Improved Health Outcomes in Patients with Systemic Lupus Erythematosus Following Early Belimumab Initiation Without Prior Immunosuppressant Use: A Real-World Descriptive Study.

IF 2.9 3区医学 Q2 RHEUMATOLOGY

Rheumatology and Therapy Pub Date : 2024-08-01 Epub Date: 2024-06-07 DOI:10.1007/s40744-024-00675-0

Bernard Rubin, Yan Chen, Karen Worley, Brendan Rabideau, Benson Wu, Rose Chang, Maral DerSarkissian

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引用次数: 0

Abstract

Introduction: Patients with systemic lupus erythematosus (SLE) have variable treatment pathways, including antimalarials, glucocorticoids, immunosuppressants, and/or biologics. This study describes differences in clinical outcomes when initiating belimumab (BEL) before and after immunosuppressant use.

Methods: This real-world, retrospective cohort study (GSK Study 217536) used de-identified administrative claims data from January 2015 to December 2022 in the Komodo Health Database. Adults with moderate/severe SLE initiating BEL (index date) were identified from January 2017 to May 2022, allowing a ≥ 24-month baseline period. Patients were stratified into those initiating BEL before immunosuppressant use (no immunosuppressant use within 24 months before index) and those initiating BEL after immunosuppressant use (one immunosuppressant used within 24 months before index). Oral glucocorticoid (OGC) use, SLE flares, new organ damage, and all-cause healthcare resource utilization (HCRU) were analyzed descriptively over a 24-month follow-up.

Results: Baseline SLE severity was similar for patients initiating BEL before (n = 2295) versus after (n = 4114) immunosuppressant use (moderate, 83.1% vs 79.0%; severe, 16.8% vs 21.0%). Patients initiating BEL before versus after immunosuppressant use had lower SLE flare rates and OGC use. Post-index, patients initiating BEL before versus after immunosuppressant use discontinued their OGC sooner (moderate baseline SLE, 4.5 vs 8.9 months; severe baseline SLE, 6.2 vs 11.6 months). Patients initiating BEL before versus after immunosuppressant use had lower SLE flare rates per person-year at all time points (especially severe flare rates in patients with severe baseline SLE, 0.70 vs 1.48 through 24 months post-index). Median time to new organ damage occurrence was longer in patients initiating BEL before versus after immunosuppressant use (moderate baseline SLE, 32.1 vs 26.7 months; severe baseline SLE, 22.7 vs 21.6 months). All-cause HCRU was similar between cohorts.

Conclusions: These results suggest that patients initiating BEL before versus after immunosuppressant use had more favorable outcomes.

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系统性红斑狼疮患者在未使用免疫抑制剂的情况下尽早使用贝利木单抗可改善健康状况：一项真实世界描述性研究

导言：系统性红斑狼疮（SLE）患者的治疗途径多种多样，包括抗疟药、糖皮质激素、免疫抑制剂和/或生物制剂。本研究描述了在使用免疫抑制剂之前和之后开始使用贝利木单抗（BEL）时临床结果的差异：这项真实世界的回顾性队列研究（葛兰素史克研究 217536）使用了 Komodo Health 数据库中 2015 年 1 月至 2022 年 12 月期间去标识化的行政报销数据。中度/重度系统性红斑狼疮成人患者于 2017 年 1 月至 2022 年 5 月期间开始使用 BEL（指数日期），基线期≥24 个月。将患者分为在使用免疫抑制剂前（指数前 24 个月内未使用过免疫抑制剂）开始 BEL 的患者和在使用免疫抑制剂后（指数前 24 个月内使用过一种免疫抑制剂）开始 BEL 的患者。对随访24个月期间的口服糖皮质激素（OGC）使用情况、系统性红斑狼疮复发、新的器官损伤和全因医疗资源利用率（HCRU）进行了描述性分析：结果：在使用免疫抑制剂之前（n = 2295）和之后（n = 4114）开始使用BEL的患者的系统性红斑狼疮严重程度基线相似（中度，83.1% vs 79.0%；重度，16.8% vs 21.0%）。在使用免疫抑制剂之前和之后开始使用BEL的患者，其系统性红斑狼疮复发率和OGC使用率均较低。索引后，使用免疫抑制剂之前和之后开始使用 BEL 的患者停用 OGC 的时间更早（中度基线系统性红斑狼疮，4.5 个月对 8.9 个月；重度基线系统性红斑狼疮，6.2 个月对 11.6 个月）。在使用免疫抑制剂之前和之后开始使用BEL的患者，在所有时间点的每人每年系统性红斑狼疮复发率都较低（尤其是重度基线系统性红斑狼疮患者的严重复发率，指数后24个月内分别为0.70和1.48）。与使用免疫抑制剂之前相比，开始使用BEL的患者出现新器官损伤的中位时间更长（中度基线SLE患者为32.1个月，重度基线SLE患者为26.7个月；重度基线SLE患者为22.7个月，重度基线SLE患者为21.6个月）。两组患者的全因HCRU相似：这些结果表明，在使用免疫抑制剂之前和之后开始使用BEL的患者的预后更佳。

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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. 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