Meta-analysis of effect of nintedanib on mortality in subjects with idiopathic pulmonary fibrosis (IPF) and other forms of progressive pulmonary fibrosis (PPF)
Bibliographic record
Abstract
Introduction: In individual placebo-controlled trials in subjects with idiopathic pulmonary fibrosis (IPF) and other forms of progressive pulmonary fibrosis (PPF), treatment with nintedanib was associated with numerical reductions in mortality. Aim: To assess the effect of nintedanib on the risk of mortality across trials in subjects with IPF and PPF. Methods: Meta-analyses of the effect of nintedanib versus placebo on time to death, and time to first acute exacerbation of ILD or death, were performed using data from randomised placebo-controlled trials in subjects with IPF (TOMORROW, INPULSIS-1 and -2, a Phase IIIb trial [NCT01979952]) and other forms of PPF (INBUILD). The heterogeneity of the effect of nintedanib across trials was assessed using the Ι 2 statistic, τ 2 and Q test p-value. Results: In the combined analysis of data from 5 clinical trials involving 2007 patients, nintedanib reduced the risk of death (HR 0.72 [95% CI: 0.53, 0.97]) and the risk of acute exacerbation of ILD or death (HR 0.62 [95% CI: 0.48, 0.81]) compared with placebo. The results were consistent across the trials ([ Fig. 1 ]). Fig. 1 Effects of nintedanib versus placebo on time to death, and time to first acute exacerbation of ILD or death, in subjects with idiopathic pulmonary fibrosis and other forms of progressive pulmonary fibrosis. Conclusions: Nintedanib had consistent effects on reducing the risk of mortality, and of acute exacerbation of ILD or mortality, across clinical trials conducted in subjects with IPF/PPF. *previously presented at ERS 2023; ‡presenting on behalf of the authors The TOMORROW, INPULSIS, Phase IIIb [NCT01979952] and INBUILD trials were supported by Boehringer Ingelheim (BI). Publication History Article published online: 01 March 2024 © 2024. Thieme. All rights reserved. Georg Thieme Verlag 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 | 0.011 | 0.015 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.010 | 0.028 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
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".