A Real-World Study on Adverse Reactions of Belimumab Based on the FDA Adverse Event Reporting System Database.

IF 2.4 4区医学 Q3 PHARMACOLOGY & PHARMACY

Pharmacoepidemiology and Drug Safety Pub Date : 2024-10-01 DOI:10.1002/pds.70037

Le Hai, Jiaojiao Wu, Yingying Xie

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Abstract

Background and objectives: This investigation leverages data derived from the United States Food and Drug Administration Adverse Event Reporting (FAERS) to real-world adverse reactions associated with Belimumab, with the intention of providing guidance for safe clinical pharmacotherapy.

Methods: Data encompassing adverse drug event (ADE) reports relating to Belimumab from Q1 2011 to Q4 2023 within the FAERS were extracted and analyzed using methodologies such as the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS).

Results: The study identified a total of 19 825 ADE reports where Belimumab was the primary suspect medication, with the United States constituting the majority of reporting countries (16 312 cases, or 82.28%). Patients aged 18 to 64.9 years accounted for the largest demographic (36.29%), while the proportion of female patients (77.91%) significantly surpassed that of male patients (5.03%). The analysis uncovered 184 unique Preferred Terms (PTs) across 21 System Organ Classes (SOCs). Following selection through ROR, the SOC signal strength was prioritized as follows: Systemic disorders and administration site conditions, infections and infestations, a variety of musculoskeletal and connective tissue disorders, and conditions related to pregnancy, puerperium, and the perinatal period. The top five PTs for ADE reports not included in the product's labeling were hypersensitivity reactions, immunosuppression, non-vascular diseases, herpes virus infections, and Sjögren's syndrome. The top five PTs for ADE signal strength not included in the labeling were disseminated cutaneous herpes zoster, herpes zoster meningitis, onycholysis, cyclothymic disorder, and mixed connective tissue disease.

Discussion: Based on pharmacovigilance research utilizing the FAERS database, it is recommended that clinical monitoring of Bevacizumab should be intensified to support effective pharmaceutical care and ensure rational clinical medication use.

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基于 FDA 不良事件报告系统数据库的贝利木单抗不良反应真实世界研究

背景和目的：本调查利用美国食品药品监督管理局不良事件报告（FAERS）中的数据，了解贝利木单抗在真实世界中的不良反应，旨在为安全的临床药物治疗提供指导：这项调查利用从美国食品和药物管理局不良事件报告（FAERS）中获得的数据来了解与贝利木单抗相关的真实世界不良反应，目的是为安全的临床药物治疗提供指导：在FAERS中提取了2011年第1季度至2023年第4季度与贝利木单抗有关的药物不良事件（ADE）报告数据，并使用报告几率比（ROR）、报告比例比（PRR）、贝叶斯置信度传播神经网络（BCPNN）和多项目伽马泊松收缩器（MGPS）等方法对数据进行了分析：研究共发现了19 825例贝利木单抗为主要可疑药物的ADE报告，其中美国占报告国家的大多数（16 312例，占82.28%）。年龄在18至64.9岁之间的患者占最大比例（36.29%），女性患者的比例（77.91%）明显高于男性患者（5.03%）。分析发现了 21 个系统器官类别 (SOC) 中的 184 个独特首选术语 (PT)。通过 ROR 筛选后，SOC 信号强度的优先顺序如下：全身性疾病和给药部位病症、感染和侵袭、各种肌肉骨骼和结缔组织疾病，以及与妊娠、产褥期和围产期相关的病症。产品标签中未包含的 ADE 报告的前五大 PT 为超敏反应、免疫抑制、非血管性疾病、疱疹病毒感染和 Sjögren's 综合征。未列入标签的 ADE 信号强度排名前五位的 PT 为播散性皮肤带状疱疹、带状疱疹性脑膜炎、荨麻疹、环状哮喘和混合性结缔组织病：根据利用 FAERS 数据库进行的药物警戒研究，建议加强对贝伐珠单抗的临床监测，以支持有效的药物治疗，确保临床合理用药。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmacoepidemiology and Drug Safety 医学-药学

CiteScore

4.80

自引率

7.70%

发文量

173

审稿时长

3 months

期刊介绍： The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.