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Pharmacovigilance in Pregnancy Studies, Exposures and Outcomes Ascertainment, and Findings from Low- and Middle-Income Countries: A Scoping Review. 妊娠期药物警戒研究、暴露和结果确定以及中低收入国家的研究结果:范围综述》。
IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-01 Epub Date: 2024-06-21 DOI: 10.1007/s40264-024-01445-1
Jenine Shafi, Maneet K Virk, Emma Kalk, James G Carlucci, Audrey Chepkemoi, Caitlin Bernard, Megan S McHenry, Edwin Were, John Humphrey, Mary-Ann Davies, Ushma C Mehta, Rena C Patel
<p><strong>Introduction: </strong>Pharmacovigilance (PV), or the ongoing safety monitoring after a medication has been licensed, plays a crucial role in pregnancy, as clinical trials often exclude pregnant people. It is important to understand how pregnancy PV projects operate in low- and middle-income countries (LMICs), where there is a disproportionate lack of PV data yet a high burden of adverse pregnancy outcomes. We conducted a scoping review to assess how exposures and outcomes were measured in recently published pregnancy PV projects in LMICs.</p><p><strong>Methods: </strong>We utilized a search string, secondary review, and team knowledge to review publications focusing on therapeutic or vaccine exposures among pregnant people in LMICs. We screened abstracts for relevance before conducting a full text review, and documented measurements of exposures and outcomes (categorized as maternal, birth, or neonatal/infant) among other factors, including study topic, setting, and design, comparator groups, and funding sources.</p><p><strong>Results: </strong>We identified 31 PV publications spanning at least 24 LMICs, all focusing on therapeutics or vaccines for infectious diseases, including HIV (n = 17), tuberculosis (TB; n = 9), malaria (n = 7), pertussis, tetanus, and diphtheria (n = 1), and influenza (n = 3). As for outcomes, n = 15, n = 31, and n = 20 of the publications covered maternal, birth, and neonatal/infant outcomes, respectively. Among HIV-specific publications, the primary exposure-outcome relationship of focus was exposure to maternal antiretroviral therapy and adverse outcomes. For TB-specific publications, the main exposures of interest were second-line drug-resistant TB and isoniazid-based prevention therapeutics for pregnant people living with HIV. For malaria-specific publications, the primary exposure-outcome relationship of interest was antimalarial medication exposure during pregnancy and adverse outcomes. Among vaccine-focused publications, the exposure was assessed during a specific time during pregnancy, with an overall interest in vaccine safety and/or efficacy. The study settings were frequently from Africa, designs varied from cohort or cross-sectional studies to clinical trials, and funding sources were largely from high-income countries.</p><p><strong>Conclusion: </strong>The published pregnancy PV projects were largely centered in Africa and concerned with infectious diseases. This may reflect the disease burden in LMICs but also funding priorities from high-income countries. As the prevalence of non-communicable diseases increases in LMICs, PV projects will have to broaden their scope. Birth and neonatal/infant outcomes were most reported, with fewer reporting on maternal outcomes and none on longer-term child outcomes; additionally, heterogeneity existed in definitions and ascertainment of specific measures. Notably, almost all projects covered a single therapeutic exposure, missing an opportunity to leverage the
简介药物警戒(PV),即药物获得许可后的持续安全性监测,在妊娠期发挥着至关重要的作用,因为临床试验通常将孕妇排除在外。了解妊娠药物警戒项目在中低收入国家(LMICs)的运行情况非常重要,这些国家的药物警戒数据非常缺乏,但妊娠不良结局的负担却很重。我们进行了一次范围界定审查,以评估最近发表的中低收入国家妊娠风险评估项目是如何测量暴露和结果的:方法:我们利用搜索字符串、二次审查和团队知识审查了关于低收入国家孕妇治疗或疫苗暴露的出版物。在进行全文审阅之前,我们对摘要进行了相关性筛选,并记录了对暴露和结果(分为孕产妇、出生或新生儿/婴儿)的测量,以及其他因素,包括研究主题、环境和设计、比较组和资金来源:我们确定了 31 篇 PV 出版物,涵盖至少 24 个低收入和中等收入国家,所有这些出版物都关注传染病的治疗或疫苗,包括 HIV(17 篇)、肺结核(9 篇)、疟疾(7 篇)、百日咳、破伤风和白喉(1 篇)以及流感(3 篇)。在结果方面,分别有 15、31 和 20 篇出版物涉及孕产妇、新生儿和婴儿的结果。在针对艾滋病病毒的出版物中,主要的暴露-结果关系是孕产妇抗逆转录病毒疗法暴露与不良结果的关系。在结核病特异性出版物中,主要关注的暴露是二线耐药结核病和以异烟肼为基础的艾滋病病毒感染孕妇预防疗法。对于疟疾特异性出版物,主要关注的暴露-结果关系是孕期抗疟药物暴露和不良后果。在以疫苗为重点的出版物中,评估的是孕期特定时间的暴露情况,总体关注点是疫苗的安全性和/或有效性。研究背景通常来自非洲,设计从队列或横断面研究到临床试验各不相同,资金来源主要来自高收入国家:结论:已发表的妊娠 PV 项目主要集中在非洲,并与传染病有关。这可能反映了低收入与中等收入国家的疾病负担,但也反映了高收入国家的优先资助重点。随着非传染性疾病在低收入与中等收入国家发病率的增加,妊娠期保健项目必须扩大其范围。报告最多的是出生和新生儿/婴儿的结果,而关于产妇结果的报告较少,没有关于儿童长期结果的报告;此外,在具体措施的定义和确定方面也存在差异。值得注意的是,几乎所有的项目都只涉及单一的治疗暴露,错失了利用其项目来涵盖更多暴露、增加科学严谨性、在医疗服务中建立统一性以及支持现有医疗系统的机会。对于许多出版物来说,暴露的时间,特别是三个月的暴露时间,对于孕产妇和新生儿的安全至关重要。虽然目前发表的妊娠期母婴风险文献为了解低收入和中等收入国家的母婴风险状况提供了深入的见解,但还需要进一步开展工作,以实现定义和测量的标准化,整合各医疗服务机构的母婴风险项目,并建立更长期的监测。
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引用次数: 0
