ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1048

Reduced Decline in Forced Vital Capacity in Patients with Progressive Fibrosing Autoimmune Disease-Related Interstitial Lung Diseases (ILDs) Treated with Nintedanib

Eric Matteson1, Oliver Distler2, Jörg HW Distler3, Masataka Kuwana4, Janet Pope5, James Seibold6, Alexandra James7, Rozsa Schlenker-Herceg8, Klaus Rohr7 and Kevin Flaherty9, 1Mayo Clinic College of Medicine and Science, Rochester, Minnesota, USA, Rochester, MN, 2Center of Experimental Rheumatology, Department of Rheumatology, University Hospital Zurich, Switzerland, Zurich, Switzerland, 3University of Erlangen-Nuremberg, Erlangen, Germany, Erlangen, Germany, 4Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Tokyo, Japan, 5Department of Medicine, University of Western Ontario, St. Joseph's Health Centre, London, ON, Canada, 6Scleroderma Research Consultants LLC, Aiken, South Carolina, USA, Aiken, SC, 7Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, Ingelheim am Rhein, Germany, 8Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA, Ridgefield, CT, 9Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor, Michigan, USA, Ann Arbor, MI

Meeting: ACR Convergence 2020

Keywords: ,

Session Information

Date: Sunday, November 8, 2020

Title: Miscellaneous Rheumatic & Inflammatory Diseases Poster II: Sarcoidosis, Interstitial Lung Disease, & Inflammatory Eye Disease

Session Type: Poster Session C

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

Background/Purpose: In the randomized placebo-controlled INBUILD trial in patients with chronic fibrosing ILDs with a progressive phenotype, nintedanib reduced the rate of decline in forced vital capacity (FVC) over 52 weeks, with an adverse event profile characterized mainly by gastrointestinal events. We analyzed the effects of nintedanib on categorical changes in FVC in the subgroup of patients with autoimmune disease-related ILDs.

Methods: The INBUILD trial enrolled patients with a fibrosing ILD other than idiopathic pulmonary fibrosis, reticular abnormality with traction bronchiectasis (with or without honeycombing) of >10% extent on high-resolution computed tomography (HRCT), FVC ≥45% predicted, and DLco ≥30%–< 80% predicted. To be eligible to participate, patients had to meet protocol-specified criteria for progression of ILD within the 24 months before screening despite management as deemed appropriate in clinical practice. In the subgroup of patients with autoimmune disease-related ILDs, we analyzed absolute changes from baseline in FVC (mL) and FVC % predicted at week 52, and the proportions of patients with categorical declines in FVC % predicted at week 52 (analyzed using a worst observation carried forward approach).

Results: The subgroup with autoimmune disease-related ILDs comprised 170 patients (Table 1). At baseline, mean (SD) FVC was 69.6 (15.1) % predicted in the nintedanib group and 72.1 (14.6) % predicted in the placebo group. Mean (SE) absolute changes from baseline in FVC were -92.7 (29.1) mL in the nintedanib group and -185.7 (27.3) mL in the placebo group (difference 93.0 [95% CI 14.1, 172.0]). Mean (SE) absolute changes from baseline in FVC % predicted were -2.7 (0.9) in the nintedanib group and -6.0 (0.8) in the placebo group (difference 3.3 [95% CI 0.9, 5.6]). The proportions of patients with absolute and relative declines in FVC >5% predicted or >10% predicted at week 52 were numerically lower in the nintedanib group than in the placebo group (Table 2).

Conclusion: In patients with progressive fibrosing autoimmune disease-related ILDs, the proportions of patients with categorical declines in FVC % predicted supported an effect of nintedanib in slowing the progression of ILD.

