Krag A, Israelsen H, Ryberg BV, Andersen KK, Bendtsen F. Safety and efficacy of Profermin® to induce remission in ulcerative colitis. World J Gastroenterol 2012; 18(15): 1773-1780 [PMID: 22553401 DOI: 10.3748/wjg.v18.i15.1773]
Corresponding Author of This Article
Aleksander Krag, MD, PhD, Gastrounit, Medical Devision 360, Copenhagen University Hospital Hvidovre, Faculty of Health Sciences, Copenhagen University, Kettegaard Alle 30, DK-2650 Hvidovre, Denmark. aleksanderkrag@hotmail.com
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World J Gastroenterol. Apr 21, 2012; 18(15): 1773-1780 Published online Apr 21, 2012. doi: 10.3748/wjg.v18.i15.1773
Safety and efficacy of Profermin® to induce remission in ulcerative colitis
Aleksander Krag, Hans Israelsen, Bjørn von Ryberg, Klaus K Andersen, Flemming Bendtsen
Aleksander Krag, Flemming Bendtsen, Gastrounit, Medical Devision 360, Copenhagen University Hospital Hvidovre, Faculty of Health Sciences, Copenhagen University, DK-2650 Hvidovre, Denmark
Hans Israelsen, Bjørn von Ryberg, Nordisk Rebalance A/S, M. D. Madsensvej 14-16, DK-3450 Allerød, Denmark
Klaus K Andersen, Statistics Section, Informatics and Mathematical Modelling, Technical University of Denmark, DK-2800 Lyngby, Denmark
Author contributions: Israelsen H, von Ryberg B and Andersen KK conceived the study and developed the overall design; Israelsen H and von Ryberg B performed the study; Andersen KK performed the statistical analyses and all authors participated in the interpretation of the overall results; all authors had full access to all data; Krag A drafted the paper and all authors participated in the critical revision for important intellectual content.
Supported by Danish Innovation Law Grant, J.nr. 3414-06-01530, from the Danish Food Industry Agency under the Ministry of Food, Agriculture and Fisheries; and Nordisk Rebalance, who developed and manufactured Profermin®, and partly financed the study
Correspondence to: Aleksander Krag, MD, PhD, Gastrounit, Medical Devision 360, Copenhagen University Hospital Hvidovre, Faculty of Health Sciences, Copenhagen University, Kettegaard Alle 30, DK-2650 Hvidovre, Denmark. aleksanderkrag@hotmail.com
Telephone: +45-3-8623182 Fax: +45-3-8623777
Received: August 15, 2011 Revised: October 23, 2011 Accepted: January 18, 2012 Published online: April 21, 2012
Abstract
AIM: To test the efficacy and safety of Profermin® in inducing remission in patients with active ulcerative colitis (UC).
METHODS: The study included 39 patients with mild to moderate UC defined as a Simple Clinical Colitis Activity Index (SCCAI) > 4 and < 12 (median: 7.5), who were treated open-label with Profermin® twice daily for 24 wk. Daily SCCAI was reported observer blinded via the Internet.
RESULTS: In an intention to treat (ITT) analysis, the mean reduction in SCCAI score was 56.5%. Of the 39 patients, 24 (62%) reached the primary endpoint, which was proportion of patients with ≥ 50% reduction in SCCAI. Our secondary endpoint, the proportion of patients in remission defined as SCCAI ≤ 2.5, was in ITT analysis reached in 18 of the 39 patients (46%). In a repeated-measure regression analysis, the estimated mean reduction in score was 5.0 points (95% CI: 4.1-5.9, P < 0.001) and the estimated mean time taken to obtain half the reduction in score was 28 d (95% CI: 26-30). There were no serious adverse events (AEs) or withdrawals due to AEs. Profermin® was generally well tolerated.
CONCLUSION: Profermin® is safe and may be effective in inducing remission of active UC.
