Ofev (nintedanib) is effective for a wide range of idiopathic pulmonary fibrosis (IPF) patients, according to Boehringer Ingelheim, the company that developed the drug. Post-hoc analysis of results of the INPULSIS clinical trial program, which tested Ofev’s effect on lung function, showed that disease progression is similar in a wide range of patients, and that the drug is effective in all subgroups. The analysis also supports new and less stringent criteria for diagnosing IPF in lung disease patients.
An IPF diagnose can be difficult because of strict guideline criteria. For instance, it is not always possible to diagnose a lung disease as IPF when scarring of the lung tissue is present but honeycombing (determined via radiological scans and indicating widespread scarring) is not visible. For this reason, many patients are not diagnosed for IPF, and disease progression and treatment effectiveness in such patients remains unknown.
Researchers analyzed the results of the INPULSIS clinical trial by dividing the patients into two subgroups. They first looked at patients with confirmed usual interstitial pneumonia (UIP), a type of lung disease characterized by progressive scarring of the lungs and honeycombing. UIP and honeycombing are two features that help establish a definitive IPF diagnosis. The team saw that in this group of patients, the annual rate of decline in lung function was significantly slower in those taking Ofev compared to those on placebo.
The team then looked at patients who did not receive a confirmed IPF diagnosis according to the current guidelines, as they exhibited features of possible UIP but no honeycombing, and an irreversible dilation of bronchi and bronchioles (called traction bronchiectasis). Interestingly, like in the first group, the annual rate of decline in lung function was also significantly slower in patients treated with Ofev compared to placebo.
Scientists showed that the drug had the same effect on both subgroups of patients, and that this was consistent with the effect of the drug in the overall pooled population.
Regarding safety, the side effects of Ofev treatment were similar between subgroups.
“This analysis confirms for the first time that disease progression and effect of treatment in a subgroup of patients not fully meeting the diagnostic criteria is similar to those meeting the current criteria, as defined in the 2011 international guidelines for diagnosis of IPF,” Dr. Ganesh Raghu, a professor of medicine at the University of Washington, Division of Pulmonary and Critical Care Medicine, and director of the Center for Interstitial Lung Diseases at the University of Washington Medical Center, Seattle, said in a press release. “This has implications to consider accepting the modified criteria, as used in this study for making a diagnosis of IPF that includes presence of possible UIP pattern and traction bronchiectasis in lower lobes (…) in an appropriate clinical setting and in future clinical trials.”
Ofev is a kinase inhibitor approved for the treatment of IPF in 2014 by the U.S. Food and Drug Administration (FDA). More information on the INPULSIS trial program and its findings is available in this report by Pulmonary Fibrosis News.