利妥昔单抗治疗难治性神经精神系统性红斑狼疮的长期临床结果和安全性：一项现实世界的单中心研究
Long-term clinical outcomes and safety of rituximab in refractory neuropsychiatric systemic lupus erythematosus: a real-world single-center study.
摘要(中文译文)
评估利妥昔单抗治疗难治性神经精神系统性红斑狼疮（NPSLE）患者的疗效。纳入2016年7月至2025年8月期间在瑞金医院接受利妥昔单抗治疗的17例难治性NPSLE患者。收集治疗前后的临床表现和实验室指标。采用预先设定的基于临床表现的临床标准评估治疗反应，并对有数据的实验室指标纵向配对变化采用Wilcoxon配对符号秩检验进行分析。17例患者中有16例（94.1%）获得显著临床改善，1例表现为部分改善，癫痫发作频率减少。在3至102个月（中位45个月）的随访期间，无一例存活患者出现神经精神表现的复发。末次随访时，泼尼松日剂量降至中位数5 mg/天。以利妥昔单抗为基础的治疗与循环CD19⁺ B细胞显著耗竭、抗dsDNA抗体滴度和SLEDAI-2000评分降低以及补体水平改善相关。随访期间2例患者死于COVID-19肺炎，1例患者发生重症耶氏肺孢子菌和巨细胞病毒肺炎。利妥昔单抗与难治性NPSLE的良好结局相关，可能代表一种替代治疗选择，尤其是对于对糖皮质激素和/或免疫抑制剂常规治疗难治的患者。要点 • 以利妥昔单抗为基础的治疗与难治性NPSLE的临床改善相关。 • 在难治性NPSLE患者中，利妥昔单抗治疗后长期随访观察到持续的无复发生存。 • 利妥昔单抗总体耐受性良好，但感染风险需要密切监测。
Abstract
To evaluate the efficacy of rituximab therapy in patients with refractory neuropsychiatric systemic lupus erythematosus (NPSLE). Seventeen patients with refractory NPSLE who received rituximab therapy at Ruijin Hospital between July 2016 and August 2025 were enrolled. Clinical manifestations and laboratory parameters were collected before and after treatment. Treatment response was evaluated using predefined manifestation-based clinical criteria, and paired longitudinal changes in laboratory parameters were analyzed using the Wilcoxon matched-pairs signed-rank test where data were available. Sixteen of 17 patients (94.1%) achieved significant clinical improvement, while one patient showed partial improvement with reduced seizure frequency. During a follow-up period of 3 to 102 months (median 45 months), none of the surviving patients experienced relapse of neuropsychiatric manifestations. Daily prednisone dose was reduced to a median of 5 mg/day at last follow-up. Rituximab-based treatment was associated with marked depletion of circulating CD19⁺ B cells, reductions in anti-dsDNA antibody titers and SLEDAI-2000 scores, and improvement in complement levels. Two patients died from COVID-19 pneumonia during follow-up, and one patient developed severe Pneumocystis jirovecii and cytomegalovirus pneumonia. Rituximab was associated with favorable outcomes in refractory NPSLE and may represent an alternative therapeutic option, particularly for patients who are refractory to conventional treatment with glucocorticoids and/or immunosuppressive agents. Key Points • Rituximab-based treatment was associated with clinical improvement in refractory NPSLE. • Sustained relapse-free remission was observed during long-term follow-up after rituximab therapy in patients with refractory NPSLE. • Rituximab was generally well tolerated, though infection risk requires careful monitoring.
如何引用
AMA
Yue Zhao, Jinchao Jia, Qichen Gao, Mengyan Wang, Yuning Ma, Hui Shi, et al. Long-term clinical outcomes and safety of rituximab in refractory neuropsychiatric systemic lupus erythematosus: a real-world single-center study.. Clinical rheumatology. 2026; doi:10.1007/s10067-026-08164-1.
APA
Yue Zhao, Jinchao Jia, Qichen Gao, Mengyan Wang, Yuning Ma, Hui Shi, et al (2026). Long-term clinical outcomes and safety of rituximab in refractory neuropsychiatric systemic lupus erythematosus: a real-world single-center study.. Clinical rheumatology. https://doi.org/10.1007/s10067-026-08164-1
GB/T 7714
Yue Zhao, Jinchao Jia, Qichen Gao, Mengyan Wang, Yuning Ma, Hui Shi, et al. Long-term clinical outcomes and safety of rituximab in refractory neuropsychiatric systemic lupus erythematosus: a real-world single-center study.[J]. Clinical rheumatology, 2026 doi:10.1007/s10067-026-08164-1.
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