Interferon beta-1a in ulcerative colitis: a placebo controlled, randomised, dose escalating study.

Authors:
S Nikolaus, P Rutgeerts, R Fedorak, A H Steinhart, G E Wild, D Theuer, J Möhrle, S Schreiber
Year of publication:
2003
Volume:
52
Issue:
9
Issn:
0017-5749
Journal title abbreviated:
GUT
Journal title long:
Gut : journal of the British Society of Gastroenterology
Impact factor:
14.921
Abstract: 
IFN-beta-1a may represent a promising novel treatment approach in ulcerative colitis.Baseline characteristics and disease severity were similar in both groups. Data from 17 patients are included in this report (10 patients in the IFN-beta-1a group and seven patients in the placebo group). Clinical response was achieved in five patients (50%) in the IFN-beta-1a group and in one (14%) in the placebo group (P=0.14). Remission was achieved in three patients in the IFN-beta-1a group and in none in the placebo group (p=0.02). Most adverse reactions associated with IFN-beta-1a were influenza-like symptoms or injection site reactions, and were mild or moderate in severity.Patients (n=18) with moderately active ulcerative colitis were randomised to receive IFN-beta-1a or placebo. IFN-beta-1a was started at a dose of 22 micro g three times a week subcutaneously, and the dose was increased at two week intervals to 44 micro g and then to 88 micro g if no response was observed. The maximum duration of treatment was eight weeks. End points were clinical treatment response, defined as a decrease of at least 3 points from baseline in the ulcerative colitis scoring system (UCSS) symptoms score and induction of endoscopically confirmed remission.and aims: Administration of interferon (IFN)-beta may represent a rational approach to the treatment of ulcerative colitis through its immunomodulatory and anti-inflammatory effects. The present study was performed to evaluate the efficacy and tolerability of IFN-beta-1a.