Disclosure: E. Matteson, Boehringer Ingelheim, 5, Gilead, 5, TympoBio, 5, Arena Pharmaceuticals, 5, Up-to-date, 7, Simply Speaking, 8; O. Distler, Actelion, 2, 5, 8, Bayer, 2, 5, 8, Boehringer Ingelheim, 2, 5, 8, Medscape, 5, 8, Novartis, 8, Roche, 5, 8, Menarini, 8, Mepha, 8, MSD, 5, 8, iQone, 8, Pfizer, 5, 8, AbbVie, 5, Acceleron Pharma, 5, Amgen, 5, AnaMar, 5, Arxx Therapeutics, 5, Beacon Discovery, 5, Blade Therapeutics, 5, CSL Behring, 5, ChemomAb, 5, Corpus Pharma, 5, Curzion Pharmaceuticals, 5, Ergonex Pharma, 5, Mitsubishi Tanabe Pharma, 2, 5, Kymera Therapeutics, 2, 5, Catenion, 5, Galapagos NV, 5, GlaxoSmithKline, 5, Glenmark Pharmaceuticals, 5, Inventiva, 5, Italfarmaco, 5, Lilly, 5, Sanofi, 5, UCB, 5, IQVIA, 5, Medac, 5, Target BioScience, 5, Patent issued, 9; J. Distler, Actelion, 5, Active Biotech, 2, 5, AnaMar, 2, 5, UCB, 2, 5, Boehringer Ingelheim, 2, 5, Novartis, 2, GlaxoSmithKline, 2, 5, RuiYi, 5, Galapagos, 2, 5, Medac, 5, Celgene, 2, 5, Inventiva, 2, 5, Redx Pharma, 2, Bayer, 2, 5, JB Therapeutics, 5, Bristol-Myers Squibb, 2, Array BioPharma, 2, Pfizer, 5, Sanofi-Aventis, 2, Arxx Therapeutics, 2, 5, 4D Science, 1, aTyr Pharma, 2; M. Kuwana, Ono Pharmaceutical, 2, 8, Chugai, 2, 8, Astellas, 8, Mitsubishi Tanabe Pharma Corporation, 2, 8, AbbVie Inc., 8, Eisai Co., Ltd., 8; J. Pope, AbbVie, 2, 5, Amgen, 5, 8, Lilly, 2, 5, 8, UCB, 2, 5, 8, Sanofi, 5, 8, Sandoz, 5, 8, Roche, 2, 5, 8, Pfizer, 5, 8, Novartis, 5, 8, Merck, 2, 5, 8, Janssen, 5, 8, Gilead Sciences, Inc., 2, 5, BMS, 2, 5, 8, Abbott, 5, Actelion, 5, AstraZeneca, 5, Bayer, 5, Boehringer Ingelheim, 5, EICOS, 5, Emerald, 5, GlaxoSmithKline, 5, Medexus, 5, Seattle Genetics, 2; J. Seibold, Atlantic, 5, Boehringer Ingelheim, 5, 8, Blade Therapeutics, 5, Corbus Pharmaceuticals, 5, Camurus, 5, Guidepoint, 5, Xenikos, 5, BriaCell, 1, Pacific Therapeutics, 1, Indalo Therapeutics, 5; A. James, Boehringer Ingelheim, 3; R. Schlenker-Herceg, Boehringer Ingelheim, 3; K. Rohr, Boehringer Ingelheim, 3; K. Flaherty, Boehringer Ingelheim, 5, Respivant Sciences, 5, Bellerophon Therapeutics, 5, Blade Therapeutics, 5.

To cite this abstract in AMA style:

Matteson E, Distler O, Distler J, Kuwana M, Pope J, Seibold J, James A, Schlenker-Herceg R, Rohr K, Flaherty K. Reduced Decline in Forced Vital Capacity in Patients with Progressive Fibrosing Autoimmune Disease-Related Interstitial Lung Diseases (ILDs) Treated with Nintedanib [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/reduced-decline-in-forced-vital-capacity-in-patients-with-progressive-fibrosing-autoimmune-disease-related-interstitial-lung-diseases-ilds-treated-with-nintedanib/. Accessed .

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