类风湿性关节炎患者利妥昔单抗输注相关反应的频率及相关因素

M. Pekdiker
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引用次数: 0

摘要

目的:利妥昔单抗是治疗类风湿性关节炎(RA)的有效生物制剂。风湿病学家可以避免利妥昔单抗治疗,因为输液相关反应(IRR)。缺乏利妥昔单抗相关IRR的数据,特别是在rituximab-naïve类风湿性关节炎患者中;因此,我们旨在确定这些患者中利妥昔单抗相关IRR的频率和相关因素。方法:记录基线人口统计学、实验室和治疗数据。95例rituximab-naïve类风湿性关节炎患者2次输注1个疗程的利妥昔单抗。输液前进行标准化预用药。记录IRR的发生率、严重程度和管理。如果有的话,也要注意疗效和感染情况。结果:95例患者中94例成功完成利妥昔单抗疗程。我们在20例患者中共观察到23例irs。IRR发生率为12.1%,严重IRR发生率为0.52%。1-2-3级irr发生率分别为52.2%、30.4%、17.4%;未检测到4级或5级IRR。IRR患者年龄<60岁、抗ccp抗体<200U/ml、未使用美罗华前未使用生物制剂显著高于未使用IRR患者(p=0.01, p=0.002, p=0.01)。通过多变量模型分析,我们发现只有发病年龄在60个月以上,才对IRR有保护作用。结论:结果支持利妥昔单抗是二级中心医院类风湿性关节炎患者的一种安全的生物制剂选择。已确定的IRR危险因素需要在更安全的利妥昔单抗治疗的更大规模研究中得到证实。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The frequency and associated factors of infusion-related reactions to rituximab for patients with rheumatoid arthritis
Objectives: Rituximab is an effective biological agent for treating patients with rheumatoid arthritis (RA). Rheumatologists can avoid rituximab therapy because of infusion-related reactions (IRR). There is a lack of data about rituximab-related IRR, especially in rituximab-naïve patients with RA; therefore, we aimed to determine the frequency and associated factors of rituximab-related IRR in these patients. Methods: Baseline demographic, laboratory, and treatment data were noted. One course of rituximab was used in two infusions to 95 rituximab-naïve patients with RA. Standardized premedication was administered before infusions. Rates, severity, and management of IRR were recorded. Efficacy and infections were also noted if there were. Results: Ninety-four of 95 patients completed the rituximab course successfully. We observed a total of 23 IRRs in 20 patients. The frequency of IRR was 12.1%, and serious IRR was 0.52%. Grade 1-2-3 IRRs had a rate of 52.2%, 30.4%, and 17.4%, respectively; grade 4 or 5 IRR wasn’t detected. Age <60 years, anti-CCP <200U/ml and absence of biologic agent use before rituximab was significantly higher in patients with IRR than without IRR (p=0.01, p=0.002, p=0.01 respectively). We found out that if only the disease age is above 60 months, it is protective against IRR as per the results of multivariate model analysis. Conclusion: Results supported that rituximab is a safe biological agent option for patients with RA at secondary central hospitals. Identified risk factors of IRR need to be corroborated in larger studies for safer rituximab therapy.
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