IPF is a devastating disease with a median survival of 2-3 years, and no proven treatment. Hospitalization of IPF patients is a common occurrence, usually due to a respiratory-related diagnosis. This study evaluated the safety and efficacy of IFN-γ 1b in steroid-refractory IPF patients (pts).
IPF pts were randomized to receive IFN-γ 1b 200 μg or placebo (PBO) SQ tiw for up to 3 years. The primary endpoint was time to death or disease progression (≥10% decrease in % pred FVC or ≥5 mm Hg increase in A-a gradient). Other endpoints included dyspnea, measures of lung function, gas exchange, and hospitalization.
330 pts were randomized. Baseline (BL) mean FVC (64% vs. 64%), % pts with surgical lung biopsy (62% vs. 67%). Death or disease progression occurred in 46.3% and 51.8% of IFN-γ 1b and PBO pts, respectively (11% reduction, p=0.53), while death occurred in 9.9% and 16.7% overall respectively (41% reduction, p=0.08). An exploratory analysis of hospitalizations demonstrated a similar number of hospitalizations (100 vs. 95) and respiratory-related hospitalizations (59 vs. 57) for IFN-γ1b versus PBO pts, but the duration of hospitalization was shorter for IFN-γ 1b pts: Overall, 9 versus 11 days (p=0.21); respiratory-related, 11.4 versus 15 days (p=0.20). In patients with a baseline FVC ≥ 55% the mean duration of respiratory-related hospitalization was significantly lower in the IFN-γ 1b group, 9.2 versus 16.3 days (p=0.04).CONCLUSIONS AND CLINICAL IMPLICATIONS: Detailed analysis of all hospitalizations, including the reasons for hospitalizations and the utilization of medical services will be presented.
W.Z. Bradford, InterMune, Inc., Shareholder.