Sakai Hidenori, Miyazaki Yusuke, Nakayamada Shingo, Kubo Satoshi, Hanami Kentaro, Fukuyo Shunsuke, Yamaguchi Ayako, Miyagawa Ippei, Ueno Masanobu, Tanaka Hiroaki, Todoroki Yasuyuki, Ohkubo Naoaki, Funada Masashi, Matsunaga Satsuki, Tanaka Yoshiya
The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan.
Department of Molecular Targeted Therapies, University of Occupational and Environmental Health, Japan.
Rheumatology (Oxford). 2025 Apr 1;64(4):1930-1939. doi: 10.1093/rheumatology/keae495.
This study investigated the efficacy, safety and predictive factors of belimumab (BEL) in induction therapy for patients with proliferative lupus nephritis (LN) in real-world settings.
Patients with biopsy-proven ISN/RPS class III or IV LN, with or without coexisting class V LN, who underwent standard of care (SoC), glucocorticoid (GC) and either mycophenolate mofetil or cyclophosphamide treatments were included. Participants were treated with SoC (SoC group, n = 32) or BEL and SoC (BEL+SoC group, n = 30). The primary end point was complete renal response (CRR) at 52 weeks.
Baseline patient characteristics were not significantly different between the two groups. The 52-week retention rate of BEL was 90.0%. The BEL+SoC group showed significantly higher CRR and primary efficacy renal response achievement at 52 weeks and significantly lower GC dosage, adverse events and Systemic Lupus International Collaborating Clinics damage index scores. Multivariate analysis of CRR achievement at 52 weeks revealed that the lack of estimated glomerular filtration rate (eGFR) improvement at 4 weeks was associated with CRR failure in the SoC group. A shorter duration (cut-off of 42 days) between the start of induction therapy and addition of BEL was also related to the CRR in the BEL+SoC group.
BEL, in addition to SoC, controls disease activity, reduces GC use and suppresses organ damage in case of proliferative LN. Earlier BEL induction within 6 weeks may help achieve CRR in treatment-resistant cases without eGFR improvement at 4 weeks after induction therapy.
本研究在现实环境中调查了贝利尤单抗（BEL）在增殖性狼疮性肾炎（LN）患者诱导治疗中的疗效、安全性及预测因素。
纳入经活检证实为ISN/RPS III级或IV级LN、伴或不伴有V级LN、接受标准治疗（SoC）、糖皮质激素（GC）以及霉酚酸酯或环磷酰胺治疗的患者。参与者接受SoC治疗（SoC组，n = 32）或BEL联合SoC治疗（BEL+SoC组，n = 30）。主要终点为52周时的完全肾脏缓解（CRR）。
两组患者的基线特征无显著差异。BEL的52周保留率为90.0%。BEL+SoC组在52周时显示出显著更高的CRR和主要疗效性肾脏缓解达成率，以及显著更低的GC剂量、不良事件和系统性红斑狼疮国际协作临床损伤指数评分。对52周时CRR达成情况的多变量分析显示，SoC组中4周时估算肾小球滤过率（eGFR）未改善与CRR失败相关。诱导治疗开始至加用BEL之间的持续时间较短（截断值为42天）也与BEL+SoC组的CRR相关。
除SoC外，BEL可控制增殖性LN患者的疾病活动、减少GC使用并抑制器官损伤。诱导治疗后4周eGFR无改善的难治性病例，在6周内尽早使用BEL诱导可能有助于实现CRR。
