Rubin Bernard, Chen Yan, Worley Karen, Rabideau Brendan, Wu Benson, Chang Rose, DerSarkissian Maral
GSK, Medical Affairs and Immuno-Inflammation, Durham, NC, USA.
Analysis Group, Boston, MA, USA.
Rheumatol Ther. 2024 Aug;11(4):947-962. doi: 10.1007/s40744-024-00675-0. Epub 2024 Jun 7.
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.
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.
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.
These results suggest that patients initiating BEL before versus after immunosuppressant use had more favorable outcomes.
系统性红斑狼疮(SLE)患者有多种治疗途径,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尤单抗(BEL)时临床结局的差异。
这项真实世界的回顾性队列研究(葛兰素史克研究217536)使用了科莫多健康数据库中2015年1月至2022年12月的去识别化管理索赔数据。从2017年1月至2022年5月识别出开始使用BEL(索引日期)的中度/重度SLE成人患者,允许有≥24个月的基线期。患者被分层为在使用免疫抑制剂之前开始使用BEL的患者(索引前24个月内未使用免疫抑制剂)和在使用免疫抑制剂之后开始使用BEL的患者(索引前24个月内使用过一种免疫抑制剂)。在24个月的随访期间,对口服糖皮质激素(OGC)的使用、SLE疾病活动、新的器官损害以及全因医疗资源利用(HCRU)进行了描述性分析。
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,基线SLE严重程度相似(中度,83.1%对79.0%;重度,16.8%对21.0%)。在使用免疫抑制剂之前开始使用BEL的患者与之后开始使用BEL的患者相比,SLE疾病活动率和OGC使用率更低。索引后,在使用免疫抑制剂之前开始使用BEL的患者与之后开始使用BEL的患者相比,更早停用了OGC(中度基线SLE,4.5个月对8.9个月;重度基线SLE,6.2个月对11.6个月)。在所有时间点,在使用免疫抑制剂之前开始使用BEL的患者与之后开始使用BEL的患者相比,每人每年的SLE疾病活动率更低(尤其是重度基线SLE患者的严重疾病活动率,索引后24个月内为0.70对1.48)。在使用免疫抑制剂之前开始使用BEL的患者与之后开始使用BEL的患者相比,发生新的器官损害的中位时间更长(中度基线SLE,32.1个月对26.7个月;重度基线SLE,22.7个月对21.6个月)。队列之间的全因HCRU相似。
这些结果表明,在使用免疫抑制剂之前开始使用BEL的患者比之后开始使用BEL的患者有更有利的结局。