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PENTASA® IS EFFECTIVE THROUGHOUT THE ENTIRE COLON INCLUDING LEFT-SIDED DISEASE 1-3

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PENTASA® shows similar efficacy when treating left-sided
disease as compared to the overall population1-3

REMISSION:

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*Patients (%) achieving UC-DAI <1

The MOTUS study used 2 x 2 g PENTASA® sachets OD + 1 g enema (100ml) OD for the first four weeks

STUDY DESIGN

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) 2g PENTASA Once-daily 1g PENTASA enema for first 4 weeks
104 (88 left-sided) 4g PENTASA Twice-daily 1g PENTASA enema for first 4 weeks

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 INCLUSION 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 inflammatory bowel disease, 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

Safety results from the MOTUS study:

  • 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=102
n (%)
BD n=100
n (%)
Total n=202
n (%)
Any TEAE 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)

AE = adverse event, BD = twice-daily, OD = once-daily, TEAE = treatment emergent adverse event

  • Flourie B, et al. Aliment Pharmacol Ther. 2013;37(8):767–75.
  • 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-2400044 - Date of preparation: November 2024

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