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

8 week MOTUS Study, 206 patients

• 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 were also eligible for inclusion

• 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.