在 COVID 19 进展风险较高的孕妇群体中使用索托维单抗:单中心经验。

IF 4.9 4区 医学 Q1 PARASITOLOGY
Pathogens and Global Health Pub Date : 2023-07-01 Epub Date: 2023-03-10 DOI:10.1080/20477724.2023.2188839
Luisa Frallonardo, Antonella Vimercati, Roberta Novara, Cherola Lepera, Ilaria Ferrante, Giulia Chiarello, Rossana Cicinelli, Michele Mongelli, Gaetano Brindicci, Francesco Vladimiro Segala, Carmen Rita Santoro, Davide Fiore Bavaro, Nicola Laforgia, Ettore Cicinelli, Annalisa Saracino, Francesco Di Gennaro
{"title":"在 COVID 19 进展风险较高的孕妇群体中使用索托维单抗:单中心经验。","authors":"Luisa Frallonardo, Antonella Vimercati, Roberta Novara, Cherola Lepera, Ilaria Ferrante, Giulia Chiarello, Rossana Cicinelli, Michele Mongelli, Gaetano Brindicci, Francesco Vladimiro Segala, Carmen Rita Santoro, Davide Fiore Bavaro, Nicola Laforgia, Ettore Cicinelli, Annalisa Saracino, Francesco Di Gennaro","doi":"10.1080/20477724.2023.2188839","DOIUrl":null,"url":null,"abstract":"<p><p>Neutralizing monoclonal antibodies (mAbs) have been shown to reduce disease progression in patients with underlying predisposing conditions. Unfortunately, there is no evidence on the use of Sotrovimab in pregnant women. Herein we present a case series of pregnant women who received mAbs with Sotrovimab following the Italian Drug Agency (AIFA) indications. Since February 1, 2022 all pregnant women - regardless of gestational age - admitted to Obstetrics & Gynaecology of Policlinico University of Bari, with positive nasopharyngeal NAAT for SARS-CoV-2 were screened according to the AIFA indications for Sotrovimab and, if eligible, were proposed for treatment. Data on COVID-19, pregnancy, delivery, newborn outcomes, and adverse events were collected. From February 1 to May 15, 2022, 58 pregnant women were screened. Fifty (86%) patients were eligible, 19 of them (32.7%) denied their consent, in 18 cases (31%), the drug was temporarily unavailable, and the remaining 13 (22%) were treated with Sotrovimab. Out of these 13 patients, 6 (46%) were in the 3rd and 7 (54%) in the 2nd trimester of pregnancy. None of the 13 patients experienced adverse reactions due to Sotrovimab and all had a good clinical outcome. Furthermore, evaluating pre- and post-infusion clinical status and hematochemical profile, a reduction in D-dimers and an increase in SARS-CoV-2 antibodies (p < 0.01) during the 72 h following the infusion were observed. Our data, the first on the use of Sotrovimab in pregnant women, showed the safety and efficacy drug profile and its potential crucial role in preventing COVID-19 disease progression.</p>","PeriodicalId":19850,"journal":{"name":"Pathogens and Global Health","volume":"117 5","pages":"513-519"},"PeriodicalIF":4.9000,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10262799/pdf/","citationCount":"0","resultStr":"{\"title\":\"Use of Sotrovimab in a cohort of pregnant women with a high risk of COVID 19 progression: a single-center experience.\",\"authors\":\"Luisa Frallonardo, Antonella Vimercati, Roberta Novara, Cherola Lepera, Ilaria Ferrante, Giulia Chiarello, Rossana Cicinelli, Michele Mongelli, Gaetano Brindicci, Francesco Vladimiro Segala, Carmen Rita Santoro, Davide Fiore Bavaro, Nicola Laforgia, Ettore Cicinelli, Annalisa Saracino, Francesco Di Gennaro\",\"doi\":\"10.1080/20477724.2023.2188839\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Neutralizing monoclonal antibodies (mAbs) have been shown to reduce disease progression in patients with underlying predisposing conditions. Unfortunately, there is no evidence on the use of Sotrovimab in pregnant women. Herein we present a case series of pregnant women who received mAbs with Sotrovimab following the Italian Drug Agency (AIFA) indications. Since February 1, 2022 all pregnant women - regardless of gestational age - admitted to Obstetrics & Gynaecology of Policlinico University of Bari, with positive nasopharyngeal NAAT for SARS-CoV-2 were screened according to the AIFA indications for Sotrovimab and, if eligible, were proposed for treatment. Data on COVID-19, pregnancy, delivery, newborn outcomes, and adverse events were collected. From February 1 to May 15, 2022, 58 pregnant women were screened. Fifty (86%) patients were eligible, 19 of them (32.7%) denied their consent, in 18 cases (31%), the drug was temporarily unavailable, and the remaining 13 (22%) were treated with Sotrovimab. Out of these 13 patients, 6 (46%) were in the 3rd and 7 (54%) in the 2nd trimester of pregnancy. None of the 13 patients experienced adverse reactions due to Sotrovimab and all had a good clinical outcome. Furthermore, evaluating pre- and post-infusion clinical status and hematochemical profile, a reduction in D-dimers and an increase in SARS-CoV-2 antibodies (p < 0.01) during the 72 h following the infusion were observed. Our data, the first on the use of Sotrovimab in pregnant women, showed the safety and efficacy drug profile and its potential crucial role in preventing COVID-19 disease progression.</p>\",\"PeriodicalId\":19850,\"journal\":{\"name\":\"Pathogens and Global Health\",\"volume\":\"117 5\",\"pages\":\"513-519\"},\"PeriodicalIF\":4.9000,\"publicationDate\":\"2023-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10262799/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pathogens and Global Health\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/20477724.2023.2188839\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/3/10 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"PARASITOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pathogens and Global Health","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/20477724.2023.2188839","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/3/10 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"PARASITOLOGY","Score":null,"Total":0}
引用次数: 0

