MedicalResearch.com Interview with:
Dr. Luca Richeldi MD PhD
Professor of Respiratory Medicine
Chair of Interstitial Lung Disease
University of Southampton
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The data presented at CHEST 2016 were from two post-hoc pooled analyses of the Phase III INPULSIS® trials that evaluated Ofev in idiopathic pulmonary fibrosis, or IPF. Both analyses, using different measures, demonstrate Ofev efficacy in a range of people with IPF, regardless of disease severity at the start of the trials.
One analyses investigated the efficacy of Ofev on disease progression in subgroups of patients defined by their GAP (gender, age, physiology) stage. Based on the index, patients were categorized as either GAP stage I or II/III. The analysis showed a similar reduction in disease progression with Ofev versus placebo regardless of GAP stage – meaning no significant difference between GAP stage I versus GAP stage II/III. Disease progression was defined as an absolute decline in forced vital capacity (FVC) ≥5% predicted or death over 52 weeks.
The other analysis investigated the effect of treatment on disease progression based on patients’ baseline composite physiologic index (CPI). This is a newer measure that also reflects disease severity through the use of spirometric volumes and measures of gas transfer without radiologic scoring. Subgroup analyses were conducted of patients bybaseline CPI of ≤45 versus >45, and ≤55 versus >55. When using the baseline CPI threshold of 45, treatment effects were comparable based on the time to absolute decline in FVC ≥5% predicted or death over 52 weeks (≤45 vs. >45) or the time to absolute decline in FVC ≥10% predicted or death over 52 weeks. Also, there were no significant differences in treatment effect when a baseline CPI threshold of 55 was used to define subgroups for time to absolute decline in FVC ≥5% or death and for time to absolute decline in FVC ≥10% or death.
MedicalResearch.com: What should readers take away from your report?
Response: Both of these analyses demonstrated a consistent clinical effect with Ofev in patients regardless of the severity of IPF at treatment initiation, adding to the growing body of evidence reinforcing the efficacy of Ofev in people with IPF. Understanding how treatment will affect disease progression for patients who begin drug therapy at different severity levels is critical to helping pulmonologists make treatment decisions.
MedicalResearch.com: Is there anything else you would like to add?
Response: Ongoing analyses like these are imperative for helping physicians better manage patients with IPF and the treatment decisions they face. IPF is a devastating disease, so I would encourage continued analyses and research to provide further scientific evidence needed to guide these important therapeutic decisions.
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Chest 2016 abstracts:
Nintedanib Reduces Disease Progression in Patients With Idiopathic Pulmonary Fibrosis Irrespective of Composite Physiologic Index at Baseline in the INPULSIS Trials
Nintedanib Reduces Disease Progression in Patients With Idiopathic Pulmonary Fibrosis Irrespective of GAP Stage at Baseline in the INPULSIS Trials
Disclosure: Studies supported by Boehringer Ingelheim Pharmaceuticals, Inc
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