Pooled data on Ofev shows efficacy, safety and tolerability in idiopathic pulmonary fibrosis.- Boehringer.

Boehringer announced new presentations that reinforce the efficacy, safety and tolerability profile of Ofev (nintedanib) in patients with idiopathic pulmonary fibrosis (IPF). Pooled data from the two Phase III INPULSIS trials and the Phase II TOMORROW study compared the observed number of deaths in patients treated with Ofev or placebo with the predicted rate of death based on GAP stage over one year. GAP stage is used to predict IPF prognosis and is based on gender, age and lung function (as measured by forced vital capacity [FVC] decline predicted and DLco % predicted). Higher stages of GAP are associated with an increasing risk of death. Across the population (n=1,228), there were fewer deaths observed in each treatment group than predicted based on GAP stage at baseline (Ofev: 42 vs. 89.9; placebo: 41 vs. 64.2).

In the Ofev group, the number of observed deaths was 46.7% of the number predicted based on GAP stage, while in the placebo group the number of observed deaths was 63.9% of the number predicted. Based on these differences, the analysis suggests that Ofev may be associated with a 26.8% relative reduction in the risk of death compared with placebo over one year. In a separate analysis of data from the INPULSIS trials, a greater decline in lung function was associated with worsening patient-reported health-related quality of life (HRQL) measuring respiratory function, shortness of breath, cough and sputum assessment and other quality of life measures.

Pooled data from patients treated with Ofev or placebo showed that patients with a decline in FVC greater than 10% predicted, regardless of treatment, experienced declines across different HRQL. Data from the largest set of Ofev-treated patients with IPF analyzed to-date further confirmed its safety and tolerability profile. The analysis included patients from six clinical trials (n=1,126), including TOMORROW, the two INPULSIS trials, and their open-label extension studies. Data were presented at the American Thoracic Society's 2018 annual conference.