Efficacy and safety of OFEV® reinforced in new presentations at ATS 2018
Boehringer Ingelheim today announced new presentations at the American Thoracic Society’s 2018 annual conference that reinforce the efficacy, safety and tolerability profile of OFEV® (nintedanib) in patients with idiopathic pulmonary fibrosis (IPF).
“The data presented at the conference support the established efficacy of OFEV®, while reaffirming the safety profile observed in the clinical trials and following approval,” said Christopher Corsico, M.D., Chief Medical Officer, Boehringer Ingelheim.
New IPF mortality analysis
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 nintedanib or placebo with the predicted rate of death based on GAP stage over one year.1 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).1 Higher stages of GAP are associated with an increasing risk of death.1
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).1 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.1 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.1
“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, M.D., Assistant Professor at the University of British Columbia Centre for Heart Lung Innovation, Vancouver, Canada. “Although the individual trials were not powered to measure mortality, our pooled analysis suggests that nintedanib may offer a survival benefit for IPF patients.”
Lung function decline and quality of life
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 (HRQoL) measuring respiratory function, shortness of breath, cough and sputum assessment and other quality of life measures.2 Pooled data from patients treated with nintedanib or placebo showed that patients with a decline in FVC >10% predicted, regardless of treatment, experienced declines across different HRQoL measures.
“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,” Michael Kreuter, M.D., 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 demonstrated an 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.”
Pooled safety data from six trials
Data from the largest set of OFEV®-treated patients with IPF analyzed to-date further confirmed its safety and tolerability profile.3 The analysis included patients from six clinical trials (n=1,126), including TOMORROW, the two INPULSIS® trials, and their open-label extension studies.3
The average exposure to OFEV® was 27.7 months with a maximum exposure of 93.1 months, for a total of nearly 2,600 patient-years.3 The rate of adverse events leading to permanent dose reduction (from 150 mg twice daily to 100 mg twice daily) or discontinuation from the studies were 12.8 and 23.8 events per 100 patient exposure-years, respectively.3 Diarrhea remained the most common AE, and led to dose reduction or discontinuation in 17.2% and 8.8% of patients, respectively.3 In the pooled data, the rate of diarrhea was lower than observed in the Phase III INPULSIS® trials.3
The corresponding abstracts can be found within the ATS online program, here: http://www.abstractsonline.com/pp8/#!/4499
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