Expert Opinion on Drug Safety最新文献_第8页

Quantification of longitudinal patient-reported burden of adverse drug reactions attributed to the use of TNF-α inhibitors in inflammatory rheumatic diseases: an observational prospective cohort study. 对炎症性风湿病患者因使用 TNF-α 抑制剂而产生的药物不良反应的纵向患者报告负担进行量化：一项前瞻性队列观察研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-07-01 Epub Date: 2024-08-30 DOI: 10.1080/14740338.2024.2383697

Benthe H König, Helen R Gosselt, Jette A van Lint, Leanne J Kosse, Bart J F van den Bemt, Peter M Ten Klooster, Harald E Vonkeman, Naomi T Jessurun

{"title":"Quantification of longitudinal patient-reported burden of adverse drug reactions attributed to the use of TNF-α inhibitors in inflammatory rheumatic diseases: an observational prospective cohort study.","authors":"Benthe H König, Helen R Gosselt, Jette A van Lint, Leanne J Kosse, Bart J F van den Bemt, Peter M Ten Klooster, Harald E Vonkeman, Naomi T Jessurun","doi":"10.1080/14740338.2024.2383697","DOIUrl":"10.1080/14740338.2024.2383697","url":null,"abstract":"Background: There is a lack of knowledge on patient perspectives on adverse drug reactions (ADRs) attributed to the use of biologics. The aim of this study is to quantify the burden over time of ADRs attributed to TNF-α inhibitors in patients with inflammatory rheumatic diseases (IRDs) and investigate whether the burden over time differs between different types of ADRs.Research design and methods: Data were used from the Dutch Biologic Monitor (DBM), an observational prospective cohort study for patient-reported ADRs attributed to biologics. Patients with an IRD using a TNF-α inhibitor reporting an ADR, lasting for three consecutive questionnaires, were included. Questionnaires were sent every 2 months and the burden was scored on a 5-point Likert-type scale. Burden scores were analyzed using linear mixed models.Results: Data from 166 unique patients reporting 274 ADRs were included. The burden score decreased every month by 0.29 points (95% CI -0.34 - -0.24) on average on a 5-point Likert-type scale. The burden score for infections and infestations decreased significantly faster than the burden score for injection site reactions.Conclusions: Patient-reported burden of ADRs attributed to the use of a TNF-α inhibitor in patients with IRDs decreased significantly over time, especially for infections and infestations.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"815-820"},"PeriodicalIF":3.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141747800","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 concerns associated with BACE1 inhibitors - past, present, and future. 与BACE1抑制剂相关的安全性问题——过去、现在和未来。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-07-01 Epub Date: 2025-02-23 DOI: 10.1080/14740338.2025.2467811

Aniketh Naidu, Bret Silverglate, Mary Silverglate, George T Grossberg

引用次数: 0

Analysis of clinical characteristics of terbinafine-induced subacute cutaneous lupus erythematosus. 特比萘芬诱发的亚急性皮肤红斑狼疮临床特点分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-07-01 Epub Date: 2024-08-17 DOI: 10.1080/14740338.2024.2390644

