利妥昔单抗治疗与皮肤硬化的显著改善相关:在印度队列中的真实世界观察。

IF 2.8 4区 医学 Q1 DERMATOLOGY
Sanjeev Handa, Anubha Dev, Anuradha Bishnoi, Dipankar De, Rahul Mahajan
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引用次数: 0

摘要

背景:利妥昔单抗对ssc相关ILD和皮肤硬化均有效。然而,大多数研究报告皮肤硬化的改善是次要结果,在利妥昔单抗的皮肤病学影响方面留下了文献空白。因此,本研究评估了利妥昔单抗在减轻皮肤硬化方面的有效性。材料和方法:本回顾性研究在印度北部的一家三级保健中心进行。回顾2016 - 2023年SSc患者的记录。根据临床表现和EULAR指南对终末器官损伤进行临床评估、调查和标准治疗。根据部门协议,利妥昔单抗的剂量为1g,间隔2周,用于基线mRSS为14或更高,伴有或不伴有ILD或基线mRSS大于71且存在ILD时小于14的患者。患者分为两组:接受利妥昔单抗治疗的患者(利妥昔单抗组)和rituximab-naïve患者。根据mRSS和总生存期的变化来评估治疗效果。结果:98例SSc患者中,37例接受利妥昔单抗治疗,61例接受利妥昔单抗- naïve治疗。利妥昔单抗组有更高的DSS患者百分比(70.3% vs 29.5%)和更高的基线mRSS (20.1 vs 11.5)。与Rituximab naïve组相比,Rituximab组mRSS降低的百分比显著更高(47.9% vs. 31.2%, p=0.013)。利妥昔单抗组140个月总生存率为65.8%,rituximab-naïve组95个月总生存率为53.2% (p=0.851)。LSS患者的生存率(100个月时77.8%)高于DSS患者(140个月时46.9%,p=0.048)。在多变量分析中,mRSS的较大百分比降低是生存的最强预测因子(p=0.039)。结论:利妥昔单抗即使在基线皮肤硬化症更严重的患者中也能显著减少皮肤硬化症,尽管它没有显示出任何生存益处。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Treatment with Rituximab is associated with significantly improved cutaneous sclerosis: real-world observations in an Indian cohort.

Background: Rituximab, is effective in both SSc-associated ILD and cutaneous sclerosis. However, most studies report improvement in skin sclerosis as secondary outcomes, leaving a gap in literature on rituximab's dermatological impact. Hence this study evaluates rituximab's effectiveness in reducing skin sclerosis.

Materials and methods: This retrospective study was conducted at a tertiary care center in northern India. Records of SSc patients from 2016 to 2023 were reviewed. Clinical assessments, investigations and standard treatment for end organ damage was done according to clinical presentation and EULAR guidelines. Rituximab was administered at a dose of 1g 2 weeks apart to patients having a baseline mRSS of 14 or higher, with or without ILD or a baseline mRSS of greater than seven1 and less than 14 in the presence of ILD, by a departmental protocol. Patients were divided into two groups: those receiving rituximab (rituximab group) and rituximab-naïve patients. Treatment response was evaluated based on change in mRSS and overall survival.

Results: Among 98 SSc patients, 37 received rituximab, and 61 were rituximab - naïve. The rituximab group had higher percentage of DSS patients (70.3% vs 29.5%) and higher baseline mRSS (20.1 vs. 11.5). There was significantly greater percentage reduction in mRSS (47.9% vs. 31.2%, p=0.013) in the Rituximab group as compared to the Rituximab naïve group. Overall survival was 65.8% at 140 months in the rituximab group as compared to 53.2% at 95 months in rituximab-naïve group (p=0.851). Patients with LSS had a better survival (77.8% at 100 months) as compared to those with DSS (46.9% at 140 months, p=0.048). On multivariate analysis, a greater percentage reduction in mRSS was the strongest predictor of survival (p=0.039).

Conclusion: Rituximab shows significant reduction in skin sclerosis even in patients with more severe baseline skin sclerosis, though it did not demonstrate any survival benefit.

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来源期刊
CiteScore
3.20
自引率
2.40%
发文量
389
审稿时长
3-8 weeks
期刊介绍: Clinical and Experimental Dermatology (CED) is a unique provider of relevant and educational material for practising clinicians and dermatological researchers. We support continuing professional development (CPD) of dermatology specialists to advance the understanding, management and treatment of skin disease in order to improve patient outcomes.
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