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首页> 外文期刊>Pulmonary therapy. >Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis: Experience from 92 Sites in an Open-Label US Expanded Access Program
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Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis: Experience from 92 Sites in an Open-Label US Expanded Access Program

机译：吡非尼酮在特发性肺纤维化患者中的安全性：美国开放标签扩展访问计划中92个站点的经验

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IntroductionIn phase 3 clinical trials, pirfenidone significantly slowed disease progression with a well-defined and medically?manageable safety profile in patients with idiopathic pulmonary fibrosis (IPF). This study examined safety events related to pirfenidone in patients with IPF in an expanded access program in the US. MethodsThe Expanded Access Program allowed patients with IPF access to pirfenidone prior to US Food and Drug Administration approval. Patients had an IPF diagnosis including a definite or possible usual interstitial pneumonia (UIP) pattern, predicted forced vital capacity ≥50%, and predicted diffusing capacity for carbon monoxide ≥30%. Clinical laboratory data and adverse drug reactions (ADRs) deemed causally related to pirfenidone were analyzed using descriptive summary statistics. ResultsOf the 1620 patients treated, 1221 (75.4%) completed the program: 66.5% had definite UIP, and 33.2% had possible UIP. Mean (SD) pirfenidone exposure was 22.8 (9.6) weeks, and mean (SD) daily dose during the course of treatment was 2058.7 (399.2) mg. ADRs occurred in 64.9% of patients: 3.3% were severe and 0.2% life threatening. The most common ADRs were nausea (22.6%) and fatigue (19.6%); 13.0% of patients discontinued due to ADRs. Serious ADRs occurred in 24 patients (1.5%), which were primarily related to elevated liver function enzymes (ten patients, 0.6%). No ADRs led to death. ConclusionsIn this open-label study of 1620 patients with IPF, including those with possible UIP, the safety profile of pirfenidone was consistent with that of earlier clinical trials, and no new safety signals were identified. NCT02141087. FundingGenentech, Inc., a member of the Roche group.
机译：简介在3期临床试验中，吡非尼酮以特发性和医学可控的安全性显着降低了特发性肺纤维化（IPF）患者的疾病进展。这项研究在美国一项扩大的访问计划中检查了IPF患者中与吡非尼酮有关的安全事件。方法：扩展获取计划允许IPF患者在获得美国食品和药物管理局批准之前可以使用吡非尼酮。患者进行了IPF诊断，包括确定的或可能的常规间质性肺炎（UIP）模式，预计的强制肺活量≥50％和预测的一氧化碳扩散能力≥30％。使用描述性摘要统计数据分析了与吡非尼酮因果相关的临床实验室数据和药物不良反应（ADR）。结果在接受治疗的1620例患者中，有1221例（75.4％）完成了该计划：66.5％的患者明确了UIP，33.2％的患者可能进行了UIP。吡非尼酮的平均（SD）暴露量为22.8（9.6）周，治疗过程中的平均（SD）日剂量为2058.7（399.2）mg。 64.9％的患者发生ADR：3.3％的患者严重，0.2％的生命受到威胁。最常见的ADR为恶心（22.6％）和疲劳（19.6％）; 13.0％的患者因ADR停药。严重的ADR发生在24例患者中（1.5％），主要与肝功能酶升高相关（10例患者，0.6％）。没有ADR导致死亡。结论在这项对1620例IPF患者（包括可能的UIP患者）进行的开放标签研究中，吡非尼酮的安全性与早期临床试验一致，未发现新的安全性信号。 NCT02141087。 FundingGenentech，Inc.，罗氏集团的成员。

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