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PENTASA formulations are licensed for achieving and maintaining remission in children from the age of 6 and upwards:2-5

Paediatric Formulations

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

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 the median PUCAI score between the OD and BD groups (p=0.48).*



PUCAI<10 points and a change of at least 10 points from baseline



PUCAI≥10 points (active disease) but an improvement of at least 20 points

*PENTASA® is licensed to be taken in divided doses only in paediatrics. †Weight-based dosing based on 75mg/kg/day.
PUCAI = Paediatric UC disease activity index, UC = Ulcerative colitis.
Note: PENTASA® OD is not licensed for paediatric use in the UK.

1g PENTASA® sachet BD for 6 weeks

Study Summary

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 Dose amount Dose frequency Rectal dose
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)

ITT = Intention to treat.

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

*PENTASA® (500 mg tablets, 1g, 2g and 4g sachets) is licensed for children from the age of 6 and older, and given in divided doses.
SAEs = Serious adverse events

PENTASA formulations are licensed for achieving and maintaining remission in children from the age of 6 and upwards:

  • Turner D, et al. J Crohn’s Colitis. 2017;11:527–533.
  • Pentasa Slow Release Tablets 500 mg. SmPC.
  • Pentasa Sachet 1 g. SmPC.
  • Pentasa Sachet 2 g. SmPC.
  • Pentasa Sachet 4 g. SmPC.

Job Code: UK-PA-2000023 - Date of preparation: October 2020


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