Risk factors for disease progression in idiopathic pulmonary fibrosis.
In this retrospective study of a randomised trial of simtuzumab in idiopathic pulmonary fibrosis (IPF), prodromal decline in forced vital capacity (FVC) was significantly associated with increased risk of mortality, respiratory and all-cause hospitalisations, and categorical disease progression. Predictive modelling of progression-free survival event risk was used to assess the effect of population enrichment for patients at risk of rapid progression of IPF; C-index values were 0.64 (death), 0.69 (disease progression), and 0.72 (adjudicated respiratory hospitalisation) and 0.76 (all-cause hospitalisation). Predictive modelling may be a useful tool for improving efficiency of clinical trials with categorical end points.
Raghu, G; Ley, B; Brown, KK; Cottin, V; Gibson, KF; Kaner, RJ; Lederer, DJ; Noble, PW; Song, JW; Wells, AU; Whelan, TP; Lynch, DA; Humphries, SM; Moreau, E; Goodman, K; Patterson, SD; Smith, V; Gong, Q; Sundy, JS; O'Riordan, TG; Martinez, FJ
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