Article
Continued treatment with Nintedanib in patients with progressive fibrosing autoimmune disease-related interstitial lung diseases: Data from INBUILD-ON
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Authors
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Ulf Müller-Ladner
- Rheumatologie und Klinische Immunologie Campus Kerckhoff, Justus-Liebig Universität Giessen, Bad Nauheim
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Eric L Matteson
- Mayo Clinic College of Medicine and Science, Rochester, MN
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Danielle Antin-Ozerkis
- Section of Pulmonary, Critical Care and Sleep Medicine, Yale University School of Medicine, New Haven, CT
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Francesco Bonella
- Center for Interstitial and Rare Lung Diseases, Pneumology Department, Ruhrlandklinik, University of Duisburg-Essen, Essen
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Nazia Chaudhuri
- North West Interstitial Lung Disease Unit, Manchester University Foundation Trust, Wythenshawe, Manchester
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Vincent Cottin
- Coordinating Reference Center for Rare Pulmonary Diseases, Louis Pradel Hospital, University of Lyon, INRAE, Lyon
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Heiko Mueller
- Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach
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Carl Coeck
- SCS Boehringer Ingelheim Comm.V., Brussels
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Klaus B Rohr
- Boehringer Ingelheim International GmbH, Ingelheim am Rhein
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Wim A Wuyts
- Unit for Interstitial Lung Diseases, Department of Pulmonary Medicine, University Hospitals Leuven, Leuven
| Published: | August 31, 2022 |
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Outline
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Introduction: Background: In the INBUILD trial in patients with progressive fibrosing ILDs other than idiopathic pulmonary fibrosis (IPF), nintedanib reduced the rate of forced vital capacity (FVC) decline over 52 weeks compared with placebo, adverse events (AEs) were manageable for most patients. Here we present the safety and efficacy of nintedanib over longer-term use in patients with autoimmune disease-related (AI-) ILDs in INBUILD-ON, an open-label extension trial.
Methods: Patients in the INBUILD trial had diffuse fibrosing ILD (reticular abnormality with traction bronchiectasis, with or without honeycombing) of >10% 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.
Patients who completed the INBUILD trial on treatment (nintedanib or placebo) were eligible to enter INBUILD-ON. We analyzed AEs and the change in FVC from baseline to week 60 of INBUILD-ON in the subgroup of patients with AI-ILDs based on a data snapshot taken on 15 October 2020. Analyses were descriptive.
Results: Of the 434 patients treated, 113 had AI-ILDs (52 RA-ILD, 29 SSc-ILD, 13 MCTD-ILD, 19 other AI-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 [Tab. 1]). AEs led to discontinuation of nintedanib in 11.5% of patients who continued nintedanib and 29.5% of patients who initiated nintedanib in INBUILD-ON (having taken placebo in INBUILD). The AE that most frequently led to discontinuation of nintedanib was diarrhea (Table 2 [Tab. 2]). Mean (SE) changes in FVC from baseline to week 60 were −77.6 (41.1) mL in patients who continued (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 AI-ILDs who received nintedanib (−78.8 [29.5] mL).
Conclusion: The AE profile of nintedanib in patients with AI-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 AI-ILDs.
