ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 374

The INBUILD Trial of Nintedanib in Patients with Progressive Fibrosing Interstitial Lung Diseases: Subgroup with Autoimmune Diseases

Eric Matteson1, Clive Kelly 2, Jörg Distler 3, Anna Maria Hoffmann-Vold 4, James Seibold 5, Shikha Mittoo 6, Oliver Distler 7, Rainer-Georg Goeldner 8, Rozsa Schlenker-Herceg 9, Susanne Stowasser 10, Manuel Quaresma 10 and Kevin Flaherty 11, 1Mayo Clinic College of Medicine and Science, Rochester, Minnesota, USA, Rochester, 2Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK, Newcastle, United Kingdom, 3Department of Internal Medicine 3 – Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nürnberg (FAU) and University Hospital Erlangen, Erlangen, Germany, Erlangen, Germany, 4Department of Rheumatology, Oslo University Hospital, Oslo, Norway, Oslo, Norway, 5Scleroderma Research Consultants LLC, Aiken, South Carolina, USA, Aiken, 6University Health Network, Toronto, Ontario, Canada, Toronto, Canada, 7Dept. of Rheumatology, University Hospital Zürich, Zürich, Switzerland, Zürich, Switzerland, 8Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany, Biberach, Germany, 9Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA, Ridgefield, 10Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, Ingelheim am Rhein, Germany, 11University of Michigan, Ann Arbor, Michigan, USA, Ann Arbor, MI

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: , , ,

Session Information

Date: Sunday, November 10, 2019

Session Title: Miscellaneous Rheumatic & Inflammatory Disease Poster I: Fibroinflammatory & Granulomatous Disorders & Therapies

Session Type: Poster Session (Sunday)

Session Time: 9:00AM-11:00AM

Background/Purpose: Some patients with autoimmune disease develop progressive fibrosing interstitial lung disease (ILD) characterized by increasing fibrosis on HRCT, decline in lung function, worsening symptoms and high mortality. Nintedanib, a tyrosine kinase inhibitor, has established efficacy and safety in patients with idiopathic pulmonary fibrosis (IPF) and is an approved treatment for IPF. Recently nintedanib was shown to reduce the rate of decline in lung function in patients with systemic sclerosis-associated ILD. The efficacy and safety of nintedanib in patients with chronic fibrosing ILDs with a progressive phenotype are being investigated in the INBUILD trial. Here we describe the subgroup of patients with autoimmune disease-related ILDs enrolled in this trial.

Methods: Patients with a physician-diagnosed ILD other than IPF were eligible to participate in the INBUILD trial if they had features of diffuse fibrosing lung disease of >10% extent on HRCT, forced vital capacity (FVC) ≥45% predicted, diffusing capacity of the lungs for carbon monoxide (DLco) ≥30–< 80% predicted, and met ≥1 of 4 criteria for ILD progression (Table) in the 24 months before screening, despite treatment of ILDs in clinical practice as applicable. Patients were randomized to receive nintedanib 150 mg bid or placebo double-blind. Randomization was stratified by HRCT pattern (usual interstitial pneumonia [UIP]-like fibrotic pattern only or other fibrotic patterns). The primary endpoint is the annual rate of decline in FVC (mL/year) assessed over 52 weeks.

Results: Of 663 patients in the trial, 171 (25.8%) had autoimmune disease-related ILDs, of which the most common were rheumatoid arthritis-associated ILD (RA-ILD) (n=88), systemic sclerosis-associated ILD (n=40), and mixed connective tissue disease ILD (n=20) (Table). At baseline, the mean±SD age of patients with autoimmune ILDs was 64.3±10.6 years, FVC was 70.8±14.8% predicted and DLco was 49.1±19.0% predicted; about half had a relative decline in FVC ≥10% predicted in the 24 months before screening. Almost three-quarters of patients with autoimmune ILDs (74.3%) had a UIP-like fibrotic pattern only on HRCT. This pattern was most common in patients with RA-ILD (87.5%). The trial is ongoing.

Conclusion: The INBUILD trial will provide insights into the efficacy and safety of nintedanib in patients with progressive fibrosing ILDs, including those with autoimmune diseases. The results will be presented at the conference.

