Acute Exacerbations in Patients with Progressive Fibrosing Interstitial Lung Diseases: Data from the INBUILD Trial*
Bibliographic record
Abstract
Rationale Few data are available on acute exacerbations (A-EX) in patients with progressive fibrosing ILDs other than idiopathic pulmonary fibrosis (IPF). Data from the INBUILD trial characterize A-EX in this population. Methods Patients had diffuse fibrosing ILD (other than IPF) of>10% on HRCT, FVC≥45%, and DLco≥30%–<80% predicted, and criteria for progression of ILD within the prior 24 months, despite appropriate management in clinical practice. Patients were randomized to nintedanib or placebo. An A-EX of ILD was defined in the protocol as a clinically significant respiratory deterioration characterized by new, widespread alveolar abnormality meeting all these criteria: i) acute worsening or development of dyspnea (typically of<1 month duration); ii) CT with new bilateral ground-glass opacity or consolidation superimposed on a background pattern consistent with fibrosing ILD, iii) not fully explained by cardiac failure or fluid overload. Infection was not an exclusion criterion. A-EX were reported by investigators as part of the pre-specified reporting of adverse events and were not adjudicated. We compared the baseline characteristics of patients who did versus did not have an A-EX during the trial (both groups pooled) and analyzed the times from A-EX to hospitalization and death ([ Abb. 1 ]). Abb. 1 Time from first acute exacerbation of ILD to i) hospitalization and ii)deaht in patents with progressive fibrosing ILDS in the INBUILD trial. Results A-EX were reported in 58 of 663 (8.7%) patients during the follow-up (median: approximately 19 months). Of these, 18 (31.0%) had hypersensitivity pneumonitis, 15 (25.9%) unclassifiable idiopathic interstitial pneumonia, 12 (20.7%) an autoimmune disease-related ILD, 6 (10.3%) idiopathic non-specific interstitial pneumonia, and 7 (12.1%) other ILDs. Compared with the patients who did not have anA-EX, the patients who had an A-EX included a greater proportion of males (65.5% vs 52.6%), current or former smokers (53.4% vs 50.7%), and patients with a usual interstitial pneumonia (UIP)-like fibrotic pattern on HRCT (65.5% vs 61.8%) and had a lower FVC (65.7% vs 69.3% predicted) and lower DLco (40.7% vs 46.6% predicted) at baseline. Kaplan-Meier estimates of rates of hospitalization and death within 180 days of an A-EX were 90.6% and 37.0%, respectively (Figure). Conclusions The INBUILD trial suggest that in patients with PF-ILDs other than IPF, A-EX are associated with a high risk of hospitalization and death. Publication History Article published online: 09 March 2023 © 2023. 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 | 0.003 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 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".