PMO-235 A randomised placebo-controlled double-blind study of Octasa<sup>®</sup>4.8 g/day (800 mg tablets 5-ASA) for the induction of endoscopic remission in patients with active ulcerative colitis
Authors: B G Feagan, U Mittmann, D Gilgen, C J Wong, E Mikhailova, O Levchenko, Y Marakhouski
Journal: Gut (2012)

<h3>Introduction</h3> High 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<sup>®</sup> tablet for induction of remission. <h3>Methods</h3> The 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 &gt;2 g/day of 5-ASA were not eligible. Eligible patients were randomly assigned to receive three Octasa<sup>®</sup> 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 χ<sup>2</sup> test. Patients who did not undergo sigmoidoscopy were analysed as not being in endoscopic remission. <h3>Results</h3> 281 patients were randomised, 140 received Octasa<sup>®</sup> 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<sup>®</sup> and placebo groups. At Week 6, endoscopic remission was achieved in 45.7% of Octasa<sup>®</sup> treated patients vs 24.8% of placebo treated patients (p&lt;0.001; 95% CI of the between group difference, 9.7% to 31.3%). The corresponding values at Week 10 were 52.1% vs 36.9% (p=0.010; 95% CI of the between group difference, 3.6% to 26.3%). The mean decrease in the sigmoidoscopic score at the end of treatment was -0.8±0.8 vs −0.5±0.7 respectively for the Octasa<sup>®</sup> and placebo treatment groups (p=0.002). The most frequently occurring adverse events were gastrointestinal disorders. Worsening of UC was reported in 9.3% Octasa<sup>®</sup> treated patients and 23.1% placebo treated patients. <h3>Conclusion</h3> The 800 mg Octasa<sup>®</sup> tablet was safe and more effective than placebo for inducing endoscopic remission in patients with active UC. <h3>Competing interests</h3> B Feagan: Grant/Research Support from: Tillotts, Consultant for: Tillotts, U Mittmann: Consultant for: Tillotts, D Gilgen: Employee of: Employee of Tillotts, C Wong: Grant/Research Support from: Tillotts, E Mikhailova: Grant/Research Support from: Tillotts, O Levchenko: Grant/Research Support from: Tillotts, Y Marakhouski: Grant/Research Support from: Tillotts.