Expert Opinion on Drug Safety最新文献_第2页

A pharmacovigilance study on the safety of faricimab in real-world scenario using FDA adverse event reporting system database. 利用FDA不良事件报告系统数据库对法利昔单抗在现实情况下的安全性进行药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2025-01-21 DOI: 10.1080/14740338.2025.2456173

Furong Han, Xiang Li, Tao Tao, Jiawei Wang

{"title":"A pharmacovigilance study on the safety of faricimab in real-world scenario using FDA adverse event reporting system database.","authors":"Furong Han, Xiang Li, Tao Tao, Jiawei Wang","doi":"10.1080/14740338.2025.2456173","DOIUrl":"10.1080/14740338.2025.2456173","url":null,"abstract":"Background: Faricimab is predominantly prescribed for conditions such as age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema related to retinal vein occlusion (RVO-ME). Currently, a notable absence of large-scale, real-world studies focusing on the adverse reactions of faricimab exists.Methods: This study assesses the side effects of faricimab by analyzing reports of adverse events (AEs) from the FDA's AE Reporting System (FAERS) database. Through disproportionality analysis, this study substantiates the drug's safety oversight.Results: Our study revealed 2,746 instances of adverse events linked to faricimab, spanning 21 system organ classes (SOCs). The study retained 121 significant disproportionality preferred terms (PTs) that met criteria across all four analytical methods. Faricimab-associated AEs not documented in the drug instructions included visual impairment, blindness, retinal hemorrhage, anterior chamber inflammation, keratic precipitates, dry eye, chorioretinitis, diabetic retinopathy, and others.Conclusion: The majority of our results align with earlier clinical studies and the details outlined in the product's manual. Additionally, we identified several unforeseen and potential AE signals related to faricimab use. These insights are instrumental for ongoing clinical surveillance and risk assessment associated with the drug.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"657-664"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143002908","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Safety assessment of clomiphene: a real-world pharmacovigilance analysis from the Food and Drug Administration adverse event reporting system. 克罗米芬的安全性评估：来自食品药品管理局不良事件报告系统的真实世界药物警戒分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2024-05-23 DOI: 10.1080/14740338.2024.2358972

Yifeng Shao, Lisha Ma, Jianqing Zhou, Baicai Yang

{"title":"Safety assessment of clomiphene: a real-world pharmacovigilance analysis from the Food and Drug Administration adverse event reporting system.","authors":"Yifeng Shao, Lisha Ma, Jianqing Zhou, Baicai Yang","doi":"10.1080/14740338.2024.2358972","DOIUrl":"10.1080/14740338.2024.2358972","url":null,"abstract":"Background: Clomiphene is widely used for the treatment of anovulatory infertility, yet there remain many unrecognized adverse events (AEs). The objective of this study is to provide a comprehensive overview of the safety profile of clomiphene.Methods: The data were derived from the first quarter of 2004 to the third quarter of 2023 from the Food and Drug Administration Adverse Event Reporting System (FAERS) database. The detection of new AE signals involved the use of four algorithms: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayesian geometric mean (EBGM).Results: A total of 16,677,289 AE reports were acquired from the FAERS database, and there were 2,620 AEs specifically reported in 720 patients following clomiphene use. The AEs encompassed 102 preferred terms (PTs) across 24 system organ classes (SOCs). Some new AEs were identified, including conjoined twins (0.5%), Potter's syndrome (0.3%), genitalia external ambiguous (0.3%), esophageal atresia (0.6%), and anal atresia (0.3%).Conclusions: Although the majority of AEs aligned with the drug instruction, some new AE signals such as conjoined twins and genitalia external ambiguous were not captured. Well-designed studies are required to demonstrate the safety of clomiphene.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"759-766"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141075903","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

An update on the safety of biologic therapies for the treatment of polyarticular juvenile idiopathic arthritis. 生物疗法治疗多关节幼年特发性关节炎安全性的最新进展。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2025-02-16 DOI: 10.1080/14740338.2025.2467179

