Real-World Data Support Use of Ofev in IPF Management, Study Finds

Real-world data shows that treatment with Ofev (nintedanib, marketed by Boehringer Ingelheim) helps stabilize idiopathic pulmonary fibrosis (IPF) and is well-tolerated, a German study reports.

The research, “Real-World Experience with Nintedanib in Patients with Idiopathic Pulmonary Fibrosis,” was published in the journal Respiration.

Ofev and Esbriet (pirfenidone, marketed by Genentech) are the two currently approved anti-fibrotic therapies for patients with IPF. Ofev blocks tyrosine kinase, a critical enzyme for cellular signaling pathways that leads to excess release of growth factors in IPF patients. These molecules promote collagen deposition, as well as maturation and multiplication of cells called fibroblasts, which lead to lung fibrosis.

Prior clinical studies have shown that twice-daily treatment with 150 mg Ofev reduced the decline in lung function and prolonged the time to first acute disease exacerbation in IPF patients. This led to Ofev’s approval for IPF treatment for adults in the U.S. and Europe.

Besides results from clinical trials, long-term data and real-world experience are needed regarding the use of Ofev in IPF. The limited available results show the long-term slowdown of patients’ disease progression, as well as Ofev’s safety and tolerability.

In order to gain further insight into real-world data, researchers analyzed the safety and effectiveness of Ofev in the treatment of IPF patients at a tertiary referral site for interstitial lung diseases in Germany.

The investigators analyzed patients’ full medical history, lung function and Ofev-related adverse events (AEs). IPF progression was defined as a 5% or greater decrease in forced vital capacity — FVC, the amount of air exhaled after a deep breath — and/or a 15% or greater reduction in the lung’s diffusing capacity for carbon monoxide, which assesses how much oxygen passes from the air sacs to the blood.

The study included 64 patients (55 men, mean age 70) treated with Ofev between June 2014 and November 2016. Ofev’s efficacy was only analyzed in patients with a treatment duration not shorter than three months.

Mean time from IPF diagnosis to start Ofev treatment was 23.8 months. Thirty patients (47%) had been treated previously with Esbriet. Mean duration of follow-up was 11 months. The most common comorbidity was hypertension, which was observed in 28 patients.

Results showed that after 6 months of treatment, 33 of 49 (67%) patients were stable. Most of these patients had no decline in FVC. At nine months, 23 patients (37.6%) still had stable lung function.

The improvements with Ofev also were observed in patients with hypertension, coronary artery disease, or lung emphysema.

Of note, patients’ respiratory function before starting Ofev treatment was lower than in prior clinical trials. “As such, our data provide support for the benefits of [Ofev] in a patient population with more severe disease at baseline,” the researchers wrote.

This worsened disease status also may explain the higher rate of acute IPF exacerbations (17%) compared to previous studies, the authors observed.

Seven patients stopped Ofev treatment due to adverse events. The most common adverse event reported was diarrhea, which occurred in 33% of patients.

Most patients received Ofev at the recommended dose of 150 mg twice daily. However, eight patients (13%) required dose reduction to 100 mg due to diarrhea and anorexia.

“The results from this real-world clinical setting support findings from previously conducted clinical trials and show that nintedanib is effective for the management of IPF and is associated with disease stabilization,” the team concluded.

The analysis further demonstrates that Ofev is well-tolerated, which was particularly evident in the low rate of serious adverse events, including major adverse cardiovascular events, the researchers noted.