• 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 Sarcoidosis Investigators.
• University of Cincinnati Medical Center, Cincinnati, OH 45267, USA. bob.baughman@uc.edu
• Am. J. Respir. Crit. Care Med. 2006 Oct 1; 174 (7): 795-802.

RationaleEvidence suggests that tumor necrosis factor (TNF)-alpha plays an important role in the pathophysiology of sarcoidosis.ObjectivesTo assess the efficacy of infliximab in sarcoidosis.MethodsA 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 ResultsThe 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.ConclusionsInfliximab 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.

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