Angela Zimmer, Gerd Horneff

{"title":"An update on the safety of biologic therapies for the treatment of polyarticular juvenile idiopathic arthritis.","authors":"Angela Zimmer, Gerd Horneff","doi":"10.1080/14740338.2025.2467179","DOIUrl":"10.1080/14740338.2025.2467179","url":null,"abstract":"Introduction: An increasing number of patients with polyarticular course juvenile idiopathic arthritis are treated with biologics with great efficacy. Consequently, the importance regarding safety data in general as well as especially serious infections, incident autoimmune processes, or malignancies rises. In children, this is crucial concerning occurrences that manifest rarely and only after a prolonged latency period.Areas covered: This study aims to analyze safety under therapy with the five most commonly used biologicals for the treatment of juvenile idiopathic arthritis in Germany: abatacept, adalimumab, etanercept, golimumab, and tocilizumab, and a control cohort, who received methotrexate. For this, data from the Biologics in Pediatric Rheumatology (BiKeR) Registry were analyzed with a focus on potential adverse drug reactions like serious infections, autoimmune processes or malignancies.Expert opinion: Besides JIA category-specific differences, investigating side effects like severe infections and the development of additional autoimmune processes due to therapy is crucial. Future clinical randomized double-blinded studies are essential for direct drug comparisons, enabling optimal individualized therapy considering comorbidities and individual risks. Large patient data over a (life-)long period beyond childhood are particularly important, especially concerning the risk of malignancy after prolonged latency.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"627-642"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143413744","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Two first-generation KRAS inhibitor safety profiles: a disproportionality analysis of individual reports from the FDA adverse event reporting system. 两种第一代KRAS抑制剂的安全性概况：来自FDA不良事件报告系统的个别报告的不成比例分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-05-27 DOI: 10.1080/14740338.2025.2499219

Ying Zhang, Shuhua Tong, Li Wan

{"title":"Two first-generation KRAS inhibitor safety profiles: a disproportionality analysis of individual reports from the FDA adverse event reporting system.","authors":"Ying Zhang, Shuhua Tong, Li Wan","doi":"10.1080/14740338.2025.2499219","DOIUrl":"10.1080/14740338.2025.2499219","url":null,"abstract":"Background: First-generation KRAS inhibitors, sotorasib and adagrasib, are approved for treating non-small cell lung cancer and colorectal cancer with specific KRAS mutations. This study analyzed data from FAERS database to evaluate adverse events (AEs) associated with KRAS inhibitors.Research design and methods: Four disproportionality analysis methods were applied to measure risk signals: reporting odds ratio (ROR), proportional reporting ratio (PRR), bayesian confidence propagation neural network (BCPNN), and multi-item gamma poisson shrinker (MGPS) algorithms.Results: Between Q2 2021 and Q1 2024, 5,580 AEs in 2,958 reports on sotorasib or adagrasib were identified. Most patients were 45 and above, with a median age of 67. After meeting four algorithms' criteria, sotorasib and adagrasib retained 43 and 18 disproportionate priority items (PTs), respectively. Common AEs were diarrhea, hepatotoxicity, and pneumonitis. Unexpected important AEs included pericardial effusion, colitis, and pancreatitis associated with sotorasib; seizure, encephalopathy, unresponsiveness to stimuli and disorientation with adagrasib. Most AEs emerged within the first month of treatment. The median time to onset was 50 days for sotorasib and 21 days for adagrasib.Conclusions: Our research revealed potential new AE signals and provided a comprehensive safety profile of KRAS inhibitors, emphasizing the importance of careful monitoring and supportive care.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-11"},"PeriodicalIF":3.0,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143999739","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Unveiling the hidden ocular risks of isotretinoin: a comprehensive FAERS-Based analysis. 揭示异维甲酸隐藏的眼部风险：基于faers的综合分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-05-23 DOI: 10.1080/14740338.2025.2505530

