Treatment of Idiopathic Pulmonary Fibrosis with Etanercept An Exploratory, Placebo-controlled Trial
Treatment of Idiopathic Pulmonary Fibrosis with Etanercept An Exploratory, Placebo-controlled Trial
复制标题
DOI：
10.1164/rccm.200709-1446oc
复制
发表时间：
2008-11-01
影响因子：
24.7
通讯作者：
Fatenejad, Saeed
中科院分区：
文献类型：
--
作者：
Raghu, Ganesh;Brown, Kevin K.;Fatenejad, Saeed
基本原理：一个有效的药物治疗特发性肺纤维化（IPF）仍然是hierful.Objectives：探讨依那西普在治疗IPF.Methods的有效性和安全性：这是一个随机，前瞻性，双盲，安慰剂对照，多中心的探索性试验，在临床进展性IPF的主题。主要终点包括预测FVC百分比和经血红蛋白校正的一氧化碳使用量（D-LCOHB）的变化以及48 wk内静息时肺泡与动脉氧压差P（A-a）（O2）相对于基线的变化。测量和主要结果：88例受试者接受皮下依那西普（25 mg）或安慰剂每周两次作为IPF的唯一治疗。两个治疗组之间未检测到基线人口统计学和疾病状态的差异;自首次诊断的平均时间为13.6个月，平均FVC为预测值的63.9%。在48周时，两组之间的疗效终点无显著差异。在接受依那西普的受试者中，在几个生理、功能和生活质量终点上观察到疾病进展无显着减少。治疗组间不良事件无差异。结论：在临床进展性IPF患者的探索性研究中，依那西普耐受性良好。尽管预定义的终点没有差异，但在几个指标上观察到疾病进展率降低。可能需要进一步评价TNF拮抗剂治疗IPF的效果。
Rationale: An efficacious medical therapy for idiopathic pulmonary fibrosis (IPF) remains elusive.Objectives: To explore the efficacy and safety of etanercept in the treatment of IPF.Methods: This was a randomized, prospective, double-blind, placebo-controlled, multicenter exploratory trial in subjects with clinically progressive IPF. Primary endpoints included changes in the percentage of predicted FVC and lung cliff using capacity for carbon monoxide corrected for hemoglobin (D-LCOHB) and change in the alveolar to arterial oxygen pressure difference P(A-a)(O2) at rest from baseline over 48 weeks.Measurements and Main Results: Eighty-eight subjects received subcutaneous etanercept (25 mg) or placebo twice weekly as their sole treatment for IPF. No differences in baseline demographics and disease status were detected between treatment groups; the mean time from first diagnosis was 13.6 months and mean FVC was 63.9% of predicted. At 48 weeks, no significant differences in efficacy end points were observed between the groups. A nonsignificant reduction in disease progression was seen in several physiologic, functional, and quality-of-life endpoints among subjects receiving etanercept. There was no difference in adverse events between treatment groups.Conclusions: In this exploratory study in patients with clinically progressive IPF, etanercept was well tolerated. Although there were no differences in the predefined endpoints, a decreased rate of disease progression was observed on several measures. Further evaluation of TNF antagonists in the treatment of IPF may be warranted.