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PAEDIATRIC PATIENTS ARE COMPLIANT TO TWICE DAILY PENTASA SACHETS1

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PAEDIATRIC PATIENTS ARE COMPLIANT TO TWICE DAILY PENTASA SACHETS1

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View PENTASA formulations to find out more

Paediatric Formulations

Granule-based formulations may reduce pill burden and encourage patient adherence.2

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Primary endpoint was mean PUCAI score between the two arms (OD and BD dosing) at week 6. At week 6, there was no difference in median PUCAI score between the OD and BD groups (p=0.48).*

 

*PENTASA® is licensed to be taken in divided doses only in paediatrics.
†Weight-based dosing based on 75 mg/kg/day.
Note: PENTASA OD is not licensed for paediatric use in the UK.

1 g PENTASA sachet† BD for 6 weeks

Study Summary

Results from a multi-centre, investigator-initiated, randomised controlled, investigator- blinded induction of remission trial1

6 week study, 83 patients (ITT), dosing based on weight (75mg/kg/day) rounded to multiples of 500mg (with a max dose of  3g daily)
Patient Numbers Weight Dose Amount Dose Frequency
40 15-<20kg 1,000 mg (500 mg, 500 mg) Twice-daily
20-<30kg 1,500 mg (1,000 mg, 500 mg)
30-<40kg 2,000 mg (1,000 mg, 1,000 mg)
≥40kg 3,000 mg (1,500 mg, 1,500 mg)

 

Key inclusion criteria

  • Children 4-18 years of age* with body weight ≥15kg
  • Confirmed diagnosis of UC in mild to moderate disease activity according to PUCAI (score of 10-55 points)

Key exclusion criteria

  • Proctitis only, IBD (Inflammatory Bowel Disease) unclassified, current systemic infection, presence of stool pathogens at screening (culture, parasites and Clostridium difficile) and significant concurrent illness (e.g. renal and hepatic failure or pancreatitis)

Safety Results

  • 23% of patients (n=9/40) in the BD group had an adverse event
  • The most common adverse events in the BD group were:

– Disease exacerbation (3 total)

– Headache (2 total)

– Fever (2 total)

– Nausea (2 total)

  • None of the SAEs were thought to be related to the study drug
  • Turner D, et al. J Crohn’s Colitis. 2017;11:527–533.
  • Ye B and van Langenberg DR. World J Gastrointest PharmacolTher.2015;6(4):137-144.
Paediatric Formulations
Pentasa in Adults
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Job Code: UK-PA-2000023 - Date of preparation: October 2020

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