Ofev, Esbriet Use Seen to Lengthen Life for IPF Patients With ‘Mild’ Disease

A real-world analysis found that idiopathic pulmonary fibrosis (IPF) patients with preserved lung function benefitted from treatment with Ofev (nintedanib) and Esbriet (pirfenidone) over three years. 

Despite untreated patients entering this study with better lung function, those using these treatments lived longer, its U.K. researchers found.

The analysis was published in the journal Advances in Therapy, in the study, “Real-World Study Analysing Progression and Survival of Patients with Idiopathic Pulmonary Fibrosis with Preserved Lung Function on Antifibrotic Treatment.”

Two anti-fibrotic medications are approved to treat IPF: Ofev — marketed by Boehringer Ingelheim — and Esbriet, marketed by Genentech. These therapies are known to be effective in slowing the progression of lung fibrosis over time. 

Data from clinical trials demonstrated the benefits of these medications in patients with moderately impaired lung function, as measured by forced vital capacity (FVC) — the amount of air that can be forcibly exhaled from the lungs after taking a deep breath.

Consensus on when anti-fibrotic treatment should start is limited.

In the U.K, both Esbriet and Ofev are restricted to people with an FVC between 50% and 80%, based on health economics. Research has shown, however, that people with preserved FVC (above 80%) may at least benefit to a similar extent from their use.

Researchers with The University of Manchester conducted an analysis using real-world data to assess how use of these two medications affect lung function and survival in IPF patients with preserved FVC. Those being treated received the medications through a compassionate use program.

Medical records were selected for 161 patients (mean age, 72; 120 or 74.5% were men), and included demographic data, clinical reports, treatment records, and lung function information across 36 months (three years).

A total of 128 patients were using anti-fibrotic therapies. Eighty-six (53.4%) were given Ofev for a mean of 24.3 months, 24 (14.9%) received Esbriet for a mean of 21.8 months, while 18 (11.2%) were prescribed both medications. The remaining 33 patients (20.5%) had no treatment.

The most common co-existing conditions were high blood pressure (14.7%),  heart disease (13.7%), and reflux disease (11.3%). Most patients (70.8%) were former smokers, 5.6% were current smokers, and 23.6% had never smoked. 

At the study’s start (baseline), lung function was significantly better in untreated patients (FVC 100.5%) compared to those using Ofev (FVC 93%) or Esbriet (FVC 90%). Patients on both therapies also had a lower FVC (92.7%) compared with the untreated group. 

Likewise, the diffusing capacity for carbon monoxide (DLCO), which measures the lung’s ability to transfer gas into the bloodstream, was significantly higher in untreated patients (4.13) than in those on Ofev (3.54) or Esbriet (3.14). 

Over one year, FVC declined by 2.96% in patients prescribed Ofev, by 2.77% (139 ml) in the those on Esbriet, and by 3.72% (158.1 ml) among untreated patients. A significant decline of 6.36% was found in the group using both medications.

Lung function decline continued over the subsequent two years, particularly in people on both Ofev and Esbriet. 

After diagnosis, median survival in untreated patients was 2.5 years. In turn, participants treated with Ofev had a median survival of three years, and those using Esbriet showed a median survival of 3.5 years. A median survival of 3.75 years was found in patients taking both therapies. 

“The important findings of this study highlight that patients with untreated IPF characterized as ‘mild’ in phenotype [evident manifestations] have a significantly reduced median survival post-diagnosis,” the investigators wrote.

“This reduced survival in the untreated cohort [group] is despite the fact that the anti-fibrotic treated cohort of patients with IPF have lower baseline lung function compared to the untreated group,” the added.

A significantly higher number of Esbriet-treated patients reported adverse effects than Ofev-treated patients, such as appetite loss (19.6% vs. 9%), fatigue (17.9% vs. 9.8%), and skin rash (8.9% vs. 0%). In contrast, diarrhea was reported in more people on Ofev compared with those taking Esbriet (33.8% vs. 5.4%). Notably, 21% of patients stopped either Ofev or Esbriet due to intolerable side effects.

“We would advocate that patients with IPF with an FVC above 80% would benefit from treatment with anti-fibrotic therapy,” the researchers concluded.