IPF patients treated with Ofev vs placebo twice as likely to have improved or stable lung function

Separate subgroup analysis demonstrates long-term efficacy of Ofev in slowing disease progression is maintained for up to 96 weeks in IPF patients who require dose adjustments to manage adverse events.

Pooled data from the two Phase III INPULSIS trials showed that Ofev-treated patients were twice as likely as those given placebo to experience an improvement or no decline in lung function, as measured by forced vital capacity (FVC), at week 52 (36.8%, Ofev vs 18.0%, placebo). A subgroup analysis of the open-label INPULSIS-ON study demonstrated a similar annual rate of FVC decline over 96 weeks among Ofev-treated patients, regardless of the dosage they received based on individual tolerability (150 mg twice daily, 100 mg twice daily, or both doses).

In addition, a pooled analysis from the TOMORROW, and INPULSIS trials assessed the incidence rates for major adverse cardiovascular events (MACE) among patients treated with Ofev and placebo. Most patients included in this analysis (90%) had a high cardiovascular (CV) risk at baseline, including a history of fatty-plaque build-up in the arteries (called atherosclerosis) and/or at least one CV risk factor such as high blood pressure, diabetes or elevated blood cholesterol levels. Overall, the incidence of MACE was similar between the treatment groups both in patients with a high CV risk (3.5%, Ofev vs 3.3%, placebo) and low CV risk (4.5%, Ofev vs 5.3%, placebo) at baseline.

"IPF is a progressive disease that requires ongoing treatment. So, it is important to assess the long-term efficacy and safety of IPF treatments like Ofev to ensure we are maintaining lung function and reducing disease progression while not exacerbating co-existing conditions," said Imre Noth, professor of medicine and director of the Interstitial Lung Disease Program at the University of Chicago. "These new data help to further strengthen the science supporting the efficacy and safety of Ofev for up to 96 weeks of treatment, and offer physicians additional evidence to support their treatment decisions."