Co., Ltd., Sanofi Japan, Sumitomo Pharma Co., Ltd., Takeda Pharmaceutical Co., Ltd.; committee member for Japanese Society of Headache, Japanese Society of Human Genetics. TT has received honoraria for lectures from Eisai Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Amgen K.K., Eli Lilly and Company, Daiichi Sankyo; research funds under contract from Eisai Co., Ltd., Eli Lilly and Company, Amgen K.K., Allergan Japan K.K., Shionogi & Co., Ltd., Lundbeck Japan K.K. MN, YS, MI, YI, and NK are full-time employees of Otsuka Pharmaceutical Co., Ltd. XN and SB are full-time employees of Teva Branded Pharmaceutical Products. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Primary endpoint according to ANCOVA analysis for Japanese patients enrolled in the (A) Japanese and Korean phase 2b/3 trial, (B) HALO trial.
Figure 2
Figure 2
Changes from baseline in the average number of weekly migraine days (MMRM analysis) over (A) 3 months (B) 4 weeks for Japanese patients enrolled in the Japanese and Korean phase 2b/3 trial. An asterisk (*) denotes p<0.05 and a dagger (†) denotes p<0.0001 for the comparison of fremanezumab monthly or quarterly with placebo; mixed-effects model for repeated measures (MMRM) analysis.
See this image and copyright information in PMC

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