| Autor: |
Fei Tang, Benjamin Weber, Susanne Stowasser, Julia Korell |
| Jazyk: |
angličtina |
| Rok vydání: |
2020 |
| Předmět: |
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| Zdroj: |
CPT: Pharmacometrics & Systems Pharmacology, Vol 9, Iss 2, Pp 87-95 (2020) |
| Druh dokumentu: |
article |
| ISSN: |
2163-8306 |
| DOI: |
10.1002/psp4.12485 |
| Popis: |
We describe a parametric time‐to‐event model for idiopathic pulmonary fibrosis (IPF) exacerbations and identify predictors of exacerbation risk using data obtained for the tyrosine‐kinase inhibitor nintedanib in two phase III studies (INPULSIS‐1/2). Parametric survival analysis was performed on time to first exacerbation (censoring on day 372), with univariate analysis to select statistically significant covariates (P = 0.05). Multivariate covariate models were developed using stepwise covariate modeling with forward inclusion (P = 0.05) and backward elimination (P = 0.01). Sixty‐three first exacerbation events were reported across 1,061 subjects in the INPULSIS studies. Baseline and decline of forced vital capacity (FVC)/percent‐predicted FVC (%pFVC), supplemental oxygen use, baseline CO diffusing capacity and age were statistically significant in the univariate analysis. The final covariate model included decline in FVC to week 52, baseline %pFVC, supplemental oxygen use, and age. The developed model may be used to identify patients at high risk of IPF exacerbations and accelerate development of novel treatments. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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