Yang He, Zhiqiang Fan, Yuge Guo, Chunjiang Wang, Yiran He, Linqi Ouyang

{"title":"Analysis of clinical characteristics of terbinafine-induced subacute cutaneous lupus erythematosus.","authors":"Yang He, Zhiqiang Fan, Yuge Guo, Chunjiang Wang, Yiran He, Linqi Ouyang","doi":"10.1080/14740338.2024.2390644","DOIUrl":"10.1080/14740338.2024.2390644","url":null,"abstract":"Introduction: Terbinafine may cause subacute cutaneous lupus erythematosus (SCLE), and we aimed to analyze its clinical characteristics.Methods: We collected literature on terbinafine-induced SCLE from 1997 to 2023 for retrospective analysis. Thirty-seven patients (33 females and 4 males) were included.Results: The patients have a median age of 49.5 years (range 18-79) and onset time of 5 weeks (range 1-12). SCLE is mainly manifested as annular erythematous (83.3%), scaly erythematous (44.4%), and maculopapular erythematous (13.9%). Mainly, histopathological manifestations are lymphocytic infiltrate (55.6%), hyperkeratosis (38.9%) and keratinocyte necrosis (38.9%). Positive immunological parameters mainly include antinuclear antibody (100.0%), anti-Ro/SSA antibody (94.1%), and anti-La/SSB antibody (72.2%). Past medical history usually includes photosensitivity (33.3%), inflammatory disease (33.33%), and lupus erythematosus (12.1%). Symptoms are completely resolved within a median time of 35 days (range 7-84) after discontinuation of terbinafine and treatment with topical corticosteroids, systemic corticosteroids, hydroxychloroquine, and immunosuppressant. No recurrence was observed within 12 months (range 1.5-48) of follow-up.Conclusion: These results suggest that terbinafine-induced SCLE should be comprehensively diagnosed based on clinical symptoms, histopathological manifestations, immunological parameters, and past medical history. Terbinafine should be immediately discontinued when SCLE occurs, while systemic and topical corticosteroids combined with hydroxychloroquine may be an effective treatment.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"847-851"},"PeriodicalIF":3.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141970932","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

Comprehensive analysis of adverse events associated with T-cell engagers using the FAERS database. 利用 FAERS 数据库全面分析与 T 细胞接合剂相关的不良事件。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-07-01 Epub Date: 2025-02-25 DOI: 10.1080/14740338.2025.2470875

Xiangyang Le, Yefu Zhang, Junlong Ma

{"title":"Comprehensive analysis of adverse events associated with T-cell engagers using the FAERS database.","authors":"Xiangyang Le, Yefu Zhang, Junlong Ma","doi":"10.1080/14740338.2025.2470875","DOIUrl":"10.1080/14740338.2025.2470875","url":null,"abstract":"Background: T-cell engagers (TCEs) are transformative immunotherapies with significant potential in treating hematologic malignancies and solid tumors. However, their real-world safety profiles remain inadequately characterized.Research design and methods: Using the FDA Adverse Event Reporting System (FAERS) database (October 2019 - September 2024, 8,747,158 reports), we analyzed adverse events (AEs) associated with nine TCEs. Disproportionality analysis identified overreported AEs, with 11,963 unique reports analyzed after deduplication.Results: Blinatumomab was the most reported TCE (n = 4,950), and Tarlatamab the least (n = 185). Predominant AEs included immune system disorders, particularly cytokine release syndrome (IC025 range: 6.08-7.47). Drug-specific signals included reproductive system and breast disorders (IC025: 2.74) and vascular disorders (IC025: 2.25) with Tebentafusp, renal and urinary disorders with Epcoritamab (IC025: 1.84), and eye disorders with Elranatamab (IC025: 1.81). Novel AEs were also uncovered, including second malignant neoplasms, vasogenic cerebral edema with Mosunetuzumab (IC025: 5.77, ROR025: 56.29), and hydronephrosis with Epcoritamab (IC025: 7.50, ROR025: 180.70). Early-onset events (0.5-9.5 days) were linked to four TCEs, while delayed-onset events (>20 days) were linked to five others.Conclusions: This study highlights diverse AE profiles of TCEs, providing insights for clinicians to optimize their safe use in practice.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"821-830"},"PeriodicalIF":3.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143467523","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

Pharmacovigilance insights into antibody-drug conjugates: a multi-database analysis of adverse events in leukemia treatment. 抗体-药物偶联物的药物警戒洞察：白血病治疗不良事件的多数据库分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-28 DOI: 10.1080/14740338.2025.2521365

