STUDY SUMMARY:
PODIUM
OVERVIEW 1
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)
2 g PENTASA
Once-Daily
187 (128 left-sided)
1 g PENTASA
Twice-Daily
INCLUSION AND EXCLUSION CRITERIA 1
Key Inclusion Criteria:
- 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 <2at 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
Key Exclusion Criteria:
- Patients with other forms of IBD, 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 (>3g/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 1
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=175n (%)
1 g mesalamine BD n=187n (%)
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)
TEAE = Treatment-emergent adverse event.
References
1. Bokemeyer B, et al. J Crohn’s Colitis. 2012;6:476-482.
