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PENTASA® SUPPOSITORY ONCE DAILY DOSING IS EFFECTIVE IN ULCERATIVE PROCTITIS 1,2

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ENDOSCOPIC REMISSION:

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*Rectal mucosal score of 0 or 1 after 4 weeks of active treatment**
(or at time of discontinuation)

CLINICAL REMISSION:

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*UC-DAI score of  2

and rectal bleeding score of 0 after 4 weeks of active treatment**
(or at time of discontinuation)

N.B. Not all patients’ active treatment was monotherapy.

**68% of patients continued to receive standard dose mesalazine (≤2.4 g/day).

1 g PENTASA suppository OD for 4 weeks

STUDY DESIGN

Results from the phase III, multi-centre, randomised, double-blind, placebo-controlled, parallel group study (Watanabe et al. 2013) 1

4 weeks, 129 patients
Patient Numbers Dose amount Dose frequency
65 1g PENTASA OD
64 1g placebo OD

DISTRIBUTION AND EXTENT OF UC:

KEY INCLUSION AND EXCLUSION CRITERIA

Key Inclusion Criteria1

  • Male or female patients aged 15 to 74 with a diagnosis of UC
  • Rectal mucosal score of ≥2
  • UC-DAI score between ≥4 and ≤8
  • Disease status of first attack or relapsing/remitting pattern
  • Where patients had continuously used a salazosulfapyridine preparation (≤4500 mg/day), a mesalazine preparation (≤2400 mg/day), a herbal anti-diarrhoeal preparation, or an IBD treatment drug for ≥4 weeks at the start of PENTASA administration continued use was allowed

Key Exclusion Criteria1

  • Patients with colonic mucosal score ≥2 in parts of the colon other than the rectum

 

IBD = Inflammatory bowel disease

SAFETY RESULTS FROM THE STUDY:

Safety results from the study1:

  • No serious AEs were reported
  • There was no difference between the two groups for type, severity or frequency of AEs
  • 15.4% (10/65 patients) in the PENTASA suppository group and 17.2% (11/64 patients) in the placebo suppository group experienced AEs
  • Nasopharyngitis was the most commonly reported AE with incidences of 7.7% (5/65 patients) in the PENTASA suppository group and 6.3% (4/64 patients) in the placebo suppository group

ONCE-DAILY vs. TWICE-DAILY SUPPOSITORIES – See the Benefits

 

PENTASA OD SUPPOSITORIES ACHIEVE REMISSION SIGNIFICANTLY FASTER THAN SALOFALK (CLAVERSAL) BD SUPPOSITORIES3

AFTER 2 WEEKS:

 

 

Pentasa OD Salofalk BD p-value
Patients achieving clinical remission

Score of 0 in the clinical portion of DAI

 64% (n=16) 28% (n=7) <0.01
Patients achieving sigmoidoscopic remission

Score of 0 in the sigmoidoscopic portion of DAI

 52% (n=13) 24% (n=6) <0.01
Response to therapy – much improved

As assessed via PGA scale

 64% (n=16) 36% (n=9) <0.01
  • The PGA showed, at 4 weeks, the frequency of ‘much improved’ response to therapy was 80% (n=20( in the PENTASA group vs. 72% (n=18) in the Salofalk group (p=NS)
  • Salofalk and Claversal are different brand names for the same medicine

DAI = Disease activity index, PGA = Physician’s global assessment, NS = Not significant

PATIENTS PREFER THE TOLERABILITY OF PENTASA OD VS. SALOFALK BD SUPPOSITORIES3

AT FOUR WEEKS:

 

Significantly more patients scored 3 for PENTASA tolerability than for Salofalk:

 

  • The main problems reported by patients in the Salofalk group were difficulty in retaining the suppository administered in the morning and perianal irritation (n=5)

Salofalk and Claversal are different brand names for the same medicine.

Salofalk-graphic-circles-1-NoPatients-NEW-300x293

1g PENTASA suppository OD for 4 weeks

STUDY DESIGN

Results from a 4-week randomised, single centre investigator-blind study (Gionchetti et al. 1997) 3

4 weeks, 50 patients
Mesalazine Patient numbers Dose amount Dose frequency
PENTASA 25 1 g OD
Salofalk 25 500 g BD
  • Symptoms assessment, medical histories, physical examination and endoscopic assessment were performed at baseline and after 2 and 4 weeks
  • Histological disease activity was also assessed at study entry and after 4 weeks according to Truelove & Richard criteria
  • Clinical assessments of therapy were made with the DAI and PGA scale, which ranges from 1 to 5

 

DAI = Disease activity index, PGA = Physician’s global assessment.

Salofalk and Claversal are different brand names for the same medicine.

Key inclusion and exclusion criteria

Key Inclusion Criteria3
  • Male and female patients >18 years
  • Diagnosis of active ulcerative proctitis or distal proctosigmoiditis
  • Minimum score of 3 on 12-point DAI that measured stool frequency, rectal bleeding, endoscopic findings, and PGA
Key Exclusion Criteria3
  • Previous history of unsuccessful treatment with topical mesalazine and those treated with any rectally administered drug during the last 14 days
  • Patients with salicylate allergy or concomitant active peptic ulcer or clinically important hepatic, renal, cardiovascular or psychiatric conditions
  • Pregnant or lactating women
Concomitant Drugs3
  • Immunosuppressive drugs were allowed until 3 months before study entry, and corticosteroid therapy until 2 weeks before. If used regularly, for more than 4 weeks before entry, oral sulphasalazine or mesalazine were allowed

SAFETY RESULTS

  • During the study no patients experienced side-effects, apart from the presence of perianal irritation in the Salofalk treatment arm (n=5)
  • No clinically significant changes from baseline values in haematology, blood chemistry or urine analysis were reported
  • Watanabe M, et al. Aliment Pharmacol Ther. 2013;38:264–273.
  • Pentasa Suppositories 1 g. SmPC.
  • Gionchetti P, et al. Aliment Pharmacol Ther. 1997;11:1053-1057.
Further Clinical Efficacy
Formulation & Dosing
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Job Code: UK-PA-2300006 - Date of preparation: November 2023

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