A Placebo-Controlled Trial of Interferon Gamma-1b in Patients with Idiopathic Pulmonary Fibrosis
Ganesh Raghu, M.D., Kevin K. Brown, M.D., Williamson Z. Bradford, M.D., Ph.D., Karen Starko, M.D., Paul W. Noble, M.D., David A. Schwartz, M.D., Talmadge E. King, Jr., M.D., for the Idiopathic Pulmonary Fibrosis Study Group
Background Idiopathic pulmonary fibrosis is a progressive, fataldisease with no known efficacious therapy.
Methods In a double-blind, multinational trial, we randomlyassigned 330 patients with idiopathic pulmonary fibrosis thatwas unresponsive to corticosteroid therapy to receive subcutaneousinterferon gamma-1b or placebo.
Results Over a median of 58 weeks, interferon gamma-1b therapydid not significantly affect the primary end point of progression-freesurvival, defined as the time to disease progression or death,and no significant treatment effect was observed on measuresof lung function, gas exchange, or the quality of life. Tenpercent of patients in the interferon gamma-1b group died, ascompared with 17 percent of patients in the placebo group (P=0.08).Treatment with interferon gamma-1b was associated with morefrequent constitutional symptoms. However, the rates of treatmentadherence and premature discontinuation of treatment were similarin the two groups. More pneumonias were reported among patientsin the interferon gamma-1b group, but the incidence of severeor life-threatening respiratory tract infections was similarin the two groups.
Conclusions In a well-defined population of patients with idiopathicpulmonary fibrosis, interferon gamma-1b did not affect progression-freesurvival, pulmonary function, or the quality of life. Owingto the size and duration of the trial, a clinically significantsurvival 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.
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.
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