Suppr超能文献

利妥昔单抗治疗成人原发性膜性肾病的疗效与安全性:一项多中心、回顾性、真实世界研究

Efficacy and safety of ripertamab for treating primary membranous nephropathy among adults: a multicenter, retrospective, real-world study.

作者信息

Wang Xichao, Song Xinyuan, Sun Na, Chang Wenxiu

机构信息

Department of Nephrology, Tianjin First Central Hospital, Tianjin, China.

出版信息

Front Immunol. 2025 Mar 26;16:1540694. doi: 10.3389/fimmu.2025.1540694. eCollection 2025.

Abstract

BACKGROUND

Ripertamab has been used in an off-label manner for treating primary membranous nephropathy (PMN) in real-world settings in China, despite limited evidence supporting the efficacy of this drug. This multicenter, retrospective study is the first to assess the effectiveness and safety of ripertamab for treating PMN in a real-world Chinese clinical setting.

METHODS

Adult patients with PMN who were treated with at least one course of ripertamab alone were included in this study. Patients were categorized into two groups based on their prior treatment of PMN: the initial therapy group and the non-initial therapy group. The primary outcome was the occurrence of complete remission (CR) or partial remission (PR) at 6 and 12 months. The secondary outcomes included the time to achieve remission, relapse rate and the incidence of adverse events (AEs).

RESULTS

Fifty-two patients were ultimately included for analysis. Among these patients, 39 received ripertamab as initial therapy, while 13 were in the non-initial therapy group. The median follow-up duration was 8.7 (4.7, 11.3) months. At 6 months, 24/40 (60.0%) patients achieved clinical remission, with 2/40 (5.0%) achieving CR and 22/40 (55.0%) achieving PR. At 12 months, 22 patients completed follow-up: 2 (9.1%) achieved CR, and 15 (68.2%) achieved PR. The median time to remission for the entire cohort was 90.5 (32, 165) days and four of the 52 patients (7.7%) relapsed. The initial therapy group had a higher remission rate at 12 months than the non-initial therapy group [13/15 (86.7%) vs. 4/7 (57.1%)]. Additionally, the initial therapy group achieved remission more quickly than the non-initial therapy group [79.0 (36, 112) vs. 165.0 (30, 313) days]. Ripertamab was well tolerated, with 9.6% (5/52) of patients experiencing AEs; none of the AEs were severe.

CONCLUSION

Ripertamab demonstrated efficacy and good tolerability for the treatment of PMN in a Chinese real-world setting. These findings support the use of ripertamab as a therapeutic option for PMN patients and suggest the need for further investigation into its long-term safety and efficacy.

摘要

背景

在中国的实际临床环境中,利妥昔单抗已被用于治疗原发性膜性肾病(PMN),尽管支持该药物疗效的证据有限。这项多中心回顾性研究首次评估了利妥昔单抗在中国实际临床环境中治疗PMN的有效性和安全性。

方法

本研究纳入了仅接受至少一个疗程利妥昔单抗治疗的成年PMN患者。根据患者先前对PMN的治疗情况将其分为两组:初始治疗组和非初始治疗组。主要结局是6个月和12个月时完全缓解(CR)或部分缓解(PR)的发生情况。次要结局包括达到缓解的时间、复发率和不良事件(AE)的发生率。

结果

最终纳入52例患者进行分析。其中,39例接受利妥昔单抗作为初始治疗,13例在非初始治疗组。中位随访时间为8.7(4.7,11.3)个月。6个月时,24/40(60.0%)的患者达到临床缓解,其中2/40(5.0%)达到CR,22/40(55.0%)达到PR。12个月时,22例患者完成随访:2例(9.1%)达到CR,15例(68.2%)达到PR。整个队列达到缓解的中位时间为90.5(32,165)天,52例患者中有4例(7.7%)复发。初始治疗组在12个月时的缓解率高于非初始治疗组[13/15(86.7%)对4/7(57.1%)]。此外,初始治疗组比非初始治疗组更快达到缓解[79.0(36,112)天对165.0(30,313)天]。利妥昔单抗耐受性良好,9.6%(5/52)的患者出现AE;均无严重AE。

结论

在中国大陆实际临床环境中,利妥昔单抗对PMN的治疗显示出有效性和良好的耐受性。这些发现支持将利妥昔单抗作为PMN患者的一种治疗选择,并表明需要进一步研究其长期安全性和有效性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cda4/11979284/6d50dcd622b1/fimmu-16-1540694-g001.jpg

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验