Pooled analysis from the TOMORROW and INPULSIS® trials, recently published in Respiratory Medicine, confirmed that OFEV reduces the risk of acute exacerbations by approximately 50% in people with idiopathic pulmonary fibrosis (IPF), a rare and serious lung disease. An acute exacerbation, a sudden worsening in respiratory function without warning or known cause, is a leading cause of hospitalization for people with IPF. Around half of all people hospitalized because of an acute IPF exacerbation die during hospitalization.
The findings also showed that OFEV slowed disease progression by approximately 50% across the range of patient types in the clinical trial program1 and reduced the risk of death.
The pooled analysis is based on data from the Phase II TOMORROW trial and the two Phase III INPULSIS® trials that included a total of 1,231 people with IPF (723 treated with OFEV, 508 treated with placebo). A separate meta analysis was conducted to summarize the data from all three trials examining OFEV efficacy and safety. Data from these three clinical trials formed the basis for the approval of OFEV in the United States, Europe, Japan and other countries worldwide.
The one-year combined data showed that:
- Fewer people overall experienced an acute exacerbation. The proportion of people with at least one acute exacerbation was 4.6% in the OFEV group and 8.7% in the placebo group. OFEV reduced the risk of an acute IPF exacerbation as reported by treating physicians by 47%, compared to placebo.
- Other study endpoints, such as forced vital capacity (FVC), were assessed in the analysis and were consistent with individual study results.
"Reducing the risk of exacerbations is an important treatment goal in the management of IPF because of their unpredictability and devastating impact on the course of the disease. Acute exacerbations often lead to death within a few months," said Luca Richeldi, Professor of Respiratory Medicine at the University of Southampton, United Kingdom.
Over the one-year period of the studies, OFEV also showed a favorable trend in all survival endpoints:
- Compared to placebo, patients taking OFEV had a 30% reduction in the risk of dying from any cause (p=0.0954).
- Patients taking OFEV also had a 43% reduced risk of dying while on treatment (on-treatment mortality) (p=0.0274).
- A 38% reduction in the risk of death because of an exacerbation or other respiratory cause versus placebo (p=0.0779).
The analysis also confirmed that OFEV slowed disease progression by approximately 50%, as measured by annual rate of decline in FVC. The overall adjusted annual rate of decline in FVC was -112.4 mL/year with OFEV and -223.3 mL/year with placebo (difference: 110.9 mL/year). The safety and tolerability profile of OFEV in the pooled analysis was consistent with results of the individual TOMORROW and the INPULSIS® trials. "The analysis was consistent with individual study results showing that OFEV significantly reduces disease progression. It also shows a reduction in the risk of acute exacerbations and a trend to reduced mortality," said Danny McBryan, M.D., vice president, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. "As a company dedicated to respiratory care, we remain focused on continually uncovering new insights into IPF and OFEV to help support physicians as they have more informed treatment discussions with their patients."