Clinical Outcomes of Patients with SLE Treated with Belimumab, Without Versus With Prior Immunosuppressant Use: a US Claims Database Study.

IF 2.9 3区医学 Q2 RHEUMATOLOGY

Rheumatology and Therapy Pub Date : 2025-08-01 Epub Date: 2025-06-17 DOI:10.1007/s40744-025-00774-6

Karen H Costenbader, Maral DerSarkissian, Yan Chen, Brendan Rabideau, Karen Worley, Theo Man, Bernard Rubin, S Sam Lim

{"title":"Clinical Outcomes of Patients with SLE Treated with Belimumab, Without Versus With Prior Immunosuppressant Use: a US Claims Database Study.","authors":"Karen H Costenbader, Maral DerSarkissian, Yan Chen, Brendan Rabideau, Karen Worley, Theo Man, Bernard Rubin, S Sam Lim","doi":"10.1007/s40744-025-00774-6","DOIUrl":null,"url":null,"abstract":"Introduction: This study examined the benefit of belimumab as standard treatment in patients with systemic lupus erythematosus (SLE) treated without versus with immunosuppressants (IS) prior to belimumab initiation.Methods: This retrospective cohort study (GSK Study 217537) used healthcare claims from the US Komodo Health Database from January 2015 to October 2023. Eligible adults had ≥ 1 inpatient or ≥ 2 outpatient SLE diagnosis codes, ≥ 1 belimumab claim (January 2017-October 2023; index date) and 24 months continuous data pre-index. Two cohorts were defined: those with ≥ 1 claim for non-IS SLE treatment (antimalarials, oral glucocorticoids [OGC] or biologics; non-IS cohort) or ≥ 1 claim for incident IS (IS cohort) within 12 months pre-index. Cohort comparability was assessed across the 12 months before non-IS/IS treatment, applying inverse probability of treatment weighting (IPTW) to adjust for confounding. Outcomes included OGC use, SLE flare rates and healthcare resource utilisation, compared using Cox, Poisson regression and logit models, respectively.Results: Overall, 2190 and 2533 patients were included in IPTW-adjusted non-IS and IS cohorts, respectively. The non-IS cohort had a median (95% confidence interval [CI]) time to OGC discontinuation of 9.8 (8.2, 12.2) months versus 11.7 (10.5, 13.4) for the IS cohort, and a 30% higher likelihood of OGC discontinuation (hazard ratio [95% CI] 1.30 [1.11, 1.52]). The likelihood of OGC dose reduction and discontinuation or dose reduction alone was similar between cohorts. The non-IS versus IS cohort had a lower incidence rate ratio (IRR [95% CI]) of total (0.94 [0.92, 0.96]) and moderate (0.77 [0.74, 0.80]) SLE flares, with similar odds of SLE-related inpatient stays (odds ratio [95% CI] 1.12 [0.94, 1.34]) and emergency visits (1.02 [0.82, 1.27]).Conclusion: In this large, retrospective, real-word study using IPTW adjustment, initiating belimumab without prior IS use was associated with OGC-sparing benefits and reduced incidence and severity of SLE flares.","PeriodicalId":21267,"journal":{"name":"Rheumatology and Therapy","volume":" ","pages":"679-694"},"PeriodicalIF":2.9000,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12246324/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Rheumatology and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40744-025-00774-6","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/6/17 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"RHEUMATOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Introduction: This study examined the benefit of belimumab as standard treatment in patients with systemic lupus erythematosus (SLE) treated without versus with immunosuppressants (IS) prior to belimumab initiation.

Methods: This retrospective cohort study (GSK Study 217537) used healthcare claims from the US Komodo Health Database from January 2015 to October 2023. Eligible adults had ≥ 1 inpatient or ≥ 2 outpatient SLE diagnosis codes, ≥ 1 belimumab claim (January 2017-October 2023; index date) and 24 months continuous data pre-index. Two cohorts were defined: those with ≥ 1 claim for non-IS SLE treatment (antimalarials, oral glucocorticoids [OGC] or biologics; non-IS cohort) or ≥ 1 claim for incident IS (IS cohort) within 12 months pre-index. Cohort comparability was assessed across the 12 months before non-IS/IS treatment, applying inverse probability of treatment weighting (IPTW) to adjust for confounding. Outcomes included OGC use, SLE flare rates and healthcare resource utilisation, compared using Cox, Poisson regression and logit models, respectively.

Results: Overall, 2190 and 2533 patients were included in IPTW-adjusted non-IS and IS cohorts, respectively. The non-IS cohort had a median (95% confidence interval [CI]) time to OGC discontinuation of 9.8 (8.2, 12.2) months versus 11.7 (10.5, 13.4) for the IS cohort, and a 30% higher likelihood of OGC discontinuation (hazard ratio [95% CI] 1.30 [1.11, 1.52]). The likelihood of OGC dose reduction and discontinuation or dose reduction alone was similar between cohorts. The non-IS versus IS cohort had a lower incidence rate ratio (IRR [95% CI]) of total (0.94 [0.92, 0.96]) and moderate (0.77 [0.74, 0.80]) SLE flares, with similar odds of SLE-related inpatient stays (odds ratio [95% CI] 1.12 [0.94, 1.34]) and emergency visits (1.02 [0.82, 1.27]).

Conclusion: In this large, retrospective, real-word study using IPTW adjustment, initiating belimumab without prior IS use was associated with OGC-sparing benefits and reduced incidence and severity of SLE flares.

查看原文本刊更多论文

使用Belimumab治疗SLE患者的临床结果，未与先前使用免疫抑制剂：一项美国索赔数据库研究

本研究考察了贝利单抗作为标准治疗系统性红斑狼疮（SLE）患者在贝利单抗开始前未接受免疫抑制剂（IS）治疗的益处。方法：这项回顾性队列研究（GSK study 217537）使用了2015年1月至2023年10月美国Komodo健康数据库中的医疗保健声明。符合条件的成年人有≥1个住院或≥2个门诊SLE诊断代码，≥1个贝利单抗申请(2017年1月- 2023年10月；指数日期)和指数前连续24个月的数据。定义了两个队列：≥1个要求非is SLE治疗（抗疟药、口服糖皮质激素[OGC]或生物制剂）的患者；非IS队列)或在索引前12个月内至少有1起事件IS索赔（IS队列）。在非IS/IS治疗前的12个月内评估队列可比性，应用治疗加权逆概率（IPTW）来调整混杂因素。结果包括OGC使用、SLE耀斑率和医疗资源利用率，分别使用Cox、泊松回归和logit模型进行比较。结果：总体而言，经iptw调整的非IS和IS队列分别纳入了2190例和2533例患者。非IS组停止OGC的中位时间（95%可信区间[CI]）为9.8（8.2,12.2）个月，而IS组为11.7（10.5,13.4）个月，OGC停止的可能性高出30%（风险比[95% CI] 1.30[1.11, 1.52]）。OGC剂量减少和停药或单独剂量减少的可能性在队列之间相似。非系统性红斑狼疮组与系统性红斑狼疮组的总体（0.94[0.92,0.96]）和中度（0.77 [0.74,0.80]）SLE发作的发生率比（IRR [95% CI]）较低，SLE相关住院（优势比[95% CI] 1.12[0.94, 1.34]）和急诊（1.02[0.82,1.27]）的发生率相似。结论：在这项使用IPTW调整的大型、回顾性、实时研究中，在未使用IS的情况下启动贝利单抗与ogc节约益处和降低SLE发作的发生率和严重程度相关。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Rheumatology and Therapy RHEUMATOLOGY-

CiteScore

6.00

自引率

5.30%

发文量

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.