T1212 The Diet Therapy for Achieving a Dietary N-3/N-6 Ratio of Approximately 1 Increase the Remission-Maintenance Rate in Patients with Inflammatory Bowel Disease

Abstract

Purpose: Balsalazide 1.1-g tablets are a new high-potency formulation of the azo-bonded 5 aminosalicylate (5-ASA) prodrug balsalazide for first-line treatment of mildly-to-moderately active ulcerative colitis (UC). Key endpoints for three phase 3, multicenter studies included evaluation of safety and tolerability of balsalazide tablets 6.6 g/d. Methods: The balsalazide tablet program consisted of 2 phase 3 double blind studies and 1 open-label extension study. Adults withmildly-to-moderately active UCwere randomized to receive either balsalazide tablets 6.6 g/d (3 tablets twice daily), placebo, or mesalamine 2.4 g/d. Safety evaluations included clinical laboratory assessments, vital sign measurements, and adverse event (AE) documentation. Eligible patients from the 2 randomized studies were offered enrollment in an open-label extension study to receive active treatment. Results: A total of 565 patients received at least 1 dose of balsalazide tablets and had at least one postbaseline safety assessment across the three studies. The mean exposure to balsalazide tablets was 225 days. The incidence of treatment emergent AEs (TEAEs) was 71% for subjects treated with balsalazide in the 3 studies, and the majority of AEs were mild or moderate in intensity. In the double-blind studies, the safety profile of the balsalazide group (n=378) was comparable with the placebo group (n=79) and the mesalamine group (n=198). Headache, the most common TEAE in the studies, occurredmore frequently in the placebo (14%) andmesalamine (10%) groups than in the balsalazide (8%) group. Worsening UC was also experienced by a larger proportion of the placebo group (15%) compared with the balsalazide (7%) and mesalamine (2%) groups. Other commonly reported AEs (eg, nausea, abdominal pain, nasopharyngitis, vomiting, urinary tract infection) were comparable across the treatment groups. Treatment-emergent serious AEs occurred more frequently in the placebo group (6%) than in either the balsalazide (3%) or mesalamine (<1%) groups. Withdrawals due to AEs were most often related to worsening UC. One death occurred in a subject diagnosed with metastatic malignant melanoma during the open-label study. The death was judged to be unrelated to study drug. Conclusions: Balsalazide 1.1-g tablets administered as 6.6 g/d (3 tablets twice daily) has a favorable safety profile in these studies. Common TEAEs were typically events frequently seen inUC patients or among the general population. The favorable safety profile of balsalazide tablets combined with a convenient, twice-daily dosing regimen, stands to improve patient adherence to therapy and clinical outcomes in the treatment of UC.