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• W3093224238 abstract "SESSION TITLE: Diffuse Lung Disease Posters SESSION TYPE: Original Investigation Posters PRESENTED ON: October 18-21, 2020 PURPOSE: In the INBUILD trial in patients with progressive fibrosing interstitial lung diseases (ILDs) other than idiopathic pulmonary fibrosis (IPF), nintedanib reduced the rate of decline in FVC compared with placebo. We assessed the effect of nintedanib on the rate of FVC decline in subgroups with well-preserved FVC versus more impaired FVC at baseline. METHODS: Participants in the INBUILD trial had a physician-diagnosed fibrosing ILD other than IPF, diffuse fibrosing lung disease of >10% extent on HRCT, FVC ≥45% predicted, and DLco ≥30%–<80% predicted. Subjects met protocol-defined criteria for progression of ILD (based on decline in FVC, worsening fibrosis on HRCT, or worsening symptoms) in the 24 months before screening. In post-hoc analyses, we analyzed the rate of decline in FVC (mL/year) over 52 weeks in subgroups by FVC ≤90% versus >90% predicted at baseline. RESULTS: At baseline, 598 (90.2%) subjects had FVC ≤90% predicted and 65 (9.8%) had FVC >90% predicted. Mean (SD) FVC was 2218 (626) mL and 3370 (832) mL in these subgroups, respectively. In patients who received placebo, the mean (SE) adjusted rate of decline in FVC over 52 weeks was numerically greater in subjects with FVC >90% predicted than ≤90% predicted at baseline (−304.2 [48.3] mL/year versus −174.0 [15.8] mL/year). In subjects treated with nintedanib, the mean (SE) adjusted rate of decline in FVC over 52 weeks was consistent between subjects with FVC >90% and ≤90% predicted at baseline (−86.5 [51.1] mL/year and −80.5 [15.9] mL/year, respectively). The treatment effect of nintedanib versus placebo was numerically more pronounced in subjects with FVC >90% than ≤90% predicted at baseline (between-group differences of 217.6 mL/year [95% CI: 88.2, 347.1] and 93.5 mL/year [95% CI: 49.8, 137.1]), but the treatment-by-subgroup-by-time interaction p-value did not reach statistical significance (p=0.07). CONCLUSIONS: In the INBUILD trial, nintedanib slowed the rate of FVC decline in patients with chronic fibrosing ILDs with a progressive phenotype both in patients with well-preserved FVC at baseline and in patients with greater impairment in FVC; it should be noted that the number of patients with well-preserved FVC at baseline in this trial was small. CLINICAL IMPLICATIONS: Patients with chronic fibrosing ILDs with a progressive phenotype experience a marked decline in FVC over 1 year. Nintedanib reduces the rate of decline in FVC in patients with progressive fibrosing ILDs and mild FVC impairment at baseline. These data are relevant to shared decision-making in patients with progressive fibrosing ILDs and preserved lung function. DISCLOSURES: No relevant relationships by Stefania Cerri, source=Web Response Advisory Committee Member relationship with Boehringer Ingelheim Please note: $5001 - $20000 Added 03/27/2020 by Yoshikazu Inoue, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Shionogi Please note: $1-$1000 Added 03/27/2020 by Yoshikazu Inoue, source=Web Response, value=Consulting fee Speaker/Speaker's Bureau relationship with Genentech Please note: $5001 - $20000 Added 04/03/2020 by Robert Kaner, source=Web Response, value=Honoraria Scientific Medical Advisor relationship with Boehringer Ingelheim Please note: $1001 - $5000 Added 04/03/2020 by Robert Kaner, source=Web Response, value=Consulting fee Investigator in Clinical Trials relationship with Boehringer Ingelheim Please note: $1-$1000 Added 04/03/2020 by Robert Kaner, source=Web Response, value=to institution Scientific Medical Advisor relationship with Astra Zeneca Please note: $1001 - $5000 Added 04/03/2020 by Robert Kaner, source=Web Response, value=Consulting fee Consultant relationship with Galapagos Please note: $1001 - $5000 Added 04/03/2020 by Robert Kaner, source=Web Response, value=Consulting fee Consultant relationship with Boehringer Ingelheim Please note: $5001 - $20000 Added 04/03/2020 by Martin Kolb, source=Web Response, value=Honoraria Consultant relationship with Roche Please note: $5001 - $20000 Added 04/03/2020 by Martin Kolb, source=Web Response, value=Honoraria Consultant relationship with Algernon Please note: $1001 - $5000 Added 04/03/2020 by Martin Kolb, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with Novartis Please note: $1-$1000 Added 04/03/2020 by Martin Kolb, source=Web Response, value=Honoraria Consultant relationship with Pieris Please note: $20001 - $100000 Added 04/03/2020 by Martin Kolb, source=Web Response, value=Grant/Research Support Consultant relationship with Boehringer Ingelheim Please note: $20001 - $100000 Added 04/03/2020 by Martin Kolb, source=Web Response, value=Grant/Research Support Employee relationship with Boehringer Ingelheim Pharma GmbH & Co. KG Please note: $5001 - $20000 Added 04/01/2020 by Heiko Mueller, source=Web Response, value=Salary Investigator initiated study/grant relationship with Boehringer Ingelheim Please note: >$100000 Added 03/27/2020 by Nina Patel, source=Web Response, value=Grant/Research Support Removed 03/27/2020 by Nina Patel, source=Web Response Investigator initiated study/grant relationship with Boehringer Ingelheim Please note: >$100000 Added 03/27/2020 by Nina Patel, source=Web Response, value=Fee not yet received Advisory relationship with Boehringer Ingelheim Please note: $1001 - $5000 Added 04/03/2020 by Nina Patel, source=Web Response, value=Honoraria Author relationship with Boehringer Ingelheim Please note: $5001 - $20000 Added 04/03/2020 by Nina Patel, source=Web Response, value=Honoraria Employee relationship with Boehringer Ingelheim International GmbH Please note: >$100000 Added 03/30/2020 by Klaus Rohr, source=Web Response, value=Salary No relevant relationships by Susanne Stowasser, source=Web Response" @default.
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• W3093224238 date "2020-10-01" @default.
• W3093224238 modified "2023-09-27" @default.
• W3093224238 title "EFFECT OF NINTEDANIB IN PATIENTS WITH PROGRESSIVE FIBROSING ILDS AND PRESERVED LUNG FUNCTION AT BASELINE: FURTHER ANALYSES OF THE INBUILD TRIAL" @default.
• W3093224238 doi "https://doi.org/10.1016/j.chest.2020.08.974" @default.
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