STUDY SUMMARY:
MOTUS
OVERVIEW 1
Results from the Phase IIIb, randomised, controlled, investigator blinded, non-inferiority, 8 week MOTUS study
8 week MOTUS Study, 206 patients
Patient Numbers
Dose Amount
Dose Frequency
Rectal Dose
102 (83 left-sided)
4 g PENTASA
Once-Daily
1 g PENTASA enema for first 4 weeks
104 (88 left-sided)
2 g PENTASA
Twice-Daily
1 g PENTASA enema for first 4 weeks
INCLUSION AND EXCLUSION CRITERIA 1
Key Inclusion Criteria:
- Male and female patients ≥18 years
- Newly diagnosed or relapsing mild to moderate UC, with disease extension beyond the rectum(≥12–18 cm from the anorectal junction)
- Patients must have had at least one total colonoscopy in the past 5 years and have a UC-DAI score of 3–8 within 15 days prior to study entry
Key Exclusion Criteria:
- Patients who had undergone previous colonic surgery, failed to respond to steroids, or failed to achieve remission with rectal or oral mesalazine therapy within the year prior to the study
- Patients in current relapse for more than 6 weeks
- Patients with severe or fulminant UC, evidence of other forms of IBD, infectious disease or allergies to acetylsalicylic acid or salicylate derivatives
- Patients with significant hepatic or renal function abnormalities or abnormal blood cell counts, pregnancy or lactation, or history of another disease that might interfere with participation in the study
SAFETY RESULTS FROM THE MOTUS STUDY 1
33.2% of patients experienced at least one treatment-emergent AE: 32.4% and 34.0% patients in the OD and BD groups respectively
OD n=102n (%)
BD n=100n (%)
Total n=202n (%)
Any TAEA
33 (32.4)
34 (34.0)
67 (33.2)
TEAE experienced by >2% of patients
Abdominal Pain
3 (2.9)
4 (4.0)
7 (3.5)
Nausea
5 (4.9)
2 (2.0)
7 (3.5)
Headache
3 (2.9)
3 (3.0)
6 (3.0)
Worsening UC
2 (2.0)
3 (3.0)
5 (2.5)
Pyrexia
3 (2.9)
2 (2.0)
5 (2.5)
Proctalgia
4 (3.9)
0 (0.0)
4 (2.0)
Arthralgia
1 (1.0)
3 (3.0)
4 (2.0)
Asthenia
1 (1.0)
3 (3.0)
4 (2.0)
TEAE = Treatment-emergent adverse event.
References
1. Flourie B, et al. Aliment Pharmacol Ther. 2013;37(8):767–775.