Tao Tao, Guo Lei Du, Zhi-Jie Zhang, Zhan Yang Luo, Jia-Feng Tang, Xiang Li

{"title":"Unveiling the hidden ocular risks of isotretinoin: a comprehensive FAERS-Based analysis.","authors":"Tao Tao, Guo Lei Du, Zhi-Jie Zhang, Zhan Yang Luo, Jia-Feng Tang, Xiang Li","doi":"10.1080/14740338.2025.2505530","DOIUrl":"10.1080/14740338.2025.2505530","url":null,"abstract":"Objective: While extensive research has been conducted on isotretinoin's systemic side effects, studies focusing on its ocular side effects remain limited and often lack substantial sample sizes. To address this gap, we conducted a comprehensive investigation of isotretinoin-related ocular toxicity using data from the FAERS spanning 2004 to 2024.Methods: After excluding duplicate and incomplete records from the FAERS database, we identified 760 eye-related adverse event reports from a total of 45,258 isotretinoin-related entries. We employed the Reporting Odds Ratio (ROR) method to assess the risk of ocular problems. Additionally, we examined the onset timing of eye toxicity.Results: Among the 760 reports analyzed, dry eye emerged as the most frequently reported condition (n = 222), although it did not exhibit the strongest association. The ROR was observed for night blindness (ROR = 35.8, 95% CI = 29.66-43.21), indicating a significant risk. This finding underscores the need to focus on isotretinoin's impact on the retina and fundus, especially since night blindness and vision loss can manifest as early as the first day of treatment.Conclusion: These findings prompt new recommendations for safety monitoring by clinicians. However, additional clinical and fundamental research is essential to substantiate these observations and further elucidate the effects of isotretinoin on ocular health.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144086058","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Thromboembolic and bleeding events associated with angiogenesis inhibitors in cancer patients. 癌症患者血管生成抑制剂与血栓栓塞和出血事件相关。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-05-21 DOI: 10.1080/14740338.2025.2494688

Zhuo Ma, Yi Zhang, Dan Sun, Min Zhu, Jiawen Yi, Yixiao Zhang, Zhuoling An, Yuhui Zhang

{"title":"Thromboembolic and bleeding events associated with angiogenesis inhibitors in cancer patients.","authors":"Zhuo Ma, Yi Zhang, Dan Sun, Min Zhu, Jiawen Yi, Yixiao Zhang, Zhuoling An, Yuhui Zhang","doi":"10.1080/14740338.2025.2494688","DOIUrl":"10.1080/14740338.2025.2494688","url":null,"abstract":"Background: Angiogenesis inhibitors are associated with increased risk of thromboembolic events (TEEs) and hemorrhagic events. However, their clinical features are not well characterized in real-world studies.Research design and methods: First, we conducted a pharmacovigilance study to investigate characteristics of TEEs and bleeding and compare vascular endothelial growth factor and its receptor inhibitors (VEGF/VEGFRIs) with other antiangiogenic agents. Second, we performed a retrospective analysis of lung cancer patients who received bevacizumab or anlotinib to assess the incidence of VEGF/VEGFRI-associated TEEs and bleeding.Results: In the pharmacovigilance study, both VEGF/VEGFR-targeted biologics and VEGFR-tyrosine kinase inhibitors were associated with higher reporting of arterial thromboembolism (ATE) (reporting odd ratio (ROR) 2.91; ROR 1.25; respectively), and bleeding (ROR 2.56; ROR 2.35; respectively). Venous thromboembolism (VTE) was only associated with VEGF/VEGFR-targeted biologics (ROR 3.11). In the cohort study, bevacizumab, aflibercept, and ramucirumab showed the strongest associations with VTE, ATE, and bleeding, respectively. In the cohort study of 261 lung cancer patients treated with bevacizumab or anlotinib, 42.9% were older than 65 years, 62.1% were male, with TEEs occurred in 11.5%, and bleeding in 8.8%.Conclusions: All VEGF/VEGFRIs were associated with increased ATE and bleeding risk. VEGF/VEGFR-targeted biologics also significantly raise the risk of VTE.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-10"},"PeriodicalIF":3.0,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143990012","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Study on analgesic-induced endocrine gland damage and its potential mechanisms. 镇痛致内分泌腺损伤及其可能机制的研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-05-19 DOI: 10.1080/14740338.2025.2505543

Qian Liu, Shiwei Sun, Xinyue Chu, Huijie Li, Haiqing Zhang, Fei Li, Yongfeng Song

