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PENTASA® shows similar efficacy when treating left-sided
disease as compared to the overall population1,2




*Patients(%) achieving UC-DAI <1

The PODIUM study used 2 g PENTASA® sachet OD for 12 months


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

12 month PODIUM study, 362 patients (safety population)
Patient Numbers Dose amount Dose frequency
175 (131 left-sided) 2g PENTASA Once daily
187 (128 left-sided) 1g PENTASA Twice-daily


  • 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)
Adverse events 2 g mesalamine OD n=175
n (%)
1 g mesalamine n=187
n (%)
Gastrointestinal disorder 35 (20.0) 24 (12.8)
Abdominal pain 6 (3.4) 5 (2.7)
Abdominal pain upper 4 (2.3) 3 (1.6)
Diarrhoea 5 (2.9) 4 (2.1)
Flatulence 3 (1.7) 4 (2.1)
General disorders and administration site conditions 7 (4.0) 5 (2.7)
Infections and infestations 30 (17.1) 25 (13.4)
Bronchitis 2 (1.1) 5 (2.7)
Gastroenteritis 4 (2.3) 2 (1.1)
Nasopharyngitis 10 (5.7) 6 (3.2)
Sinusitis 6 (3.4) 2 (1.1)
Musculoskeletal/connective tissue disorders 11 (6.3) 6 (3.2)
Back pain 1 (0.6) 4 (2.1)
Nervous system disorders 5 (2.9) 6 (3.2)
Skin/subcutaneous tissue disorders 8 (4.6) 2 (1.1)

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

  • Dignass AU, et al. Clin. Gastroenterol Hepatol. 2009;7(7):762–9.
  • Bokemeyer B, et al. J Crohn’s Colitis. 2012;6:476-82.

Job Code: UK-PA-2300006 - Date of preparation: November 2023


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