Safety and Effectiveness of COVID-19 Vaccines During Pregnancy: A Living Systematic Review and Meta-analysis. 孕期接种 COVID-19 疫苗的安全性和有效性:活体系统综述与元分析》。
IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-01 Epub Date: 2024-07-15 DOI: 10.1007/s40264-024-01458-w
Agustín Ciapponi, Mabel Berrueta, Fernando J Argento, Jamile Ballivian, Ariel Bardach, Martin E Brizuela, Noelia Castellana, Daniel Comandé, Sami Gottlieb, Beate Kampmann, Agustina Mazzoni, Edward P K Parker, Juan M Sambade, Katharina Stegelmann, Xu Xiong, Andy Stergachis, Pierre Buekens
<p><strong>Background: </strong>Pregnant persons are susceptible to significant complications following COVID-19, even death. However, worldwide COVID-19 vaccination coverage during pregnancy remains suboptimal.</p><p><strong>Objective: </strong>This study assessed the safety and effectiveness of COVID-19 vaccines administered to pregnant persons and shared this evidence via an interactive online website.</p><p><strong>Methods: </strong>We followed Cochrane methods to conduct this living systematic review. We included studies assessing the effects of COVID-19 vaccines in pregnant persons. We conducted searches every other week for studies until October 2023, without restrictions on language or publication status, in ten databases, guidelines, preprint servers, and COVID-19 websites. The reference lists of eligible studies were hand searched to identify additional relevant studies. Pairs of review authors independently selected eligible studies using the web-based software COVIDENCE. Data extraction and risk of bias assessment were performed independently by pairs of authors. Disagreements were resolved by consensus. We performed random-effects meta-analyses of adjusted relative effects for relevant confounders of comparative studies and proportional meta-analyses to summarize frequencies from one-sample studies using R statistical software. We present the GRADE certainty of evidence from comparative studies. Findings are available on an interactive living systematic review webpage, including an updated evidence map and real-time meta-analyses customizable by subgroups and filters.</p><p><strong>Results: </strong>We included 177 studies involving 638,791 participants from 41 countries. Among the 11 types of COVID-19 vaccines identified, the most frequently used platforms were mRNA (154 studies), viral vector (51), and inactivated virus vaccines (17). Low to very low-certainty evidence suggests that vaccination may result in minimal to no important differences compared to no vaccination in all assessed maternal and infant safety outcomes from 26 fewer to 17 more events per 1000 pregnant persons, and 13 fewer to 9 more events per 1000 neonates, respectively. We found statistically significant reductions in emergency cesarean deliveries (9%) with mRNA vaccines, and in stillbirth (75-83%) with mRNA/viral vector vaccines. Low to very low-certainty evidence suggests that vaccination during pregnancy with mRNA vaccines may reduce severe cases or hospitalizations in pregnant persons with COVID-19 (72%; 95% confidence interval [CI] 42-86), symptomatic COVID-19 (78%; 95% CI 21-94), and virologically confirmed SARS-CoV-2 infection (82%; 95% CI 39-95). Reductions were lower with other vaccine types and during Omicron variant dominance than Alpha and Delta dominance. Infants also presented with fewer severe cases or hospitalizations due to COVID-19 and laboratory-confirmed SARS-CoV-2 infection (64%; 95% CI 37-80 and 66%; 95% CI 37-81, respectively).</p><p><str
背景:孕妇接种 COVID-19 后容易出现严重并发症,甚至死亡。然而,全球范围内孕期接种 COVID-19 疫苗的覆盖率仍未达到最佳水平:本研究评估了孕妇接种 COVID-19 疫苗的安全性和有效性,并通过互动在线网站分享了这些证据:方法:我们遵循 Cochrane 方法开展了这项活系统综述。我们纳入了评估 COVID-19 疫苗对孕妇影响的研究。我们每隔一周在十个数据库、指南、预印本服务器和 COVID-19 网站上检索一次研究,检索期至 2023 年 10 月,不限制语言和出版状态。对符合条件的研究的参考文献目录进行人工检索,以确定其他相关研究。一对综述作者使用基于网络的软件 COVIDENCE 独立选择符合条件的研究。数据提取和偏倚风险评估由两位作者独立完成。如有分歧,则以协商一致的方式解决。我们使用 R 统计软件对比较研究中相关混杂因素的调整相对效应进行了随机效应荟萃分析,并对单样本研究的频率进行了比例荟萃分析。我们介绍了比较研究证据的 GRADE 确定性。研究结果可在互动式活体系统综述网页上查阅,其中包括最新的证据地图和可按亚组和过滤器自定义的实时荟萃分析:我们纳入了 177 项研究,涉及 41 个国家的 638,791 名参与者。在已确定的 11 种 COVID-19 疫苗中,最常用的平台是 mRNA(154 项研究)、病毒载体(51 项)和灭活病毒疫苗(17 项)。低确定性到极低确定性的证据表明,与不接种疫苗相比,接种疫苗在所有评估的孕产妇和婴儿安全结果中可能会导致极小到无重要差异,分别是每 1000 名孕妇少发生 26 例到多发生 17 例事件,以及每 1000 名新生儿少发生 13 例到多发生 9 例事件。我们发现,接种 mRNA 疫苗后,紧急剖宫产率(9%)和死胎率(75%-83%)均有明显降低。低确定性到极低确定性的证据表明,怀孕期间接种 mRNA 疫苗可减少 COVID-19 (72%;95% 置信区间 [CI]42-86)、无症状 COVID-19 (78%;95% CI 21-94)和病毒学证实的 SARS-CoV-2 感染(82%;95% CI 39-95)孕妇的严重病例或住院治疗。接种其他类型疫苗以及在 Omicron 变种占优势期间,降低率低于 Alpha 和 Delta 占优势期间。婴儿因 COVID-19 和实验室确诊的 SARS-CoV-2 感染而导致的严重病例或住院治疗也较少(分别为 64%; 95% CI 37-80 和 66%; 95% CI 37-81):我们发现大量证据支持孕期接种 COVID-19 疫苗的安全性和有效性。结论:我们发现大量证据支持 COVID-19 疫苗在妊娠期的安全性和有效性。虽然证据的确定性不高,但鉴于目前临床试验中没有妊娠期个体,COVID-19 是最可靠的选择。研究结果将以近乎实时的可访问和互动形式与科学家、决策者、临床医生和公众分享。这篇有生命力的系统性综述强调了在引入新疫苗期间持续监测疫苗安全性和有效性的意义,尤其是在孕妇等受 COVID-19 影响的高危人群中:临床试验注册:prospero: crd42021281290。
