Treatment with Ofev (nintedanib) works to stabilize lung function in patients with idiopathic pulmonary fibrosis (IPF), according to a study published in the scientific journal Respiration. The drug was also seen to be generally well-tolerated by patients.
In the study, “Insights from the German Compassionate Use Program of Nintedanib for the Treatment of Idiopathic Pulmonary Fibrosis,” a team of researchers led by Professor Antje Prasse, from the Department of Pneumology at the Medical School Hannover and Fraunhofer Institute in Hannover, analyzed a cohort of 62 people, ages 40 and older, with moderate IPF.
All patients were treated with Ofev as part of a compassionate use program in nine centers in Germany from May 2014 through February 2015, when Ofev became available in that country shortly after being approved in Europe as an IPF treatment. Compassionate use programs are intended to facilitate the availability of new treatment options, those still being developed and not yet available commercially, to patients.
Patients’ lung function was assessed in the study using forced vital capacity (FVC), meaning the volume of air that the patient is able to exhale with maximum effort and speed after a full inspiration.
At the beginning of the trial, all patients had a predicted FVC of 50% or less. A majority, 77%, of the patients had been using Esbriet (pirfenidone) for 12 to 16 months prior to the start of the study; these patients switched from Esbriet to Ofev due to disease progression and lung function (FVC) decline.
Six months after the start of Ofev treatment, 63% of the patients had a stable FVC, indicating that the drug was able to stabilize lung function and avoid its decline. The most common adverse effects associated with the drug were diarrhea (seen in 63% of patients) and weight loss (seen in half of the patients).
According to the researchers, these results are in agreement with previously published data.
The safety and efficacy of Ofev has previously been tested on almost 1,500 IPF patients in three clinical trials. Their results showed that the drug is able to reduce the decline of annual FVC by approximately 50% compared to placebo.
The trials were followed by open label extension studies and provided ongoing treatment options for patients. Interim results from these studies have confirmed the long-term safety and tolerability of Ofev in patients with IPF.
Ofev is one of two approved anti-fibrotic drugs for the treatment of IPF, the other being Esbriet. Although neither drug can completely stop the disease course, they can considerably reduce declines in lung function. Ofev, manufactured by Boehringer Ingelheim, was approved by the U.S. Food and Drug administration in October 2014, and by the European Commission in January 2015.