TY - JOUR

T1 - Safety and tolerability evaluation of erenumab for the preventive treatment of migraine

AU - Deligianni, Christina I.

AU - Mitsikostas, Dimos D

AU - Ashina, Messoud

N1 - Publisher Copyright: © 2021 Informa UK Limited, trading as Taylor & Francis Group.

PY - 2021

Y1 - 2021

N2 - 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.

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.

KW - adverse events

KW - AMG334

KW - Erenumab

KW - migraine

KW - safety

U2 - 10.1080/14740338.2021.1933941

DO - 10.1080/14740338.2021.1933941

M3 - Journal article

C2 - 34037500

AN - SCOPUS:85110875644

VL - 20

SP - 867

EP - 876

JO - Expert Opinion on Drug Safety

JF - Expert Opinion on Drug Safety

SN - 1474-0338

IS - 8

ER -