Honglong Wu, Xuchen Fan, Sheng Wu, Yiming Sun, Meiling Yu, Zhe Liu

{"title":"Pharmacovigilance insights into antibody-drug conjugates: a multi-database analysis of adverse events in leukemia treatment.","authors":"Honglong Wu, Xuchen Fan, Sheng Wu, Yiming Sun, Meiling Yu, Zhe Liu","doi":"10.1080/14740338.2025.2521365","DOIUrl":"10.1080/14740338.2025.2521365","url":null,"abstract":"Background: Gemtuzumab ozogamicin and inotuzumab ozogamicin play a crucial role in leukemia treatment. This study aims to explore multiple databases to identify adverse event (AE) signals that could enhance the safe use of these drugs.Methods design and methods: The FDA Adverse Event Reporting System (FAERS) database ASCII packages, covering 83 quarters from Q1 2004 to Q3 2024, were imported into SAS software (version 9.4) for data cleaning and analysis. Signal detection methods included the ROR, PRR, BCPNN and MGPS. The Japanese Adverse Drug Event Report database (JADER) and WHO Adverse Drug Event Report database (VigiAccess) were used to validate the results.Results: In FAERS and VigiAccess, the most frequent positive PT signal for gemtuzumab ozogamicin was 'febrile neutropenia.' In FAERS, the most frequent positive PT signal for inotuzumab ozogamicin was 'death.' The top five PTs with the highest signal intensity for both drugs across the three databases consistently included 'fibrin degradation products increased' and 'veno-occlusive liver disease.'Conclusion: Mining multiple databases enabled the identification of SOCs and AEs strongly associated with frequent adverse reactions to gemtuzumab ozogamicin and inotuzumab ozogamicin, offering valuable insights for clinical dosing guidance.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144301475","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

Adverse event profiles of four monomethyl auristatin E-conjugated antibody drug conjugates: a disproportionality analysis based on the US FDA adverse event reporting system (FAERS) database. 四种单甲基auristatin e偶联抗体药物偶联物的不良事件概况：基于美国FDA不良事件报告系统（FAERS）数据库的歧化分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-27 DOI: 10.1080/14740338.2025.2526790

Yohei Doi, Ichiro Ieiri, Mayako Uchida, Takeshi Hirota

{"title":"Adverse event profiles of four monomethyl auristatin E-conjugated antibody drug conjugates: a disproportionality analysis based on the US FDA adverse event reporting system (FAERS) database.","authors":"Yohei Doi, Ichiro Ieiri, Mayako Uchida, Takeshi Hirota","doi":"10.1080/14740338.2025.2526790","DOIUrl":"https://doi.org/10.1080/14740338.2025.2526790","url":null,"abstract":"Background: Antibody-drug conjugates (ADCs) with monomethyl auristatin E (MMAE) have recently become prevalent in cancer treatment. This study aimed to comprehensively examine the adverse events (AEs) associated with regulatory-approved MMAE-conjugated ADCs using the FDA Adverse Event Reporting System (FAERS).Research design and methods: A disproportionality analysis of reports from July 2011 to September 2024 was conducted to detect AE signals in adult patients with cancer receiving any of the four MMAE-conjugated ADCs (brentuximab vedotin, enfortumab vedotin, polatuzumab vedotin, and tisotumab vedotin) using reporting odds ratio and information component.Results: FAERS yielded 12,655 reported cases with 4,958 drug-AE pairs. Positive signals observed across the four MMAE-ADCs included 'blood and lymphatic system disorders' and 'metabolism and nutrition disorders' at the system organ class, and anemia, febrile neutropenia, hypokalemia, peripheral neuropathy, and pneumonitis for individual AEs, with 54 other overlapping AEs shared by at least three of the ADCs.Conclusions: FAERS analysis revealed overlapping safety signals in MMAE-conjugated ADCs. Although further research is necessary to clarify the causal relationships, our findings provide a basis for understanding the characteristics of possible AEs in MMAE-ADCs, aiding clinical decision-making for patient safety management.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144505278","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

Neural dysfunction, inflammatory disorder, and metabolic interference feature in amantadine-related adverse drug events: a perspective from FAERS and network toxicology. 金刚烷胺相关药物不良事件的神经功能障碍、炎症障碍和代谢干扰特征：来自FAERS和网络毒理学的视角

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-26 DOI: 10.1080/14740338.2025.2524400

Jing Yang, Yang Tian, Yue Luo, Hong-Wei Luo, Yi-Ling Wang, Bin Chen, Xing Jiang, Gu-Yu Liu, Ying-Qiu Wu, Zhi Liu, Rui-Ling Ye, Chao Wang, Xin-Lan Guan

