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Abstract Number: 1049

Effects of Nintedanib in Patients with Progressive Fibrosing Autoimmune Disease-related Interstitial Lung Diseases (ILDs) in the INBUILD Trial: Subgroups by HRCT Pattern

Paul Dellaripa1, Martin Aringer2, Anna Maria Hoffmann-Vold3, Clive Kelly4, Shikha Mittoo5, Alexandra James6, Klaus Rohr6, Susanne Stowasser6 and Yoshikazu Inoue7, 1Division of Rheumatology, Brigham and Women's Hospital, Boston, Massachusetts, USA, Boston, MA, 2Rheumatology, Medicine III, University Medical Center & Faculty of Medicine, TU Dresden, Dresden, Germany, Dresden, Germany, 3Department of Rheumatology, Oslo University Hospital, Oslo, Norway, Oslo, Norway, 4Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK, Newcastle upon Tyne, United Kingdom, 5University Health Network, Toronto, Ontario, Canada, Toronto, ON, Canada, 6Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, Ingelheim am Rhein, Germany, 7Clinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai City, Osaka, Japan, Sakai City, Osaka, Japan

Meeting: ACR Convergence 2020

Keywords: autoimmune diseases, Imaging, interstitial lung disease, radiography

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Session Information

Date: Sunday, November 8, 2020

Session 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 INBUILD trial, nintedanib reduced the rate of decline in forced vital capacity (FVC) over 52 weeks compared with placebo in patients with chronic fibrosing ILDs with a progressive phenotype. Several studies have suggested that a usual interstitial pneumonia (UIP) pattern on high-resolution computed tomography (HRCT) is associated with faster progression of ILD. We assessed the effect of nintedanib on FVC decline in patients with autoimmune disease-related ILDs in the INBUILD trial in subgroups by fibrotic pattern on HRCT at baseline.

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 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. Patients were randomized to receive nintedanib or placebo, stratified by fibrotic pattern on HRCT (UIP-like fibrotic pattern or other fibrotic patterns) based on central review. In a post-hoc analysis, we analyzed the rate of decline in FVC over 52 weeks in patients with autoimmune disease-related ILDs in subgroups by UIP-like fibrotic pattern on HRCT and other fibrotic patterns on HRCT.

Results: The subgroup with autoimmune disease-related ILDs comprised 170 patients (89 rheumatoid arthritis-ILD, 39 systemic sclerosis-ILD, 19 mixed connective tissue disease-ILD, 23 other autoimmune disease-related ILDs), of whom 127 (74.7%) had a UIP-like fibrotic pattern on HRCT and 43 (25.3%) had other fibrotic patterns on HRCT. In the placebo group, the rate of decline in FVC over 52 weeks was similar in patients with a UIP-like fibrotic pattern on HRCT (n=65) and with other fibrotic patterns on HRCT (n=23) (-182.8 [SE 32.6] vs -168.1 [51.8] mL/year). The effect of nintedanib versus placebo on reducing the rate of decline in FVC was numerically greater in subjects with a UIP-like fibrotic pattern on HRCT than in those with other fibrotic patterns on HRCT (difference 124.2 mL/year [95% CI 31.1, 217.4] vs 41.7 mL/year [95% CI -112.2, 195.5]) but the interaction p-value did not indicate heterogeneity in the treatment effect between the subgroups by HRCT pattern (p=0.37) (Figure).

Conclusion: In patients with progressive fibrosing autoimmune disease-related ILDs in the INBUILD trial, nintedanib slowed the rate of FVC decline both in patients with a UIP-like fibrotic pattern on HRCT and in patients with other fibrotic patterns on HRCT, with a numerically greater effect in patients with a UIP-like fibrotic pattern on HRCT.


Disclosure: P. Dellaripa, Genentech, 1, Bristol Myers Squibb, 1; M. Aringer, Boehringer Ingelheim, 1, 2, Roche, 1, 2, Bristol Myers Squibb, 1, 2, Chugai, 1, 2, Sanofi, 1, 2, AbbVie, 1, 2, AstraZeneca, 1, 2, Lilly, 1, 2, MSD, 1, 2, Novartis, 1, Pfizer, 1, UCB, 1; A. Hoffmann-Vold, Boehringer Ingelheim, 1, 2, 3, Actelion Pharmaceuticals, 1, 2, Roche, 1, Bayer, 1; C. Kelly, Boehringer Ingelheim, 1; S. Mittoo, None; A. James, Boehringer Ingelheim, 3; K. Rohr, Boehringer Ingelheim, 3; S. Stowasser, Boehringer Ingelheim, 1; Y. Inoue, Boehringer Ingelheim, 1, 2, 3.

To cite this abstract in AMA style:

Dellaripa P, Aringer M, Hoffmann-Vold A, Kelly C, Mittoo S, James A, Rohr K, Stowasser S, Inoue Y. Effects of Nintedanib in Patients with Progressive Fibrosing Autoimmune Disease-related Interstitial Lung Diseases (ILDs) in the INBUILD Trial: Subgroups by HRCT Pattern [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/effects-of-nintedanib-in-patients-with-progressive-fibrosing-autoimmune-disease-related-interstitial-lung-diseases-ilds-in-the-inbuild-trial-subgroups-by-hrct-pattern/. Accessed June 27, 2022.
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