Adverse Event reporting information can be found in footer

Request a Meeting

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

Artboard-23AnneShopSidebar-1

 

 

ENDOSCOPIC REMISSION:

parkAsset-1@4x-1

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

CLINICAL REMISSION:

parkAsset-1@4x-1

*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
FAQs
Resources
Pentasa Home

Job Code: UK-PA-2400044 - Date of preparation: November 2024

cookiepopup

Our use of cookies

We use cookies (including third party cookies) to collect data while you use this website in order to make it work, keep it secure and comply with regulations. We’d also like your consent to use cookies so we can provide you with tailored content and advertising and analyse how you and other people use the website.

Select “On” to consent to our use of these cookies and continue to the website, or select “Off” to control which types of cookies we use. You can read more about cookies in our Privacy Policy.

Necessary cookies

Necessary cookies enable core functionality such as security, network management, and accessibility. You may disable these by changing your browser settings, but this may affect how the website functions.

Analytics cookies

We’d like to set Google Analytics cookies to help us to improve our website by collecting and reporting information on how you use it. The cookies collect information in away that does not directly identify anyone. For more information on how these cookies work, please see our Privacy Policy.