妊娠期使用索托维单抗:COVID-19国际药物妊娠登记处的经验。

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Drug Safety Pub Date : 2024-09-01 Epub Date: 2024-05-09 DOI:10.1007/s40264-024-01439-z
Diego F Wyszynski, Lydia Demetriou, Cheryl Renz, Shirin Aliabadi, Dragutin Rafailovic, Lee P Shulman, Myriam Drysdale, Keele E Wurst
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引用次数: 0

摘要

导言:由于索托维单抗被排除在临床试验之外,有关其对妊娠患者安全性和有效性的现有数据仍然有限:由于索托维单抗被排除在临床试验之外,有关索托维单抗对孕妇的安全性和有效性的现有数据仍然有限:COVID-19国际药物妊娠登记处(COVID-PR)的建立旨在收集妊娠期接受单克隆抗体(mAb)或抗病毒治疗的轻度、中度或重度冠状病毒病2019(COVID-19)孕妇的全面安全性数据。除社会人口学和健康相关特征外,参与者还积极提供了有关其 COVID-19 症状的自我报告数据。产科、新生儿和婴儿的结果也被记录在案,随访时间长达产后12个月:截至 2023 年 11 月 30 日,COVID-PR 共对 39 名参与者使用了索托维单抗。在撰写本报告时,有 26 名参与者已经分娩,其中 9 人是通过剖腹产分娩的。婴儿出生体重从 2381 克到 4762 克不等,平均为 3439.91 克。12名参与者共报告了31起不良事件(AE)。报告最多的不良反应是妊娠高血压,有 3 名参与者出现了这种情况。COVID-19再感染、疲劳、妊娠糖尿病、头痛和孕吐各有两名参与者报告。在所报告的不良反应中,有 8 例(5 名参与者)被归类为严重不良反应,包括 4 例影响妊娠的不良反应(产程延长、先兆子痫、多羊水、早产)。这8例严重不良反应(SAE)中有7例与索曲单抗无关,1例(尿潴留)无法评估。19例分娩婴儿或宫内胎儿共发生44例AE。最常见的是 COVID-19(6 例)、耳部感染(5 例)、新生儿呼吸困难(3 例)和呼吸道合胞病毒感染(3 例)。有 16 例 AE(发生在 11 名婴儿/胎儿身上)被归类为严重 AE,其中包括胎儿心脏功能紊乱、先天性强直、持续性右脐静脉和先天性肾积水各 1 例;后者被认为是严重的先天性畸形。对于所有可评估的SAE,由于缺乏时间关系或缺乏可信的机制,因此排除了索托维单抗治疗的因果关系:结论:在COVID-PR中,相当一部分接受索托维单抗治疗的参与者患有与严重COVID-19风险增加相关的潜在疾病。在可评估的SAE中,没有一项被认为与索托维单抗治疗有关。
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Use of Sotrovimab in Pregnancy: Experiences from the COVID-19 International Drug Pregnancy Registry.

Introduction: Available data regarding the safety and efficacy of sotrovimab in pregnant patients remain limited due to their exclusion from clinical trials.

Methods: The COVID-19 International Drug Pregnancy Registry (COVID-PR) was established to gather comprehensive safety data from pregnant women who have received monoclonal antibody (mAb) or antiviral treatments for mild, moderate, or severe coronavirus disease 2019 (COVID-19) during pregnancy. Participants actively contributed self-reported data concerning their COVID-19 symptoms, in addition to sociodemographic and health-related characteristics. Obstetric, neonatal, and infant outcomes were also documented, with follow-up extending up to 12 months after childbirth.

Results: As of 30 November 2023, sotrovimab was administered to 39 participants enrolled in the COVID-PR. At the time of this report, 26 participants had given birth, with nine deliveries performed via cesarean section. The infants' birthweight ranged from 2381 g to 4762 g, with a mean of 3439.91 g. Twenty-five infants were born at ≥37 weeks. A total of 31 adverse events (AEs) were reported by 12 participants. The most frequently reported AE was gestational hypertension, observed in three participants. COVID-19 re-infection, fatigue, gestational diabetes, headache, and morning sickness were each reported by two participants. Of the reported AEs, eight (in five participants) were classified as serious, including four AEs (prolonged labor, pre-eclampsia, polyhydramnios, premature labor) that affected pregnancy. Seven of these eight serious AEs (SAEs) were found to be unrelated to sotrovimab, with one event (urinary retention) not assessable. A total of 44 AEs were reported in 19 delivered infants or in utero fetuses. The most common were COVID-19 (n = 6 events), ear infection (n = 5 events), neonatal dyspnea (n = 3 events), and respiratory syncytial virus infection (n = 3 events). Sixteen AEs (in 11 infants/fetuses) were classified as serious, including one report each of fetal cardiac disorder, congenital ankyloglossia, persistent right umbilical vein, and congenital hydronephrosis; the latter was considered a major congenital malformation. For all assessable SAEs, causality of sotrovimab treatment was ruled out based on lack of a temporal relationship alone or in combination with absence of a plausible mechanism.

Conclusion: A sizable proportion of sotrovimab-treated participants in the COVID-PR had underlying medical conditions associated with an increased risk of severe COVID-19. None of the assessable SAEs were considered to be related to sotrovimab treatment.

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来源期刊
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
期刊介绍: Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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