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Previous Volume 350:125-133 January 8, 2004 Number 2 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Teirstein, A. S. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

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.

Source Information

From the University of Washington, Seattle (G.R.); the National Jewish Medical and Research Center, Denver (K.K.B.); InterMune, Brisbane, Calif. (W.Z.B., K.S.); Yale University, New Haven, Conn. (P.W.N.); Duke University School of Medicine, Durham, N.C. (D.A.S.); and the University of California, San Francisco (T.E.K.).

Address reprint requests to Dr. Raghu at the Division of Pulmonary Medicine, University of Washington, Seattle, BB 1237, Health Sciences, Box 356522, Seattle, WA 98195, or at graghu{at}u.washington.edu.

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Interferon Gamma-1b for Pulmonary Fibrosis
Hill A. R., Fruchter O., Eisner M. D., Tsoutsou P. G., Gourgoulianis K. I., Vourlekis J. S., Richeldi L., Raghu G., King T. E. Jr., Teirstein A. S.
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N Engl J Med 2004; 350:1794-1797, Apr 22, 2004. Correspondence

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