IPF is a uniformly fatal disease with a median survival of 2-3 years and limited therapeutic options. A recent Phase III, double blind, placebo-controlled study evaluated the safety and efficacy of Interferon gamma-1b (IFN-γ 1b) in 330 patients with mild-to-moderate IPF; however, limited data are available in patients with severe disease. The current analysis evaluated the safety of IFN-γ 1b in patients with severe IPF.
Pharmacovigilance techniques were used to identify a cohort of patients in the safety database with a baseline FVC < 50% who received IFN-γ 1b for the treatment of IPF. The safety database included patients from the Phase III clinical trial, the subsequent open-label observational study, and a U.S. Patient Registry.
More than 150 patients with a baseline FVC < 50% were identified. Pulmonary function, vital status as well as serious adverse experiences (SAEs) are available for these patients. Analyses of mortality and SAE rates will be presented.CONCLUSIONS AND CLINICAL IMPLICATIONS: This study will provide the first detailed assessment of the safety of IFN-γ 1b in a large cohort of patients with severe IPF, and foster a better understanding of the therapeutic utility of IFN-γ 1b in patients with severe disease.
R.E. Kaye, InterMune, Inc., Shareholder.