Article(id=1292135549389795897, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.10.016, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1777132800000, receivedDateStr=2026-04-26, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785998721691, onlineDateStr=2026-08-06, pubDate=1779897600000, pubDateStr=2026-05-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785998721691, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785998721691, creator=13701087609, updateTime=1785998721691, updator=13701087609, issue=Issue{id=1292135425250976333, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='10', pageStart='1351', pageEnd='1500', issueExtLink='null', onlineDate='null', pubDate='1779897600000', pubDateStr='2026-05-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785998692095, creator='13701087609', updateTime=1786014373634, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201198489202995, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201198489202996, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1451, endPage=1456, ext={EN=ArticleExt(id=1292135549691785786, articleId=1292135549389795897, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=A study on patient subgroup characteristics and temporal patterns of adverse events associated with efgartigimod, columnId=1246531412438966969, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Reader’s Field, runingTitle=null, highlight=null, articleAbstract=
Objective To analyze the characteristics of patient subgroups and temporal patterns of adverse events (AE) associated with efgartigimod treatment for generalized myasthenia gravis (gMG), based on the U.S. FDA Adverse Event Reporting System (FAERS) database, providing evidence for personalized clinical use and long-term drug safety monitoring.
Methods Individual case safety reports (ICSRs) in which efgartigimod was the primary suspect drug were extracted from the FAERS database covering Q1 2020 to Q4 2023. After deduplication and MedDRA standardization, binary logistic regression was used to assess the impact of age, sex, and body weight on symptom recurrence risk; K-means clustering identified high-risk patient subgroups; and descriptive analysis characterized the distribution of AE onset times (TTO).
Results A total of 788 ICSRs were included, of which 321 had complete time information. Logistic regression revealed that low body weight (OR=0.97, P=0.021) and younger age (OR=0.96, P=0.014) were risk factors for symptom recurrence. Clustering analysis divided patients into three groups: older and heavier individuals (mainly cardiovascular or procedure related AEs), younger and lighter individuals (primarily immune or hypersensitivity related AEs), and a heterogeneous group. The overall TTO distribution of AEs was right-skewed, with 68% occurring within 30 days. Median TTO for serious AEs (73 days) was longer than for non-serious AEs (54 days), indicating a clear delayed risk (>180 days).
Conclusion Efgartigimod related AE risks exhibit heterogeneity across populations and time dependency. Younger, lower weight patients require close monitoring for immune related AEs, while older, higher weight patients should be monitored for cardiovascular risks. A comprehensive, long-term monitoring strategy throughout the treatment cycle is warranted clinically. The integrated framework proposed here "risk stratification-subgroup identification-temporal monitoring" can be directly applied to other neonatal Fc receptor (FcRn) targeted drugs, offering an innovative model for post-marketing evaluation of biologics in China.
, authors=Xin LIANG
1, Yi-yang LIU
1, Cui-cui YANG
2, Jia-qing WANG
2, authorsList=Xin LIANG, Yi-yang LIU, Cui-cui YANG, Jia-qing WANG, authorCompany=null, correspAuthors=Jia-qing WANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1292135551428227643, articleId=1292135549389795897, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=艾加莫德不良事件的患者亚组特征与发生时间模式研究, columnId=1246531414020219657, journalTitle=中国临床药理学杂志, columnName=读者园地, runingTitle=null, highlight=null, articleAbstract=
目的 基于美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）数据库，分析艾加莫德治疗全身性重症肌无力（gMG）的不良事件（AE）患者亚组特征与发生时间模式，为临床个体化用药与长期药物警戒提供依据。
方法 提取2020年第1季度—2023年第4季度FAERS数据库中艾加莫德为首要怀疑药物的个例安全性报告（ICSRs），经去重与MedDRA标准化后，采用二元Logistic回归分析年龄、性别、体重对症状复发风险的影响；K-means聚类识别高风险患者亚组；描述性分析不良事件发生时间（TTO）分布特征。
结果 共纳入788例ICSRs，321例具备完整时间信息。Logistic回归显示，低体重（OR=0.97，P=0.021）、低龄（OR=0.96，P=0.014）是症状复发的危险因素；聚类分析将患者分为3组：年长体重重组（心血管／操作相关AE为主）、年轻体重轻组（免疫／超敏反应为主）、异质组；AE总体TTO呈右偏分布，68%发生于30 d内，严重AE中位TTO（73 d）长于非严重AE（54 d），存在明确迟发风险（>180 d）。
结论 艾加莫德AE风险存在人群异质性与时间依赖性，年轻低体重患者需重点监测免疫相关AE，年长高体重患者需关注心血管风险，临床应建立全周期长期监测策略。本研究构建的“风险分层 — 亚组识别 — 时间监测”一体化框架，可直接推广至其他FcRn靶向药物，为我国生物制剂上市后评价提供创新范式。
, authors=梁欣
1, 刘伊阳
1, 杨翠翠
2, 王佳庆
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梁欣（1984-），女，副主任药师，主要从事药事管理工作
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