Esbriet, Ofev Remain Only Effective IPF Therapies Though PRM-151 is Gaining Ground, Comparison Study Finds
Esbriet (pirfenidone) and Ofev (nintedanib) remain the most reliably effective treatments for idiopathic pulmonary fibrosis (IPF), according to a study that used a time-course model to compare the effectiveness of various approved and experimental drugs.
But a compound now in development might challenge their position. The analysis found that Promedior‘s PRM-151 had a larger impact on lung function change than the other two. But since little data was available, the results were less reliable than for Genentech‘s Esbriet and Boehringer Ingelheim‘s Ofev.
The study, “Model-based Meta-Analysis on the Efficacy of Pharmacological Treatments for Idiopathic Pulmonary Fibrosis,” appeared in the journal Pharmacometrics & Systems Pharmacology.
The analysis assessed 14 drugs and 15 treatment regimens from 20 clinical trials that included 4,919 participants.
Researchers from Bristol-Myers Squibb conducted this research after noticing the lack of studies directly comparing various IPF treatments. To overcome this, they compared data from different studies, while considering factors like the speed of treatment effect onset and the magnitude of treatment effects.
Since most studies used changes in percent predicted forced vital capacity (FVC) as their main outcome measure, the researchers focused their analysis on FVC, which measures lung capacity. . Percent predicted FVC is a measure of lung capacity.
Ranked according to their maximum effect, PRM-151 came out on top — though its effectiveness varied hugely. This was likely due to the small number of treated patients, the team reported.
The treatment is currently undergoing a Phase 2 trial (NCT02550873).
Esbriet and Ofev were the only drugs that showed a statistically significant effect, with a 2403 mg dose of Esbriet having a somewhat higher effect than 300 mg of Ofev. Earlier studies have also suggested that the two drugs were similar, but a separate study directly comparing them would be need to really find out if one of them is more efficient.
Researchers also concluded that except for interferon-gamma, available evidence was conclusive for all the drugs included. In interferon’s case, earlier trials showed the treatment to be somewhat effective, while a newer, larger trial found no evidence of its effectiveness at all.
“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,” the team concluded.