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Ann Rheum Dis:当代实践中使用利妥昔单抗治疗系统性硬化症的结局

2019-04-10 xiangting MedSci原创

在这个大型SSc队列中,使用利妥昔单抗与良好的安全性相关。

这项研究旨在评价临床实践中利妥昔单抗治疗系统性硬化症(SSc)的安全性和疗效。

这是一项前瞻性研究,纳入欧洲硬皮病试验和研究网络(EUSTAR)中使用利妥昔单抗治疗的SSc患者,并与未治疗的SSc患者进行匹配。主要结局指标是使用或不使用利妥昔单抗治疗的倾向评分匹配患者中不良事件、皮肤纤维化改善、肺纤维化恶化和类固醇使用。

254例患者接受利妥昔单抗治疗,58%因肺部受累接受治疗,32%因皮肤受累。中位随访2年后,约70%的患者无副作用。接受治疗的患者与9575例倾向评分匹配患者的比较显示,使用利妥昔单抗治疗的患者更可能出现皮肤纤维化改善(每100人年22.7 vs 14.03事件; OR:2.79 [1.47-5.32];p=0.002)。治疗患者用力肺活量(FVC)下降>10%(OR:1.03 [0.55-1.94]; p=0.93)或一氧化碳弥散能力(DLCO)下降的比率没有显著差异。利妥昔单抗治疗的患者更容易停用或减少类固醇用量(OR:2.34 [1.56-3.53],p<0.0001)。与单独接受利妥昔单抗治疗的患者相比,同时使用霉酚酸酯治疗的患者有结局更好的趋势(与对照组相比δFVC:5.22 [0.83-9.62];p=0.019 vs 3 [0.66-5.35];p=0.012)。

在这个大型SSc队列中,使用利妥昔单抗与良好的安全性相关。观察到皮肤纤维化有显著改变,而不是肺部。然而,该研究局限性是观察性设计。利妥昔单抗可能稳定肺部纤维化,必须通过随机试验来解决。

原始出处:

Muriel Elhai. Outcomes of patients with systemic sclerosis treated with rituximab in contemporary practice: a prospective cohort study. Ann Rheum Dis. 09 April 2019.

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