TY -的T1 - 2期临床试验评估特发性肺纤维化患者lebrikizumab JF -欧洲呼吸杂志》乔和J - 10.1183/13993003.02442 -2019欧元六世- 57 - 2 SP - 1902442 AU -马赫,托比·m . AU - Costabel乌尔里希盟——Glassberg玛丽莲·k . AU - Kondoh Yasuhiro盟——Ogura隆非盟- Scholand,玛丽•贝思盟——Kardatzke大卫AU -霍华德,莫奈AU -奥尔森,朱莉盟——邻居玛格丽特AU - Belloni,宝拉盟——Swigris杰弗里·J·Y1 - 2021/02/01 UR - //www.qdcxjkg.com/content/57/2/1902442.abstract N2 -这个阶段2,随机,双盲,安慰剂对照试验评估lebrikizumab的疗效和安全性,白介素(IL) -13单克隆抗体,单独或与背景pirfenidone治疗,患者的特发性肺纤维化(IPF)。≥40岁IPF患者用力肺活量(FVC)预测的40% - -100%和25% - -90%的一氧化碳扩散能力预测和人首次治疗(组)或接收pirfenidone (2403 mg·天−1;群B)是随机1:1接收lebrikizumab 250毫克或安慰剂每4周皮下注射。主要终点是FVC %的年增长率预测下降超过52周。在队列上,154名患者随机接受lebrikizumab (n = 78)或安慰剂(n = 76)。在B组,351名患者接受pirfenidone随机接受lebrikizumab (n = 174)或安慰剂(n = 177)。基线人口平衡在两组治疗武器。主要终点(FVC %的年增长率预测下降)并不是在队列(lebrikizumab与安慰剂,−−6.2% 5.2%;p = 0.456)和B组(lebrikizumab与安慰剂,−−6.0% 5.5%;p = 0.557)。在B组,非统计性死亡率显著不平衡有利于观察联合治疗(危险比为0.42 (95% CI 0.17 - -1.04))。 Pharmacodynamic biomarkers indicated lebrikizumab activity. The safety profile was consistent with that in previous studies of lebrikizumab and pirfenidone as monotherapies.Lebrikizumab alone or with pirfenidone was not associated with reduced FVC % predicted decline over 52 weeks despite evidence of pharmacodynamic activity. Lebrikizumab was well tolerated with a favourable safety profile. These findings suggest that blocking IL-13 may not be sufficient to achieve a lung function benefit in patients with IPF.This phase 2 RCT found no benefit in FVC decline over 52 weeks in IPF patients for lebrikizumab versus placebo as monotherapy (n=78 versus 76) or in combination with pirfenidone (n=174 versus 177); pirfenidone therapy was consistent with previous results https://bit.ly/313NVR8 ER -