{"title":"Neural dysfunction, inflammatory disorder, and metabolic interference feature in amantadine-related adverse drug events: a perspective from FAERS and network toxicology.","authors":"Jing Yang, Yang Tian, Yue Luo, Hong-Wei Luo, Yi-Ling Wang, Bin Chen, Xing Jiang, Gu-Yu Liu, Ying-Qiu Wu, Zhi Liu, Rui-Ling Ye, Chao Wang, Xin-Lan Guan","doi":"10.1080/14740338.2025.2524400","DOIUrl":"10.1080/14740338.2025.2524400","url":null,"abstract":"Background: Adverse drug events (ADEs) related to amantadine gradually increase as the drug is broadly acknowledged for remission of Parkinson's disease or Parkinsonism. The ADEs vary according to the affected organs and the potential mechanisms remain elusive.Methods: We mined data from the FAERS Database and employed network toxicology to appraise amantadine-related ADEs and dissect the toxicological mechanisms.Results: We found 1,917 ADE reports relevant to amantadine that embodied 1,871 intense-signal ADEs (implicating 134 preferred terms (PTs)). Of those PTs, 69 were undeclared in current amantadine insert. System organ class (SOC) term-based analysis showed that PDGFRB, STAT3, and PRKCD, as well as the enriched pathways such as Neuroactive ligand - receptor interaction and Toll-like receptor signaling pathway were instrumental in amantadine-related Death outcome. Toxicological analysis for the representative undeclared ADEs showed that the toxic targets like STAT3, MAPK1, and CYP3A4 played central roles in amantadine toxicity and adverse events. Molecular docking revealed high-affinity binding of amantadine to MAPK1, MAPK3, HSP90AA1, CYP3A4, and CYP2C19 which were involved in neural function, inflammation, and metabolism.Conclusion: The mechanisms underlying amantadine-related ADEs allow new insights into pharmacovigilance for amantadine use.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-17"},"PeriodicalIF":3.0,"publicationDate":"2025-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144368741","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

Risk of musculoskeletal disorders associated with Bruton's tyrosine kinase inhibitors: a disproportionality analysis of FAERS database and meta-analysis. 与布鲁顿酪氨酸激酶抑制剂相关的肌肉骨骼疾病风险：FAERS数据库的歧化分析和荟萃分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-18 DOI: 10.1080/14740338.2025.2521358

Mohammed Zuber, Christy Thomas, Shifa Taj, Muhammed Rashid, Krishna Undela, Jeyanthi Ramanarayanan, Francisco J Hernandez-Ilizaliturri, Lorenzo Villa Zapata

{"title":"Risk of musculoskeletal disorders associated with Bruton's tyrosine kinase inhibitors: a disproportionality analysis of FAERS database and meta-analysis.","authors":"Mohammed Zuber, Christy Thomas, Shifa Taj, Muhammed Rashid, Krishna Undela, Jeyanthi Ramanarayanan, Francisco J Hernandez-Ilizaliturri, Lorenzo Villa Zapata","doi":"10.1080/14740338.2025.2521358","DOIUrl":"10.1080/14740338.2025.2521358","url":null,"abstract":"Background: Randomized controlled trials (RCTs) have reported an increased risk of musculoskeletal disorders with BTK inhibitors (BTKis). We conducted a disproportionality analysis using the FDA Adverse Event Reporting System (FAERS) and a meta-analysis of RCTs to further investigate.Research design and methods: A retrospective case/non-case study was performed using FAERS reports through Q2 2024. Disproportionality analysis calculated Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Information Component (IC) to identify signals (PRR ≥2, lower bound ROR > 1, IC025 > 0). A meta-analysis calculated risk ratios (RR) for musculoskeletal outcomes.Results: In FAERS, ibrutinib was associated with increased reports of muscle spasms [PRR: 2.2 (χ2 : 521.9), LB ROR: 2.1, IC025 = 1.0]. Acalabrutinib showed higher risks for myalgia [PRR: 2.4, LB ROR: 2.0, IC025 = 0.9] and bone pain [PRR: 2.2, LB ROR: 1.6, IC025 = 0.6]. In the meta-analysis, ibrutinib was associated with higher risks of arthralgia (RR: 1.46, 95% CI 1.21-1.76), muscle spasm (RR: 2.32, 95% CI 1.72-3.12), and back pain (RR: 1.22, 95% CI 0.75-1.96).Conclusions: Findings from FAERS and meta-analysis suggest a stronger association between BTKis, particularly ibrutinib, and musculoskeletal adverse events.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144301476","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 and effectiveness of empagliflozin in Japanese patients with heart failure: a 1-year post-marketing surveillance study stratified by age. 恩格列净在日本心力衰竭患者中的安全性和有效性：一项按年龄分层的1年上市后监测研究

