Bell Christopher F, Chung Jake, Rubin Bernard
US Value Evidence and Outcomes, GSK, 410 Blackwell Street, Durham, NC, 27701, USA.
Specialty Care, Global Medical Affairs, GSK, Philadelphia, PA, USA.
Rheumatol Ther. 2023 Apr;10(2):447-462. doi: 10.1007/s40744-022-00524-y. Epub 2023 Jan 18.
This analysis aims to describe real-world clinical outcomes in US African American and Hispanic patients with systemic lupus erythematosus (SLE) receiving belimumab.
In this post hoc analysis of OBSErve US (GSK Study 117,295) data, patients received intravenous belimumab (10 mg/kg) over 24 months. Outcomes assessed every 6 months after belimumab initiation (index) included: physician-assessed overall clinical response (worse, no improvement, < 20%, 20-49%, 50-79%, ≥ 80% improvement), physician-assessed disease severity (mild, moderate, severe), oral corticosteroid (OCS) use and healthcare resource utilization (HCRU).
Of 501 patients enrolled, 123 and 88 were African American and Hispanic respectively; 69 (56.1%) and 43 (48.8%) were receiving belimumab at 24 months. Of those, 88.4%/95.3% (African American/Hispanic) were female; mean (standard deviation [SD]) age was 41.6 (12.5)/42.2 (10.5) years. Within 6 months post-index, 91.3%/90.7% of patients still receiving belimumab had a ≥ 20% physician-assessed clinical improvement. Among 24 months completers, proportions of patients with severe SLE fell from 34.8%/25.6% at index to 2.9%/4.7% at Month 6 and 2.9%/0% at Month 24. The proportion of patients receiving OCS and mean (SD) daily OCS dose also decreased, from 82.6%/81.4% and 19.7 (12.8)/18.8 (10.0) mg/day at index to 50.7%/34.9% and 3.1 (3.2)/1.6 (2.4) mg/day at Month 24. Fewer patients were hospitalized or required ancillary care services at 18-24 months post-index versus 6 months pre-index.
Belimumab treatment for up to 2 years improved clinical outcomes, disease severity, mean OCS dose and HCRU in US African American and Hispanic patients with SLE, providing real-world evidence for enduring belimumab effectiveness in populations that are markedly impacted by SLE.
本分析旨在描述美国接受贝利尤单抗治疗的非裔美国人和西班牙裔系统性红斑狼疮（SLE）患者的真实世界临床结局。
在对美国观察性研究（葛兰素史克研究117295）数据的这项事后分析中，患者在24个月内接受静脉注射贝利尤单抗（10mg/kg）。在开始使用贝利尤单抗（索引）后每6个月评估的结局包括：医生评估的总体临床反应（更差、无改善、改善<20%、改善20 - 49%、改善50 - 79%、改善≥80%）、医生评估的疾病严重程度（轻度、中度、重度）、口服糖皮质激素（OCS）使用情况和医疗资源利用（HCRU）。
在入组的501例患者中，分别有123例和88例为非裔美国人和西班牙裔；69例（56.1%）和43例（48.8%）在24个月时仍在接受贝利尤单抗治疗。其中，88.4%/95.3%（非裔美国人/西班牙裔）为女性；平均（标准差[SD]）年龄为41.6（12.5）/42.2（10.5）岁。在索引后6个月内，仍在接受贝利尤单抗治疗的患者中，91.3%/90.7%经医生评估有≥20%的临床改善。在24个月完成治疗的患者中，重度SLE患者的比例从索引时的34.8%/25.6%降至第6个月时的2.9%/4.7%和第24个月时的2.9%/0%。接受OCS治疗的患者比例以及平均（SD）每日OCS剂量也有所下降，从索引时的82.6%/81.4%和19.7（12.8）/18.8（10.0）mg/天降至第24个月时的50.7%/34.9%和3.1（3.2）/1.6（2.4）mg/天。与索引前6个月相比，索引后18 - 24个月住院或需要辅助护理服务的患者更少。
长达2年的贝利尤单抗治疗改善了美国非裔美国人和西班牙裔SLE患者的临床结局、疾病严重程度、平均OCS剂量和HCRU，为贝利尤单抗在受SLE显著影响的人群中持续有效的真实世界证据提供了支持。
