| アブストラクト | BACKGROUND: Safety data on the use of migraine preventive monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) system in pregnancy are limited. METHODS: Updated pharmacovigilance assessment of the safety reports related to pregnancy associated with erenumab, galcanezumab, fremanezumab and eptinezumab, retrieved from VigiBase(R) 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. RESULTS: 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). CONCLUSIONS: This updated safety analysis on erenumab, galcanezumab, fremanezumab and eptinezumab in pregnancy showed no signals of foeto-maternal toxicity according to VigiBase(R) safety reports. |
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| ジャーナル名 | Cephalalgia : an international journal of headache |
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| 投稿日 | 2023/3/2 |
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| 投稿者 | Noseda, Roberta; Bedussi, Francesca; Gobbi, Claudio; Ceschi, Alessandro; Zecca, Chiara |
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| 組織名 | 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.;Faculty of Biomedical Sciences, Universita della Svizzera Italiana, Lugano,;Department of Neurology, University Hospital Basel, Basel, Switzerland.;Clinical Trial Unit, Ente Ospedaliero Cantonale, Lugano, Switzerland.;Department of Clinical Pharmacology and Toxicology, University Hospital Zurich,;Zurich, Switzerland. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/36855950/ |
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