抽象的
This phase 2, randomised, double-blind, placebo-controlled trial evaluated the efficacy and safety of lebrikizumab, an interleukin-13 monoclonal antibody, alone or with background pirfenidone therapy, in patients with idiopathic pulmonary fibrosis (IPF).
Patients with IPF aged ≥40 years with % predicted forced vital capacity (%FVC) 40%–100% and diffusing capacity for carbon monoxide 25%–90% and who were treatment-naive (Cohort A) or receiving pirfenidone (2403 mg·day−1; Cohort B) were randomised 1:1 to receive lebrikizumab 250 mg or placebo subcutaneously every 4 weeks. The primary endpoint was annualised rate of %FVC decline over 52 weeks.
在群组中,154名患者随机接受lebrikizumab(n = 78)或安慰剂(n = 76)。在Cohort B中,接受pirfenidone的351名患者被随机化接受lebrikizumab(n = 174)或安慰剂(n = 177)。基线人口统计学在两个队列中的治疗臂均衡。在COHORT A(Lebrakizumab中,没有举行主要终点(%FVC衰退的年化率)(Lebrikizumabversus安慰剂,-5.2%versus−6.2%; p=0.456) or Cohort B (lebrikizumabversus安慰剂,-5.5%versus−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 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.
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Conflict of interest: Dr. Maher reports grants from Funding from GlaxoSmithKline and University of California, Berkeley (UCB), during the conduct of the study; and Served as a consultant and speaker for Apellis, AstraZeneca, Bayer, Blade Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Galapagos, GlaxoSmithKline, Indalo, Novartis, Pliant, ProMetic, Respivnat, Roche, Samumed and UCB.
利益冲突:Codeabel博士报告是Gilead的研究裁决委员会的成员;曾担任拜耳,Boehringer Ingelheim和长期/罗氏的顾问和演讲者;已收到来自Boehringer Ingelheim和二期的赠款,并作为Centecor,纤维原,吉尔德,Glaxosmithkline,UCB Celltech和Biogen的顾问。
利益冲突:Glassberg博士在研究期间报告Genentech / Roche的赠款;并是上升研究指导委员会的成员;曾担任Bellerophon,Boehringer Ingelheim,Bristol Myers Squibb,长期,Redx Pharma和Roche的顾问。
兴趣冲突:Kondoh博士报告日本卫生,劳工和福利部的赠款在该研究中;并曾担任Genentech的顾问,并担任Asahi Kasei,Boehringer Ingelheim,Eisai,Jansen,Kyorin,Mitsubishi Tanabe Pharma,Novartis和Shionogi的顾问和演讲者。
兴趣冲突:Ogura博士报告了日本福尔海姆和卫生部,卫生,劳工和福利部的赠款;并担任Asahi Kasei,Boehringer Ingelheim,Eisai,Nitto Denko,Shionogi和Toray的顾问或演讲者。
利益冲突:Scholand博士曾在Boehringer Ingelheim和罗氏/ Genentech担任顾问委员会。
利益冲突:Kardatzke博士是Genentech,Inc。的员工
利益冲突:霍华德博士是Genentech,Inc。的员工
Conflict of interest: Dr. Olsson is an employee of Genentech, Inc.
利益冲突:邻居博士是Genentech,Inc。的员工
Conflict of interest: Dr. Belloni is an employee of Genentech, Inc.
兴趣冲突:萨姆博士在研究期间报道了来自二期,Genentech的个人费用的赠款;并作为上升研究指导委员会的成员,在科学咨询委员会担任两部经销委员会,并担任Boehringer Ingelheim和Roche的顾问。
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- 已收到2019年12月18日。
- AcceptedAugust 11, 2020.
- 复制right ©ERS 2020