Safety evaluation of inotuzumab ozogamicin: a pharmacovigilance study based on the FAERS database.

IF 12.5 2区医学 Q1 SURGERY

International journal of surgery Pub Date : 2025-05-12 DOI:10.1097/JS9.0000000000002435

Xueyu Duan, Yongkun Deng, Lei Li, Zhaoheng Yin, Limei Yu

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引用次数: 0

Abstract

Objective: Given inotuzumab ozogamicin (InO) relatively recent market introduction and ongoing new drug surveillance period, further research is needed on its adverse drug events (ADEs) in the real world.

Methods: Retrieve and analyze ADE reports associated with InO from the FAERS database, covering the period from 2004Q1 to 2024Q3, and employ the reporting odds ratio (ROR) methodology to conduct signal detection for InO-related ADEs.

Results: This study analyzed 1007 (2725 ADEs) patients, focusing on critical issues like veno-occlusive liver disease (VOD) (n = 97, ROR = 486.02), infections (n = 20, ROR = 3.27), and febrile neutropenia (n = 57, ROR = 20.43). Additionally, it also revealed some new ADEs, including sepsis (n = 35, ROR = 7.14), cytokine release syndrome (n = 22, ROR = 36.78), graft-versus-host disease (n = 20, ROR = 62.21), enterocolitis infectious (n = 3, ROR = 69.07), pneumonia fungal (n = 6, ROR = 30.76), and multiple organ dysfunction syndrome (n = 21, ROR = 10.65), among others. Consequently, it is imperative to exercise increased vigilance regarding these potential ADEs in the clinical administration of InO.

Conclusion: This study underscores the potential ADEs and associated risks with the clinical application of InO, with particular emphasis on the risks of VOD, infections, and febrile neutropenia. The implementation of a vigilant monitoring strategy is crucial for the early detection and timely management of these potential complications.

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inotuzumab ozogamicin的安全性评价：基于FAERS数据库的药物警戒研究。

目的：鉴于inotuzumab ozogamicin （inotuzumab ozogamicin, InO）上市时间较短，且正在进行新药监测期，需要进一步研究其在现实世界中的不良事件（ADEs）。方法：从FAERS数据库中检索并分析2004年第一季度至2024Q3年期间与InO相关的ADE报告，采用报告优势比（ROR）方法对InO相关ADE进行信号检测。结果：本研究分析了1007例（2725例ade）患者，重点关注静脉闭塞性肝病（VOD）（n = 97, ROR = 486.02）、感染（n = 20, ROR = 3.27）和发热性中性粒细胞减少（n = 57, ROR = 20.43）等关键问题。此外，还发现了一些新的不良反应，包括败血症（n = 35, ROR = 7.14）、细胞因子释放综合征（n = 22, ROR = 36.78）、移植物抗宿主病（n = 20, ROR = 62.21）、感染性小肠结肠炎（n = 3, ROR = 69.07）、真菌性肺炎（n = 6, ROR = 30.76）、多器官功能障碍综合征（n = 21, ROR = 10.65）等。因此，在临床给药时必须提高对这些潜在不良事件的警惕。结论：本研究强调了InO临床应用的潜在ade和相关风险，特别强调了VOD、感染和发热性中性粒细胞减少的风险。实施警惕的监测战略对于早期发现和及时管理这些潜在的并发症至关重要。

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

International journal of surgery SURGERY-

CiteScore

17.70

自引率

3.30%

发文量

审稿时长

6-12 weeks

期刊介绍： The International Journal of Surgery (IJS) has a broad scope, encompassing all surgical specialties. Its primary objective is to facilitate the exchange of crucial ideas and lines of thought between and across these specialties.By doing so, the journal aims to counter the growing trend of increasing sub-specialization, which can result in "tunnel-vision" and the isolation of significant surgical advancements within specific specialties.