Disclosure: E. Matteson, Boehringer Ingelheim, 5, Pfizer, 2, Sun Pharmaceuticals, 2; C. Kelly, Boehringer Ingelheim, 5, 8; J. Distler, 4D Science, 4, Actelion, 5, Actelion Pharmaceuticals, 5, Active Biotech, 2, 5, AnaMar, 2, 5, Array Biopharma, 2, aTyr, 2, Bayer, 2, 5, BMS, 2, Boehringer Ingelheim, 2, 5, Bristol-Myers Squibb, 2, Celgene, 2, 5, Galapagos, 2, 5, GlaxoSmithKline, 2, 5, Inventiva, 2, 5, JB Therapeutics, 5, medac, 5, Medac, 5, Novartis, 2, Pfizer, 5, RedX, 2, RuiYi, 5, Sanofi, 2, Sanofi-Aventis, 2, UCB, 2, 5; A. Hoffmann-Vold, Actelion, 5, 8, Boehringer Ingelheim, 2, 5, 8, GSK, 5, 8; J. Seibold, Boehringer Ingelheim, 5, Camurus AB, 5, Octapharma, 5, Corbus, 5, Bayer, 5, Indalo, 5, Blade, 5, Mitsubishi Tanabe Pharma, 5, Eicos Sciences, 5, Athersys, 4, Pacific Therapeutics, 4, BriaCell, 4; S. Mittoo, The Clinic Network, 1, 3; O. Distler, A. Menarini, 5, Abbvie, Acceleron, 5, Acceleron Pharma, 5, Actelion, 2, 5, 8, Actelion Pharmaceuticals, 2, 5, 8, 9, Amgen, 5, AnaMar, 2, 5, Bayer, 2, 5, 8, 9, Biogen Idec, 2, 5, Blade Therapeutics, 5, Boehringer Ingelheim, 2, 5, 8, 9, Catenion, 5, 9, ChemomAb, 2, 5, ChemomAB, 5, CSL Behring, 5, Ergonex, 5, espeRare Foundation, 2, 5, Genentech/Roche, 2, 5, GlaxoSmithKline, 5, GSK, 2, 5, Holds Patent mir-29 for the treatment of systemic sclerosis, 9, Inventiva, 2, 5, iQvia, 5, Italfarmaco, 2, 5, Italfarmco, 5, Lilly, 2, 5, med, 5, 8, medac, 5, Medac, 2, 5, MedImmune, 2, 5, Medscape, 5, 8, 9, Menarini, 8, Mepha, 8, Mitsubishi Tanabe, 2, 5, Mitsubishi Tanabe Pharma, 2, 5, MSD, 5, 8, Novartis, 2, 5, 8, 9, Patent, 9, Patent issued, 9, Pfizer, 2, 5, 8, Pharmacyclics, 2, 5, Roche, 5, 8, 9, Sanofi, 2, 5, Sinoxa, 2, 5, Target Bio Science, 5, Target BioScience, 5, UCB, 2, 5, 9, UCB in the area of potential treatments of scleroderma and its complications, 2, 5; R. Goeldner, Boehringer Ingelheim, 3; R. Schlenker-Herceg, Boehringer Ingelheim, 3; S. Stowasser, Boehringer Ingelheim, 3; M. Quaresma, Boehringer Ingelheim, 3; K. Flaherty, Bellepheron, 5, Blade, 5, Boehringer Ingelheim, 5, Roche/Genentech, 5, Veracyte, 5.

To cite this abstract in AMA style:

Matteson E, Kelly C, Distler J, Hoffmann-Vold A, Seibold J, Mittoo S, Distler O, Goeldner R, Schlenker-Herceg R, Stowasser S, Quaresma M, Flaherty K. The INBUILD Trial of Nintedanib in Patients with Progressive Fibrosing Interstitial Lung Diseases: Subgroup with Autoimmune Diseases [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/the-inbuild-trial-of-nintedanib-in-patients-with-progressive-fibrosing-interstitial-lung-diseases-subgroup-with-autoimmune-diseases/. Accessed January 28, 2023.

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