PENTASA^® IS EFFECTIVE IN 2 WEEKS ^1,2

Study design: 2 g PENTASA sachet BD + 1 g PENTASA® enema (100ml)

8 week post-hoc analysis of PINCE 116 (ITT)

• Male or female patients aged >18 years
• A previously established diagnosis of extensive UC
• Mild to moderate exacerbation of known extensive UC (without suspected superinfection)
• UC-DAI score of ≥3–≤8 at enrolment

• >3.0 g mesalazine, sulfasalazine or 5-ASA orally/day in the previous 30 days
• Chronic use (intake for a minimum of 7 consecutive days) of NSAIDs within the past week
• Use of corticosteroids (oral and/or topical) within the past week
• Intake of immunosuppressants in the previous 30 days

Safety results from the PINCE study:

• 34% of patients in the mesalazine enema group and 50% of patients in the placebo enema group had at least one adverse event after the start of treatment
• The most common adverse events considered drug-related in the mesalazine enema group were: Diarrhoea (4%), headache (4%), vomiting (3%)
• The most common drug-related adverse event in the placebo enema group was abdominal pain (4%)

^{BD, Twice-daily;  ITT, Intention-to-treat; NSAIDs, Non-steroidal inflammatory drugs; UC-DAI, Ulcerative colitis-disease activity index.}