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引用次数: 0
What is the Safety of COVID-19 Vaccines in Immunocompromised Patients? Results from the European "Covid Vaccine Monitor" Active Surveillance Study. 免疫力低下患者接种 COVID-19 疫苗的安全性如何?欧洲 "Covid 疫苗监测 "主动监测研究的结果。
IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-01 Epub Date: 2024-06-22 DOI: 10.1007/s40264-024-01449-x
Chiara Bellitto, Nicoletta Luxi, Francesco Ciccimarra, Luca L'Abbate, Monika Raethke, Florence van Hunsel, Thomas Lieber, Erik Mulder, Fabio Riefolo, Felipe Villalobos, Nicolas H Thurin, Francisco B Marques, Kathryn Morton, Fergal O'Shaughnessy, Simona Sonderlichová, Andreea Farcas, Giele-Eshuis Janneke, Miriam C Sturkenboom, Gianluca Trifirò
<p><strong>Background: </strong>The safety profile of COVID-19 vaccines in immunocompromised patients has not been comprehensively evaluated.</p><p><strong>Aim: </strong>To measure the frequency of patient-reported adverse drug reactions (ADRs) related to the first/second/booster dose of COVID-19 vaccine in immunocompromised subject versus matched cohort. As a secondary objective, the time course, evaluated as time to onset (TTO) and time to recovery (TTR), of COVID-19 vaccine-related ADRs was explored.</p><p><strong>Methods: </strong>A prospective cohort study, based on electronic questionnaires filled by vaccinees from 11 European countries in the period February 2021 to February 2023 was conducted. All immunocompromised vaccinees who provided informed consent and registered to the project's web-app within 48 h after first/booster vaccine dose administration of any EMA-authorised COVID-19 vaccine were recruited. Participants filled baseline and up to six follow-up questionnaires (FU-Qs) over 6 months from vaccination, collecting information on suspected COVID-19 vaccine-related ADRs. As a control group, non-immunocompromised vaccinees from the same source population were 1:4 matched by sex, age, vaccine dose, and brand. A descriptive analysis of demographic/clinical characteristics of vaccinees was conducted. Heatmaps of the frequency of solicited ADRs, stratified by gender and vaccine brand, were generated. Median TTO/TTR of reported ADRs were visualised using violin/box-plots.</p><p><strong>Results: </strong>A total of 773 immunocompromised vaccines were included in the analyses. Most participants were females (F/M ratio: 2.1 and 1.6) with a median age of 56 (43-74) and 51 (41-60) years, at the first vaccination cycle and booster dose, respectively. Injection-site pain and fatigue were the most frequently reported ADRs in immunocompromised vaccinees with higher frequency than matched control, especially after the first dose (41.2% vs 37.8% and 38.2% vs 32.9%, respectively). For both cohorts, all solicited ADRs were more frequently reported in females than males, and in those who had received a first dose of the Vaxzevria vaccine. Dizziness was the most frequently reported unsolicited ADR after the first dose in both groups (immunocompromised subjects: 2.5% and matched controls: 2.1%). At the booster dose, lymphadenopathy (3.9%) and lymphadenitis (1.8%) were the most reported unsolicited ADRs for immunocompromised subjects and matched controls, respectively. A very low number of subjects reported adverse event of special interest (AESI) (2 immunocompromised, 3 matched controls) and serious ADRs (5 immunocompromised, 5 matched controls). A statistically significant difference among study cohorts was observed for median TTO after the booster dose, and for median TTR after the first vaccination cycle and booster dose (p < 0.001).</p><p><strong>Conclusion: </strong>The overall safety profile of COVID-19 vaccines in immunocompromised people was fav
背景:COVID-19疫苗在免疫功能低下患者中的安全性尚未得到全面评估:目的:测量免疫功能低下受试者与匹配队列相比,患者报告的与第一/第二/加强剂量COVID-19疫苗相关的药物不良反应(ADRs)的频率。作为次要目标,研究还探讨了与 COVID-19 疫苗相关的药物不良反应的时间过程,即发病时间(TTO)和恢复时间(TTR):方法:根据来自 11 个欧洲国家的疫苗接种者在 2021 年 2 月至 2023 年 2 月期间填写的电子问卷,开展了一项前瞻性队列研究。所有免疫力低下的疫苗接种者在接种任何一种欧洲药品管理局(EMA)授权的 COVID-19 疫苗首剂/加强剂后 48 小时内提供知情同意并在项目的网络应用程序上注册,均被纳入研究范围。参与者在接种后 6 个月内填写基线问卷和多达 6 份随访问卷 (FU-Q),收集疑似 COVID-19 疫苗相关不良反应的信息。作为对照组,来自同一来源人群的非免疫缺陷疫苗接种者按性别、年龄、疫苗剂量和品牌以1:4的比例进行配对。对接种者的人口统计学/临床特征进行了描述性分析。生成了按性别和疫苗品牌分层的ADR频率热图。使用小提琴/方框图对已报告 ADR 的中位 TTO/TTR 进行了可视化分析:共有 773 例免疫力低下的疫苗被纳入分析。大多数参与者为女性(男女比例分别为 2.1 和 1.6),第一个接种周期和加强剂量的中位年龄分别为 56(43-74)岁和 51(41-60)岁。注射部位疼痛和疲劳是免疫力低下的接种者最常报告的不良反应,其发生率高于匹配的对照组,尤其是首剂接种后(分别为 41.2% 对 37.8% 和 38.2% 对 32.9%)。在两组接种者中,女性比男性更常报告所有诱发的不良反应,而接种过第一剂 Vaxzevria 疫苗的接种者也更常报告不良反应。头晕是两组接种第一剂疫苗后最常报告的非主动ADR(免疫功能低下受试者:2.5%,匹配对照组:2.1%)。在加强剂量中,淋巴结病(3.9%)和淋巴结炎(1.8%)分别是免疫力低下受试者和匹配对照组报告最多的非主动不良反应。极少数受试者报告了特别关注的不良反应(AESI)(2 例免疫功能低下者,3 例匹配对照组)和严重不良反应(5 例免疫功能低下者,5 例匹配对照组)。在加强剂量后的中位TTO以及第一个接种周期和加强剂量后的中位TTR方面,研究队列之间存在统计学意义上的显著差异(p < 0.001):免疫功能低下者接种COVID-19疫苗的总体安全性良好,与非免疫功能低下者相比差异较小。接种者大多会出现轻微的不良反应,主要发生在接种第一剂 Vaxzevria 和 Jcovden 疫苗后。严重的不良反应和AESI很少见。
