Treatment of idiopathic pulmonary fibrosis with etanercept: An exploratory, placebo-controlled trial

Ganesh Raghu, Kevin K. Brown, Ulrich Costabel, Vincent Cottin, Roland M. Du Bois, Joseph A. Lasky, Michiel Thomeer, James P. Utz, Rezaul K. Khandker, Lawrence McDermott, Saeed Fatenejad

Research output: Contribution to journalArticle

241 Scopus citations

Abstract

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 inefficacy 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).

Original languageEnglish (US)
Pages (from-to)948-955
Number of pages8
JournalAmerican journal of respiratory and critical care medicine
Volume178
Issue number9
DOIs
StatePublished - Nov 1 2008

Keywords

  • Etanercept
  • Idiopathic pulmonary fibrosis
  • Placebo-controlled
  • Quality of life
  • Tumor necrosis factor antagonist

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Critical Care and Intensive Care Medicine

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    Raghu, G., Brown, K. K., Costabel, U., Cottin, V., Du Bois, R. M., Lasky, J. A., Thomeer, M., Utz, J. P., Khandker, R. K., McDermott, L., & Fatenejad, S. (2008). Treatment of idiopathic pulmonary fibrosis with etanercept: An exploratory, placebo-controlled trial. American journal of respiratory and critical care medicine, 178(9), 948-955. https://doi.org/10.1164/rccm.200709-1446OC