{"title":"Study on analgesic-induced endocrine gland damage and its potential mechanisms.","authors":"Qian Liu, Shiwei Sun, Xinyue Chu, Huijie Li, Haiqing Zhang, Fei Li, Yongfeng Song","doi":"10.1080/14740338.2025.2505543","DOIUrl":"10.1080/14740338.2025.2505543","url":null,"abstract":"Background: Analgesics are widely used for pain management, yet their association with endocrine dysfunction remains understudied. This pharmacovigilance study analyzes endocrine-related adverse events (AEs) linked to analgesics, identifies high-risk populations, and explores mechanistic pathways.Research design and methods: FAERS data (Q1 2004 to Q3 2023) were analyzed via OpenVigil 2.1 disproportionality analysis to assess analgesic-endocrine AE associations. Risk variations were evaluated through age/gender stratification, and molecular pathways were investigated via enrichment analysis.Results: Opioids exhibited the strongest endocrine associations, particularly codeine with parathyroid injury (Reporting Odds Ratio [ROR]: 14.867, 95% Confidence interval [95% CI]: 12.336-17.918) and hypothalamic-pituitary injury (ROR: 3.197, 95% CI: 1.52-6.722), and methadone with testicular injury (ROR: 2.126, 95% CI: 1.446-3.126). Flurbiprofen (NSAIDs) exhibited pancreatic injury risk (ROR: 8.416, 95% CI: 5.187-13.656). Gabapentin/pregabalin showed no significant associations. Stratified analyses revealed elevated risks in females (e.g. codeine-parathyroid injury: ROR = 19.028 vs. non-significance in males) and in patients aged ≥ 60 years. Enrichment analysis implicated dysregulated hormone-metabolic pathways underlying tissue-specific injuries and pointed to disruption of several key signaling pathways.Conclusions: Specific analgesics (not all) are associated with endocrine risks, particularly in females and older adults, necessitating personalized monitoring despite limited dose-response data.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-13"},"PeriodicalIF":3.0,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143971132","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Mechanism and clinical utility of abatacept in the treatment of rheumatoid arthritis. 阿巴接受治疗类风湿关节炎的机制及临床应用。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-05-16 DOI: 10.1080/14740338.2025.2505542

Qin-Yi Su, Jing-Ting Zhang, Hong-Jie Gao, Yan Zhang, Jing Luo, Ting-Yu Cao, Meng-Yu Yang, Sheng-Xiao Zhang

{"title":"Mechanism and clinical utility of abatacept in the treatment of rheumatoid arthritis.","authors":"Qin-Yi Su, Jing-Ting Zhang, Hong-Jie Gao, Yan Zhang, Jing Luo, Ting-Yu Cao, Meng-Yu Yang, Sheng-Xiao Zhang","doi":"10.1080/14740338.2025.2505542","DOIUrl":"10.1080/14740338.2025.2505542","url":null,"abstract":"Introduction: Abatacept, a biological disease-modifying antirheumatic drug(bDMARD), has demonstrated unique and effective therapeutic properties for rheumatoid arthritis (RA).Areas covered: This review offers an in-depth examination of the mechanism by which abatacept exerts its effects in RA treatment and assesses its efficacy and safety based on a range of studies. We conducted a comprehensive search of PubMed, Embase databases, Web of Science, the Cochrane Library, MEDLINE, Wanfang Data, and CNKI from the time the databases were created until 30 July 2024.Expert opinion: By modulating the CD28 and CD80/CD86 costimulatory signaling pathways, abatacept is instrumental in regulating immune cells and cytokines implicated in the pathogenesis RA. Longitudinal studies have highlighted its capacity to mitigate disease advancement and maintain joint functionality. The most frequently reported adverse effects associated with abatacept are headache, nausea, and upper respiratory tract infections, which are typically self-resolving. The incidence of serious infections was not high, mainly various types of bacterial pneumonia. Comparative safety analyses of abatacept with other DMARDs yield encouraging results. As our understanding of the mechanism of action of abatacept improves, we may be able to better identify appropriate biologic therapies and advanced combination therapies for RA patients and ultimately improve patient outcomes.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-12"},"PeriodicalIF":3.0,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143984824","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The adverse reactions of bevacizumab in combination with the FOLFOX chemotherapy regimen in metastatic colorectal cancer. 贝伐单抗联合 FOLFOX 化疗方案治疗转移性结直肠癌的不良反应。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-05-13 DOI: 10.1080/14740338.2025.2490274

