Chen Yiting, Lei Xin, Xu Jianhang, Chen Xiaochan, Pan Hong, Zhang Qiankun, Wang Junni, Ren Pingping, Lan Lan, Shi Nan, Chen Liangliang, Wang Yaomin, Chen Jianghua, Jin Lie, Yang Yi, Xue Jing, Han Fei
Kidney Disease Center, The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Department of Rheumatology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Lupus Sci Med. 2025 Jan 6;12(1):e001296. doi: 10.1136/lupus-2024-001296.
Both belimumab and telitacicept are recognised blockers for B lymphocyte activation, both of which have been approved as add-on therapies for SLE in China. The aim of this study is to compare the efficacy of rituximab (RTX) followed by belimumab or telitacicept in a real-world cohort.
A total of 49 refractory lupus nephritis patients were enrolled from four independent centres, subsequently categorised into two treatment groups: belimumab group (n=35) and telitacicept group (n=14) based on their treatment following RTX. The outcomes of renal response rates were evaluated.
In this study cohort, 63.3% presented with anti-dsDNA antibody positivity and 79.6% exhibited hypocomplementemia, with a mean Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score of 13±6, estimated glomerular filtration rate (eGFR) of 76.2 (30.2, 113.7) mL/min and urinary protein creatinine ratio (uPCR) of 2.45 (0.77, 5.19) g/g. There was no significant differences between groups. After a follow-up duration of 26±12 months, renal objective remission rate was 80.0% (28 patients) in belimumab group and 85.7% (12 patients) in telitacicept group (difference, 5.7 percentage points, 95% CI, -25.8 to 26.8, p=1.000). Renal complete response was 54.3% (19 patients) in belimumab group and 78.6% (11 patients) in telitacicept group (difference, 24.3 percentage points, 95% CI, 9.7 to 47.8, p=0.194). The anti-dsDNA antibody, complement, eGFR, uPCR and SLEDAI-2K Score were improved in both groups with a significant reduction in prednisone dose. Major adverse effects included immunoglobulin deficiency, respiratory tract infection and urinary tract infection. No death occurred.
The sequential treatment of belimumab or telitacicept following RTX may represent a promising therapeutic approach in the management of refractory lupus nephritis. Further investigation is necessary to establish optimal protocols and long-term benefits.
贝利尤单抗和泰它西普均为公认的B淋巴细胞激活阻滞剂,二者在中国均已获批作为系统性红斑狼疮(SLE)的附加疗法。本研究旨在比较在真实世界队列中,利妥昔单抗(RTX)后序贯使用贝利尤单抗或泰它西普的疗效。
从四个独立中心纳入49例难治性狼疮性肾炎患者,随后根据RTX后的治疗情况将其分为两个治疗组:贝利尤单抗组(n = 35)和泰它西普组(n = 14)。评估肾脏反应率的结果。
在本研究队列中,63.3%的患者抗双链DNA(dsDNA)抗体呈阳性,79.6%的患者表现为低补体血症,系统性红斑狼疮疾病活动指数2000(SLEDAI - 2K)评分平均为13±6,估计肾小球滤过率(eGFR)为76.2(30.2,113.7)mL/分钟,尿蛋白肌酐比值(uPCR)为2.45(0.77,5.19)g/g。两组之间无显著差异。随访26±12个月后,贝利尤单抗组的肾脏客观缓解率为80.0%(28例患者),泰它西普组为85.7%(12例患者)(差异为5.7个百分点,95%置信区间为 - 25.8至26.8,p = 1.000)。贝利尤单抗组的肾脏完全缓解率为54.3%(19例患者),泰它西普组为78.6%(11例患者)(差异为24.3个百分点, 95%置信区间为9.7至47.8,p = 0.194)。两组患者的抗dsDNA抗体、补体、eGFR、uPCR和SLEDAI - 2K评分均有所改善,泼尼松剂量显著降低。主要不良反应包括免疫球蛋白缺乏、呼吸道感染和尿路感染。无死亡病例发生。
RTX后序贯使用贝利尤单抗或泰它西普可能是治疗难治性狼疮性肾炎的一种有前景的治疗方法。需要进一步研究以确定最佳方案和长期获益情况。