Nintedanib Effective in IPF Regardless of Disease Severity
Two post-hoc analyses have demonstrated efficacy of nintedanib in idiopathic pulmonary fibrosis (IPF), regardless of a patient's disease severity at the start of the trials.
IPF is a rare lung disease that typically affects men over the age of 65. The analysis pooled data from the two Phase III INPULSIS trials, which investigated the efficacy of Ofev (nintedanib; Boehringer Ingelheim) on disease progression in subgroups of IPF patients.
The subgroups were defined by their GAP (gender, age, and physiology) stage. Based on the index, 500 patients were categorized as GAP stage I (nintedanib 304; placebo 196), and 560 were categorized as GAP stage II/III (nintedanib 334; placebo 226).
Results showed similar disease progression reductions regardless of GAP stage, as defined by absolute decline in forced vital capacity (FVC) ≥5% predicted or death over 52 weeks. A second analysis assessed the treatment effects based on patients' baseline composite physiologic index (CPI), with a higher CPI score associated with a worse prognosis.
This analysis divided patients by baseline CPI of ≤45 versus >45, and ≤55 versus >55. At baseline, 500 patients (nintedanib 304; placebo 196) were at GAP stage I, and 560 patients (nintedanib 334; placebo 226) were at GAP stage II/III.
Results showed that the effects were comparable based on the time to absolute decline in FVC ≥5% predicted or death over 52 weeks (≤45 vs. >45) or the time to absolute decline in FVC ≥10% predicted or death over 52 weeks. Additionally, in the 55 CPI threshold group there were no significant differences for time to absolute decline in FVC ≥5% or death, and for time to absolute decline in FVC ≥10% or death.
The results were presented at the CHEST 2016 conference in Los Angeles.
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