Phase 3 Data from INPULSIS Trials Confirm Efficacy of Ofev as IPF Treatment


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Results from two Phase 3 studies, known as the INPULSIS trials, further confirmed the efficacy of Ofev (nintedanib) to treat idiopathic pulmonary fibrosis (IPF) regardless of disease severity.

The results, from post-hoc pooled analyses of the trials, were recently presented at the CHEST 2016 Annual Meeting, running in Los Angeles through Wednesday, Oct. 26.

INPULSIS-1 (NCT01335464) and INPULSIS-2 (NCT01335477) were designed to determine the ability of Ofev to prevent or slow IPF progression in specific subgroups of patients. These subgroups were defined by a prognostic predictive index calculation based on the patients’ gender, age, and physiology (GAP stage). Patients were categorized as either GAP stage I or II/III.

The studies enrolled 500 patients at GAP stage I, and 560 patients at GAP stage II/III to undergo treatment with either Ofev or placebo.

“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,” said Luca Richeldi, a professor of Respiratory Medicine at the University of Southampton, U.K., in a press release.

In the first CHEST presentation, “Nintedanib Reduces Disease Progression in Patients With Idiopathic Pulmonary Fibrosis Irrespective of GAP Stage at Baseline in the INPULSIS Trials,” researchers determined disease progression by measuring forced vital capacity (FVC), the amount of air that a patient could exhale after taking the deepest breath possible.

They found that, over the 52-week study period, 51.3% of the GAP I patients treated with Ofev, and 72.4% of those given placebo, experienced an absolute FVC decline ≥5% or succumbed to the disease. In GAP II/III patients, the percentages were 52.1% in the Ofev group and 70.8% in the placebo.

An ever worse situation of FVC decline ≥10% predicted or death was observed in 24.7% of the GAP I stage treated patients, and in 39.8% of the placebo patients, and in 29.3% of treated GAP II/III patients and 42.9% in the related placebo group.

Results showed that the effect of Ofev in FVC decline (≥5% or ≥10% predicted) or death over the analyzed 52-week period was similar in patients with GAP I and II/III at baseline, which led the team to suggest that Ofev reduces the risk of disease progression irrespective of IPF severity at baseline.

In the second presentation, “Nintedanib Reduces Disease Progression in Patients With Idiopathic Pulmonary Fibrosis Irrespective of Composite Physiologic Index at Baseline in the INPULSIS Trials,” researchers investigated the effect of Ofev treatment on disease progression based on patients’ initial composite physiologic index (CPI).

CPI is a measure of different pulmonary functional tests reflecting disease severity, while excluding symptoms related to emphysema. A higher CPI score is associated with a worse prognosis.

Researchers analyzed the clinical effects of Ofev according to the initial CPI score, and found similar results when analyzing results based on GAP index. The team observed similar treatment responses in patients (absolute decline in FVC ≥5% predicted, or death, over the study period), regardless of  initial CPI score higher than 45 (50.6% in Ofev group, 71.4% placebo) or lower (53.2% Ofev, 71.7% placebo). Moreover, treatment presented the same effectiveness even when comparing patients with worse prognosis — patients with CPI scores higher than 55 versus patients with values lower than 55.

In summary, “both of these analyses demonstrated a consistent clinical effect with Ofev in patients irrespective of the severity of IPF at treatment initiation,” Richeldi concluded.

Ofev was approved for IPF treatment by the U.S. Food and Drug Administration (FDA) in October 2014, becoming one of the first FDA-approved therapies for the disease.

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