The therapy Ofev (nintedanib) was shown to slow down the progression of idiopathic pulmonary fibrosis (IPF) through 96 weeks, regardless of a patient’s lung disease severity at the beginning of the study period, a preliminary analysis of the extension INPULSIS-ON trial found.
Patients who completed a 52-week treatment period and a four-week follow-up period in the INPULSIS trials were invited to continue to receive Ofev in an open-label extension trial — INPULSIS-ON (NCT01619085) — to assess the long-term safety and tolerability of Ofev. The extension trial included 734 patients and is still ongoing.
Ofev manufacturer Boehringer Ingelheim recently presented preliminary results from the extension study at the 2017 CHEST Annual Meeting, along with a separate analysis of data from the IPF-PRO Registry (NCT01915511), which showed trial enrollees were representative of IPF patients in a real-world setting.
The U.S. Food and Drug Administration (FDA) approved Ofev for the treatment of IPF in October 2014. It is one of the first FDA-approved treatments for IPF and the only kinase inhibitor available for the treatment of the disease.
The results presented at CHEST 2017 show that Ofev slows the annual rate of decline in lung function, as measured by forced vital capacity (FVC), over 96 weeks regardless of the severity of patients’ lung conditions at the start of the study. FVC measures the amount of air that can be forcibly exhaled after a breath.
Specifically, the adjusted annual rates of decline in lung function over 96 weeks were consistent among patients with FVC equal or inferior to both 70% and 90% predicted at baseline, and with FVC superior to both 70% and 90%.
Additionally, the adjusted annual rate of lung function decline in all participants in the INPULSIS-ON extension study at 96 weeks was comparable to the rate observed at 52 weeks in the IMPULSIS trials.
“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, MD, president of the Minnesota Lung Center/Minnesota Sleep Institute, in Minneapolis, in a press release.
“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,” he added.
A second abstract presented at CHEST 2017 presented findings from the IPF-PRO Registry, which concluded that the characteristics of patients with IPF who participated in these clinical trials were comparable to patients in the real-world, according to data from 18 pulmonary care sites.
“Boehringer Ingelheim is continually focused on better understanding IPF and identifying prescribing patterns and treatment outcomes in real-world settings,” said Thomas Leonard, PhD, executive director of clinical development and medical affairs, specialty care, at Boehringer Ingelheim.
“The knowledge we are unlocking through the ongoing IPF-PRO Registry underscores this commitment and will help us improve the care of those living with this disease,” he added.