Published ahead of print on July 31, 2008, doi:10.1164/rccm.200709-1446OC
© 2008 American Thoracic Society doi: 10.1164/rccm.200709-1446OC
Treatment of Idiopathic Pulmonary Fibrosis with EtanerceptAn Exploratory, Placebo-controlled Trial1 University of Washington Medical Center, Seattle, Washington; 2 National Jewish Medical and Research Center, Denver, Colorado; 3 Ruhrlandklinik Essen-Heidhausen, Essen, Germany; 4 Hôpital Louis Pradel, Université Lyon I, Lyon, France; 5 Tulane University Health Sciences Center, New Orleans, Louisiana; 6 Universitaire Ziekenhuizen KU Leuven, Leuven, Belgium; 7 Mayo Clinic, Rochester, Minnesota; and 8 Wyeth Research, Collegeville, Pennsylvania Correspondence and requests for reprints should be addressed to Ganesh Raghu, M.D., F.C.C.P., F.A.C.P., Division of Pulmonary and Critical Care Medicine, Campus Box 356175, University of Washington, Seattle, WA 98195-6522. E-mail: graghu{at}u.washington.edu Rationale: An efficacious medical therapy for idiopathic pulmonary fibrosis (IPF) remains elusive. Objectives: To explore the efficacy and safety of etanercept in the treatment of IPF. Methods: This was a randomized, prospective, double-blind, placebo-controlled, multicenter exploratory trial in subjects with clinically progressive IPF. Primary endpoints included changes in the percentage of predicted FVC and lung diffusing capacity for carbon monoxide corrected for hemoglobin (DLCOHb) and change in the alveolar to arterial oxygen pressure difference P(A–a)O2 at rest from baseline over 48 weeks. Measurements and Main Results: Eighty-eight subjects received subcutaneous etanercept (25 mg) or placebo twice weekly as their sole treatment for IPF. No differences in baseline demographics and disease status were detected between treatment groups; the mean time from first diagnosis was 13.6 months and mean FVC was 63.9% of predicted. At 48 weeks, no significant differences in efficacy endpoints were observed between the groups. A nonsignificant reduction in disease progression was seen in several physiologic, functional, and quality-of-life endpoints among subjects receiving etanercept. There was no difference in adverse events between treatment groups. Conclusions: In this exploratory study in patients with clinically progressive IPF, etanercept was well tolerated. Although there were no differences in the predefined endpoints, a decreased rate of disease progression was observed on several measures. Further evaluation of TNF antagonists in the treatment of IPF may be warranted. Clinical trial registered with www.clinicaltrials.gov (NCT 00063869).
Key Words: Idiopathic pulmonary fibrosis • etanercept • tumor necrosis factor antagonist • quality of life • placebo-controlled
Related articles in AJRCCM:
This article has been cited by other articles:
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
blocking agent, etanercept, was well tolerated, there were no differences in the predefined endpoints among patients with idiopathic pulmonary fibrosis who received etanercept or placebo.
