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Trial of etanercept in a patient with Crohns disease

Trial of etanercept in a patient with Crohns disease

FASEB Journal 15(4): A24, March 7

Agents that target TNF-alpha are of therapeutic benefit in Crohn's disease (CD). Etanercept or TNFR:Fc was tried at 25 mg s.c. twice weekly in a patient with severe fistulizing and stricturing CD as a steriod sparing agent and to decrease fistula risk perioperatively. The patient, now 30 years, presented at age 11 with fulminant disease, including rectovaginal fistulae, after initial misdiagnosis, perineal incision and exposure to podophyllotoxins. Despite treatment with steroids. TPN, metronidazole, and sulfasalazine, colectomy with ileostomy and Hartmann pouch was required at age 20. Postoperative peristomal fistula developed, requiring three additional surgeries. The rectovaginal fistula remained open, but the patient did well on metronidazole until age 24 when recurrent partial small bowel obstruction began, resulting in steriod dependence and need for reoperation at age 30. Genetic analysis revealed homozygous normal thiopurine s-methyltransferase, factor 5, prothrombin, heterozygosity for HLA-H H63D, and HLA-DRB1 0701 and 15, HLA-DRB4 0101, HLA-DRB5 0101, HLA-DQB1 02, HLA-DQB1 0602 (Innotype PCR SSO). Baseline and weekly CBC, ESR, disease activity index, TNF- alpha TNF-beta, IL-6, IL-1beta, HGF, sIL-2Ralpha, sICAM-1, and leptin (ELISA R&D) were determined. A rapid response was observed, with normalization of ESR (38% decrease), decreased activity index (31%), and reduced prednisone requirement (28%) by 2 weeks. TNF-alpha levels increased over 100-fold by one week, TNF-beta increased from 0 to 35pg/ml, HGF and sIL-2Ralpha declined, and other cytokines remained within normal range. However, after weaning the prednisone to 4mg/day (week 5), obstruction again resulted, requiring 40 mg/day of prednisone, and the etanercept was held. One month later, ileostomy revision, stricture removal, and adhesiolysis were performed without complication. Etanercept was well tolerated, and larger trials are warranted in CD, but use in the probable or proven presence of strictures or the concomitant withdrawal of steriods must be carefully considered.

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Accession: 035985875

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