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WHY IS MUCOSAL HEALING IMPORTANT?

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Artboard-23Kid1Sidebar-1

Mucosal healing is an important treatment goal and has
been correlated with: 1,2

  • Long-term disease remission rates
  • Reduced need for colectomy
  • Reduced risk of colorectal cancer
  • Improved patient quality of life
The BSG consensus guidelines on the management of IBD in adults suggest that symptomatic remission, combined with mucosal healing, should be the target of medical therapy in UC.2

PENTASA® OD DOSING ACHIEVES HIGH RATES OF MUCOSAL HEALING

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THE PODIUM STUDY:3

THE MOTUS STUDY:1

Comparable mucosal healing scores in the overall study population at 12 months:

MUCOSAL HEALING:

UC-DAI endoscopic sub-score of ≤1

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parkAsset-7@4x

The PODIUM study used 2g PENTASA sachet OD for 12 months

Comparable mucosal healing scores in the overall study population at 8 weeks:

MUCOSAL HEALING:

UC-DAI endoscopic sub-score of ≤1

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parkAsset-7@4x

2g PENTASA sachet BD for 8 weeks +1g PENTASA enema (100 ml) for the 1st 4 weeks

STUDY DESIGN

Results from the multicentre, randomised, single-blind, non-inferiority, 12 month PODIUM study post-hoc analysis

8 week MOTUS Study, 206 patients
Patient Numbers Dose amount Dose frequency
175 (131 left-sided) 2g PENTASA Once daily
187 (128 left-sided) 1g PENTASA Twice-daily

KEY INCLUSION AREA

  • 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 <2 at 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 AREA

  • Patients with other forms of inflammatory bowel disease, 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 (>3 g/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 MOTUS STUDY

Safety results from the PODIUM study:

  • 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 mesalazine OD n=175
n (%)		 1 g mesalazine n=187
n (%)
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)

AEs = adverse events, BD = twice-daily, OD = once-daily.

  • Flourie B, et al. Aliment Pharmacol Ther. 2013;37(8):767–75.
  • Lamb CA, et al. British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. June 2019. Available at: https://www.bsg.org.uk/resource/ bsgconsensus-guidelines-ibd-in-adults.html (accessed December 2019).
  • Bokemeyer B, et al. J Crohn’s Colitis. 2012;6:476-82.
Further Clinical Efficacy
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Job Code: UK-PA-2300006 - Date of preparation: November 2023

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