Safety of Accelerated Rituximab Infusion in Rheumatic Diseases: A Systematic Review.

IF 2.9 3区 医学 Q2 RHEUMATOLOGY
Rheumatology and Therapy Pub Date : 2025-08-01 Epub Date: 2025-06-15 DOI:10.1007/s40744-025-00773-7
Jozélio Freire de Carvalho, Samuel de Oliveira Andrade, Ana Tereza Amoedo Martinez, Thelma Skare, Simone Appenzeller
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引用次数: 0

Abstract

Objective: To systematically evaluate the safety and feasibility of rapid rituximab (RTX) infusion protocols in patients with autoimmune rheumatic diseases.

Methods: 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.

Results: 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/m2 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.

Conclusion: 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.

加速输注利妥昔单抗治疗风湿病的安全性:系统综述。
目的:系统评价自身免疫性风湿病患者快速输注利妥昔单抗(RTX)方案的安全性和可行性。方法:采用PubMed、LILACS和Scielo数据库,从1965年至2024年5月,无语言限制,进行全面的文献综述。研究报告了风湿病条件下与加速RTX方案(输注超过90至120分钟)相关的输注反应。根据美国国家癌症研究所不良事件通用术语标准(1-5级)对输液相关不良事件进行评估和分级。提取的关键变量包括患者人口统计学、基础疾病、RTX剂量、用药前使用、输注次数、输注反应的频率和严重程度。结果:纳入了7项研究,包括538例年龄在14-78岁之间的患者。患者队列涵盖了一系列自身免疫性风湿病,包括系统性红斑狼疮、类风湿性关节炎、系统性血管炎、Sjögren综合征、系统性硬化症、igg4相关疾病和抗合成酶综合征。所有的研究都实施了快速RTX输注方案,专门用于第二次和随后的剂量。在大多数研究中,对乙酰氨基酚、苯海拉明和皮质类固醇是常规的预用药。RTX的剂量在375 mg/m2和1000 mg之间变化,两次输注,间隔两周。输液反应的发生率从3%到15%不等,主要是轻微的严重程度(1级和2级),只有6例被列为3级。未见4级或5级反应。快速输液方案持续减少患者在输液诊所花费的总时间。结论:自身免疫性风湿病患者快速输注RTX似乎是一种安全有效的替代标准输注方案。输液反应的频率和严重程度与传统的输液速率相当,并且减少了临床时间。这些发现支持在风湿病学中更广泛地实施快速输液方案。然而,有必要进行更大规模的前瞻性研究,对不良事件进行标准化报告,以验证这些结果,并探索更短输注时间的可行性,就像肿瘤学中看到的那样。
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来源期刊
Rheumatology and Therapy
Rheumatology and Therapy RHEUMATOLOGY-
CiteScore
6.00
自引率
5.30%
发文量
91
审稿时长
6 weeks
期刊介绍: Aims and Scope Rheumatology and Therapy is an international, open access, peer reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world and health outcomes research around the discovery, development, and use of rheumatologic therapies. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also welcomed. Areas of focus include, but are not limited to, rheumatoid arthritis, gout, gouty arthritis, psoriatic arthritis, osteoarthritis, juvenile idiopathic/rheumatoid arthritis, systemic lupus erythematosus, axial spondyloarthritis, Pompe’s disease, inflammatory joint conditions, musculoskeletal conditions, systemic sclerosis, and fibromyalgia. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, case reports, trial protocols, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Rheumatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research. Ethics and Disclosures The journal is a member of the Committee on Publication Ethics (COPE) and subscribes to its principles on how to deal with acts of misconduct thereby committing to investigate allegations of misconduct in order to ensure the integrity of research. Content in this journal is peer-reviewed (Single-blind). For more information on our publishing ethics policies, please see here: https://www.springer.com/gp/editorial-policies Rapid Publication The journal’s rapid publication timelines aim for a peer review decision within 2 weeks of submission. If an article is accepted it will be published online 3-4 weeks from acceptance. These rapid timelines are achieved through the combination of a dedicated in-house editorial team, who closely manage article workflow, and an extensive Editorial and Advisory Board who assist with rapid peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid and efficient communication of the latest research and reviews, allowing the advancement of rheumatologic therapies. Personal Service The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning that authors will always have a personal point of contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE, GPP and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research. We also encourage pre-submission enquiries and are always happy to provide a confidential assessment of manuscripts. Digital Features Rheumatology and Therapy offers a range of additional features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by key summary points, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand the scientific content and overall implications of the article. The journal also provides the option to include various types of digital features including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations. All