PROOF Real-world Data Continues to Show Esbriet’s Ability to Preserve Lung Function in IPF

Alice Melão, MSc avatar

by Alice Melão, MSc |

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PROOF Esbriet pirfenidone

Treatment with the approved therapy Esbriet (pirfenidone), marketed by Genentech, helps preserve lung function in people with idiopathic pulmonary fibrosis (IPF), real-world data from the PROOF registry show.

The results were reported in “Longitudinal clinical outcomes in a real-world population of patients with idiopathic pulmonary fibrosis: the PROOF registry,” a study published in the journal Respiratory Research.

The PROOF registry was launched in October 2013 to assess the long-term progression of people with IPF in a real-world setting. The study, which enrolled patients until January 2016, tracked a total of 277 people with IPF across centers in Belgium and one in Luxembourg. Participants were followed-up until July 2017.

During this period, 233 patients were treated with Esbriet, of whom 162 (69.5%) had started on the medication before registry enrollment. The remaining 44 people in the study were not prescribed treatment with Esbriet at any time during follow-up.

A total of 28 people with IPF received Ofev (nintedanib) — an IPF-approved therapy sold by Boehringer Ingelheim — during the 24-month follow-up period of the PROOF study. Among these patients, 26 had been previously treated with Esbriet.

Clinical data from PROOF showed that 15 participants (5.4%) experienced acute IPF symptom exacerbations and 17 (6.1%) had secondary pulmonary hypertension. A total of 14 (5.1%) IPF patients underwent lung transplant. In all, 64 people (23.1%) died during follow-up, with 45 of those deaths considered as related to IPF.

Long-term evaluation of patients’ pulmonary function showed that those who were treated with Esbriet had a 2.9% reduction in mean predicted forced vital capacity (FVC) at month 24, changing from 81.2% at study enrollment to 78.3%. Changes in mean predicted diffusing capacity for carbon monoxide (DLco) also showed a slight, non-significant reduction, dropping from 47% to 45% after two years of follow-up.

A more detailed monthly progression analysis for 12 months of follow-up showed that “pulmonary function remained largely stable in patients with IPF who received pirfenidone [Esbriet] for any duration of treatment,” the researchers said.

Additional data analysis revealed that, during the three years before the patients started treatment with Esbriet, they experienced an estimated FVC decline of 2.83% per year. Meanwhile, during the following five years of treatment, FVC decline was 0.87% per year.

“The PROOF registry provides valuable evidence from a real-world population of patients with IPF in Europe,” the researchers said.

“Over 12 months of follow-up, pulmonary function remained largely stable in patients with IPF who received pirfenidone [Esbriet] for any duration of treatment. Pulmonary function remained similar at 24 months of follow-up, although patient numbers were lower,” the researchers added.

Approximately 63.1% of PROOF participants continued on in a new observational study, called PROOF-NEXT (NCT03732859), which will further explore the long-term clinical course of IPF.

This new registry study, sponsored by the Belgian Thoracic Society, Boehringer Ingelheim, and Roche, is currently recruiting IPF patients in Belgium and Luxembourg. Find more information here.