de Carvalho Jozélio Freire, de Oliveira Andrade Samuel, Martinez Ana Tereza Amoedo, Skare Thelma, Appenzeller Simone
Núcleo de Pesquisa em Doenças Crônicas não Transmissíveis (NUPEC), School of Nutrition, Federal University of Bahia, Basílio da Gama, 200, Canela, Salvador, BA, 40110-040, Brazil.
Medical Pathophysiology Program, School of Medical Sciences, University of Campinas, Campinas, Brazil.
Rheumatol Ther. 2025 Aug;12(4):601-607. doi: 10.1007/s40744-025-00773-7. Epub 2025 Jun 15.
To systematically evaluate the safety and feasibility of rapid rituximab (RTX) infusion protocols in patients with autoimmune rheumatic diseases.
A comprehensive literature review was conducted using PubMed, LILACS, and Scielo databases from 1965 to May 2024 without language restrictions. Studies reporting infusion reactions associated with accelerated RTX protocols (infusion over 90 to 120 min) in rheumatologic conditions were included. Infusion-related adverse events were assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (Grades 1-5). Key variables extracted included patient demographics, underlying diseases, RTX dosage, use of premedication, number of infusions, and frequency and severity of infusion reactions.
Seven studies encompassing 538 patients aged 14-78 years were included. The patient cohort covered a spectrum of autoimmune rheumatic conditions, including systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, Sjögren's syndrome, systemic sclerosis, IgG4-related disease, and anti-synthetase syndrome. All studies implemented rapid RTX infusion protocols exclusively for the second and subsequent doses. Premedication with acetaminophen, diphenhydramine, and corticosteroids was routine in most studies. RTX dosage varied between 375 mg/m and 1000 mg, administered in two infusions spaced two weeks apart. The incidence of infusion reactions ranged from 3 to 15%, predominantly of mild severity (Grades 1 and 2), with only six cases classified as Grade 3. No Grade 4 or 5 reactions were reported. Rapid infusion protocols consistently reduced the total time patients spent in infusion clinics.
Rapid infusion of RTX in patients with autoimmune rheumatic diseases appears to be a safe and efficient alternative to standard infusion protocols. The frequency and severity of infusion reactions were comparable to traditional infusion rates, with the added benefit of reduced clinic time. These findings support the broader implementation of rapid infusion protocols in rheumatology. However, larger prospective studies with standardized reporting of adverse events are necessary to validate these results and explore the feasibility of even shorter infusion durations, as seen in oncology.
系统评估快速输注利妥昔单抗（RTX）方案在自身免疫性风湿病患者中的安全性和可行性。
使用PubMed、LILACS和Scielo数据库对1965年至2024年5月的文献进行全面回顾，无语言限制。纳入报告在风湿性疾病中与加速RTX方案（90至120分钟内输注）相关的输注反应的研究。根据美国国立癌症研究所不良事件通用术语标准（1 - 5级）评估和分级输注相关不良事件。提取的关键变量包括患者人口统计学特征、基础疾病、RTX剂量、预处理药物的使用、输注次数以及输注反应的频率和严重程度。
纳入了7项研究，共538例年龄在14 - 78岁的患者。患者队列涵盖一系列自身免疫性风湿性疾病，包括系统性红斑狼疮、类风湿关节炎、系统性血管炎、干燥综合征、系统性硬化症、IgG4相关疾病和抗合成酶综合征。所有研究仅在第二剂及后续剂量时实施快速RTX输注方案。在大多数研究中，常规使用对乙酰氨基酚、苯海拉明和皮质类固醇进行预处理。RTX剂量在375mg/m²至1000mg之间，分两次输注，间隔两周。输注反应的发生率在3%至15%之间，主要为轻度严重程度（1级和2级），只有6例分类为3级。未报告4级或5级反应。快速输注方案持续减少了患者在输注诊所花费的总时间。
在自身免疫性风湿病患者中快速输注RTX似乎是标准输注方案的一种安全有效的替代方法。输注反应的频率和严重程度与传统输注速率相当，还有减少诊所时间的额外益处。这些发现支持在风湿病学中更广泛地实施快速输注方案。然而，需要进行更大规模的前瞻性研究，并对不良事件进行标准化报告，以验证这些结果，并探索如肿瘤学中所见的更短输注持续时间的可行性。
