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Published ahead of print on July 13, 2006, doi:10.1164/rccm.200603-402OC

Am. J. Respir. Crit. Care Med., Volume 174, Number 7, October 2006, 795-802

A more recent version of this article appeared on October 1, 2006
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Submitted on March 20, 2006
Accepted on July 13, 2006

Infliximab Therapy in Patients with Chronic Sarcoidosis and Pulmonary Involvement

Robert P Baughman1*, Marjolein Drent2, Mani Kavuru3, Marc A Judson4, Ulrich Costabel5, Roland du Bois6, Carlo Albera7, Martin Brutsche8, Gerald Davis9, James F Donohue10, Joachim Muller-Quernheim11, Rozsa Schlenker-Herceg12, Susan Flavin12, Kim Hung Lo12, Barry Oemar12, and Elliot S Barnathan12

1 University of Cincinnati Medical Center, Cincinnnati, OH, USA, 2 University Hospital Maastricht, Maastricht, The Netherlands, 3 Cleveland Clinic, Cleveland, OH, USA, 4 Medical University of South Carolina, Charleston, SC, USA, 5 Medical Faculty, University of Essen, Essen, Germany, 6 Imperial College of Science, Technology, and Medicine, London, United Kingdom, 7 Dipartimento di Scienze Cliniche e Biologiche, Universita Di Torino, Torino, Italy, 8 University Hospital Basel, Basel, Switzerland, 9 University of Vermont, Burlington, VT, USA, 10 University of North Carolina, Chapel Hill, NC, USA, 11 University of Freiburg Medical Center, Freiburg, Germany, 12 Centocor, Inc., Malvern, PA, USA

* To whom correspondence should be addressed. E-mail: bob.baughman{at}uc.edu.

Rationale: Evidence suggests that tumor necrosis factor alpha (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 followed through week 52. Measurements and Main Results: The primary endpoint was the change from baseline to week 24 in percent of predicted forced vital capacity. Major secondary efficacy parameters included Saint George's Respiratory Questionnaire, 6-minute 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 forced vital capacity, 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 percent of 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: Prednisone, tumor necrosis factor, pulmonary function tests, clinical trial




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