Case series on monoclonal antibodies targeting calcitonin gene-related peptide in migraine patients during pregnancy: Enhancing safety data

Cephalalgia. 2024 Sep;44(9):3331024241273966. doi: 10.1177/03331024241273966.

Abstract

Background: Monoclonal antibodies targeting calcitonin gene-related peptide (CGRP-mAbs) are approved for adult migraine prevention but pose safety concerns in pregnancy. We assess the safety of CGRP-mAbs in the periconceptional period through a case series and literature review.

Methods: Six migraine-diagnosed women received CGRP-mAbs; treatment ceased upon pregnancy. We collected data and conducted safety assessments. To provide a comprehensive context, we performed a literature review.

Results: The series includes three erenumab, two fremanezumab and one galcanezumab case. A fremanezumab recipient experienced miscarriage; severe perinatal asphyxia linked to dystocia occurred with erenumab (140 mg). Database reviews revealed 63 spontaneous abortions, eight premature births, and seven birth defects among 286 World Health Organization and 65 European Medicines Agency cases. These rates align with untreated population rates.

Conclusions: CGRP-mAbs use in the periconceptional period does not lead to clinically significant increase in pregnancy-related pathology or adverse effects on newborns within our case series and the literature reviewed.

Keywords: CGRP monoclonal antibodies; adverse drug reaction; migraine; pregnancy; safety.

Publication types

  • Case Reports
  • Review

MeSH terms

  • Adult
  • Antibodies, Monoclonal* / adverse effects
  • Antibodies, Monoclonal* / therapeutic use
  • Antibodies, Monoclonal, Humanized / adverse effects
  • Antibodies, Monoclonal, Humanized / therapeutic use
  • Calcitonin Gene-Related Peptide Receptor Antagonists / adverse effects
  • Calcitonin Gene-Related Peptide Receptor Antagonists / therapeutic use
  • Calcitonin Gene-Related Peptide* / antagonists & inhibitors
  • Calcitonin Gene-Related Peptide* / immunology
  • Female
  • Humans
  • Migraine Disorders* / drug therapy
  • Pregnancy
  • Pregnancy Complications* / drug therapy
  • Pregnancy Complications* / immunology

Substances

  • Calcitonin Gene-Related Peptide
  • Antibodies, Monoclonal
  • erenumab
  • Antibodies, Monoclonal, Humanized
  • fremanezumab
  • galcanezumab
  • Calcitonin Gene-Related Peptide Receptor Antagonists