PMO-235 A randomised placebo-controlled double-blind study of Octasa® 4.8 g/day (800 mg tablets 5-ASA) for the induction of endoscopic remission in patients with active ulcerative colitis

IntroductionHigh concentration 5-ASA formulations have potential to improve patient adherence and increase therapeutic efficacy in ulcerative colitis (UC). We conducted a multicenter, double-blind, randomised placebo controlled trial to assess the efficacy and safety of an 800 mg Octasa® tablet for induction of remission.MethodsThe trial was conducted at 26 centres in Belarus, India, Turkey and Ukraine from November 2009 to May 2011. Eligible patients had active UC with a minimum disease extent of 15 cm from the anal verge, a modified UC disease activity index (UC-DAI) score of 4–10 with a sigmoidoscopic score of ≥2 and a rectal bleeding score of ≥1. Patients requiring other treatments for UC, those with severe disease or those who had previously failed treatment with >2 g/day of 5-ASA were not eligible. Eligible patients were randomly assigned to receive three Octasa® 800 mg tablets BID or matching placebo for 10 weeks. At Week 6 and Week 10, the proportion of patients in endoscopic remission, defined by a sigmoidoscopic score of ≤1, was compared by the χ2 test. Patients who did not undergo sigmoidoscopy were analysed as not being in endoscopic remission.Results281 patients were randomised, 140 received Octasa® and 141 received placebo. Of the 281 randomised patients, 248 had an evaluable post-randomisation sigmoidoscopy. The baseline characteristics were similar between the treatment groups; the mean age was 42.4 and 40.1 years, disease duration was 54.3 and 51.8 months, UC-DAI was 6.7 and 6.6, respectively for Octasa® and placebo groups. At Week 6, endoscopic remission was achieved in 45.7% of Octasa® treated patients vs 24.8% of placebo treated patients (p