Article(id=1309634598326330341, tenantId=1146029695717560320, journalId=1227999776411738115, issueId=1309634614356968036, articleNumber=null, orderNo=null, doi=10.12048/j.issn.1674-229X.2026.03.007, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1749139200000, receivedDateStr=2025-06-06, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1790170820074, onlineDateStr=2026-09-23, pubDate=1774368000000, pubDateStr=2026-03-25, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1790170820074, onlineIssueDateStr=2026-09-23, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1790170820074, creator=13701087609, updateTime=1790170820074, updator=13701087609, issue=Issue{id=1309634614356968036, tenantId=1146029695717560320, journalId=1227999776411738115, year='2026', volume='36', issue='3', pageStart='161', pageEnd='240', issueExtLink='null', onlineDate='null', pubDate='1774368000000', pubDateStr='2026-03-25', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1790170823897, creator='13701087609', updateTime=1790219059643, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1309836929789682362, tenantId=1146029695717560320, journalId=1227999776411738115, issueId=1309634614356968036, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1309836929789682363, tenantId=1146029695717560320, journalId=1227999776411738115, issueId=1309634614356968036, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=199, endPage=205, ext={EN=ArticleExt(id=1309634598657680358, articleId=1309634598326330341, tenantId=1146029695717560320, journalId=1227999776411738115, language=EN, title=Real-World Drug Safety Analysis of Baricitinib: Signal Detection and Risk Assessment From FAERS, columnId=null, journalTitle=Pharmacy Today, columnName=null, runingTitle=null, highlight=null, articleAbstract=
OBJECTIVE Baricitinib, a JAK1/JAK2 inhibitor, is already used to treat rheumatoid arthritis and other immune diseases. Clinical trials have demonstrated its effectiveness, but long-term use may lead to adverse drug reactions (ADRs) such as infections, thrombosis, and liver dysfunction. Real-world safety studies of baricitinib are limited. This study aims to evaluate the safety of baricitinib using the FDA Adverse Event Reporting System (FAERS) database.
METHODS This study adopted baricitinib-related report data from the FAERS database for the period from the third quarter of 2017 to the fourth quarter of 2023. Data cleaning and screening were conducted using the OpenVigil 2.1 platform, excluding duplicate and irrelevant reports. Signal detection was performed using four statistical methods, including Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR)(hereinafter referred to as ROR and PRR), to analyze the potential risks of baricitinib-related ADRs. Descriptive statistical analyses were also conducted.
RESULTS From 2017 to 2023, a total of 47 776 724 adverse event reports related to baricitinib were received, and after data cleaning, 9 592 793 reports were included in the final analysis. Among these reports, female patients accounted for 61.4%, and most reports originated from the United States (45.4%). The main adverse reactions included pulmonary embolism, deep vein thrombosis, herpes zoster, and mitral valve perforation, with some signals (e.g., interstitial lung disease, ischemic stroke) not mentioned in the drug package insert. Baricitinib-related ADRs primarily involved infections, respiratory, nervous, and cardiovascular systems.
CONCLUSION Through the latest database, this study reflects the real-world safety data of baricitinib over a longer time period. The research found that the main adverse reactions of baricitinib include infections, pulmonary embolism, and herpes zoster, and for the first time identified previously unreported risk signals, such as interstitial pneumonia and atrial fibrillation. This study provides updated evidence for both the academic community and clinical practice, offering guidance for patient management in future clinical applications. In clinical practice, special attention should be paid to the safety of elderly patients and high-risk groups to ensure rational use.
, authors=Huiqiong ZENG
1, Wei LIU
2, Hui LIN
3, Ye ZHANG
1, *, authorsList=Huiqiong ZENG, Wei LIU, Hui LIN, Ye ZHANG, authorCompany=null, correspAuthors=Ye ZHANG, 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=1309634600335401959, articleId=1309634598326330341, tenantId=1146029695717560320, journalId=1227999776411738115, language=CN, title=巴瑞替尼真实世界药物安全性分析：来自FAERS的信号检测与风险评估, columnId=1228268589086606089, journalTitle=今日药学, columnName=论著, runingTitle=null, highlight=null, articleAbstract=
目的 巴瑞替尼（Baricitinib）为JAK1/JAK2抑制剂，已用于治疗类风湿关节炎等免疫性疾病。临床试验表明其有效，但长期使用可能导致感染、血栓、肝功能异常等不良反应。关于其真实世界安全性研究较少。本研究通过FDA不良事件报告系统（FAERS）数据库评估巴瑞替尼的安全性。
方法 本研究采用FAER数据库中2017年第3季度~2023年第4季度期间的巴瑞替尼相关报告数据。利用OpenVigil 2.1平台进行数据清理与筛选，排除重复报告和非相关报告。采用报告比值比（ROR）、比例报告比（PRR）等4种统计方法进行信号检测，分析巴瑞替尼相关不良事件（ADRs）的潜在风险，并进行描述性统计分析。
结果 2017~2023年间共收到巴瑞替尼相关的47776724例不良事件报告，经过数据清洗后，最终纳入9592793例报告。在这些报告中，女性患者占61.4%，且大部分报告来自美国（45.4%）。主要的不良反应包括肺栓塞、深静脉血栓、带状疱疹、二尖瓣穿孔等，且部分信号（如间质性肺病、缺血性中风等）未在药品说明书中提及。巴瑞替尼的ADRs主要涉及感染、呼吸系统、神经系统和心血管系统等。
结论 本研究通过最新的数据库反映出巴瑞替尼在更多时间段内的真实世界安全性数据。研究发现，巴瑞替尼的主要不良反应包括感染、肺栓塞和带状疱疹等，并首次识别出未被报道的风险信号，如间质性肺炎、房颤等。该研究为学术界和临床实践提供了更新的证据，并为未来临床应用中的患者管理提供了指导。在临床应用中，尤其应关注老年患者和高风险群体的安全性，确保合理使用。
, authors=曾惠琼
1, 刘维
2, 林茴
3, 张烨
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曾惠琼，主任医师，硕士，研究方向：免疫相关疾病诊疗
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