Etanercept in the treatment of active refractory Crohn's disease: A single-center pilot trial

OBJECTIVES: Etanercept, an injectable tumor necrosis factor (TNF) receptor fusion protein, binds and inactivates human TNF and is used in active rheum atoid arthritis. Blocking TNF with monoclonal antibodies has also been bene ficial in Crohn's disease. We attempted to determine the efficacy and safet y of etanercept for induction of clinical, endoscopic, and histological imp rovement in patients with moderate to severe Crohn's disease despite standa rd treatment. METHODS: Ten patients with active Crohn's disease were treated with etanerc ept (25 mg s.c.) twice per week for 12 wk. Background therapy was kept stab le during the trial. Crohn's disease activity index (CDAI), Inflammatory Bo wel Disease Questionnaire, and C-reactive protein levels were measured at w eeks 0, 2, 4, 8, and 12. Colonoscopies were performed before and after ther apy in responders, endoscopic biopsies were scored for inflammation. RESULTS: At week 2 after the start, a clinical response (Delta CDAI greater than or equal to 70) was observed in 6/10 patients (median, = 305 [294-418 ] to 166 [107-392]), with reduction in serum C-reactive protein levels (med ian = 17.2 [6.8-67.2] to 9.1 [0.9-17.2] mg/dl). Colonoscopies showed a redu ction in inflammatory lesions in the four patients who attained remission ( CDAI < 150), whereas the inflammatory score of the biopsies did not decreas e significantly. No moderate or severe adverse events were observed. CONCLUSIONS: Etanercept may be effective in Crohn's disease refractory to s tandard therapy. (Am J Gastroenterol 2001;96:2564-2568. (C) 2001 by Am. Col l. of Gastroenterology).