New data presented yesterday at the American Thoracic Society’s 2018 annual conference suggest that treatment with nintedanib (Ofev) is associated with a reduced risk of death in patients with idiopathic pulmonary fibrosis.
New data presented yesterday at the American Thoracic Society’s (ATS) 2018 annual conference suggest that treatment with nintedanib (Ofev) is associated with a reduced risk of death in patients with idiopathic pulmonary fibrosis (IPF).
The mortality analysis was pooled from a pair of phase 3 INPULSIS trial, as well as the phase 2 TOMORROW trial, each of which compared the observed number of deaths in patients treated with nintedanib or placebo with the predicted rate of death based on the Gender-Age-Physiology (GAP) stage over one year.
Between the studies, 1,228 patients with IPF were enrolled, and there were fewer reported deaths in each treatment group than predicted on GAP stage at baseline (Ofev: 42 vs. 89.9; placebo: 41 vs. 64.2). The number of observed deaths in the nintedanib groups was 46.7% of the number predicted based on GAP stage, and in the placebo group, the number of observed deaths was 63.9% of the predicted number.
The differences exhibited in the analysis suggest that nintedanib may be associated with 26.8% relative reduction in the risk of death versus placebo over 1 year.
"IPF is a progressive and fatal disease, and treatment with nintedanib can slow disease progression by reducing the rate of lung function decline," said Christopher J. Ryerson, MD, Assistant Professor at the University of British Columbia Centre for Heart Lung Innovation, Vancouver, Canada in a press release. "Although the individual trials were not powered to measure mortality, our pooled analysis suggests that nintedanib may offer a survival benefit for IPF patients."
A separate analysis of INPULSIS trials demonstrated an association between a decline of lung function and worsening in health-required quality of life (HRQL). Respiratory function, shortness of breath, cough, and sputum assessment were measured, among other quality of life (QoL) gauges. In the data, it was observed that, regardless of treatment (nintedanib or placebo), patients with a decline in forced vital capacity (FVC) >10% predicted experienced declines across different HRQL.
"The symptoms of IPF can have a serious impact on a patient's quality of life, resulting in a loss of independence and involvement in daily activities," said Michael Kreuter, MD, Professor at the Center for Interstitial and Rare Lung Diseases, Pneumology and Respiratory Care Medicine, University of Heidelberg, and a Member of the German Center for Lung Research, Germany. "Our analysis observed association between the extent of lung function decline and quality of life. Stabilizing lung function, therefore, may allow patients to retain some of their daily level of functioning, which might improve quality of life."
Data from the combined 6 trials showed consistency as it pertains to the product’s manageable safety and tolerability profile. Of the 1,126 total patients evaluated, the average exposure to nintedanib was 27.7 months with a maximum exposure of 93.1 months for a total of nearly 2,600 patient years.
The most common adverse event (AE) was diarrhea, remaining consistent with previous studies conducted for this indication. It led to a dose reduction or discontinuation in 17.2% and 8.8% of patients, respectively. However, the data showed that the rate of diarrhea was lower than observed in the Phase 3 INPULSIS trial.