The first two approved therapies for idiopathic pulmonary fibrosis (IPF), Genentech’s Esbriet (pirfenidone) and Boehringer Ingelheim’s Ofev (nintedanib), are still the most reliable treatments among several approved and experimental therapies, according to a comparison study featured in the journal Pharmacometrics & Systems Pharmacology.
Since the U.S. FDA’s approval of these two IPF therapies in 2014, the overall treatment landscape for the illness has changed dramatically. Although many new therapies have been in development and evaluated in clinical trials, a lack of direct comparison with the approved treatments makes it harder to identify possible advantages of other investigational medicines.
Finding ways to compare available data from clinical trials for approved and in-development therapies is important for improving future patient trials and for accurately evaluating the new therapies, researchers said.
In the study titled, “Model-based Meta-Analysis on the Efficacy of Pharmacological Treatments for Idiopathic Pulmonary Fibrosis,” researchers from Bristol-Myers Squibb in collaboration with Quantitative Solutions used a model-based meta-analysis to create a database of combined clinical trial data to assess the effectiveness of different IPF therapies.
The research team compiled data from several treatments and 4,919 participants in 20 clinical trials for both approved and unapproved IPF therapies. They compared the treatments’ effectiveness based on change from baseline of percent predicted forced vital capacity (FVC, which measures lung function) for 14 different IPF drugs, including Esbriet and Ofev.
Results showed that the already approved therapies offered more reliable and positive results. Esbriet, at the recommended dose of 2403 mg/day, was found to be more effective than 300 mg/day of Ofev.
“In order to confirm these findings, a head-to-head comparison between pirfenidone and nintedanib is needed,” the authors wrote. “As more data are published based on administration of pirfenidone and nintedanib as marketed products, continuous enhancement of the database in the future could help improve the understanding of the efficacy responses of these two new standard-of-care pharmacotherapies.”
In addition, the analysis showed that the investigational therapy PRM-151, developed by Promedior, had a larger impact on lung function change than the other two. However, few studies are available on this therapy and additional data is needed to confirm its reliability.