A placebo-controlled trial of interferon gamma-1b in patients with idiopathic pulmonary fibrosis.

Abstract

BACKGROUND:

Idiopathic pulmonary fibrosis is a progressive, fatal disease with no known efficacious therapy.

METHODS:

In a double-blind, multinational trial, we randomly assigned 330 patients with idiopathic pulmonary fibrosis that was unresponsive to corticosteroid therapy to receive subcutaneous interferon gamma-1b or placebo.

RESULTS:

Over a median of 58 weeks, interferon gamma-1b therapy did not significantly affect the primary end point of progression-free survival, defined as the time to disease progression or death, and no significant treatment effect was observed on measures of lung function, gas exchange, or the quality of life. Ten percent of patients in the interferon gamma-1b group died, as compared with 17 percent of patients in the placebo group (P=0.08). Treatment with interferon gamma-1b was associated with more frequent constitutional symptoms. However, the rates of treatment adherence and premature discontinuation of treatment were similar in the two groups. More pneumonias were reported among patients in the interferon gamma-1b group, but the incidence of severe or life-threatening respiratory tract infections was similar in the two groups.

CONCLUSIONS:

In a well-defined population of patients with idiopathic pulmonary fibrosis, interferon gamma-1b did not affect progression-free survival, pulmonary function, or the quality of life. Owing to the size and duration of the trial, a clinically significant survival benefit could not be ruled out.

• Authors: Ganesh Raghu, Kevin K Brown, Williamson Z Bradford, Karen Starko, Paul W Noble, David A Schwartz, Talmadge E King Jr, Idiopathic Pulmonary Fibrosis Study Group
• Journal: The New England journal of medicine (N Engl J Med) Vol. 350 Issue 2 Pg. 125-33 (Jan 08 2004) ISSN: 1533-4406 [Electronic] United States
• PMID: 14711911 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright 2004 Massachusetts Medical Society

Chemical References

• Recombinant Proteins
• Interferon-gamma

Topics

• Disease Progression
• Double-Blind Method
• Female
• Humans
• Injections, Subcutaneous
• Interferon-gamma (adverse effects, therapeutic use)
• Male
• Middle Aged
• Proportional Hazards Models
• Pulmonary Fibrosis (complications, drug therapy, mortality, physiopathology)
• Recombinant Proteins
• Respiratory Function Tests
• Respiratory Tract Infections (etiology)
• Risk
• Treatment Failure