PMID- 34037500
OWN - NLM
STAT- MEDLINE
DCOM- 20210920
LR  - 20210920
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 20
IP  - 8
DP  - 2021 Aug
TI  - Safety and tolerability evaluation of erenumab for the preventive treatment of 
      migraine.
PG  - 867-876
LID - 10.1080/14740338.2021.1933941 [doi]
AB  - Introduction: Erenumab, a monoclonal antibody targeting the receptor of 
      calcitonin gene related peptide (CGRP), is the first disease-specific and 
      mechanism-based treatment approved for the prevention of migraine. Although the 
      safety and tolerability data from randomized trials are clear, the physiological 
      effects of CGRP rise reasonable concerns. We aimed to evaluate the current 
      evidence for safety and tolerability related to erenumab use in migraine. Areas 
      covered: This review outlines the severe adverse events (AEs), common AEs, AEs 
      leading to treatment discontinuation and AEs of special interest, reported in all 
      phase 2, phase 3, open label, and observational studies with erenumab in 
      migraine. Individual safety reports were also included in the systematic review 
      of evidence. Expert opinion: No safety and tolerability flags were detected in 
      this review. The most common AE are local skin reactions and constipation. No 
      severe AEs, or frequent AEs leading to treatment discontinuation were detected. 
      Treatment is well tolerated. The only AE of interest that may play a role in 
      decision making and treatment monitoring is constipation. These findings are in 
      line with previous safety reports, further highlighting the substantial 
      tolerability and safety profile of the modern anti-CGRP monoclonal antibodies for 
      the prevention of migraine.
FAU - Deligianni, Christina I
AU  - Deligianni CI
AD  - Danish Headache Center, Rigshospitalet Glostrup, University of Copenhagen, 
      Copenhagen, Denmark.
FAU - Mitsikostas, Dimos D
AU  - Mitsikostas DD
AD  - 1st Department of Neurology, Eginition Hospital, Medical School, National and 
      Kapodistrian University of Athens, Athens, Greece.
FAU - Ashina, Messoud
AU  - Ashina M
AD  - Danish Headache Center, Rigshospitalet Glostrup, University of Copenhagen, 
      Copenhagen, Denmark.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20210716
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Calcitonin Gene-Related Peptide Receptor Antagonists)
RN  - I5I8VB78VT (erenumab)
SB  - IM
MH  - Antibodies, Monoclonal, Humanized/administration & dosage/*adverse effects
MH  - Calcitonin Gene-Related Peptide Receptor Antagonists/administration & 
      dosage/*adverse effects
MH  - Humans
MH  - Migraine Disorders/*prevention & control
MH  - Randomized Controlled Trials as Topic
MH  - Severity of Illness Index
OTO - NOTNLM
OT  - AMG334
OT  - Erenumab
OT  - adverse events
OT  - migraine
OT  - safety
EDAT- 2021/05/27 06:00
MHDA- 2021/09/21 06:00
CRDT- 2021/05/26 12:18
PHST- 2021/05/27 06:00 [pubmed]
PHST- 2021/09/21 06:00 [medline]
PHST- 2021/05/26 12:18 [entrez]
AID - 10.1080/14740338.2021.1933941 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2021 Aug;20(8):867-876. doi: 10.1080/14740338.2021.1933941. 
      Epub 2021 Jul 16.