Abstract: Poster Presentations |

Using Pharmacovigilance to Assess the Safety of Interferon Gamma-1b in Patients With Severe Idiopathic Pulmonary Fibrosis (IPF) FREE TO VIEW

Randall E. Kaye, MD; Williamson Z. Bradford, MD; Karen Starko, MD; Steven Nathan, MD
Author and Funding Information

InterMune, Inc., Brisbane, CA


Chest. 2003;124(4_MeetingAbstracts):193S. doi:10.1378/chest.124.4_MeetingAbstracts.193S
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PURPOSE:  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.

METHODS:  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.

RESULTS:  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.

DISCLOSURE:  R.E. Kaye, InterMune, Inc., Shareholder.

Wednesday, October 29, 2003

12:30 PM - 2:00 PM




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