STUDY SUMMARY:
PINCE
OVERVIEW 1
Results from a post-hoc analysis of efficacy at 2 weeks taken from the PINCE trial
8 week PINCE study, 116 patients (ITT)
Placebo enema arm results
Remission rate at week 2 (abbreviated UC-DAI <2), was 30% for patients in the oral therapy arm
Improvement rate at week 2 (abbreviated UC-DAI decrease ≥2), was 45% for the oral therapy arm, compared to baseline
INCLUSION AND EXCLUSION CRITERIA 1
Key Inclusion Criteria:
- Male or female, 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
Key Exclusion Criteria:
- >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 1
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%)
References
1. Probert CSJ, et al. J Crohn’s Colitis. 2014;8:200–207.
