Adverse Events Reported with Therapies Targeting the CGRP Pathway During the First 6 Months Post-launch: A...

Area of Science:

• Neurology
• Pharmacology
• Public Health

Background:

• Three calcitonin gene-related peptide pathway-targeted monoclonal antibodies (CGRP mAbs) were approved by the FDA for migraine prevention by 2018.
• These CGRP mAbs include erenumab, fremanezumab, and galcanezumab.

Purpose of the Study:

• To evaluate the real-world safety profile of the first three CGRP mAbs approved for migraine prevention.
• To analyze adverse events (AEs) reported in the FDA Adverse Event Reporting System (FAERS) database within the initial six months post-approval for each CGRP mAb.

Main Methods:

• Retrospective analysis of spontaneously reported AEs in the FAERS database.
• Calculation of reporting rates (RR) per 1000 exposed patients for each AE category.
• Estimation of treated patient numbers using de-identified prescription data from the IQVIA database.

Main Results:

• Commonly reported AEs across all three CGRP mAbs included "migraine," "headache," "drug ineffective," "nausea," and injection-site reactions (pain, swelling, pruritus, erythema).
• "Constipation" was a notable AE for erenumab but less frequent for fremanezumab and galcanezumab.
• Cardiovascular events were not among the top ten AEs for any CGRP mAb, and serious outcomes represented ≤2% of all reported AEs.

Conclusions:

• The real-world safety data support the overall safety profile of CGRP mAbs for migraine prevention.
• Findings provide valuable insights for clinicians and patients when selecting migraine preventive therapies.