Once versus twice daily mesalazine to induce remission in paediatric ulcerative colitis: a randomized controlled trial.

BACKGROUND: Trials in adults suggested once-daily (QD) dosing of 5-ASA may be as or more effective as twice-daily (BID) dosing in ulcerative colitis (UC). In this induction of remission, investigator-blinded, randomized-controlled-trial we aimed to compare effectiveness and safety of once vs. twice daily mesalazine (Pentasa®), in paediatric UC.

METHODS: Children, 4-18 years with a PUCAI ( Paediatric Ulcerative Colitis Activity Index) of 10-55 points at inclusion, were randomized in blocks of 6 with blinded allocation to QD or BID mesalamine using a weight-based dosing table. The primary outcome was mean PUCAI score at week 6.

RESULTS: 83/86 randomized children were eligible and analyzed: 43 in the QD group and 40 in the BID group (mean age 14±2.7 years, 43 (52%) males, 51 (62%) extensive colitis). The groups did not differ with regard to disease activity or any other parameter at baseline. There was no difference in median PUCAI score between the QD group and BID group at week 6 (15 (IQR 5-40) vs. 10 (0-40) p=0.48). Response was seen in 25 (60%) QD vs. 25 (63%) BID dosing (p=0.78). Proportion of children in remission (PUCAI<10) at week 6 was 13 (30%) QD vs. 16 (40%) BID; p=0.35). Most adverse events were related to disease aggravation; the rate of serious adverse events was similar (p>0.2).

CONCLUSION: In this first randomized-controlled-trial in children, no differences were found between QD and BID dosing for any clinical outcome. Remission was achieved in 35% of children treated with mesalazine for active UC.ClinicalTrials.gov ID NCT01201122.