Division of Pulmonary and Sleep Medicine, Salem Veterans Affairs Medical Center, Salem, Virginia.
Department of Medicine, University of Virginia, Charlottesville, Virginia.
Ann Am Thorac Soc. 2024 Feb;21(2):317-327. doi: 10.1513/AnnalsATS.202301-055OC.
The American Thoracic Society convened an international, multidisciplinary panel to develop clinical practice guidelines for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD). To conduct a systematic review and evaluate the literature to determine whether patients with SSc-ILD should be treated with rituximab. A literature search was conducted across MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) databases through June 2022 for studies using rituximab to treat patients with SSc-ILD. Disease progression, quality of life, mortality, and adverse event data were extracted. The intervention was rituximab. The standard-of-care comparator group was decided by consensus of the panel as either placebo or mycophenolate. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Working Group approach was used to assess the quality of evidence. Three relevant studies were selected. Rituximab significantly improved the forced vital capacity % predicted (mean difference, 3.13; 95% confidence interval [CI], 0.37 to 5.90) and the modified Rodnan Skin Score (mean difference, -7.01; 95% CI, 11.46 to -2.56) at 24-48 weeks. Rituximab use in patients with SSc-ILD is associated with stabilization of lung function. The quality of evidence for study outcomes was considered to be very low, as defined by the GRADE approach. Additional research on treatment with rituximab is imperative.
美国胸科学会召集了一个国际、多学科的专家组,制定了治疗系统性硬化症相关间质性肺病(SSc-ILD)的临床实践指南。为了进行系统评价并评估文献,以确定是否应使用利妥昔单抗治疗 SSc-ILD 患者。通过 MEDLINE、EMBASE 和 Cochrane 对照试验中心注册库(CENTRAL)数据库进行了文献检索,检索时间截至 2022 年 6 月,检索内容为使用利妥昔单抗治疗 SSc-ILD 患者的研究。提取疾病进展、生活质量、死亡率和不良事件数据。干预措施为利妥昔单抗。标准治疗对照组由专家组共识决定为安慰剂或霉酚酸酯。采用推荐分级、评估、制定与评价(GRADE)工作组方法评估证据质量。选择了三项相关研究。利妥昔单抗在 24-48 周时显著改善了用力肺活量%预计值(平均差异,3.13;95%置信区间 [CI],0.37 至 5.90)和改良 Rodnan 皮肤评分(平均差异,-7.01;95%CI,11.46 至 -2.56)。在 SSc-ILD 患者中使用利妥昔单抗与肺功能稳定相关。研究结果的证据质量被认为非常低,这是 GRADE 方法定义的。需要进一步研究利妥昔单抗的治疗作用。