additional features are peer reviewed to the same high standard as the article itself. If you consider that your paper would benefit from the inclusion of a digital feature, please let us know. Our editorial team are able to create high-quality slide decks and infographics in-house, and video abstracts through our partner Research Square, and would be happy to assist in any way we can. For further information about digital features, please contact the journal editor (see ‘Contact the Journal’ for email address), and see the ‘Guidelines for digital features and plain language summaries’ document under ‘Submission guidelines’. For examples of digital features please visit: https://springerhealthcare.com/expertise/publishing-digital-features/ Preprints We encourage posting of preprints of primary research manuscripts on preprint servers, authors'' or institutional websites, and open communications between researchers whether on community preprint servers or preprint commenting platforms. Posting of preprints is not considered prior publication and will not jeopardize consideration in our journals. Authors should disclose details of preprint posting during the submission process or at any other point during consideration in the journal. Once the manuscript is published, it is the author''s responsibility to ensure that the preprint record is updated with a publication reference, including the DOI and a URL link to the published version of the article on the journal website. Please see here for further information on preprint sharing: https://www.springer.com/gp/authors-editors/journal-author/journal-author-helpdesk/submission/1302#c16721550 Peer Review Process Upon submission, manuscripts are assessed by the editorial team to ensure they fit within the aims and scope of the journal and are also checked for plagiarism. All suitable submissions are then subject to a comprehensive single-blind peer review. Reviewers are selected based on their relevant expertise and publication history in the subject area. The journal has an extensive pool of editorial and advisory board members who have been selected to assist with peer review based on the afore-mentioned criteria. At least two extensive reviews are required to make the editorial decision. Where reviewer recommendations are conflicted, the editorial board will be contacted for further advice and a presiding decision. Manuscripts are then either accepted, rejected or authors are required to make major or minor revisions (both reviewer comments and editorial comments may need to be addressed). Once a revised manuscript is re-submitted, it is assessed along with the responses to reviewer comments and if it has been adequately revised it will be accepted for publication. Accepted manuscripts are then copyedited and typeset by the production team before online publication. Appeals against decisions following peer review are considered on a case-by-case basis and should be sent to the journal editor, and authors are welcome to make rebuttals against individual reviewer comments if appropriate. Considering the time and effort required for a detailed peer review we reward our regular reviewers with the opportunity to publish without publication fees (pending peer review) for every three reviews completed per calendar year. Copyright Rheumatology and Therapy is published under the Creative Commons Attribution-Noncommercial License, which allows users to read, copy, distribute, and make derivative works for non-commercial purposes from the material, as long as the author of the original work is cited. The author assigns the exclusive right to any commercial use of the article to Springer. For more information about the Creative Commons Attribution-Noncommercial License, click here: http://creativecommons.org/licenses/by-nc/4.0. Publication Fees Upon acceptance of an article, authors will be required to pay the mandatory Rapid Service Fee of €5,250/$6,000/£4,300. The journal will consider fee discounts and waivers for developing countries and this is decided on a case-by-case basis. Open Access All articles published by Rheumatology and Therapy are published open access. Contact For more information about the journal, including pre-submission enquiries, please contact charlotte.maddocks@springernature.com.
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