Phase 3 Trial Data Supports Effectiveness of Ofev in Treating IPF, Regardless of Disease Severity

Phase 3 Trial Data Supports Effectiveness of Ofev in Treating IPF, Regardless of Disease Severity

Analyses of data from two Phase 3 INPULSIS trials support using Ofev (nintedanib) for patients with idiopathic pulmonary fibrosis (IPF). The trials included IPF patients at different disease stages, and revealed that Ofev treatment is effective across groups with different disease severity.

The results were presented at this year’s annual meeting of the American College of Chest Physicians (CHEST), taking place through Wednesday, Oct. 26, in Los Angeles.

INPULSIS-1 (NCT01335464) and INPULSIS-2 (NCT01335477) analyzed the effectiveness of Ofev in IPF progression. In each clinical trial, participants were divided in sub-categories based primarily on three parameters using the GAP composite index (gender, age, and physiology) to predict prognosis in IPF patients.

In the presentation “Nintedanib Reduces Disease Progression in Patients With Idiopathic Pulmonary Fibrosis Irrespective of GAP Stage at Baseline in the INPULSIS Trials,” researchers recounted the investigation into whether Ofev could reduce the risk of disease progression compared to placebo in patients with different GAP stages.

The study utilized 500 participants at GAP 1, and 560 participants at GAP 2 or Gap 3. Within the GAP 1 group, 304 patients were given Ofev, while in the GAP 2-3 group, 334 patients received the therapy. The remaining participants in both groups received placebo.

The team analyzed participant lung function through a measure called forced vital capacity (FVC) — the amount of air exhaled during a forced breath.

Researchers found that, over the 52-week period study, 51.3% of the GAP 1 patients receiving Ofev and 72.4% of those given placebo experienced an absolute FVC decline of greater or equal to 5%, or succumbed to the disease. In GAP 2-3 patients, the percentages were 52.1% in the Ofev group and 70.8% in the placebo.

An FVC decline of greater than or equal to 10% predicted or death was observed in 24.7% of the GAP I stage patients and  39.8% in the placebo patients; and in 29.3% of GAP II/III patients and 42.9% in the related placebo group.

The results showed that the effect of Ofev in FVC decline (≥5% or ≥10% predicted) or death over the 52-week period was similar in patients with GAP 1 versus 2-3 at baseline, which led the team to suggest that Ofev reduces the risk of disease progression irrespective of initial IPF severity.

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 assessed the effect of Ofev treatment on disease progression based on the patients’ initial composite physiologic index (CPI), a measure that reflects the extent of pulmonary fibrosis on computed tomography. A higher CPI score reflects a worse prognosis. Participants were divided in subcategories based on their baseline CPI (≤45 versus >45; and ≤55 versus >55).

The team found that implementing either index (CPI or GAP) produced similar results. The absolute decline in FVC ≥5% predicted or death, over the 52-week study period, was similar regardless of an initial CPI score higher than 45 (50.6% in Ofev group, 71.4% placebo) or lower (53.2% Ofev, 71.7% placebo). Moreover, the treatment presented the same effectiveness even when comparing patients with worse prognosis — patients with a CPI score higher than 55 versus patients with values lower than 55.

“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. “Both of these analyses demonstrated a consistent clinical effect with Ofev in patients irrespective of the severity of IPF at treatment initiation.”

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