{"title":"What is the Safety of COVID-19 Vaccines in Immunocompromised Patients? Results from the European \"Covid Vaccine Monitor\" Active Surveillance Study.","authors":"Chiara Bellitto, Nicoletta Luxi, Francesco Ciccimarra, Luca L'Abbate, Monika Raethke, Florence van Hunsel, Thomas Lieber, Erik Mulder, Fabio Riefolo, Felipe Villalobos, Nicolas H Thurin, Francisco B Marques, Kathryn Morton, Fergal O'Shaughnessy, Simona Sonderlichová, Andreea Farcas, Giele-Eshuis Janneke, Miriam C Sturkenboom, Gianluca Trifirò","doi":"10.1007/s40264-024-01449-x","DOIUrl":"10.1007/s40264-024-01449-x","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The safety profile of COVID-19 vaccines in immunocompromised patients has not been comprehensively evaluated.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Aim: &lt;/strong&gt;To measure the frequency of patient-reported adverse drug reactions (ADRs) related to the first/second/booster dose of COVID-19 vaccine in immunocompromised subject versus matched cohort. As a secondary objective, the time course, evaluated as time to onset (TTO) and time to recovery (TTR), of COVID-19 vaccine-related ADRs was explored.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A prospective cohort study, based on electronic questionnaires filled by vaccinees from 11 European countries in the period February 2021 to February 2023 was conducted. All immunocompromised vaccinees who provided informed consent and registered to the project's web-app within 48 h after first/booster vaccine dose administration of any EMA-authorised COVID-19 vaccine were recruited. Participants filled baseline and up to six follow-up questionnaires (FU-Qs) over 6 months from vaccination, collecting information on suspected COVID-19 vaccine-related ADRs. As a control group, non-immunocompromised vaccinees from the same source population were 1:4 matched by sex, age, vaccine dose, and brand. A descriptive analysis of demographic/clinical characteristics of vaccinees was conducted. Heatmaps of the frequency of solicited ADRs, stratified by gender and vaccine brand, were generated. Median TTO/TTR of reported ADRs were visualised using violin/box-plots.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 773 immunocompromised vaccines were included in the analyses. Most participants were females (F/M ratio: 2.1 and 1.6) with a median age of 56 (43-74) and 51 (41-60) years, at the first vaccination cycle and booster dose, respectively. Injection-site pain and fatigue were the most frequently reported ADRs in immunocompromised vaccinees with higher frequency than matched control, especially after the first dose (41.2% vs 37.8% and 38.2% vs 32.9%, respectively). For both cohorts, all solicited ADRs were more frequently reported in females than males, and in those who had received a first dose of the Vaxzevria vaccine. Dizziness was the most frequently reported unsolicited ADR after the first dose in both groups (immunocompromised subjects: 2.5% and matched controls: 2.1%). At the booster dose, lymphadenopathy (3.9%) and lymphadenitis (1.8%) were the most reported unsolicited ADRs for immunocompromised subjects and matched controls, respectively. A very low number of subjects reported adverse event of special interest (AESI) (2 immunocompromised, 3 matched controls) and serious ADRs (5 immunocompromised, 5 matched controls). A statistically significant difference among study cohorts was observed for median TTO after the booster dose, and for median TTR after the first vaccination cycle and booster dose (p &lt; 0.001).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;The overall safety profile of COVID-19 vaccines in immunocompromised people was fav","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1011-1023"},"PeriodicalIF":4.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11399172/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141440296","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pregnancy Outcomes in Patients Treated with Upadacitinib: Analysis of Data from Clinical Trials and Postmarketing Reports. 乌达替尼治疗患者的妊娠结局:来自临床试验和上市后报告的数据分析。
IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-01 Epub Date: 2024-07-15 DOI: 10.1007/s40264-024-01454-0
Uma Mahadevan, Gweneth Levy, Lianne Gensler, Mira Ali, Ana P Lacerda, Lani Wegrzyn, Hannah Palac, Tina Bhutani-Jacques, Millie Long, Megan E B Clowse, Alexa B Kimball, Christina Chambers, Anthony R Scialli

