Etanercept in the treatment of active refractory Crohn's disease: a single-center pilot trial.
OBJECTIVE
Etanercept, an injectable tumor necrosis factor (TNF) receptor fusion protein, binds and inactivates human TNF and is used in active rheumatoid arthritis. Blocking TNF with monoclonal antibodies has also been beneficial in Crohn's disease. We attempted to determine the efficacy and safety of etanercept for induction of clinical, endoscopic, and histological improvement in patients with moderate to severe Crohn's disease despite standard treatment.


METHODS
Ten patients with active Crohn's disease were treated with etanercept (25 mg s.c.) twice per week for 12 wk. Background therapy was kept stable during the trial. Crohn's disease activity index (CDAI), Inflammatory Bowel Disease Questionnaire, and C-reactive protein levels were measured at weeks 0, 2, 4, 8, and 12. Colonoscopies were performed before and after therapy in responders; endoscopic biopsies were scored for inflammation.


RESULTS
At week 2 after the start, a clinical response (deltaCDAI > or = 70) was observed in 6/10 patients (median = 305 [294-418] to 166 [107-392]), with reduction in serum C-reactive protein levels (median = 17.2 [6.8-67.2] to 9.1 [0.9-17.2] mg/dl). Colonoscopies showed a reduction in inflammatory lesions in the four patients who attained remission (CDAI < 150), whereas the inflammatory score of the biopsies did not decrease significantly. No moderate or severe adverse events were observed.


CONCLUSIONS
Etanercept may be effective in Crohn's disease refractory to standard therapy.
D'Haens
G
G
Department of Internal Medicine, University Hospital Gasthuisberg, Leuven, Belgium.
Swijsen
C
C
Noman
M
M
Lemmens
L
L
Ceuppens
J
J
Agbahiwe
H
H
Geboes
K
K
Rutgeerts
P
P
D000293:Adolescent; D000328:Adult; D000368:Aged; D003424:Crohn Disease / Q000188:drug therapy* / Q000473:pathology; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*
D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept