Effects of nintedanib on progression of ILD in patients with fibrosing ILDs and a progressive phenotype: further analyses of the INBUILD trial
Bibliographic record
Abstract
Introduction: In the INBUILD trial in subjects with fibrosing ILDs and a progressive phenotype despite management deemed appropriate in clinical practice, nintedanib slowed the rate of decline in FVC (mL/year) over 52 weeks versus placebo. Subjects continued blinded randomised treatment until the end of the trial. The treatment period was variable and dependent on the date of enrollment. Aim: To assess the effects of nintedanib on progression of ILD over the whole INBUILD trial. Methods: Time to i) death, ii) first acute exacerbation of ILD or death, and iii) disease progression (absolute decline in FVC ≥ 10% predicted) or death were assessed over the whole trial. Results: Mean (SD) exposure to trial medication was 15.6 (7.2) and 16.8 (5.8) months in the nintedanib (n = 332) and placebo (n = 331) groups, respectively. In the nintedanib and placebo groups, respectively, 10.8% and 13.6% of subjects died (HR 0.78 [95% CI: 0.50, 1.21]), 13.9% and 19.6% of subjects had an acute exacerbation of ILD or died (HR 0.67 [95% CI: 0.46, 0.98]), and 40.4% and 54.7% of subjects had disease progression or died (HR 0.66 [95% CI: 0.53, 0.83]). Diarrhoea was the most common adverse event, with incidence rates of 136.4 and 23.0 events per 100 patient–years in the nintedanib and placebo groups, respectively. Adverse events led to treatment discontinuation in 22.0% and 14.5% of subjects in the nintedanib and placebo groups, respectively. Conclusions: In the INBUILD trial, nintedanib slowed the progression of ILD in patients with fibrosing ILD and a progressive phenotype. * previously presented at ERS2020 ‡ presenting on behalf of the authors Publication History Article published online: 30 April 2021 © 2021. Thieme. All rights reserved. Georg Thieme Verlag KG Rüdigerstraße 14, 70469 Stuttgart, Germany
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".