PMID- 29490307 OWN - NLM STAT- MEDLINE DCOM- 20181023 LR - 20220409 IS - 1423-0356 (Electronic) IS - 0025-7931 (Print) IS - 0025-7931 (Linking) VI - 95 IP - 5 DP - 2018 TI - Real-World Experience with Nintedanib in Patients with Idiopathic Pulmonary Fibrosis. PG - 301-309 LID - 10.1159/000485933 [doi] AB - BACKGROUND: Nintedanib, an oral tyrosine kinase inhibitor, has been shown to slow down the progression of idiopathic pulmonary fibrosis (IPF) in two randomised placebo-controlled trials by reducing the annual decline in forced vital capacity (FVC). However, real-world experience is limited. OBJECTIVE: To assess the efficacy and safety of nintedanib in a large cohort of patients treated at a tertiary referral site for interstitial lung diseases. METHODS: The records of patients with a confirmed diagnosis of IPF were reviewed. Full medical history, pulmonary function, and adverse events (AEs) were recorded from each clinic visit. Disease progression was defined as a reduction in FVC >/=5% and/or in diffusing capacity of the lung for carbon monoxide >/=15% according to recent publications. Only patients with a treatment duration >/=3 months were included in the efficacy evaluation. RESULTS: A total of 64 patients were treated. Mean +/- standard deviation (SD) FVC was 71 +/- 21% predicted, and the mean time from diagnosis to initiation of nintedanib treatment was 23.8 months. Nearly half of patients (n = 30, 47%) had received prior pirfenidone treatment. The mean duration of follow-up was 11 months. At 6 months following initiation of nintedanib, 67% of the patients were stable. The mean +/- SD change in percent predicted FVC from baseline was 0.2 +/- 7.8% at 3 months, -1.3 +/- 7.9% at 6 months, and -2.1 +/- 9% at 9 months. Diarrhoea was the most common AE experienced by 33% of patients and was generally manageable. CONCLUSION: The results from this real-world clinical setting support findings from previously conducted clinical trials and show that nintedanib is effective for the management of IPF and is associated with disease stabilisation. Nintedanib is generally well tolerated. CI - (c) 2018 The Author(s) Published by S. Karger AG, Basel. FAU - Brunnemer, Eva AU - Brunnemer E AD - Centre for Interstitial and Rare Lung Diseases, Department of Pneumology and Respiratory Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany. AD - Translational Lung Research Centre Heidelberg (TLRC), Member of the German Centre for Lung Research (DZL), Heidelberg, Germany. FAU - Walscher, Julia AU - Walscher J AD - Centre for Interstitial and Rare Lung Diseases, Department of Pneumology and Respiratory Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany. AD - Translational Lung Research Centre Heidelberg (TLRC), Member of the German Centre for Lung Research (DZL), Heidelberg, Germany. FAU - Tenenbaum, Svenja AU - Tenenbaum S AD - Centre for Interstitial and Rare Lung Diseases, Department of Pneumology and Respiratory Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany. AD - Translational Lung Research Centre Heidelberg (TLRC), Member of the German Centre for Lung Research (DZL), Heidelberg, Germany. FAU - Hausmanns, Julia AU - Hausmanns J AD - Centre for Interstitial and Rare Lung Diseases, Department of Pneumology and Respiratory Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany. AD - Translational Lung Research Centre Heidelberg (TLRC), Member of the German Centre for Lung Research (DZL), Heidelberg, Germany. FAU - Schulze, Karen AU - Schulze K AD - Centre for Interstitial and Rare Lung Diseases, Department of Pneumology and Respiratory Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany. AD - Translational Lung Research Centre Heidelberg (TLRC), Member of the German Centre for Lung Research (DZL), Heidelberg, Germany. FAU - Seiter, Marianne AU - Seiter M AD - Centre for Interstitial and Rare Lung Diseases, Department of Pneumology and Respiratory Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany. AD - Translational Lung Research Centre Heidelberg (TLRC), Member of the German Centre for Lung Research (DZL), Heidelberg, Germany. FAU - Heussel, Claus Peter AU - Heussel CP AD - Translational Lung Research Centre Heidelberg (TLRC), Member of the German Centre for Lung Research (DZL), Heidelberg, Germany. AD - Department of Diagnostic and Interventional Radiology with Nuclear Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany. AD - Department of Diagnostic and Interventional Radiology, University Hospital of Heidelberg, Heidelberg, Germany. FAU - Warth, Arne AU - Warth A AD - Translational Lung Research Centre Heidelberg (TLRC), Member of the German Centre for Lung Research (DZL), Heidelberg, Germany. AD - Institute of Pathology, University of Heidelberg, Heidelberg, Germany. FAU - Herth, Felix J F AU - Herth FJF AD - Centre for Interstitial and Rare Lung Diseases, Department of Pneumology and Respiratory Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany. AD - Translational Lung Research Centre Heidelberg (TLRC), Member of the German Centre for Lung Research (DZL), Heidelberg, Germany. FAU - Kreuter, Michael AU - Kreuter M AD - Centre for Interstitial and Rare Lung Diseases, Department of Pneumology and Respiratory Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany. AD - Translational Lung Research Centre Heidelberg (TLRC), Member of the German Centre for Lung Research (DZL), Heidelberg, Germany. LA - eng PT - Journal Article DEP - 20180228 PL - Switzerland TA - Respiration JT - Respiration; international review of thoracic diseases JID - 0137356 RN - 0 (Antineoplastic Agents) RN - 0 (Indoles) RN - G6HRD2P839 (nintedanib) SB - IM MH - Aged MH - Antineoplastic Agents/*therapeutic use MH - Female MH - Humans MH - Idiopathic Pulmonary Fibrosis/*drug therapy MH - Indoles/*therapeutic use MH - Male MH - Middle Aged MH - Retrospective Studies MH - Tertiary Care Centers PMC - PMC5985741 OTO - NOTNLM OT - Idiopathic pulmonary fibrosis OT - Nintedanib OT - Real-world experience EDAT- 2018/03/01 06:00 MHDA- 2018/10/24 06:00 PMCR- 2018/02/28 CRDT- 2018/03/01 06:00 PHST- 2017/07/06 00:00 [received] PHST- 2017/11/29 00:00 [accepted] PHST- 2018/03/01 06:00 [pubmed] PHST- 2018/10/24 06:00 [medline] PHST- 2018/03/01 06:00 [entrez] PHST- 2018/02/28 00:00 [pmc-release] AID - 000485933 [pii] AID - res-0095-0301 [pii] AID - 10.1159/000485933 [doi] PST - ppublish SO - Respiration. 2018;95(5):301-309. doi: 10.1159/000485933. Epub 2018 Feb 28.