Evaluation of the mycophenolate mofetil–rituximab combination in systemic sclerosis: a French retrospective multicenter study (MycRiSSc)

IF 6.8 1区 医学 Q1 IMMUNOLOGY
Journal of autoimmunity Pub Date : 2025-12-01 Epub Date: 2025-10-15 DOI:10.1016/j.jaut.2025.103492
François Barde , Kevin Chevalier , Paul Decker , Matéo Merin , Amélie Nicolas , Alain Lescoat , Alban Deroux , Vincent Koether , Emmanuel Chatelus , Cyrille Coustal , Alexandre Maria , Martin Michaud , Grégory Pugnet , Anne Murarasu , Sébastien Riviere , Pierre Charles , Claire de Moreuil , Juliette Lodovichetti , François Maillet , Arthur Renaud , Benjamin Chaigne
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引用次数: 0

Abstract

Objectives

Mycophenolate mofetil (MMF) and rituximab (RTX) are recommended as first-line therapies for skin and interstitial lung disease (ILD) involvement in systemic sclerosis (SSc). However, data on their combined use remain limited. This study evaluated the efficacy and safety of MMF/RTX combination therapy compared to each drug alone.

Methods

We conducted a retrospective multicenter French study including SSc patients treated with MMF, RTX, or MMF/RTX combination for ≥12-months. Primary outcomes were changes in modified Rodnan skin score (mRSS) and predicted forced vital capacity (FVC) at 12 months. Secondary outcomes included factors associated with improvement in skin or ILD and adverse events.

Results

Forty-seven patients received MMF/RTX combination, 30 received RTX, and 50 received MMF. At 12 months, intra-group analyses showed significant mRSS improvement with MMF/RTX combination and MMF (p = 0.002 and p = 0.04, respectively). FVC increased significantly only with combination group (p = 0.003). In multivariate inter-group analysis, MMF/RTX combination was independently associated with greater mRSS improvement versus RTX (OR 0.07, 95 % CI [0.007–0.67], p = 0.02) and greater skin and/or lung improvement compared to RTX (OR 0.27 [0.08–0.89], p = 0.03) or MMF (OR 0.24 [0.07–0.81], p = 0.02). Adverse events were not significantly increased with MMF/RTX combination. In subgroup analyses restricted to MMF/RTX combination group, patients with upfront initiation significantly improved their FVC compared to patients with sequential introduction. Upfront initiation of MMF/RTX was associated with ILD improvement in multivariate analysis.

Conclusion

In SSc, MMF/RTX combination is well-tolerated and improves skin and ILD involvement, particularly when MMF and RTX are introduced simultaneously.
评价霉酚酸酯-利妥昔单抗联合治疗系统性硬化症:一项法国回顾性多中心研究(MycRiSSc)
目的:霉酚酸酯(MMF)和利妥昔单抗(RTX)被推荐作为皮肤和间质性肺疾病(ILD)累及系统性硬化症(SSc)的一线治疗药物。然而,关于它们联合使用的数据仍然有限。本研究评估了MMF/RTX联合治疗与单独用药相比的有效性和安全性。方法:我们在法国进行了一项回顾性多中心研究,纳入了MMF、RTX或MMF/RTX联合治疗≥12个月的SSc患者。主要结局是12个月时改良罗德曼皮肤评分(mRSS)和预测用力肺活量(FVC)的变化。次要结局包括与皮肤或ILD改善和不良事件相关的因素。结果:MMF/RTX联合治疗47例,RTX治疗30例,MMF治疗50例。在12个月时,组内分析显示MMF/RTX联合治疗和MMF显著改善mRSS (p = 0.002和p = 0.04分别)。FVC只有联合组显著升高(p = 0.003)。在多变量组间分析中,与RTX相比,MMF/RTX联合治疗与更大的mRSS改善(OR 0.07, 95% CI [0.007-0.67], p = 0.02)以及与RTX (OR 0.27 [0.08-0.89], p = 0.03)或MMF (OR 0.24 [0.07-0.81], p = 0.02)相比,更大的皮肤和/或肺改善独立相关。MMF/RTX联合治疗的不良事件没有显著增加。在仅限于MMF/RTX联合组的亚组分析中,与顺序引入患者相比,预先引入患者的FVC显著改善。在多变量分析中,MMF/RTX的前期治疗与ILD的改善相关。结论:在SSc中,MMF/RTX联合使用耐受性良好,可改善皮肤和ILD受损伤,特别是当MMF和RTX同时使用时。
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
Journal of autoimmunity
Journal of autoimmunity 医学-免疫学
CiteScore
27.90
自引率
1.60%
发文量
117
审稿时长
17 days
期刊介绍: The Journal of Autoimmunity serves as the primary publication for research on various facets of autoimmunity. These include topics such as the mechanism of self-recognition, regulation of autoimmune responses, experimental autoimmune diseases, diagnostic tests for autoantibodies, as well as the epidemiology, pathophysiology, and treatment of autoimmune diseases. While the journal covers a wide range of subjects, it emphasizes papers exploring the genetic, molecular biology, and cellular aspects of the field. The Journal of Translational Autoimmunity, on the other hand, is a subsidiary journal of the Journal of Autoimmunity. It focuses specifically on translating scientific discoveries in autoimmunity into clinical applications and practical solutions. By highlighting research that bridges the gap between basic science and clinical practice, the Journal of Translational Autoimmunity aims to advance the understanding and treatment of autoimmune diseases.
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