PENTASA^® MAINTAINS REMISSION FOR 12 MONTHS^1,2

Results from the multicentre, randomised, single-blind, non-inferiority, 12 month PODIUM study

12 month PODIUM study, 362 patients (safety population)

• Male or female, aged ≥18 years with an established diagnosis of UC
• Disease >15 cm from the anal verge, and in clinical remission (based on a UC-DAI score <2 at enrolment)
• Clinical relapse (requiring adjustment of maintenance therapy) within 12 months prior to study entry
• Maintenance treatment with oral mesalazine (≤2.5 g/day), sulfasalazine (≤3.0 g/day) or olsalazine (≤1.5 g/day) at randomisation. Patients who were not using these drugs at randomisation, but who had received oral mesalazine, sulfasalazine, or olsalazine in the 12 months prior to the study

• Patients with other forms of inflammatory bowel disease, idiopathic proctitis, or infectious disease, abnormal hepatic or renal function, or a history of alcohol or drug abuse
• Use of the following drugs within 1 month of study entry: oral mesalazine, sulfasalazine, or olsalazine (>2.5 g/day, >3.0 g/day, or >1.5 g day, respectively); rectal mesalazine (>3 g/week) or sulfasalazine (>3 g/week); and orally or rectally administered corticosteroids; or use of immunosuppressants within the previous 3 months
• Pregnant and lactating women
• Patients with an allergy to acetylsalicylic acid and other salicylate derivatives

Safety results from the PODIUM study:

• Overall, no statistical difference was reported in the number of AEs experienced between treatment groups (42.9% of patients in the OD group and 36.4% in the BD group reported  one or more AEs during the study)

^{AEs = adverse events, BD = twice-daily, OD = once-daily.}