Division of Clinical Pharmacology and Toxicology, Institute of Pharmacological Sciences of Southern Switzerland, Ente Ospedaliero Cantonale, Lugano, Switzerland.
Department of Neurology, Neurocenter of Southern Switzerland, Ente Ospedaliero Cantonale, Lugano, Switzerland.
Cephalalgia. 2023 Apr;43(4):3331024231158083. doi: 10.1177/03331024231158083.
Safety data on the use of migraine preventive monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) system in pregnancy are limited.
Updated pharmacovigilance assessment of the safety reports related to pregnancy associated with erenumab, galcanezumab, fremanezumab and eptinezumab, retrieved from VigiBase® as of 31 December 2021. As primary outcome, the whole group of monoclonal antibodies targeting the CGRP system was considered and sex and age subgroup disproportionality analyses using the reporting odds ratio (ROR) were conducted.
286 safety reports were found: 116 (40.6%) on erenumab, 125 (43.7%) on galcanezumab, 39 (13.6%) on fremanezumab, 6 (2.1%) on eptinezumab. One hundred and forty-nine (52.1%) safety reports reported only drug exposure in relation to pregnancy while 137 (47.9%) also included ≥1 pregnancy outcomes: maternal outcomes (n = 64), spontaneous abortion (n = 63), foetal growth restriction (n = 1), prematurity (n = 8), neonatal outcomes (n = 13), and poor breastfeeding (n = 1). No specific patterns of maternal, foetal and neonatal toxicity were observed. Spontaneous abortion was not disproportionally more frequently reported with erenumab, galcanezumab, fremanezumab and eptinezumab compared with the entire database (ROR 1.1, 95% confidence interval, CI, 0.8-1.5), the entire database since 2018 (ROR 1.3, 95% CI 1.0-1.8), and triptans (ROR 1.2, 95% CI 0.8-1.9).
This updated safety analysis on erenumab, galcanezumab, fremanezumab and eptinezumab in pregnancy showed no signals of foeto-maternal toxicity according to VigiBase® safety reports.
关于使用靶向降钙素基因相关肽（CGRP）系统的偏头痛预防单克隆抗体治疗妊娠的安全性数据有限。
对截至 2021 年 12 月 31 日从 VigiBase®检索到的与妊娠相关的依那西普、加兰他敏、佛来美尼单抗和依替尼单抗的安全性报告进行更新的药物警戒评估。主要结局为考虑靶向 CGRP 系统的所有单克隆抗体，采用报告比值比（ROR）进行性别和年龄亚组不均衡性分析。
共发现 286 份安全性报告：依那西普 116 份（40.6%），加兰他敏 125 份（43.7%），佛来美尼单抗 39 份（13.6%），依替尼单抗 6 份（2.1%）。149 份（52.1%）安全性报告仅报告了与妊娠相关的药物暴露情况，而 137 份（47.9%）还包括≥1 项妊娠结局：母亲结局（n=64）、自然流产（n=63）、胎儿生长受限（n=1）、早产（n=8）、新生儿结局（n=13）和母乳喂养不良（n=1）。未观察到特定的母婴和新生儿毒性模式。与整个数据库（ROR 1.1，95%置信区间，CI，0.8-1.5）、整个数据库自 2018 年以来（ROR 1.3，95%CI 1.0-1.8）和曲坦类药物（ROR 1.2，95%CI 0.8-1.9）相比，依那西普、加兰他敏、佛来美尼单抗和依替尼单抗的自然流产报告比例没有显著增加。
根据 VigiBase®安全性报告，这项关于依那西普、加兰他敏、佛来美尼单抗和依替尼单抗在妊娠期间的最新安全性分析未显示出胎儿-母体毒性信号。
