Authors: Sandborn, W. J.; Sands, B. E.; Wolf, D. C.¹; Valentine, J. F.²; Safdi, M.³; Katz, S.⁴; Isaacs, K. L.⁵; Wruble, L. D.⁶; Katz, J.⁷; Present, D. H.⁸; Loftus, E. V.⁹; Graeme-Cook, F.¹⁰; Odenheimer, D. J.¹¹; Hanauer, S. B.

Source: Alimentary Pharmacology & Therapeutics, Volume 17, Number 11, June 2003 , pp. 1355-1364(10)

Publisher: Wiley-Blackwell

Abstract:

Summary Background:

Repifermin (keratinocyte growth factor-2) has been shown to reduce inflammation in animal models of colitis. Aim:

To evaluate repifermin for the treatment of active ulcerative colitis. Methods:

Eighty-eight patients with active ulcerative colitis were enrolled in a 6-week, double-blind trial. Patients were randomized to receive treatment for five consecutive days with intravenous repifermin at a dose of 1, 5, 10, 25 or 50 μg/kg, or placebo. The primary objective of the study was to evaluate the safety of repifermin. The primary efficacy outcome was clinical remission at week 4, defined as a score of zero on the endoscopic appearance and stool blood components of the Mayo score and a score of zero or unity on the stool frequency and physician's global assessment components. Results:

At week 4, the rates of clinical remission in the 1, 5, 10, 25 and 50 μg/kg repifermin groups were 19%, 9%, 0%, 0% and 0%, respectively, and 11% for the placebo group (P = 0.32 for repifermin vs. placebo). The frequencies of commonly occurring adverse events and severe adverse events were similar in both groups. Conclusions:

Intravenous repifermin at a dose of 1-50 μg/kg was very well tolerated, but there was no evidence that repifermin was effective for the treatment of active ulcerative colitis at these doses. An additional study to determine the efficacy of repifermin at doses of > 50 μg/kg or for a longer treatment duration may be warranted, as the maximally tolerated dose was not reached in the present study.

Document Type: Research article

DOI: http://dx.doi.org/10.1046/j.1365-2036.2003.01589.x

Affiliations: 1: Atlanta Gastroenterology Associates, Atlanta, GA, USA; 2: Gainesville Veterans Administration Medical Center and University of Florida, Gainesville, FL, USA; 3: Consultants for Clinical Research, Cincinnati, OH, USA; 4: Long Island Clinical Research Associates, Great Neck, NY, USA; 5: University of North Carolina Chapel Hill, Chapel Hill, NC, USA; 6: Memphis Gastroenterology Group, Memphis, TN, USA; 7: Case Western Reserve University, Cleveland, OH, USA; 8: Mount Sinai School of Medicine, New York, NY, USA; 9: Mayo Clinic, Rochester, MN, USA; 10: Massachusetts General Hospital, Boston, MA, USA; 11: Human Genome Sciences Inc., Rockville, MD, USA;

Publication date: 2003-06-01

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• In this Subject: Pathology ,  Pharmacology ,  Surgery ,  Therapeutics & Alternative Medicine
• By this author: Sandborn, W. J. ;  Sands, B. E. ;  Wolf, D. C. ;  Valentine, J. F. ;  Safdi, M. ;  Katz, S. ;  Isaacs, K. L. ;  Wruble, L. D. ;  Katz, J. ;  Present, D. H. ;  Loftus, E. V. ;  Graeme-Cook, F. ;  Odenheimer, D. J. ;  Hanauer, S. B.

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