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

IF 5 2区 医学 Q1 CLINICAL NEUROLOGY
Iker Elosua-Bayes, Alicia Alpuente, Laura Melgarejo, Edoardo Caronna, Marta Torres-Ferrús, Patricia Pozo-Rosich
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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.

针对妊娠期偏头痛患者降钙素基因相关肽的单克隆抗体病例系列:增强安全性数据。
背景:以降钙素基因相关肽为靶点的单克隆抗体(CGRP-mAbs)已被批准用于成人偏头痛的预防,但在妊娠期却存在安全性问题。我们通过一个病例系列和文献综述评估了CGRP-mAbs在围孕期的安全性:方法:六名确诊为偏头痛的女性接受了 CGRP-mAbs;怀孕后停止治疗。我们收集了数据并进行了安全性评估。为了提供全面的背景资料,我们进行了文献综述:结果:该系列包括三例艾伦单抗、两例氟马尼珠单抗和一例galcanezumab。一名氟马尼珠单抗受试者流产;使用艾伦单抗(140 毫克)时发生了与难产有关的围产期严重窒息。数据库审查显示,在世界卫生组织的 286 例病例和欧洲药品管理局的 65 例病例中,有 63 例自然流产、8 例早产和 7 例出生缺陷。这些比率与未经治疗的人群比率一致:结论:在我们的病例系列和回顾的文献中,围孕期使用 CGRP-mAbs 不会导致妊娠相关病理或新生儿不良反应的临床显著增加。
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来源期刊
Cephalalgia
Cephalalgia 医学-临床神经学
CiteScore
10.10
自引率
6.10%
发文量
108
审稿时长
4-8 weeks
期刊介绍: Cephalalgia contains original peer reviewed papers on all aspects of headache. The journal provides an international forum for original research papers, review articles and short communications. Published monthly on behalf of the International Headache Society, Cephalalgia''s rapid review averages 5 ½ weeks from author submission to first decision.
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