文摘
目前药物批准用于治疗特发性肺纤维化(IPF) (pirfenidone或nintedanib)减缓FVC的下降(用力肺活量)。尽管如此,仍有医疗需要有效并具有更好的耐受性疗法。Pamrevlumab (fg - 3019)是一种人类单克隆抗体对结缔组织生长因子(CTGF)由IPF患者耐受良好。初步数据从一个开放在IPF 2期临床试验表明,pamrevlumab可能稳定或改善FVC以及肺纤维化评估量化HRCT (qHRCT)在大约三分之一的病人。基于这些积极发现,赞美了。103 IPF患者当前的指导方针,FVC≥55%预测、DLCO≥30%的预测,在10%和50%之间由HRCT肺纤维化,被随机分配接受16支pamrevlumab(30毫克/公斤IV q3w)或安慰剂48周。另外两个同伴稳定剂量pirfenidone (n = 36)或nintedanib (n = 21)也报名参加了24周。患者评估FVC,病人报告结果和生物标记每12周。肺纤维化是由qHRCT评估集中阅读每24周。安全评估中不断学习。 At baseline, randomized patients were male (71.9%), white (88.8%) and former smoker (64.4%). Mean age was 68.3 years, median % predicted FVC and DLCO were 70.3% and 51.5% respectively and the median GAP score was 4. Last enrolled subject will complete participation in June 2017, at which time data will be unblinded. Safety and efficacy results of pamrevlumab in monotherapy and in combination with current IPF standard of care will be presented.
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