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-18 DOI: 10.1080/14740338.2025.2519835

Kazuhiro Yamamoto, Yusuke Naito, Sakurako Watanabe

{"title":"Safety and effectiveness of empagliflozin in Japanese patients with heart failure: a 1-year post-marketing surveillance study stratified by age.","authors":"Kazuhiro Yamamoto, Yusuke Naito, Sakurako Watanabe","doi":"10.1080/14740338.2025.2519835","DOIUrl":"10.1080/14740338.2025.2519835","url":null,"abstract":"Background: The sodium-glucose cotransporter-2 (SGLT2) inhibitor empagliflozin is approved in Japan for the treatment of heart failure (HF) with reduced left ventricular ejection fraction (HFrEF) and HF with preserved left ventricular ejection fraction (HFpEF). We conducted a post-marketing surveillance study of empagliflozin for HF in Japan.Research design & methods: This was a 1-year prospective, multicenter, observational study of patients with chronic HF who had not previously received empagliflozin. The primary endpoint was incidence of adverse drug reactions (ADRs). Prespecified effectiveness endpoints were all-cause death, cardiovascular (CV) death, and hospitalization for HF (HHF).Results: 1,166 patients were included (61.0% male, mean age 74.9 years). At baseline, mean left ventricular ejection fraction was 49.0%, mean body mass index was 24.2 ± 4.6 kg/m2, and 34.2% had type 2 diabetes. ADRs occurred in 61 (5.2%) patients overall, 5.8% of those aged ≥ 75 years, 6.2% of those aged 65 to < 75 years, and 2.2% of those aged < 65 years. Incidences of all-cause death, CV death, and HHF were 3.0, 0.9, and 2.5 per 100 PY, respectively.Conclusions: In this 1-year post-marketing surveillance study, empagliflozin was generally well-tolerated in patients with HF in Japan.Trial registration: ClinicalTrials.gov identifier is NCT05262764.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144283151","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

Comprehensive post-marketing safety analysis of tildrakizumab: insights from the FDA adverse event reporting system. 全面的Tildrakizumab上市后安全性分析：来自FDA不良事件报告系统的见解

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-17 DOI: 10.1080/14740338.2025.2520422

Kaidi Zhao, Shengxiang Xiao, Yang Zhao, Chen Tu

{"title":"Comprehensive post-marketing safety analysis of tildrakizumab: insights from the FDA adverse event reporting system.","authors":"Kaidi Zhao, Shengxiang Xiao, Yang Zhao, Chen Tu","doi":"10.1080/14740338.2025.2520422","DOIUrl":"10.1080/14740338.2025.2520422","url":null,"abstract":"Background: Tildrakizumab is a biologic agent approved for the treatment of moderate to severe psoriasis. Although its safety has been established in clinical trials, its real-world safety profile remains to be further investigated.Research design and methods: This study analyzed adverse events (AEs) from the FDA Adverse Event Reporting System (FAERS) database between the first quarter of 2018 and the first quarter of 2024. Four disproportionality analysis methods were applied: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS). Subgroup analyses, sensitivity analyses, and Weibull distribution modeling were conducted.Results: A total of 1,263 reports involving 2,344 AEs were included. Several known AEs were confirmed, and unexpected AEs such as urinary tract infections, herpes zoster, atrial fibrillation, and basal cell carcinoma were identified. Sensitivity analysis further confirmed the reliability of the overall findings.Conclusions: This study confirmed some known AEs and identified several unexpected AEs, highlighting the importance of early-stage monitoring. These findings may provide preliminary insights into the safe use of tildrakizumab. However, the FAERS database has limitations, including reporting bias, incomplete clinical information, and the inability to establish causality. These findings warrant further validation through prospective studies.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144283150","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