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Effects of nintedanib on circulating biomarkers of idiopathic pulmonary fibrosis
Open accessAbstract
Background: Biomarkers that change in response to nintedanib in subjects with idiopathic pulmonary fibrosis (IPF) would be valuable. We investigated the effects of nintedanib on circulating biomarkers in subjects with IPF in the INMARK trial. Methods: Subjects with IPF were randomised 1:2 to receive nintedanib 150 mg twice daily or placebo for 12 weeks, after which all patients received open-label nintedanib for 40 weeks. Fold changes in adjusted mean levels of circulating biomarkers were analysed using a linear mixed model for repeated measures. Results: 346 subjects were treated (116 randomised to nintedanib, 230 to placebo). Surfactant protein D (SP-D) and cancer antigen 125 (CA-125), markers of epithelial injury, decreased in subjects treated with nintedanib versus placebo. Fold changes from baseline in SP-D at week 12 corresponded to a 4% decrease and 3% increase in the nintedanib and placebo groups, respectively (ratio 0.94, 95% CI 0.89–0.99; p=0.024). Fold changes in CA-125 at week 12 corresponded to a 22% decrease and 4% increase in the nintedanib and placebo groups, respectively (ratio 0.75, 95% CI 0.71–0.81; p<0.0001). A mediation analysis suggested that 42.1% of the effect of nintedanib on change in forced vital capacity over 12 weeks was attributable to the change in CA-125. A small increase in C3A (collagen 3 degraded by ADAMTS-1/4/8) and a small decrease in C3M (collagen 3 degraded by matrix metalloproteinase-9), markers of extracellular matrix turnover, were observed in subjects treated with nintedanib versus placebo. Conclusions: Effects of nintedanib on circulating markers of epithelial dysfunction and collagen degradation, most notably CA-125, were observed in patients with IPF.
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The 5% drop in SP-D is comparable to decreases described in standard of care IPF drug trials after longer treatment durations, notably the CAPACITY study of pirfenidone (5% at 12 weeks) and the INMARK study of nintedanib (4% at 12 weeks).
“the 5% drop in SP-D is comparable to decreases described in standard of care IPF drug trials after longer treatment durations, notably the CAPACITY study of pirfenidone (5% at 12 weeks)35 and the INMARK study of nintedanib (4% at 12 weeks)36,37”
From Inhaled LTI-03 for idiopathic pulmonary fibrosis: a randomized dose escalation study (2026) · cites this paper as [36]
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Efficacy and Safety of Nintedanib in Idiopathic Pulmonary Fibrosis
Richeldi, L., du Bois, R. M., Raghu, G., Azuma, A., Brown, K. K., Costabel, U., Cottin, V., Flaherty, K. R., Hansell, D. M., Inoue, Y., et al. (2014) · New England Journal of Medicine · doi:10.1056/nejmoa1402584 · Cited by 4,654
Self-citationNintedanib in Progressive Fibrosing Interstitial Lung Diseases
Flaherty, K. R., Wells, A. U., Cottin, V., Devaraj, A., Walsh, S. L. F., Inoue, Y., Richeldi, L., Kolb, M., Tetzlaff, K., Stowasser, S., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1908681 · Cited by 2,403
Self-citationNintedanib for systemic sclerosis–associated interstitial lung disease
Distler, O., Highland, K. B., Gahlemann, M., Azuma, A., Fischer, A., Mayes, M. D., Raghu, G., Sauter, W., Girard, M., Alves, M., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1903076 · Cited by 1,647
Self-citationEfficacy of a Tyrosine Kinase Inhibitor in Idiopathic Pulmonary Fibrosis
Richeldi, L., Costabel, U., Selman, M., Kim, D. S., Hansell, D. M., Nicholson, A. G., Brown, K. K., Flaherty, K. R., Noble, P. W., Raghu, G., et al. (2011) · New England Journal of Medicine · doi:10.1056/nejmoa1103690 · Cited by 1,157
Self-citationMode of action of nintedanib in the treatment of idiopathic pulmonary fibrosis
Wollin, L., Wex, E., Pautsch, A., Schnapp, G., Hostettler, K. E., Stowasser, S., & Kolb, M. (2015) · European Respiratory Journal · doi:10.1183/09031936.00174914 · Cited by 1,005
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Inhaled LTI-03 for idiopathic pulmonary fibrosis: a randomized dose escalation study
Molyneaux, P. L., Hirani, N. A., Chia, C. C. K., Kulkarni, T., Zaman, T., Kaner, R. J., Coelho, A. L., Jannini-Sa, Y. A. P., Windsor, B., Kruger, S., et al. (2026) · Nature Communications · doi:10.1038/s41467-026-75291-3 · Cited by 1
“…decreases described in standard of care IPF drug trials after longer treatment durations, notably the CAPACITY study of pir-fenidone (5% at 12 weeks) 35 and the INMARK study of nintedanib (4% at 12 weeks) 36,37 which may indicate the potential for LTI-03 to slow the rate of lung function decline.”
Metadata
- Authors
- Jenkins, R. G., Cottin, V., Nishioka, Y., Noth, I., White, E. S., Ittrich, C., Diefenbach, C., Rohr, K. B., Selman, M., & Maher, T. M.
- Affiliations
- Lyon 1 Université (FR)
- Tokushima University (JP)
- University of Virginia (US)
- Boehringer Ingelheim (United States) (US)
- Boehringer Ingelheim (Germany) (DE)
- Instituto Nacional de Enfermedades Respiratorias (MX)
- University of Southern California (US)
- Venue
- ERJ Open Research
- Publisher
- European Respiratory Society (ERS)
- Published
- 2024-08-22
- Volume
- 10
- Issue
- 6
- Pages
- 00558-2023
- ISSN
- 2312-0541 (ISSN-L)
- PMC
- PMC11647937
- OpenAlex
- W4401754976
- Cited by
- 6
- References
- 6
- Citations by year
- 2026: 3 · 2025: 3
- FWCI
- 1.74
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- ERJ Open Research (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Institutional Repositories DataBase (IRDB) (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Boehringer Ingelheim (N/A)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Chronic Obstructive Pulmonary Disease (COPD) Research
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Pulmonary Hypertension Research and Treatments
- Keywords
- nintedanib, idiopathic pulmonary fibrosis, circulating biomarkers, surfactant protein D, CA125, epithelial damage, collagen degradation, extracellular matrix turnover, forced vital capacity, mediation analysis
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