Vig Sierra J, Garza Julia, Tao Yunting
Department of Pharmacy, South Texas Veterans Health Care System, San Antonio, Texas, USA.
Department of Pharmacy, The University of Texas at Austin College of Pharmacy, Austin, Texas, USA.
Headache. 2022 Nov;62(10):1256-1263. doi: 10.1111/head.14305. Epub 2022 Apr 25.
To report a case of a woman who continued erenumab for migraine prophylaxis throughout her pregnancy and to review the literature for pregnancy safety data for the calcitonin gene-related peptide (CGRP) receptor and ligand-directed therapies currently approved for migraine prophylaxis in the United States.
Migraine is a common headache disorder that can be significantly disabling. Many people experiencing migraine seek out preventative therapies to improve their quality of life. Unfortunately, currently approved prophylactic agents may not be safe to use during pregnancy, potentially limiting the use of these agents in women of childbearing potential. As the newest class of prophylactic agents for migraine, CGRP agents have limited pregnancy safety data in humans.
A review of the literature was conducted through the PubMed database using the terms pregnancy and either erenumab, fremanezumab, galcanezumab, eptinezumab, rimegepant, or atogepant. Additional sources of information such as prescribing information, assessment reports submitted to the European Medicines Agency (EMA), and manufacturer data were sought.
One case report was found in the literature documenting a human pregnancy with no adverse effects in the baby after exposure to erenumab. However, the last dose was administered in the second week of pregnancy and discontinued thereafter. The evaluation of 92 safety reports describing maternal exposure prior to or during pregnancy to either erenumab, galcanezumab, or fremanezumab was located. Incidence of miscarriage and congenital anomalies appear to be similar to rates in the general population.
The use of erenumab during pregnancy in our patient resulted in no known harm to the child. This case is unique in that the mother continued to receive erenumab throughout the pregnancy. Safety data is lacking regarding the use of these agents during pregnancy, despite their frequent use in women of childbearing potential.
报告一例女性在整个孕期持续使用erenumab预防偏头痛的病例，并回顾美国目前批准用于预防偏头痛的降钙素基因相关肽（CGRP）受体和配体导向疗法的妊娠安全性数据文献。
偏头痛是一种常见的头痛疾病，可能会严重致残。许多偏头痛患者寻求预防性治疗以改善生活质量。不幸的是，目前批准的预防药物在孕期使用可能不安全，这可能限制了这些药物在有生育潜力女性中的使用。作为最新一类偏头痛预防药物，CGRP药物在人类中的妊娠安全性数据有限。
通过PubMed数据库，使用“妊娠”以及erenumab、fremanezumab、galcanezumab、eptinezumab、rimegepant或atogepant等关键词进行文献检索。还寻求其他信息来源，如处方信息、提交给欧洲药品管理局（EMA）的评估报告以及制造商数据。
文献中发现一例病例报告，记录了一名孕妇在接触erenumab后婴儿未出现不良反应。然而，最后一剂药物是在怀孕第二周使用的，此后停药。对92份描述孕妇在怀孕前或怀孕期间接触erenumab、galcanezumab或fremanezumab的安全性报告进行了评估。流产和先天性异常的发生率似乎与一般人群的发生率相似。
我们的患者在孕期使用erenumab对孩子未造成已知伤害。该病例的独特之处在于母亲在整个孕期持续接受erenumab治疗。尽管这些药物在有生育潜力的女性中经常使用，但关于其在孕期使用的安全性数据仍然缺乏。
