Costenbader Karen H, DerSarkissian Maral, Chen Yan, Rabideau Brendan, Worley Karen, Man Theo, Rubin Bernard, Lim S Sam
Division of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Analysis Group, Los Angeles, CA, USA.
Rheumatol Ther. 2025 Jun 17. doi: 10.1007/s40744-025-00774-6.
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.
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.
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]).
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.
本研究探讨了在系统性红斑狼疮（SLE）患者中，在开始使用贝利尤单抗之前未使用免疫抑制剂（IS）与使用免疫抑制剂的情况下，将贝利尤单抗作为标准治疗的益处。
这项回顾性队列研究（葛兰素史克研究217537）使用了2015年1月至2023年10月美国科莫多健康数据库中的医疗理赔数据。符合条件的成年人有≥1个住院或≥2个门诊SLE诊断代码、≥1次贝利尤单抗理赔记录（2017年1月至2023年10月；索引日期）以及索引日期前24个月的连续数据。定义了两个队列：在索引日期前12个月内有≥1次非IS SLE治疗（抗疟药、口服糖皮质激素[OGC]或生物制剂；非IS队列）理赔记录或≥1次新发IS（IS队列）理赔记录的患者。在非IS/IS治疗前的12个月内评估队列可比性，应用治疗权重的逆概率（IPTW）来调整混杂因素。结果包括OGC使用情况、SLE发作率和医疗资源利用情况，分别使用Cox模型、泊松回归模型和logit模型进行比较。
总体而言，IPTW调整后的非IS队列和IS队列分别纳入了2190例和2533例患者。非IS队列OGC停药的中位时间（95%置信区间[CI]）为9.8（8.2，12.2）个月，而IS队列为11.7（10.5，13.4）个月，且OGC停药的可能性高30%（风险比[95%CI]1.30[1.11，1.52]）。队列之间OGC剂量减少以及停药或仅剂量减少的可能性相似。非IS队列与IS队列相比，总体（0.94[0.92，0.96]）和中度（0.77[0.74，0.80]）SLE发作的发病率比值（IRR[95%CI]）较低，SLE相关住院（优势比[95%CI]1.12[0.94，1.34]）和急诊就诊（1.02[0.82，1.27]）的几率相似。
在这项使用IPTW调整的大型回顾性真实世界研究中，在未预先使用IS的情况下开始使用贝利尤单抗与节省OGC以及降低SLE发作的发生率和严重程度相关。
