Real-world Use of Esbriet and Ofev Supports Their Safety and Tolerability, Study Says

Patricia Inácio, PhD avatar

by Patricia Inácio, PhD |

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The tolerability and safety of Ofev (nintedanib) and Esbriet (pirfenidone) treatments in a small group of patients with idiopathic pulmonary fibrosis (IPF) in South England were found to be similar to real-world data.

The research confirmed the safety of both IPF therapies.

The retrospective study, “South-West of England’s Experience of the Safety and Tolerability Pirfenidone and Nintedanib for the Treatment of Idiopathic Pulmonary Fibrosis (IPF),” was published in Frontiers in Pharmacology.

Boehringer Ingelheim‘s Ofev and Genentech’s Esbriet are approved to treat IPF patients, specifically those with a predicted forced vital capacity (FVC, a measure of lung function) between 50% and 80%.  

Prior to approval, both medications were made available in England to IPF patients under two special programs — the Mild Patient Program, and Patient In Need Scheme.

Clinicians looked to identify the population of patients in the northern hub of southwestern England, who were prescribed these therapies between August 2012 and July 2017. The team also assessed the therapies’ tolerability.

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Over the five-year period, 164 people diagnosed with moderate IPF were prescribed Ofev or Esbriet. Of these, 115 out of 164 (70.1%) received Esbriet as their initial treatment.

Most were male ex-smokers, with both groups showing limited lung function — mean FVC of 75.4% in those given Ofev, and 74.4% among  Esbriet users.

Patients prescribed Esbriet were followed for a mean of 423.6 days, and those taking Ofev for 320.9 days.

In both groups, patients who discontinued treatment did so because of adverse treatment-related events — 46 out of 115 (40%) in those prescribed Esbriet, and eight out of 49 (16.3%) in those treated with Ofev.

In the Esbriet group, the most common reasons for stopping treatment were anorexia (lack of appetite), rash, and gastrointestinal disturbances; while in the Ofev group, the main reasons were anorexia, nausea, and weight loss. The duration of the treatment prior to stopping because of adverse events did not differ in a statistically significant way between the two groups — 204 days for Esbriet, and 122 days for Ofev.

No deaths were directly related to either treatment.  

Long-term follow-up assessments were performed at 52 and 104 weeks for Esbriet (91 patients), and at 52 weeks for Ofev (30 patients).

Those on Esbriet, 35% (32 out of 91) halted treatment due to adverse events within the first year, and more than half of these (18 of 32) within the first six months. Within the second year, 10 more patients discontinued treatment.

Among Ofev-treated patients, follow-up data at 52 weeks showed that five out of 30 (17%) stopped treatment within the first six months of follow-up.

The team concluded that in those treated with Ofev, the rate of treatment-emergent adverse events was similar to those seen in clinical trials. With Esbriet, although the profile of such events was higher in this study than in previous clinical trials, the results correlate to real-world datasets.

“Further work is required to explore the possible reasons underpinning this finding, including whether this is related to population co-morbidities,” the researchers said.

They went on to stress that “no new safety concerns were identified” in either therapy.