Trial reportRespiratory research2021
Nintedanib and immunomodulatory therapies in progressive fibrosing interstitial lung diseases.
Trial report in Respiratory research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 37 papers, 5 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Nintedanib Over 52 Weeks in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Multicentre Clinical Trial Evaluating the Safety and Efficacy of the Combination of Nintedanib+Tocilizumab Compared to Standard Treatment in Patients With Systemic Sclerosis and Interstitial Lung Disease. Analysis With Theranostic Approach
Who cites it
37 citing papers in PubMed, 5 syntheses or guidelines pooled it, 67 citations in OpenAlex.
- ERS/EULAR clinical practice guidelines for connective tissue disease-associated interstitial lung disease.The European respiratory journal · 2026Guideline
- Diagnosis and Treatment of Hypersensitivity Pneumonitis: S2k Guideline of the German Respiratory Society and the German Society for Allergology and Clinical Immunology.Respiration; international review of thoracic diseases · 2025Guideline
- Efficacy of Pirfenidone and Nintedanib in Interstitial Lung Diseases Other than Idiopathic Pulmonary Fibrosis: A Systematic Review.International journal of molecular sciences · 2023Pooled it
- Guidelines of the Polish Respiratory Society on the Diagnosis and Treatment of Progressive Fibrosing Interstitial Lung Diseases Other than Idiopathic Pulmonary Fibrosis.Advances in respiratory medicine · 2022Guideline
- Meta-Analysis of Effect of Nintedanib on Reducing FVC Decline Across Interstitial Lung Diseases.Advances in therapy · 2022Pooled it
- Trial
- Effect of nintedanib in patients with progressive pulmonary fibrosis associated with rheumatoid arthritis: data from the INBUILD trial.Clinical rheumatology · 2023Trial
- Nintedanib in Patients With Autoimmune Disease-Related Progressive Fibrosing Interstitial Lung Diseases: Subgroup Analysis of the INBUILD Trial.Arthritis & rheumatology (Hoboken, N.J.) · 2022Trial
- Safety and tolerability of nintedanib in patients with progressive fibrosing interstitial lung diseases: data from the randomized controlled INBUILD trial.Respiratory research · 2022Trial
- Advances in pharmacotherapy for fibrotic interstitial lung disease.Medical review (2021) · 2026Review
- Real-World Data on Halting Radiographic Progression with Antifibrotics in Connective Tissue Disease-Associated Interstitial Lung Disease: A Two-Center Study from Hungary.Journal of clinical medicine · 2026Article
- Advances in Biomarkers and Therapeutic Targets for Idiopathic Inflammatory Myopathies Related Lung Disease.Clinical reviews in allergy & immunology · 2026Review
- Combination antifibrotic and immunosuppressive therapy in progressive fibrosing ILD.Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG · 2026Article
- Fibrotic Patterns and Diagnostic Correlates in Hypersensitivity Pneumonitis: Clinical, Radiologic, and Hematologic Insights.Diagnostics (Basel, Switzerland) · 2025Article
- Diagnostics, Efficacy, and Safety of Immunomodulatory and Anti-Fibrotic Treatment for Interstitial Lung Disease Associated with Systemic Scleroderma (SSc-ILD).Diagnostics (Basel, Switzerland) · 2025Review
- Design of a randomised controlled hybrid trial of nintedanib in patients with progressive myositis-associated interstitial lung disease.BMC pulmonary medicine · 2024Article
- Review
- Pirfenidone and Nintedanib in Pulmonary Fibrosis: Lights and Shadows.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Progressive Pulmonary Fibrosis: Where Are We Now?Tuberculosis and respiratory diseases · 2024Article
- Interstitial Pneumonia with Autoimmune Features: Aiming to Define, Refine, and Treat.Revista colombiana de reumatologia · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 12 institutions in 9 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn the INBUILD trial in patients with chronic fibrosing interstitial lung diseases (ILDs) and a progressive phenotype, nintedanib reduced the rate of ILD progression with adverse events that were manageable for most patients. We investigated the potential impact of immunomodulatory therapies on the efficacy and safety of nintedanib.
methodsSubjects with fibrosing ILDs other than idiopathic pulmonary fibrosis, who had shown progression of ILD within the prior 24 months despite management in clinical practice, were randomized to receive nintedanib or placebo. Certain immunomodulatory therapies were restricted for the first 6 months. We analyzed post-hoc the rate of decline in forced vital capacity (FVC) over 52 weeks in subgroups by glucocorticoid use at baseline and in analyses excluding subjects or FVC measurements taken after initiation of restricted immunomodulatory or antifibrotic therapies.
resultsOf 663 subjects, 361 (54.4%) were taking glucocorticoids at baseline (353 at a dose of ≤ 20 mg/day). In the placebo group, the adjusted rate of decline in FVC (mL/year) over 52 weeks was numerically greater in subjects taking than not taking glucocorticoids at baseline (- 206.4 [SE 20.2] vs - 165.8 [21.9]). The difference between the nintedanib and placebo groups was 133.3 (95% CI 76.6, 190.0) mL/year in subjects taking glucocorticoids at baseline and 76.1 (15.0, 137.2) mL/year in subjects who were not (interaction P = 0.18). The effect of nintedanib on reducing the rate of FVC decline in analyses excluding subjects or measurements taken after initiation of restricted immunomodulatory or antifibrotic therapies was similar to the primary analysis. The adverse event profile of nintedanib was similar between subjects who did and did not use prohibited or restricted therapies at baseline or during treatment with trial drug.
conclusionsIn patients with progressive fibrosing ILDs, the effect of nintedanib on reducing FVC decline was not influenced by the use of immunomodulatory therapies. Nintedanib can be used in combination with immunomodulatory therapies in patients with progressive fibrosing ILDs. Trial registration ClinicalTrials.gov, NCT02999178. Registered 21 December 2016, https://clinicaltrials.gov/ct2/show/NCT02999178.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.