Phase III results with Ofev (nintedanib) shows benefits in idiopathic pulmonary fibrosis- Boehringer

Boehringer Ingelheim announced the presentation of new analyses on the use of Ofev (nintedanib) in treating idiopathic pulmonary fibrosis (IPF) which supports the established efficacy and safety data for Ofev and offer further insights into its effect on lung function in IPF patients. 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). Additionally, 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. Data were presented at the 2017 American Thoracic Society (ATS) conference.