96-week Study Shows Ofev Continues to be Effective in Slowing IPF Progression

James Radke

Today, Boehringer Ingelheim provided a preview of data that will be presented at the 2017 CHEST Annual Meeting in Toronto, Canada next week. The new data displays the long term efficacy (96 weeks) of Ofev (nintedanib) for treating patients with idiopathic pulmonary fibrosis (IPF).

The information indicates the drug is effective in slowing disease progression in these patients.

IPF is a chronic, progressive fibrotic interstitial pneumonia of unknown origin. The disease is usually fatal within a few years of initial symptoms if not treated and until recently, treatment was limited to oxygen therapy, pulmonary rehabilitation, and/or lung transplant.

In 2014, 2 orphan drugs were approved for IPF, Esbriet (pirfenidone) and Ofev (nintedanib), the latter of which is a tyrosine kinase inhibitor that blocks multiple pathways that may be involved in the scarring of lung tissue seen in IPF patients.

The data to be presented at CHEST is currently available online, and represents results from an open label extension of INPULSIS, trials that led to Ofev’s approval by the FDA.

A total of 734 IPF patients participated in the open label study, and researchers observed that the rate in disease progression, as measured by the adjusted annual rate) of decline in forced vital capacity (FVC) over 96 weeks, was −117.8 mL/year for all patients in the study. These results are similar to the results observed in the original Phase 3 trials that led to the FDA approval (117.8 and 113.6 mL/year in the 2 phase trials).

Decline in lung function seemed to be fairly consistent regardless of the patients’ baseline lung function at the start of the study. For example, patients with FVC≤ 90% predicted at baseline had a decline of 125.8 mL/year compared to a 98.7 mL/year decline in patients with FVC >90% predicted at baseline.

Per Boehringer Ingelheim: "Baseline lung function and changes in FVC over time are both important predictors of long-term outcomes in IPF, so it is critical to maintain lung function across disease severities," said Mitchell Kaye, M.D., president of Minnesota Lung Center/Minnesota Sleep Institute, Minneapolis. "These new results provide further supportive evidence for the long-term efficacy of Ofev, suggesting the value of initiating IPF treatment irrespective of a person's disease severity at diagnosis."

Huggins J, Meyer K Stansen W, Quaresma M, Kreuter M.  No Effect of Dose Adjustments on Long-Term Reduction in FVC Decline With Nintedanib in Patients With Idiopathic Pulmonary Fibrosis (IPF). Chest. October 2017; 152 (suppl): A452,

Image courtesy the National Institutes of Health

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