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

ABSTRACT

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.

KEYWORDS:

• Erenumab
• AMG334
• adverse events
• migraine
• safety

Declaration of interest

M Ashina has received personal fees from AbbVie/Allergan, Amgen, Eli Lilly, Lundbeck, Novartis and Teva. He is currently the principal investigator for AbbVie/Allergan, Amgen, Eli Lilly and Lundbeck in ongoing clinical trials. He reports Research grants form Lundbeck Foundation, Novo Nordisk Foundation, and Novartis. Has no ownership interest and does not own stocks of any pharmaceutical company. M Ashina also serves as an Associate editor of Cephalalgia and associate editor of the Journal of Headache and Pain. He is currently the President of the International Headache Society. DD Mitsikostas has received honoraria, research, and travel grants from Allergan, Almiral, Amgen, Bayer, Biogen, Cefaly Technology, Genesis Pharma, Electrocore, Eli Lilly, Lundbeck, Merck-Serono, Merz, Novartis, Roche, Sanofi-Genzyme, Teva, and Specifar. He is currently principal investigator on clinical trials for Eli Lily, Novartis, Lundbeck, and Teva. He is Associate Editor in Journal of Headache and Pain, President of the Hellenic Headache Society, and Co-chairman of the Headache Panel, at the European Academy of Neurology. He has no ownership interest and does not own stocks of any pharmaceutical company. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

A reviewer on this manuscript has disclosed that they have served in the Advisory Board of Amgen-Novartis. All other peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.