Background and objective: Upadacitinib is indicated for diseases affecting persons of childbearing potential including rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, Crohn's disease, and ulcerative colitis; however, teratogenicity was observed in animal studies. Given the potential for human fetal risk, pregnancy avoidance measures were required during clinical trials. This analysis describes pregnancy outcomes in patients exposed to upadacitinib during pregnancy.

Methods: Clinical trial and postmarketing cases of in utero exposure to upadacitinib were identified in AbbVie's safety database through 25 April, 2023. Analysis of clinical trial cases and postmarketing reports are presented separately; prospective and retrospectively reported pregnancy outcomes are integrated for each. Descriptive rates are presented to summarize outcomes.

Results: There were 128 maternal upadacitinib-exposed pregnancies with known outcomes identified; 80 and 48 pregnancies were reported in clinical trials and the postmarketing setting, respectively. In clinical trials (mean in utero exposure of 5 weeks, 3 days), live births (54%), spontaneous abortions (24%), elective terminations (21%), and ectopic pregnancy (1%) were reported. There was one report of a congenital malformation: a 35-week infant with an atrial septal defect. In postmarketing cases, live births (46%), spontaneous abortions (38%), elective terminations (15%), and ectopic pregnancy (2%) were reported.

Conclusions: As the data are limited for in utero exposure to upadacitinib, definitive conclusions cannot be drawn regarding the effect of upadacitinib on pregnancy outcomes. Rates of adverse pregnancy outcomes with upadacitinib exposure were comparable to rates observed in the general population or patients with autoimmune inflammatory diseases. To date, no apparent evidence of teratogenicity exists in the analyses of human pregnancies exposed to upadacitinib during the first trimester.

背景和目的奥帕他替尼适用于影响育龄人群的疾病,包括类风湿性关节炎、银屑病关节炎、轴性脊柱关节炎、特应性皮炎、克罗恩病和溃疡性结肠炎;然而,在动物实验中观察到了致畸性。鉴于对人类胎儿的潜在风险,临床试验期间需要采取避孕措施。本分析报告描述了妊娠期接触达达替尼的患者的妊娠结局:方法:从艾伯维的安全数据库中找到了截至 2023 年 4 月 25 日期间子宫内暴露于奥达替尼的临床试验和上市后病例。对临床试验病例和上市后报告的分析单独列出;对前瞻性和回顾性报告的妊娠结局分别进行整合。对结果进行了描述性比率总结:结果:共发现128例暴露于达帕替尼的孕产妇,并确定了已知的结果;临床试验和上市后报告的妊娠分别为80例和48例。在临床试验中(平均宫内暴露时间为 5 周 3 天),报告了活产(54%)、自然流产(24%)、选择性终止妊娠(21%)和宫外孕(1%)。有一例先天性畸形报告:一名 35 周的婴儿患有房间隔缺损。在上市后病例中,有活产(46%)、自然流产(38%)、选择性终止妊娠(15%)和宫外孕(2%)的报告:结论:由于宫内暴露于达达替尼的数据有限,因此无法就达达替尼对妊娠结局的影响得出明确结论。与普通人群或自身免疫性炎症患者相比,奥达替尼不良妊娠结局的发生率相当。迄今为止,在对妊娠头三个月暴露于达达替尼的人类妊娠进行的分析中,尚无明显的致畸证据。
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引用次数: 0
Real-World Effectiveness and Safety of Tixagevimab-Cilgavimab: A Target Trial Emulation Study. Tixagevimab-Cilgavimab 的真实世界有效性和安全性:目标试验模拟研究
IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-01 Epub Date: 2024-06-25 DOI: 10.1007/s40264-024-01450-4
Vincent Ka Chun Yan, Yu Yang, Eric Yuk Fai Wan, Francisco Tsz Tsun Lai, Celine Sze Ling Chui, Xue Li, Carlos King Ho Wong, Ivan Fan Ngai Hung, Chak Sing Lau, Ian Chi Kei Wong, Esther Wai Yin Chan

Background: Immunocompromised individuals are at high risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and subsequent severe or fatal coronavirus disease 2019 (COVID-19), yet they have suboptimal responses to mRNA and inactivated COVID-19 vaccines. The efficacy of tixagevimab-cilgavimab in reducing symptomatic SARS-CoV-2 infection was demonstrated in phase III clinical trials. Nevertheless, real-world data on the effectiveness and safety of tixagevimab-cilgavimab remain limited.

Objective: The aim was to evaluate the effectiveness and safety of tixagevimab-cilgavimab among immunocompromised individuals.

Methods: Adults who were immunocompromised or receiving immunosuppressive therapies were included in this target trial emulation using territory-wide electronic health records in Hong Kong. A sequential trial emulation approach was adopted to compare effectiveness and safety outcomes between individuals who received tixagevimab-cilgavimab and individuals who did not.

Results: A total of 746 tixagevimab-cilgavimab recipients and 2980 controls were included from 1 May 2022 to 30 November 2022. Tixagevimab-cilgavimab significantly reduced the risk of COVID-19 infection (hazard ratio [HR] 0.708, 95% confidence interval [CI] 0.527-0.951) during a median follow-up of 60 days. No significant difference was observed in the risk of COVID-19-related hospitalisation. Zero versus eight COVID-19 mortality cases and zero versus two severe COVID-19 cases were observed in tixagevimab-cilgavimab recipients and controls, respectively. Notably, significant risk reduction in COVID-19 infection was also observed among immunocompromised individuals who had been previously vaccinated with three or more doses of COVID-19 vaccine, or had no prior COVID-19 infection history.

Conclusions: Tixagevimab-cilgavimab was effective in reducing COVID-19 infection among immunocompromised patients during the Omicron wave. Findings were consistent among individuals who previously received three or more doses of COVID-19 vaccine, or had no previous history of COVID-19 infection.

