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

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. Methods: 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 mug three times a week subcutaneously, and the dose was increased at two week intervals to 44 mug and then to 88 mug 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. Results: 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. Conclusions: IFN-beta-1a may represent a promising novel treatment approach in ulcerative colitis.