Long-term treatment of patients with idiopathic pulmonary fibrosis with nintedanib: results from the TOMORROW trial and its open-label extension

被引:65
|
作者
Richeldi, Luca [1 ,2 ]
Kreuter, Michael [3 ,4 ]
Selman, Moises [5 ]
Crestani, Bruno [6 ]
Kirsten, Anne-Marie [7 ]
Wuyts, Wim A. [8 ]
Xu, Zuojun [9 ]
Bernois, Katell [10 ]
Stowasser, Susanne [11 ]
Quaresma, Manuel [3 ,4 ,11 ]
Costabel, Ulrich [12 ]
机构
[1] Univ Southampton, Natl Inst Hlth Res Southampton Resp Biomed Res Un, Southampton SO17 1BJ, Hants, England
[2] Univ Southampton, Clin & Expt Sci, Southampton SO17 1BJ, Hants, England
[3] Heidelberg Univ, Ctr Interstitial & Rare Lung Dis, Dept Pneumol, Thoraxklin, Heidelberg, Germany
[4] German Ctr Lung Res Germany, Translat Lung Res Ctr Heidelberg, Heidelberg, Germany
[5] Inst Nacl Enfermedades Resp, Mexico City, DF, Mexico
[6] Hop Bichat Claude Bernard, Pneumol, Paris, France
[7] German Ctr Lung Res, Airway Res Ctr North, Lung Clin Grosshansdorf, Pulm Res Inst, Grosshansdorf, Germany
[8] Univ Hosp Leuven, Dept Resp Med, Leuven, Belgium
[9] Peking Union Med Coll Hosp, Beijing, Peoples R China
[10] Boehringer Ingelheim France SAS, Paris, France
[11] Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany
[12] Univ Duisburg Essen, Univ Hosp, Ruhrlandklin, Essen, Germany
关键词
EFFICACY;
D O I
10.1136/thoraxjnl-2016-209701
中图分类号
R56 [呼吸系及胸部疾病];
学科分类号
摘要
The TOMORROW trial of nintedanib comprised a randomised, placebo-controlled, 52-week period followed by a further blinded treatment period and an open-label extension. We assessed outcomes across these periods in patients randomised to nintedanib 150 mg twice daily or placebo at the start of TOMORROW. The annual rate of decline in FVC was -125.4 mL/year (95% CI -168.1 to -82.7) in the nintedanib group and -189.7 mL/year (95% CI -229.8 to -149.6) in the comparator group. The adverse event profile of nintedanib remained consistent throughout the studies. These results support a benefit of nintedanib on slowing progression of idiopathic pulmonary fibrosis beyond 52 weeks.
引用
收藏
页码:581 / 583
页数:3
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