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Published ahead of print on July 13, 2006, doi:10.1164/rccm.200603-402OC
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American Journal of Respiratory and Critical Care Medicine Vol 174. pp. 795-802, (2006)
© 2006 American Thoracic Society
doi: 10.1164/rccm.200603-402OC

Original Article

Infliximab Therapy in Patients with Chronic Sarcoidosis and Pulmonary Involvement

Robert P. Baughman, Marjolein Drent, Mani Kavuru, Marc A. Judson, Ulrich Costabel, Roland du Bois, Carlo Albera, Martin Brutsche, Gerald Davis, James F. Donohue, Joachim Müller-Quernheim, Rozsa Schlenker-Herceg, Susan Flavin, Kim Hung Lo, Barry Oemar, Elliot S. Barnathan and on behalf of the Sarcoidosis Investigators

University of Cincinnati Medical Center, Cincinnati; Cleveland Clinic, Cleveland, Ohio; University Hospital Maastricht, Maastricht, The Netherlands; University of Essen, Medical Faculty, Ruhrlandklinik Essen, Essen; University of Freiburg Medical Center, Freiburg, Germany; Medical University of South Carolina, Charleston, South Carolina; Imperial College of Science, Technology, and Medicine, London, United Kingdom; Dipartimento di Scienze Cliniche e Biologiche, Università Di Torino, ASO San Luigi, Orbassano (Torino), Italy; University Hospital Basel, Basel, Switzerland; University of Vermont, Burlington, Vermont; University of North Carolina, Chapel Hill, North Carolina; and Centocor, Inc., Malvern, Pennsylvania

Correspondence and requests for reprints should be addressed to Robert P. Baughman, M.D., University of Cincinnati Medical Center, 1001 Holmes, Eden Ave., Cincinnati, OH 45267. E-mail: bob.baughman{at}uc.edu

Rationale: Evidence suggests that tumor necrosis factor (TNF)-{alpha} plays an important role in the pathophysiology of sarcoidosis.

Objectives: To assess the efficacy of infliximab in sarcoidosis.

Methods: A phase 2, multicenter, randomized, double-blind, placebo-controlled study was conducted in 138 patients with chronic pulmonary sarcoidosis. Patients were randomized to receive intravenous infusions of infliximab (3 or 5 mg/kg) or placebo at Weeks 0, 2, 6, 12, 18, and 24 and were followed through Week 52.

Measurements and Main Results: The primary endpoint was the change from baseline to Week 24 in percent of predicted FVC. Major secondary efficacy parameters included Saint George's Respiratory Questionnaire, 6-min walk distance, Borg's CR10 dyspnea score, and the proportion of Lupus Pernio Physician's Global Assessment responders for patients with facial skin involvement. Patients in the combined infliximab groups (3 and 5 mg/kg) had a mean increase of 2.5% from baseline to Week 24 in the percent of predicted FVC, compared with no change in placebo-treated patients (p = 0.038). No significant differences between the treatment groups were observed for any of the major secondary endpoints at Week 24. Results of post hoc exploratory analyses suggested that patients with more severe disease tended to benefit more from infliximab treatment.

Conclusions: Infliximab therapy resulted in a statistically significant improvement in % predicted FVC at Week 24. The clinical importance of this finding is not clear. The results of this Phase 2 clinical study support further evaluation of anti–TNF-{alpha} therapy in severe, chronic, symptomatic sarcoidosis.

Key Words: clinical trial • prednisone • pulmonary function tests • tumor necrosis factor


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