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Abstract Number: 0186

Continued Treatment with Nintedanib in Patients with Progressive Fibrosing Autoimmune Disease-Related Interstitial Lung Diseases: Data from INBUILD-ON

Eric Matteson1, Danielle Antin-Ozerkis2, Francesco Bonella3, Nazia Chaudhuri4, Vincent Cottin5, Heiko Mueller6, Carl Coeck7, Klaus B Rohr8 and Wim A Wuyts9, 1Mayo Clinic College of Medicine and Science, Rochester, MN, 2Section of Pulmonary, Critical Care and Sleep Medicine, Yale University School of Medicine, New Haven, CT, 3Center for Interstitial and Rare Lung Diseases, Pneumology Department, Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany, 4North West Interstitial Lung Disease Unit, Manchester University Foundation Trust, Wythenshawe, Manchester, UK, Manchester, United Kingdom, 5Coordinating Reference Center for Rare Pulmonary Diseases, Louis Pradel Hospital, University of Lyon, INRAE, Lyon, France, Lyon, France, 6Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany, 7SCS Boehringer Ingelheim Comm.V., Brussels, Belgium, Brussels, Belgium, 8Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, Ingelheim, Germany, 9Unit for Interstitial Lung Diseases, Department of Pulmonary Medicine, University Hospitals Leuven, Leuven, Belgium, Leuven, Belgium

Meeting: ACR Convergence 2021

Keywords: autoimmune diseases, interstitial lung disease

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Session Information

Date: Saturday, November 6, 2021

Session Title: Miscellaneous Rheumatic & Inflammatory Diseases Poster I (0183–0209)

Session Type: Poster Session A

Session Time: 8:30AM-10:30AM

Background/Purpose: In the INBUILD trial in patients with progressive fibrosing ILDs other than idiopathic pulmonary fibrosis (IPF), nintedanib reduced the rate of decline in forced vital capacity (FVC) over 52 weeks compared with placebo, with adverse events that were manageable for most patients. The safety and efficacy of nintedanib over longer-term use are being assessed in an open-label extension trial, INBUILD-ON. Here we present the safety and efficacy of nintedanib in patients with autoimmune disease-related ILDs in INBUILD-ON.

Methods: Patients in the INBUILD trial had diffuse fibrosing ILD (reticular abnormality with traction bronchiectasis, with or without honeycombing) of >10% extent on HRCT, FVC ≥45% predicted, DLco ≥30%–< 80% predicted, and met criteria for progression of ILD within the 24 months before screening, despite management deemed appropriate in clinical practice. Patients who completed the INBUILD trial on treatment (nintedanib or placebo) were eligible to enter INBUILD-ON. We analyzed adverse events and the change in FVC from baseline to week 60 of INBUILD-ON in the subgroup of patients with autoimmune disease-related ILDs based on a data snapshot taken on 15 October 2020. Analyses were descriptive.

Results: Of the 434 patients treated in INBUILD-ON, 113 had autoimmune disease-related ILDs (52 RA-ILD, 29 SSc-ILD, 13 MCTD-ILD, 19 other autoimmune disease-related ILDs). Of these, 61.9% took ≥1 disease-modifying anti-rheumatic drug or high-dose glucocorticoid during the trial. Diarrhea was the most frequent adverse event (Table 1). Adverse events led to discontinuation of nintedanib in 11.5% of patients who continued nintedanib in INBUILD-ON (having taken nintedanib in INBUILD) and 29.5% of patients who initiated nintedanib in INBUILD-ON (having taken placebo in INBUILD). The adverse event that most frequently led to discontinuation of nintedanib was diarrhea (Table 2). Mean (SE) changes in FVC from baseline to week 60 of INBUILD-ON were −77.6 (41.1) mL in patients who continued nintedanib (n=32), −32.8 (29.3) mL in patients who initiated nintedanib (n=32) and −55.2 (25.2) mL in all patients (n=64), similar to the change from baseline to week 52 of the INBUILD trial in patients with autoimmune disease-related ILDs who received nintedanib (−78.8 [29.5] mL).

Conclusion: The adverse event profile of nintedanib in patients with autoimmune disease-related ILDs participating in INBUILD-ON was characterized mainly by gastrointestinal events and was consistent with that reported over 52 weeks in INBUILD. These data support the manageable safety profile of nintedanib over continued use in patients with autoimmune disease-related ILDs.


Disclosures: E. Matteson, Boehringer Ingelheim, 1, 6, Gilead Sciences, 1, 6; D. Antin-Ozerkis, Boehringer Ingelheim, 5, FibroGen, 5, Pliant, 5, Galecto, 5, Galapagos, 5, Genentech/Roche, 5; F. Bonella, Boehringer Ingelheim, 1, 6, 12, Travel costs, Bristol-Myers Squibb, 1, Fujirebio, 1, 6, Galapagos NV, 1, 6, GlaxoSmithKline, 1, Roche, 1, 6, Roche, 12, Travel costs, Takeda, 1; N. Chaudhuri, Boehringer Ingelheim, 1, 6, 12, UK Chief Investigator for the INBUILD study; V. Cottin, AstraZeneca, 6, Bayer/Merck Sharp & Dohme, 1, Boehringer Ingelheim, 2, 5, 6, 12, Travel costs for medical meetings, Bristol-Myers Squibb, 1, Celgene, 12, Member of Data Safety Monitoring Board, FibroGen, 12, Member of trial event adjudication committee, Galapagos NV, 1, Galapagos NV, 12, Co-Chair of Data Safety Monitoring Board, Galecto, 12, Member of Data Safety Monitoring Board, Novartis, 1, Novartis, 6, Roche/Promedior, 2, 6, 12, Travel costs for medical meetings and member of steering committee, Roche/Promedior, 12, Chair of Data Safety Monitoring Board, Sanofi, 6, Shionogi, 1; H. Mueller, Boehringer Ingelheim, 3; C. Coeck, Boehringer Ingelheim, 3; K. Rohr, Boehringer Ingelheim, 3; W. Wuyts, Boehringer Ingelheim, 5, Roche, 5.

To cite this abstract in AMA style:

Matteson E, Antin-Ozerkis D, Bonella F, Chaudhuri N, Cottin V, Mueller H, Coeck C, Rohr K, Wuyts W. Continued Treatment with Nintedanib in Patients with Progressive Fibrosing Autoimmune Disease-Related Interstitial Lung Diseases: Data from INBUILD-ON [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/continued-treatment-with-nintedanib-in-patients-with-progressive-fibrosing-autoimmune-disease-related-interstitial-lung-diseases-data-from-inbuild-on/. Accessed January 30, 2023.
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