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——SwigrisJeffrey J. Y1 - 201/02/01 UR - //www.qdcxjkg.com/content/57/2/1902442.abstract N2 -这项随机、双盲、安慰剂对照试验评估了lebrikizumab(一种白细胞介素(IL)-13单克隆抗体)单独或联合吡非尼酮治疗特发性肺纤维化(IPF)患者的疗效和安全性。年龄≥40岁的IPF患者，预测强迫肺活量(FVC)为40%-100%，预测一氧化碳扩散能力为25%-90%，treatment-naïve(队列A)或接受吡非尼酮(2403 mg·天−1;B组)随机1:1接受每4周皮下注射250mg lebrikizumab或安慰剂。主要终点是预计在52周内植被覆盖度%的年化下降率。在队列A中，154例患者随机接受lebrikizumab (n=78)或安慰剂(n=76)。在队列B中，351例接受吡非尼酮的患者随机接受lebrikizumab (n=174)或安慰剂(n=177)。两组治疗组的基线人口统计数据平衡。A队列的主要终点(预测下降的年化FVC %率)未达到(莱布利珠单抗vs安慰剂，−5.2% vs−6.2%;p=0.456)或B组(lebrikizumab vs安慰剂，−5.5% vs - 6.0%;p = 0.557)。 In cohort B, a non-statistically significant imbalance in mortality favouring combination therapy was observed (hazard ratio 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 -