A placebo-controlled trial of interferon gamma-1b in patients with idiopathic pulmonary fibrosis.
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.
Raghu
Ganesh
G
Division of Pulmonary Medicine, University of Washington, Seattle 98195, USA. graghu@u.washington.edu
Brown
Kevin K
KK
Bradford
Williamson Z
WZ
Starko
Karen
K
Noble
Paul W
PW
Schwartz
David A
DA
King
Talmadge E
TE
D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D007371:Interferon-gamma / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011658:Pulmonary Fibrosis / Q000150:complications / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D011994:Recombinant Proteins; D012129:Respiratory Function Tests; D012141:Respiratory Tract Infections / Q000209:etiology; D012306:Risk; D017211:Treatment Failure
D011994:Recombinant Proteins; D007371:Interferon-gamma