Real-World Clinical Outcomes in Belimumab-Treated US African American and Hispanic Patients with Systemic Lupus Erythematosus: A Retrospective, Observational Study

贝利木单抗治疗美国非裔和西班牙裔系统性红斑狼疮患者的真实世界临床结果:一项回顾性观察研究

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Abstract

INTRODUCTION: This analysis aims to describe real-world clinical outcomes in US African American and Hispanic patients with systemic lupus erythematosus (SLE) receiving belimumab. METHODS: 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). RESULTS: 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. CONCLUSION: 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.

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