Results of a study by INMARK® suggest that early administration of antifibrosis therapy allows to slow down the progression of idiopathic pulmonary fibrosis.
Scientific journal The Lancet Respiratory Medicine published the results of a randomized double-blinded study by INMARK®, which validated the effectiveness of Vargatef (nintedanib) versus placebo in patients with idiopathic pulmonary fibrosis (IPF) for 12 weeks, followed by a 40-week open trial.
INMARK® is a first clinical study that was targeted at evaluating the predictive value of biomarkers in patients with IPF, receiving antifibrosis therapy (nintedanib).
The results showed that even in patients with preserved lung function, a significant difference could be noticed in the rate of reduction of forced vital capacity (FVC) with a 12-week nintedanib versus placebo therapy.
Idiopathic pulmonary fibrosis (IPF) is a rare, chronic and lethal pulmonary disease which affect approximately 3 million people worldwide.
It causes progressive pulmonary fibrosis, leading to permanent and irreversible decrease in lung function and shortness of breath.
Due to the unpredictable progression of IPF and the irreversible decrease in lung function, specialists think that the treatment has to be administered as soon as possible.
INMARK® looked at the rate of change in CPRM, a biomarker, which has previously demonstrated the ability to predict the mortality due to IPF. The level of CPRM was measured from the beginning of the study till 12thweek. The study also measured t the proportion of patients with disease progression defined by the absolute reduction in FVC ≥10% predicted or dead over 52 weeks.
Nintedanib treatment versus placebo for 12 weeks did not affect the rate of change in CRPM, however was associated with a decrease in the rate lowering of CRPM levels.
29% of patients in the trial experienced an FVC decrease of ≥10% predicted, or died over 52 weeks of follow-up, which demonstrated the progressive nature of IPF even in population with normal FVC value of ≥80%.
Within 12 weeks, patients treated with nintedanib exhibited reduced rate of decline in FVC versus patients receiving placebo (5,9 (18,5) mL/12 weeks in nintedanib group and −70,2 (13,1) mL/12 weeks in placebo group).
“Even in this population of patients with very well-preserved lung function, a difference in FVC decline could be demonstrated between patients treated with nintedanib vs. placebo over 12 weeks of treatment. Considering the unpredictable nature of IPF and the fact that loss of lung function is irreversible the results reinforce a growing body of evidence that early treatment of IPF is the best course of action.” commented Prof Toby Maher, Consultant Respiratory Physician at the Royal Brompton Hospital in London, United Kingdom and principle investigator of the study.
Dr. Susanne Stowasser, Associate Head of Medicine Respiratory at Boehringer Ingelheim, said “Biomarker research is a key driver of modern medicine with huge impact on the understanding of health and disease states, diagnosis, drug development, and prediction of disease course or response to therapy. INMARK was the first clinical trial to investigate the predictive value of biomarkers in IPF patients treated with an antifibrotic. Being poorly understood, IPF has been subject of increasing biomarker research for years with a main focus on identifying markers for prognosis.”
She added: “Pulmonary Fibrosis continue to have a devastating impact on people’s lives. Boehringer Ingelheim is committed to research such as the INMARK trial which helps our understanding of how interstitial lung diseases such as IPF progress in individual patients, and identify those who may respond best to treatment.”