Adverse event reporting of four anti-Calcitonin gene-related peptide monoclonal antibodies for migraine prevention: a real-world study based on the FDA adverse event reporting system

Sun, Wenfang; Li, Yali; Xia, Binbin; Chen, Jing; Liu, Yang; Pang, Jingyao; Liu, Fang; Cheng, Hua

doi:10.3389/fphar.2023.1257282

Cited by 5 publications

(1 citation statement)

References 51 publications

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“…A connection between the use of CGRP inhibitors and alopecia in patients with migraine has been reported in recent studies, although it has rarely been identi ed at the clinical stage and has not received clinical attention. 38,39 However, studies have shown that CGRP de ciency affects alopecia. 40,41 CGRP is an immunomodulatory neuropeptide containing substance P, and the skin levels of substance P and CGRP are decreased in scalp biopsies from patients with alopecia areata.…”

Section: Discussionmentioning

confidence: 99%

Adverse event analysis and signal detection of calcitonin gene-related peptide inhibitors using the FDA Adverse Event Reporting System database

Lee,

Ok,

Lee

et al. 2024

Preprint

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Background Calcitonin gene-related peptide (CGRP) inhibitors have been FDA-approved for migraine prophylaxis and relief. However, their safety profile remains uncertain. This study analyzes adverse events (AEs) and signals of disproportionate reporting (SDRs) using the FDA Adverse Event Reporting System (FAERS). Methods We examined AEs reported to FAERS from the approval date to August 2023, standardizing data using preferred terms and system organ classes (SOCs). Disproportionality analyses, including reporting odds ratio (ROR), proportional reporting ratio (PRR) and information component (IC), were used to quantify SDRs. Inclusion in FDA prescribing information was also checked. Results Potential safety signals for monoclonal antibodies, not listed in FDA prescribing information, included psychiatric disorders (e.g., depression - erenumab: ROR 1.97; 95% CI 1.78–2.17) and vascular disorders (e.g., hypertension - erenumab: ROR 1.44; 1.29–1.62). Epitinezumab was associated with throat irritation (ROR 36.94; 30.66–44.52). Commonly reported SOCs included general disorders and administration site conditions (27,578 events; 43.68%), injury, poisoning and procedural complications (26,201 events; 41.5%), and nervous system disorders (15,788 events; 25.01%). Conclusion This study highlights CGRP inhibitor-associated AEs, underscoring the need for clinical monitoring and risk identification. Early detection of AEs and SDRs can inform protective measures to enhance patient safety.

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Section: Discussionmentioning

confidence: 99%

Adverse event analysis and signal detection of calcitonin gene-related peptide inhibitors using the FDA Adverse Event Reporting System database

Lee,

Ok,

Lee

et al. 2024

Preprint

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Migraine treatment: Position paper of the French Headache Society

Moisset,

Demarquay,

de Gaalon

et al. 2024

Revue Neurologique

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Updated Canadian Headache Society Migraine Prevention Guideline with Systematic Review and Meta-analysis

Medrea,

Cooper,

Langman

et al. 2024

Can. J. Neurol. Sci.

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Objective: We have updated the migraine prevention guideline of the Canadian Headache Society from 2012, as there are new therapies available, and additionally, we have provided guidelines for the prevention of chronic migraine, which was not addressed in the previous iteration. Methods: We undertook a systematic review to identify new studies since the last guideline. For studies identified, we performed data extraction and subsequent meta-analyses where possible. We composed a summary of the evidence found and undertook a modified Delphi recommendation process. We provide recommendations for treatments identified and additionally expert guidance on the use of the treatments available in important clinical situations. Results: We identified 61 studies that were included in this evidence update and identified 16 therapies we focused on. The anti-calcitonin gene-related peptide (CGRP) agents were approved by Health Canada between 2018 and 2024 and provide additional options for episodic and chronic migraine prevention. We also summarize evidence for the use of propranolol, topiramate and onabotulinumtoxinA in addition to anti-CGRP agents as treatments for chronic migraine. We have downgraded topiramate to a weak recommendation for use and gabapentin to a weak recommendation against its use in episodic migraine. We have weakly recommended the use of memantine, levetiracetam, enalapril and melatonin in episodic migraine. Conclusion: Based on the evidence synthesis, we provide updated recommendations for the prevention of episodic and chronic migraine utilizing treatments available in Canada. We additionally provided expert guidance on their use in clinical situations.

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Adverse event reporting of four anti-Calcitonin gene-related peptide monoclonal antibodies for migraine prevention: a real-world study based on the FDA adverse event reporting system

Cited by 5 publications

References 51 publications

Adverse event analysis and signal detection of calcitonin gene-related peptide inhibitors using the FDA Adverse Event Reporting System database

Adverse event analysis and signal detection of calcitonin gene-related peptide inhibitors using the FDA Adverse Event Reporting System database

Migraine treatment: Position paper of the French Headache Society

Updated Canadian Headache Society Migraine Prevention Guideline with Systematic Review and Meta-analysis

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