DongQiang Luo, Jiyuan Zheng, Bingshuo Liu, Bohui Zheng, JiaZhen Jiang, Shulan Huang, Zilan Zhong, Wenling Zeng

{"title":"The adverse reactions of bevacizumab in combination with the FOLFOX chemotherapy regimen in metastatic colorectal cancer.","authors":"DongQiang Luo, Jiyuan Zheng, Bingshuo Liu, Bohui Zheng, JiaZhen Jiang, Shulan Huang, Zilan Zhong, Wenling Zeng","doi":"10.1080/14740338.2025.2490274","DOIUrl":"10.1080/14740338.2025.2490274","url":null,"abstract":"Background: Bevacizumab combined with FOLFOX improves outcomes in metastatic colorectal cancer (mCRC), but comprehensive safety evaluations remain limited.Research design and methods: We analyzed adverse drug reactions (ADRs) in the FDA Adverse Event Reporting System (FAERS), comparing FOLFOX monotherapy (366 reports), combination therapy (517 reports), and bevacizumab monotherapy (1,604 reports). Disproportionality analysis using ROR, PRR, BCPNN, and EBGM identified significant ADRs.Results: Twenty-one ADRs were significantly associated with FOLFOX-bevacizumab combination therapy, predominantly infections (e.g. febrile infection) and gastrointestinal disorders (e.g. anastomotic leak, ulcerative gastritis). The combination exhibited comparable but fewer ADRs than monotherapies, excluding pneumothorax and hypertension. Certain ADRs showed higher incidence and shorter median onset time (3 days post-treatment).Conclusions: Combination therapy demonstrates manageable safety with early monitoring, though stricter criteria for ADR detection may overlook rare events. Key risks align with monotherapy profiles, emphasizing vigilance for infection-related and gastrointestinal complications. Further studies are warranted to validate these pharmacovigilance findings.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-11"},"PeriodicalIF":3.0,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143803032","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Janus kinase inhibitors and the risk of infections: a network meta-analysis across disease indications. Janus激酶抑制剂和感染风险：跨疾病适应症的网络荟萃分析

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-05-06 DOI: 10.1080/14740338.2025.2502037

Xiaoqi Li, Qiaozhi Hu, Ting Xu

{"title":"Janus kinase inhibitors and the risk of infections: a network meta-analysis across disease indications.","authors":"Xiaoqi Li, Qiaozhi Hu, Ting Xu","doi":"10.1080/14740338.2025.2502037","DOIUrl":"10.1080/14740338.2025.2502037","url":null,"abstract":"Introduction: To compare the risks of serious infections, herpes zoster (HZ), and opportunistic infections associated with Janus kinase (JAK) inhibitors versus placebo, tumor necrosis factor-α inhibitors (TNFi), methotrexate (MTX), and among different JAK inhibitors.Methods: We searched PubMed, Embase, Cochrane Library, and Web of Science databases from their inception until 23 January 2024. Network meta-analysis estimated odds ratios for infections using restricted maximum likelihood models.Results: Eighty randomized controlled trials were included with 40,460 patients. Part of JAK inhibitors including tofacitinib (5 mg [2.01; 95%CI, 1.25-3.23], 10 mg [1.84; 95%CI, 1.06-3.17]), baricitinib (4 mg [1.57; 95%CI, 1.05-2.35]), and upadacitinib (15 mg [1.55; 95%CI, 1.06-2.27], 30 mg [1.94; 95%CI, 1.26-2.98]), exhibited a significantly different risk of serious infections compared to placebo. Similarly, tofacitinib (10 mg), baricitinib (4 mg), upadacitinib (15 mg, 30 mg), abrocitinib (200 mg), and peficitinib (100 mg) showed a significantly different risk of HZ infection compared to placebo. Most JAK inhibitors didn't raise opportunistic infections risks vs. TNFi and MTX, and risks among JAK inhibitors weren't statistically significant.Conclusion: Attention should be paid to JAK inhibitor's types, dosages, and it is important to be aware of the risk of serious infections and HZ infections. Future long-term studies should be conducted.Prospero: CRD42024523067.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-13"},"PeriodicalIF":3.0,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143981644","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0