摘要

中和单克隆抗体(mAbs)已被证明可以减少潜在易感疾病患者的疾病进展。遗憾的是,目前还没有证据表明索罗单抗可用于孕妇。在此,我们将介绍一组按照意大利药品管理局(AIFA)的适应症接受索罗单抗 mAb 治疗的孕妇病例。自 2022 年 2 月 1 日起,巴里大学 Policlinico 妇产科根据 AIFA 索特罗维奇单抗适应症对 SARS-CoV-2 鼻咽 NAAT 阳性的所有孕妇(不考虑孕龄)进行筛查,如果符合条件,则建议其接受治疗。收集了有关 COVID-19、妊娠、分娩、新生儿结局和不良事件的数据。2022 年 2 月 1 日至 5 月 15 日,58 名孕妇接受了筛查。50名(86%)患者符合条件,其中19名(32.7%)患者拒绝同意,18名(31%)患者暂时无法获得药物,其余13名(22%)患者接受了索托维单抗治疗。在这 13 名患者中,有 6 人(46%)处于妊娠期的第三个月,7 人(54%)处于妊娠期的第二个月。13 名患者中没有一人因使用索特罗维奇单抗而出现不良反应,临床疗效良好。此外,在对输注前后的临床状态和血液生化指标进行评估后发现,D-二聚体减少,SARS-CoV-2 抗体增加(P<0.05)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Use of Sotrovimab in a cohort of pregnant women with a high risk of COVID 19 progression: a single-center experience.

Neutralizing monoclonal antibodies (mAbs) have been shown to reduce disease progression in patients with underlying predisposing conditions. Unfortunately, there is no evidence on the use of Sotrovimab in pregnant women. Herein we present a case series of pregnant women who received mAbs with Sotrovimab following the Italian Drug Agency (AIFA) indications. Since February 1, 2022 all pregnant women - regardless of gestational age - admitted to Obstetrics & Gynaecology of Policlinico University of Bari, with positive nasopharyngeal NAAT for SARS-CoV-2 were screened according to the AIFA indications for Sotrovimab and, if eligible, were proposed for treatment. Data on COVID-19, pregnancy, delivery, newborn outcomes, and adverse events were collected. From February 1 to May 15, 2022, 58 pregnant women were screened. Fifty (86%) patients were eligible, 19 of them (32.7%) denied their consent, in 18 cases (31%), the drug was temporarily unavailable, and the remaining 13 (22%) were treated with Sotrovimab. Out of these 13 patients, 6 (46%) were in the 3rd and 7 (54%) in the 2nd trimester of pregnancy. None of the 13 patients experienced adverse reactions due to Sotrovimab and all had a good clinical outcome. Furthermore, evaluating pre- and post-infusion clinical status and hematochemical profile, a reduction in D-dimers and an increase in SARS-CoV-2 antibodies (p < 0.01) during the 72 h following the infusion were observed. Our data, the first on the use of Sotrovimab in pregnant women, showed the safety and efficacy drug profile and its potential crucial role in preventing COVID-19 disease progression.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Pathogens and Global Health
Pathogens and Global Health PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH-PARASITOLOGY
CiteScore
6.00
自引率
0.00%
发文量
60
审稿时长
6-12 weeks
期刊介绍: Pathogens and Global Health is a journal of infectious disease and public health that focuses on the translation of molecular, immunological, genomics and epidemiological knowledge into control measures for global health threat. The journal publishes original innovative research papers, reviews articles and interviews policy makers and opinion leaders on health subjects of international relevance. It provides a forum for scientific, ethical and political discussion of new innovative solutions for controlling and eradicating infectious diseases, with particular emphasis on those diseases affecting the poorest regions of the world.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信