PMID- 33764538
OWN - NLM
STAT- MEDLINE
DCOM- 20211214
LR  - 20211214
IS  - 1526-4610 (Electronic)
IS  - 0017-8748 (Print)
IS  - 0017-8748 (Linking)
VI  - 61
IP  - 4
DP  - 2021 Apr
TI  - Long-term efficacy and safety during open-label erenumab treatment in Japanese 
      patients with episodic migraine.
PG  - 653-661
LID - 10.1111/head.14096 [doi]
AB  - OBJECTIVE: To assess long-term (up to 2 years) efficacy, tolerability, and safety 
      of erenumab for the prevention of episodic migraine (EM) in Japanese patients. 
      BACKGROUND: Previously published results from the double-blind treatment phase 
      (DBTP) of a phase 2 clinical study have demonstrated the efficacy and safety of 
      erenumab in Japanese patients with EM. METHODS: Patients completing the 24-week 
      placebo-controlled DBTP could continue into the 76-week open-label treatment 
      phase (OLTP), receiving erenumab 70 mg or 140 mg subcutaneously once monthly. The 
      initial dose in the OLTP was erenumab 70 mg monthly, which was later changed to 
      140 mg. After study completion, the following were assessed: change from baseline 
      in monthly migraine days (MMD), change from baseline in monthly acute 
      migraine-specific medication days (MSMD), percentage of patients achieving >/=50% 
      and >/=75% reduction in MMD, change from baseline in the 6-item Headache Impact 
      Test (HIT-6) score, and safety (exposure-adjusted patient-incidence of adverse 
      events [AEs], calculated as number of patients per 100 patient-years). RESULTS: 
      Of 475 patients enrolled in the DBTP, 459 (96.6%) continued in the OLTP. The mean 
      (SD) MMD was 7.9 (2.3) at baseline with the overall change from baseline at week 
      100 of -2.9 (4.1) days. The monthly acute MSMD was 5.7 (2.8) at baseline with 
      change from baseline at week 100 of -1.7 (3.7) days. The proportion of patients 
      who achieved >/=50% and >/=75% reduction in MMD from baseline at week 100 was 177/398 
      (44.5%) and 94/398 (23.6%), respectively. The HIT-6 score was 58.4 (5.4) at 
      baseline with a change of -6.4 (8.2) at week 100. The exposure-adjusted 
      patient-incidence of AEs during the OLTP was 207.1/100 patient-years for the 
      combined erenumab group, similar to that observed for either erenumab (271.0/100 
      patient-years) or placebo (257.3/100 patient-years) during the DBTP, and no new 
      safety signals were detected during the OLTP. CONCLUSION: Long-term erenumab 
      treatment in Japanese patients with EM demonstrated sustained efficacy for up to 
      2 years, with a safety profile similar to previous studies, supporting erenumab 
      as a potential new therapy for EM prevention in Japan.
CI  - (c) 2021 The Authors. Headache: The Journal of Head and Face Pain published by 
      Wiley Periodicals LLC on behalf of American Headache Society.
FAU - Sakai, Fumihiko
AU  - Sakai F
AD  - Neurology, Saitama International Headache Center, Saitama, Japan.
FAU - Takeshima, Takao
AU  - Takeshima T
AD  - Headache Center, Department of Neurology, Tominaga Hospital, Osaka, Japan.
FAU - Tatsuoka, Yoshihisa
AU  - Tatsuoka Y
AD  - Department of Neurology, Tatsuoka Neurology Clinic, Kyoto, Japan.
FAU - Hirata, Koichi
AU  - Hirata K
AD  - Department of Neurology, Dokkyo Medical University, Tochigi, Japan.
FAU - Cheng, Sunfa
AU  - Cheng S
AD  - Global Development, Amgen Inc., Thousand Oaks, CA, USA.
FAU - Numachi, Yotaro
AU  - Numachi Y
AD  - Research & Development, Amgen K.K., Tokyo, Japan.
FAU - Peng, Cheng
AU  - Peng C
AD  - Global Biostatistical Science, Amgen Inc., Thousand Oaks, CA, USA.
FAU - Xue, Fei
AU  - Xue F
AD  - Global Safety, Amgen Inc., Thousand Oaks, CA, USA.
FAU - Mikol, Daniel D
AU  - Mikol DD
AD  - Global Development, Amgen Inc., Thousand Oaks, CA, USA.
LA  - eng
GR  - Amgen Inc./
GR  - Novartis/
PT  - Journal Article
DEP - 20210325
PL  - United States
TA  - Headache
JT  - Headache
JID - 2985091R
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Calcitonin Gene-Related Peptide Receptor Antagonists)
RN  - I5I8VB78VT (erenumab)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal, Humanized/adverse effects/*therapeutic use
MH  - Calcitonin Gene-Related Peptide Receptor Antagonists/adverse effects/*therapeutic 
      use
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Migraine Disorders/*drug therapy
MH  - Treatment Outcome
PMC - PMC8251924
OTO - NOTNLM
OT  - Japanese
OT  - efficacy
OT  - episodic migraine
OT  - erenumab
OT  - long-term
OT  - safety
COIS- Fumihiko Sakai has received consulting fees from Amgen Inc. Takao Takeshima and 
      Yoshihisa Tatsuoka have nothing to disclose. Koichi Hirata has received royalties 
      from Amgen, Astellas, Daiichi Sankyo, Eisai, Merck Sharp & Dohme, and Pfizer. 
      Sunfa Cheng, Yotaro Numachi, Cheng Peng, Fei Xue, and Daniel D. Mikol are 
      employees and stockholders of Amgen Inc.
EDAT- 2021/03/26 06:00
MHDA- 2021/12/15 06:00
PMCR- 2021/07/02
CRDT- 2021/03/25 12:56
PHST- 2021/01/12 00:00 [revised]
PHST- 2020/09/24 00:00 [received]
PHST- 2021/01/24 00:00 [accepted]
PHST- 2021/03/26 06:00 [pubmed]
PHST- 2021/12/15 06:00 [medline]
PHST- 2021/03/25 12:56 [entrez]
PHST- 2021/07/02 00:00 [pmc-release]
AID - HEAD14096 [pii]
AID - 10.1111/head.14096 [doi]
PST - ppublish
SO  - Headache. 2021 Apr;61(4):653-661. doi: 10.1111/head.14096. Epub 2021 Mar 25.