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P409 Mesalamine enemas for induction of remission in pediatric ulcerative colitis refractory to oral mesalamine: a prospective cohort study

Levine A.*1, Yerushalmi B.2, Kori M.3, Broide E.4, Mozer-Glassberg Y.5, Shaoul R.6, Kolho K.-L.7, Shteyer E.8, Shamaly H.9, Ledder O.10, Cohen S.11, Peleg S.12, Sarbagili-Shabat C.1, Focht G.10, Shachmon E.10, Boaz M.13, On A.14, Turner D.10

1Paediatric and Gastroenterology and Nutrition Unit, Wolfson Medical Center, Tel Aviv University, Holon, Israel 2Soroka University Medical Center and Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel 3Kaplan Hospital, Rehovot, Israel 4Assaf Harofeh Medical Center, Tel Aviv, Israel 5Schneider's Children Hospital, Peatach Tikva, Israel 6Rambam Medical Center, Haifa, Israel 7Children's Hospital and Helsinki University, Helsinki, Finland 8Hadassah Medical Center, Jerusalem, Israel 9French Hospital, Nazareth Hospital, Israel 10Juliet Keidan Institute of Paediatric Gastroenterology, Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Jerusalem, Israel 11Tel Aviv Medical Center, Tel Aviv University, Tel Aviv, Israel 12Haemek Hospital, Afula, Israel 13Department of Nutrition Sciences, Ariel University; Epidemiology and Research Unit, E. Wolfson Medical Center, Holon, Israel 14Poriah Hospital, Tiberius, Israel and Bar-Ilan University, The faculty of medicine in the Galilee, Sefad, Israel

Background

There are no prospective trials of mesalamine enemas in children with active Ulcerative Colitis (UC). Unlike in adults, most children with UC are not treated with enemas during the first year of disease. The goal of the current study was to prospectively evaluate the ability of mesalamine enemas to induce remission in children with mild to moderate UC failing to achieve remission with high dose oral mesalamine.

Methods

This was a 3- week open label arm of a multicenter, single blinded randomized controlled trial for active UC (i.e. the MUPPIT trial). Children, aged 4–18 years of age, with a PUCAI score between 10–55 were enrolled after failing at least 3 weeks of full dose oral mesalamine. Patients treated with steroids or enemas in the previous month and those with isolated proctitis were excluded. Children received Pentasa enemas 25 mg/kg (max one gram) daily for three weeks in combination with the previous high dose oral mesalamine. The primary endpoint was clinical remission by week 3, defined as PUCAI<10; secondary endpoint was change in PUCAI of 20 points (i.e. response) or remission.

Results

Thirty eight children were enrolled (mean age 14.6±2.3 years; 17/38 (45%) with extensive colitis. Clinical remission was obtained in 42% (n=16) while response rate was 71% (n=27) at week 3. Remission rates were similar between left sided (43%) and extensive (41%) colitis, and did not differ between mild (44%) or moderate (41%) disease (p>0.05 for both). Eight children deteriorated and required steroids. There were no differences in baseline parameters between those who entered or failed to enter remission.

Conclusion

Clinical remission can be markedly increased in children who are refractory to high dose oral mesalamaine by adding mesalamine enemas for 3 weeks, prior to commencing steroids.