背景:免疫力低下的人极易感染严重急性呼吸系统综合征冠状病毒 2(SARS-CoV-2),继而引发严重或致命的冠状病毒病 2019(COVID-19),但他们对 mRNA 和 COVID-19 灭活疫苗的反应却不理想。tixagevimab-cilgavimab 在减少无症状 SARS-CoV-2 感染方面的疗效已在 III 期临床试验中得到证实。然而,有关 tixagevimab-cilgavimab 的有效性和安全性的实际数据仍然有限:目的:评估替沙吉单抗-西格维单抗在免疫力低下人群中的有效性和安全性:方法:利用全港范围内的电子健康记录,将免疫功能低下或正在接受免疫抑制疗法的成年人纳入目标试验模拟中。方法:利用全港电子病历将免疫功能低下或正在接受免疫抑制治疗的成年人纳入目标试验仿真,并采用顺序试验仿真法比较接受了 tixagevimab-cilgavimab 和未接受 tixagevimab-cilgavimab 的个体之间的有效性和安全性结果:结果:从2022年5月1日至2022年11月30日,共纳入了746名接受tixagevimab-cilgavimab治疗的患者和2980名对照组患者。在中位随访60天期间,tixagevimab-cilgavimab可显著降低COVID-19感染风险(危险比[HR]0.708,95%置信区间[CI]0.527-0.951)。在与COVID-19相关的住院风险方面没有观察到明显差异。在tixagevimab-cilgavimab受试者和对照组中分别观察到0例和8例COVID-19死亡病例以及0例和2例严重COVID-19病例。值得注意的是,在既往接种过三针或三针以上COVID-19疫苗或既往无COVID-19感染史的免疫力低下者中,也观察到COVID-19感染风险明显降低:结论:Tixagevimab-cilgavimab能有效降低Omicron波期间免疫力低下患者的COVID-19感染率。在之前接种过三针或三针以上COVID-19疫苗或之前没有COVID-19感染史的患者中,研究结果是一致的。
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引用次数: 0
The PrescIT platform: An interoperable Clinical Decision Support System for ePrescription to Prevent Adverse Drug Reactions and Drug-Drug Interactions. PrescIT 平台:可互操作的电子处方临床决策支持系统,用于预防药物不良反应和药物间相互作用。
IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-01 Epub Date: 2024-07-20 DOI: 10.1007/s40264-024-01455-z
Pantelis Natsiavas, George Nikolaidis, Jenny Pliatsika, Achilles Chytas, George Giannios, Haralampos Karanikas, Margarita Grammatikopoulou, Martha Zachariadou, Vlasios Dimitriadis, Spiros Nikolopoulos, Ioannis Kompatsiaris

Introduction: Preventable medication errors have been proven to cause significant public health burden, and ePrescription is a key part of the process where medication errors and adverse effects could be prevented. Information systems and "intelligent" computational approaches could provide a valuable tool to prevent such errors with profound impact in clinical practice.

Objectives: The PrescIT platform is a Clinical Decision Support System (CDSS) that aims to facilitate the prevention of adverse drug reactions (ADRs) and drug-drug interactions (DDIs) in the phase of ePrescription in Greece. The proposed platform could be relatively easily localized for use in other contexts too.

Methods: The PrescIT platform is based on the use of Knowledge Engineering (ΚΕ) approaches, i.e., the use of Ontologies and Knowledge Graphs (KGs) developed upon openly available data sources. Open standards (i.e., RDF, OWL, SPARQL) are used for the development of the platform enabling the integration with already existing IT systems or for standalone use. The main KG is based on the use of DrugBank, MedDRA, SemMedDB and OpenPVSignal. In addition, the Business Process Management Notation (BPMN) has been used to model long-term therapeutic protocols used during the ePrescription process. Finally, the produced software has been pilot tested in three hospitals by 18 clinical professionals via in-person think-aloud sessions.

Results: The PrescIT platform has been successfully integrated in a transparent fashion in a proprietary Hospital Information System (HIS), and it has also been used as a standalone application. Furthermore, it has been successfully integrated with the Greek National ePrescription system. During the pilot phase, one psychiatric therapeutic protocol was used as a testbed to collect end-users' feedback. Summarizing the feedback from the end-users, they have generally acknowledged the usefulness of such a system while also identifying some challenges in terms of usability and the overall user experience.

Conclusions: The PrescIT platform has been successfully deployed and piloted in real-world environments to evaluate its ability to support safer medication prescriptions.

简介可预防的用药错误已被证明会对公众健康造成重大负担,而电子处方是可预防用药错误和不良反应的关键环节。信息系统和 "智能 "计算方法可为预防此类错误提供有价值的工具,并对临床实践产生深远影响:PrescIT 平台是一个临床决策支持系统(CDSS),旨在促进希腊电子处方阶段药物不良反应(ADR)和药物相互作用(DDI)的预防。所提议的平台可以相对容易地本地化,以便在其他情况下使用:PrescIT 平台基于知识工程 (ΚΕ)方法的使用,即使用本体论和知识图谱 (KG) 开发公开可用的数据源。开放标准(即 RDF、OWL、SPARQL)被用于开发平台,使其能够与现有 IT 系统集成或独立使用。主要的 KG 基于 DrugBank、MedDRA、SemMedDB 和 OpenPVSignal 的使用。此外,还使用了业务流程管理符号(BPMN)对电子处方过程中使用的长期治疗方案进行建模。最后,18 名临床专业人员通过面对面的 "高声思考 "环节,在三家医院对所开发的软件进行了试点测试:结果:PrescIT 平台已成功地以透明的方式集成到医院信息系统(HIS)中,并作为独立的应用程序使用。此外,该平台还与希腊国家电子处方系统成功整合。在试点阶段,一个精神病治疗方案被用作收集最终用户反馈意见的试验平台。在总结最终用户的反馈意见时,他们普遍认可该系统的实用性,同时也指出了在可用性和整体用户体验方面存在的一些挑战:PrescIT 平台已在现实环境中成功部署和试用,以评估其支持更安全处方的能力。
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引用次数: 0
The STAR Compass to Guide Future Pharmacovigilance Based on a 10-Year Review of the Strengthened EU System. 基于欧盟强化系统 10 年回顾的指导未来药物警戒的 STAR 指南针。
IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-01 Epub Date: 2024-07-10 DOI: 10.1007/s40264-024-01451-3
Priya Bahri, Georgy Genov, Peter Arlett, Viola Macolić Šarinić, Evdokia Korakianiti, Alexis Nolte, Martin Huber, Sabine M J M Straus

