Two new analyses of data from late-stage trials of Boehringer Ingelheim's lung drug Ofev presented at CHEST 2016 lend further weight to the body of evidence backing its effectiveness in people with idiopathic pulmonary fibrosis (IPF).
Pooled analysis of the two Phase III INPULSIS trials looked at the impact of Ofev (nintedanib) on disease progression in subgroups of patients defined by their GAP (gender, age, physiology) stage, a composite index developed to predict prognosis in patients with the condition.
The analysis showed a similar reduction in disease progression - defined as an absolute decline in forced vital capacity ≥5 percent predicted or death over 52 weeks - with BI's drug versus placebo regardless of GAP stage.
The treatment effect also remained consistent between the two GAP subgroups when progression was measured as an absolute FVC decline ≥10 percent predicted or death over 52 weeks, the firm noted.
A second post-hoc pooled analysis of the data investigated the effect of treatment on disease progression based on patients' baseline composite physiologic index (CPI), a newer measure that also reflects disease severity through the use of spirometric volumes and measures of gas transfer without radiologic scoring.
When using the baseline CPI threshold of 45, treatment effects were comparable based on the time to absolute decline in FVC ≥ 5 percent or 10 percent predicted or death over 52 weeks, and there were no significant differences in treatment effect when a baseline CPI threshold of 55 was used to define subgroups.
The data presented further demonstrate the efficacy of Ofev in a range of people with IPF, regardless of disease severity at the start of the trials, the BI said.
"Understanding how treatment will affect disease progression for patients who begin drug therapy at different severity levels is critical to helping pulmonologists make treatment decisions," said Luca Richeldi, Professor of Respiratory Medicine at the University of Southampton, UK. "Both of these analyses demonstrated a consistent clinical effect with Ofev in patients irrespective of the severity of IPF at treatment initiation."
IPF is a rare and serious lung disease that causes permanent scarring of the lungs. Around 15,000 people in the UK are affected by the condition. Without treatment, patients only live for around two to five years from diagnosis on average.