Efficacy and safety of rituximab versus intravenous cyclophosphamide for systemic sclerosis-associated interstitial lung disease: a retrospective cohort study

IF 4.6 2区医学 Q1 Medicine

Arthritis Research & Therapy Pub Date : 2025-10-17 DOI:10.1186/s13075-025-03654-0

Rioko Hiura, Masahiro Ayano, Ayumi Uchino, Junki Hiura, Naoyasu Ueda, Atsushi Tanaka, Seiji Yoshizawa, Shotaro Kawano, Fumiaki Sagawa, Shun-Ichiro Ota, Akie Hirata, Sho Fujimoto, Naoya Nishimura, Ayako Takaki-Kuwahara, Yasutaka Kimoto, Koichi Akashi, Hiroaki Niiro

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引用次数: 0

Abstract

The efficacy of rituximab (RTX) for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) has not been fully established. This study compared the efficacy and safety of RTX and intravenous cyclophosphamide (CY) for SSc-ILD. This retrospective study compared the efficacy and safety of RTX (20 patients) and CY (30 patients) after adjusting for the stabilised inverse probability of treatment weighting based on propensity scores. The efficacy endpoints were the absolute changes in forced vital capacity (FVC) and serum Krebs von den Lungen-6 (KL-6) levels from baseline to 6 and 12 months after treatment. The incidence of progression based on the definition of progressive pulmonary fibrosis was also recorded. The safety endpoint was the frequency of adverse events. The clinical characteristics of the two groups were well-balanced after adjusting for confounders (i.e., FVC, nintedanib use, and newly diagnosed cases). From baseline to 6 and 12 months after the start of treatment, the median FVC increased by 50 and 60 ml in the RTX group and 40 and 15 ml in the CY group, respectively, with no difference after adjustment. The changes in serum KL-6 levels and the incidences of progression were identical in both groups after adjustment. The overall adverse events were similar in both groups after adjustment. RTX demonstrated comparable safety and efficacy as CY in patients with SSc-ILD. Thus, RTX may be an alternative to CY for the treatment of SSc-ILD.

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利妥昔单抗与静脉注射环磷酰胺治疗系统性硬化症相关间质性肺病的疗效和安全性：一项回顾性队列研究

利妥昔单抗（RTX）治疗系统性硬化症相关间质性肺疾病（SSc-ILD）的疗效尚未完全确定。本研究比较了RTX和静脉注射环磷酰胺（CY）治疗SSc-ILD的疗效和安全性。本回顾性研究比较了RTX（20例患者）和CY（30例患者）在调整基于倾向评分的治疗加权的稳定逆概率后的疗效和安全性。疗效终点是治疗后6个月和12个月的强迫肺活量（FVC）和血清Krebs von den Lungen-6 （KL-6）水平的绝对变化。根据进行性肺纤维化的定义，还记录了进展的发生率。安全性终点是不良事件发生的频率。在调整混杂因素（即FVC、尼达尼布使用和新诊断病例）后，两组的临床特征很好地平衡。从基线到治疗开始后6个月和12个月，RTX组的中位FVC分别增加了50和60 ml， CY组增加了40和15 ml，调整后无差异。调整后两组血清KL-6水平变化及进展发生率相同。调整后两组总体不良事件相似。RTX在SSc-ILD患者中的安全性和有效性与CY相当。因此，RTX可能是治疗SSc-ILD的替代方法。

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

Arthritis Research & Therapy RHEUMATOLOGY-

CiteScore

8.60

自引率

2.00%

发文量

261

审稿时长

14 weeks

期刊介绍： Established in 1999, Arthritis Research and Therapy is an international, open access, peer-reviewed journal, publishing original articles in the area of musculoskeletal research and therapy as well as, reviews, commentaries and reports. A major focus of the journal is on the immunologic processes leading to inflammation, damage and repair as they relate to autoimmune rheumatic and musculoskeletal conditions, and which inform the translation of this knowledge into advances in clinical care. Original basic, translational and clinical research is considered for publication along with results of early and late phase therapeutic trials, especially as they pertain to the underpinning science that informs clinical observations in interventional studies.