This article reflects on the 2010 pharmacovigilance legislation of the European Union (EU). Its legislative aim of better patient and public health protection through new responsibilities for pharmaceutical companies and regulatory bodies is considered to have been achieved and is well supported by the good pharmacovigilance practices 'EU-GVP'. For future progress, we set out a vision for high-quality pharmacovigilance in a world of ongoing medical, technological and social changes. To deliver this vision, four principles are proposed to guide actions for further progressing the EU pharmacovigilance system: synergistic interactions with healthcare systems; trustworthy evidence for regulatory decisions; adaptive process efficiency; and readiness for emergency situations (the 'STAR principles'). Like a compass, these principles should guide actions for building capacity, technology and methods; improving regulatory processes; and expanding policies, frameworks and research agendas. Fit for the future, the EU system should achieve further improved outputs in terms of safe, effective and trusted use of medicines and positive health outcomes within patient-centred healthcare.

本文对欧盟(EU)2010 年药物警戒立法进行了反思。该立法旨在通过赋予制药公司和监管机构新的责任来更好地保护患者和公众的健康,我们认为这一立法目标已经实现,并得到了良好药物警戒实践 "EU-GVP "的有力支持。对于未来的进展,我们提出了在医疗、技术和社会不断变革的世界中实现高质量药物警戒的愿景。为了实现这一愿景,我们提出了四项原则来指导欧盟药物警戒系统的进一步发展:与医疗保健系统的协同互动;监管决策的可信证据;适应性流程效率;以及为紧急情况做好准备("STAR 原则")。这些原则就像指南针一样,应指导能力、技术和方法建设行动;改进监管流程;扩大政策、框架和研究议程。为适应未来的发展,欧盟体系应在安全、有效和可信的用药方面取得进一步的成果,并在以患者为中心的医疗保健中取得积极的健康成果。
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引用次数: 0
Investigation of the Role of Chemical Analysis in Causality Assessment of Herbal and Dietary Supplement-Induced Liver Injury. 调查化学分析在草药和膳食补充剂诱发肝损伤的因果关系评估中的作用
IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-01 DOI: 10.1007/s40264-024-01484-8
Dina Halegoua-DeMarzio, Victor J Navarro, Ashley Davis, Jawad Ahmad, Bharathi Avula, Huiman Barnhart, A Sidney Barritt, Herbert L Bonkovsky, Vincent L Chen, Gina Choi, Robert J Fontana, Marwan S Ghabril, Ikhlas Khan, Christopher Koh, Joseph Odin, Don C Rockey, Hoss Rostami, Jose Serrano, Averell H Sherker, Andrew Stolz, Hans L Tillmann, Raj Vuppalanchi

Background:  The attribution of drug-induced liver injury (DILI) to specific herbal and dietary supplements (HDS) is confounded by inaccurate labels and undisclosed ingredients. The US Drug-Induced Liver Injury Network (DILIN) determines the attribution of injury to an agent through its structured expert opinion causality assessment process, but without the use of chemical analysis data of HDS. We aimed to determine the impact of chemical analysis of HDS products on prior causality assessment scores.

Methods: Obtained samples of HDS consumed by DILIN-enrolled patients were analyzed by high-performance liquid chromatography-mass spectrometry (HPLC-MS). Chemical analysis data were compared to label accuracy and detect whether the product contained botanical and non-botanical compounds. A comparison of the causality scores reassessed with chemical analysis was compared with the original scores.

Results: A total of 54 previously adjudicated cases with chemical analysis available were reassessed for causality with chemical analysis data; reviewers were blinded to original causality scores. Using the chemical analysis data, 37% (n = 20) of the 54 cases were scored with a higher likelihood of DILI compared with the original causality scores; 14 of the 20 (70%) moved from probable to highly likely; 52% had no change in causality score; and 11% of cases were scored as a lower likelihood of DILI.

Conclusions:  Our study demonstrates that there is value in using HDS chemical analysis data in the causality assessment process for DILI. In more than a third of cases, chemical analysis of products led to an increased confidence in DILI attribution to HDS. These findings suggest that chemical analysis is an important tool in causality assessment for HDS agents, specifically in challenging situations, and further studies are needed to confirm its applicability in clinical practice.

背景: 药物性肝损伤(DILI)与特定草药和膳食补充剂(HDS)的归属问题因标签不准确和成分未披露而受到混淆。美国药物性肝损伤网络(DILIN)通过其结构化的专家意见因果关系评估程序来确定损伤是否归因于某种药物,但不使用 HDS 的化学分析数据。我们旨在确定 HDS 产品的化学分析对先前因果关系评估得分的影响:通过高效液相色谱-质谱法(HPLC-MS)对加入 DILIN 的患者所食用的 HDS 样品进行分析。将化学分析数据与标签准确性进行比较,并检测产品是否含有植物和非植物化合物。通过化学分析重新评估的因果关系得分与原始得分进行了比较:利用化学分析数据重新评估了 54 个先前已裁定但有化学分析数据的病例的因果关系;审查人员对最初的因果关系评分是盲法。使用化学分析数据后,与原始因果关系评分相比,54 个病例中有 37% (n = 20)的 DILI 可能性更高;20 个病例中有 14 个病例(70%)的因果关系评分从可能变为极有可能;52% 的病例因果关系评分没有变化;11% 的病例 DILI 可能性较低: 我们的研究表明,在 DILI 的因果关系评估过程中使用 HDS 化学分析数据是有价值的。在超过三分之一的案例中,对产品的化学分析提高了将 DILI 归因于 HDS 的可信度。这些研究结果表明,化学分析是对 HDS 制剂进行因果关系评估的重要工具,特别是在具有挑战性的情况下。
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引用次数: 0
Safeguarding Patients in the AI Era: Ethics at the Forefront of Pharmacovigilance. 在人工智能时代保护患者:药物警戒最前沿的伦理。
IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-27 DOI: 10.1007/s40264-024-01483-9
Ashish Jain, Maribel Salas, Omar Aimer, Zahabia Adenwala

