TITLE

A randomised placebo controlled trial of pegylated interferon α in active ulcerative colitis

AUTHOR(S)
Tilg, H.; Vogelsang, H.; Ludwiczek, O.; Lochs, H.; Kaser, A.; Colombel, J. -F.; Ulmer, H.; Rutgeerts, P.; Krüger, S.; Cortot, A.; D'Haens, G.; Harrer, M.; Gasche, C.; Wrba, F.; Kuhn, I.; Reinisch, W.
PUB. DATE
December 2003
SOURCE
Gut;Dec2003, Vol. 52 Issue 12, p1728
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Background: Pilot studies of interferon cc (IFN-α) suggest a high remission rate in the treatment of active ulcerative colitis. We evaluated the safely of pegylated interferon α (PegIFN) and its role in induction of remission in patients with active ulcerative colitis, in a multicentre placebo controlled trial. Methods: Sixty patients with a clinical activity score (Cal) of >6 were randomised to receive placebo (n=20), Pe9IFN 0.5 μg/kg (n= 19), or PegIFN 1.0 μg/kg body weight (n=21) once weekly (Peglntron; Schering-Plough, USA) over 12 weeks. Patients receiving 5-aminosalicylates, steroids, and/or azathioprine in stable dosages were included. Results: Serious adverse events were seen in none of the placebo patients, in 3/19 patients in the PegIFN 0.5 μg/kg group (hospitalisation due to disease flare up n = 3), and in 3/21 in the PegIFN 1.0 μg/kg group (hospitalisation due to disease Hare up n = 1; thrombosis n = 1; grand mal seizure n = 1). Otherwise, we observed only minor IFN-α side effects. Clinical remission rates at week 12 (Cal ⩽ 4) were 7/20(35%) in the placebo, 9/19 (47%) in the PegIFN 0.5 μg/kg group, and 7/21 (33%) in the PeglFN 1 .0 μg/kg group (NS). Early withdrawal from the study was observed in 11/20 placebo patients, in 6/19 in the PeglFN 0.5 μg/kg group, and in 10/21 in the PegIFN 1.0 μg/kg group, mainly due to lack of efficacy. The higher PegIFN dose was associated with a significant decrease in levels of C reactive protein (p=0.003, day o v85). Conclusions: PegIFN is safe but not effective, at the dosages used, in patients with ulcerative colitis.
ACCESSION #
12940912

 

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