Real-World Effectiveness of Intravenous Belimumab on Clinical Outcomes in Patients With Systemic Lupus Erythematosus in Saudi Arabia: The OBSErve Observational Study.

IF 1.7 Q3 RHEUMATOLOGY
Open Access Rheumatology-Research and Reviews Pub Date : 2025-02-14 eCollection Date: 2025-01-01 DOI:10.2147/OARRR.S497802
Ibrahim Abdulrazag Al-Homood, Ibrahim Almaghlouth, Alhussain Mohammed Asiri, Hanan Hamdy, Ali Alhammad, Alaa Mustafa, Mohamed Othman, Munther Khamashta, Tamer Elfishawy, Lindsey Teichman, Debora Dos Santos, Juliana Domenico Queiroz, Saeed Noibi
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引用次数: 0

Abstract

Purpose: To describe intravenous (IV) belimumab's clinical effectiveness in patients with systemic lupus erythematosus (SLE) in real-world practice in Saudi Arabia.

Patients and methods: This retrospective, observational OBSErve study (GSK Study 215349) analyzed medical record data for adults with SLE receiving IV belimumab. Index date was the date of belimumab initiation. The primary endpoint was overall clinical response per physician judgement (categorized as worse, no improvement, improvement of <20%, 20-49%, 50-79%, ≥80%) at 6 months post-index. The secondary endpoints included changes from index in Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) score and corticosteroid dose at 6 months post-index; and healthcare resource utilization (HCRU) 6 months pre- and post-index.

Results: Of 47 patients enrolled, 44 patients completed ≥6 months of IV belimumab treatment and were included in the analysis. Most patients were female (91.5%) and the mean (standard deviation [SD]) age was 33.1 (8.1) years. At 6 months post-index, overall physician-assessed clinical improvements of ≥20% and ≥50% were reported for 97.7% (n=43) and 79.5% (n=35) of patients, respectively; 2.3% (n=1) of patients had no improvement, and no patient worsened. Mean SELENA-SLEDAI score decreased by 7.8 points during the 6 months post-index. Mean (SD) corticosteroid dose decreased from 10.2 (7.5) mg/day at index to 6.2 (3.4) mg/day at 6 months post-index. Reductions in unscheduled physician office and emergency room visits were observed during the post-index versus pre-index periods.

Conclusion: Real-world data from patients with SLE treated with IV belimumab in Saudi Arabia demonstrated clinical improvements and reductions in corticosteroid dose and HCRU. Although the low number of patients and lack of a control group limit interpretation, the similar findings to the other OBSErve studies support the effectiveness of belimumab for patients with SLE in Saudi Arabia.

静脉注射Belimumab对沙特阿拉伯系统性红斑狼疮患者临床结果的实际有效性:观察性研究
目的:描述静脉注射(IV)贝利姆单抗在沙特阿拉伯系统性红斑狼疮(SLE)患者中的临床疗效。患者和方法:这项回顾性观察性研究(GSK study 215349)分析了接受静脉注射贝利单抗治疗的成年SLE患者的病历数据。索引日期为贝利单抗起始日期。主要终点是每个医生判断的总体临床反应(分类为更差,无改善,结果改善):在入组的47例患者中,44例患者完成了≥6个月的静脉贝利单抗治疗,并被纳入分析。大多数患者为女性(91.5%),平均(标准差[SD])年龄为33.1(8.1)岁。在指数后6个月,97.7% (n=43)和79.5% (n=35)的患者报告了经医生评估的总体临床改善≥20%和≥50%;2.3% (n=1)的患者无改善,无患者恶化。SELENA-SLEDAI平均分在指数后的6个月内下降了7.8分。平均(SD)皮质类固醇剂量从指数时的10.2 (7.5)mg/天降至指数后6个月时的6.2 (3.4)mg/天。在指数后与指数前期间,观察到计划外的医生办公室和急诊室就诊减少。结论:来自沙特阿拉伯IV belimumab治疗SLE患者的真实世界数据显示临床改善,皮质类固醇剂量和HCRU降低。尽管患者数量少且缺乏对照组限制了解释,但与其他观察研究相似的发现支持贝利姆单抗对沙特阿拉伯SLE患者的有效性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
3.80
自引率
0.00%
发文量
34
审稿时长
16 weeks
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