Artificial intelligence is increasingly being used in pharmacovigilance. However, the use of artificial intelligence in pharmacovigilance raises ethical concerns related to fairness, non-discrimination, compliance, and responsibility as the central ethical principles in risk assessment and regulatory requirements. This paper explores these concerns and provides a roadmap to how to address these challenges by considering data collection, privacy protection, transparency and accountability, model training, and explainability in artificial intelligence decision making for drug safety surveillance. A number of responsible approaches have been identified including an ethics framework and best practices to enhance artificial intelligence use in healthcare. The document also recognizes some initiatives that have demonstrated the importance of ethics in artificial intelligence pharmacovigilance. Nevertheless, the major needs mentioned in this paper are transparency, accountability, data protection, and fairness, which stress the necessity of collaboration to construct a cognitive framework aimed at integrating ethical artificial intelligence into pharmacovigilance. In conclusion, innovation should be balanced with ethical responsibility to enhance public health outcomes as well as patient safety.

人工智能正越来越多地应用于药物警戒领域。然而,在药物警戒中使用人工智能会引发与公平、非歧视、合规和责任有关的伦理问题,而这些是风险评估和监管要求的核心伦理原则。本文探讨了这些问题,并通过考虑药物安全监控人工智能决策中的数据收集、隐私保护、透明度和问责制、模型训练和可解释性,为如何应对这些挑战提供了路线图。文件提出了一些负责任的方法,包括伦理框架和最佳实践,以加强人工智能在医疗保健领域的应用。该文件还认可了一些表明伦理在人工智能药物警戒中重要性的倡议。不过,本文提到的主要需求是透明度、问责制、数据保护和公平性,这强调了合作构建认知框架的必要性,旨在将符合伦理的人工智能纳入药物警戒。总之,创新应与伦理责任相平衡,以提高公共卫生成果和患者安全。
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引用次数: 0
An Integrated Approach for Representing Knowledge on the Potential of Drugs to Cause Acute Kidney Injury. 表示药物导致急性肾损伤可能性知识的综合方法。
IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-26 DOI: 10.1007/s40264-024-01474-w
Daniel Fernández-Llaneza, Romy M P Vos, Joris E Lieverse, Helen R Gosselt, Sandra L Kane-Gill, Teun van Gelder, Joanna E Klopotowska

Introduction and objective: The recent rise in acute kidney injury (AKI) incidence, with approximately 30% attributed to potentially preventable adverse drug events (ADEs), poses challenges in evaluating drug-induced AKI due to polypharmacy and other risk factors. This study seeks to consolidate knowledge on the drugs with AKI potential from four distinct sources: (i) bio(medical) peer-reviewed journals; (ii) spontaneous reporting systems (SRS); (iii) drug information databases (DIDs); and (iv) NephroTox website. By harnessing the potential of these underutilised sources, our objective is to bridge gaps and enhance the understanding of drug-induced AKI.

Methods: By searching Medline, studies with lists of drugs with AKI potential established through consensus amongst medical experts were selected. A final list of 63 drugs was generated aggregating the original studies. For these 63 drugs, the AKI reporting odds ratios (RORs) using three SRS databases, the average frequency of ADEs from four different DIDs and the number of published studies identified via NephroTox was reported.

Results: Drugs belonging to the antivirals, antibacterials, and non-steroidal anti-inflammatory pharmacological classes exhibit substantial consensus on AKI potential, which was also reflected in strong ROR signals, frequent to very frequent AKI-related ADEs and a high number of published studies reporting adverse kidney events as identified via NephroTox. Renin-angiotensin aldosterone system inhibitors and diuretics also display comparable signal strengths, but this can be attributed to expected haemodynamic changes. More variability is noted for proton-pump inhibitors.

Conclusions: By integrating four disjointed sources of knowledge, we have created a novel, comprehensive resource on drugs with AKI potential, contributing to kidney safety improvement efforts.

引言和目的:最近,急性肾损伤(AKI)发病率上升,其中约 30% 归因于潜在可预防的药物不良事件 (ADE),这给评估由多种药物和其他风险因素引起的药物性 AKI 带来了挑战。本研究试图从以下四个不同来源整合有关可能引发 AKI 的药物的知识:(i) 生物(医学)同行评审期刊;(ii) 自发报告系统 (SRS);(iii) 药物信息数据库 (DID);(iv) NephroTox 网站。我们的目标是利用这些未得到充分利用的资料来源的潜力,缩小差距并加深对药物诱发 AKI 的了解:方法:通过搜索 Medline,筛选出医学专家一致认为可能引发 AKI 的药物清单。在汇总了原始研究后,最终得出了一份包含 63 种药物的清单。对于这 63 种药物,报告了使用三个 SRS 数据库得出的 AKI 报告几率(ROR)、四个不同 DID 的 ADE 平均频率以及通过 NephroTox 确定的已发表研究的数量:结果:抗病毒药物、抗菌药物和非甾体抗炎药物类别的药物在潜在的肾脏损伤方面表现出很大的共识,这也反映在强烈的ROR信号、频繁或非常频繁的肾脏损伤相关ADE以及通过NephroTox确定的大量已发表的报告肾脏不良事件的研究中。肾素-血管紧张素醛固酮系统抑制剂和利尿剂也显示出相似的信号强度,但这可归因于预期的血流动力学变化。质子泵抑制剂的变化更大:通过整合四种互不关联的知识来源,我们创建了一个新颖、全面的资源库,其中包含了可能导致 AKI 的药物,为改善肾脏安全做出了贡献。
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Drug Safety
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