P484 Is topical therapy necessary for patients with acute mild and/or moderately active extensive or left-sided Ulcerative Colitis treated with mmx-mesalazine? A pilot, single-center, faecal calprotectin-guided study
P. Karatzas, E. Archavlis, A. Christidou, N. Kyriakos, X. Tzannetakou, I. Internos, S. Anastasiadis, L. Varytimiadis, P. Konstantopoulos, I. Drougas, G.J. Mantzaris*
Evangelismos Hospital, Gastroenterology Department, Athens, Greece
According to the ECCO guidelines patients with mild-to-moderately active extensive or left-sided ulcerative colitis (UC) should be treated with combined oral and topical mesalazine(COTP). However, these guidelines were based almost exclusively on studies with slow-release and/or pH-dependent release mesalazine. MMX-mesalazine (MMX-M) allows preferential delivery of 5-ASA especially in the left colon. Therefore, question arises whether topical therapy is still needed for patients treated with MMX-M. Aim: To assess in a prospective, single-center, pilot study whether adding topical 5-ASA therapy improves the remission rates achieved by MMX-M monotherapy.
Eligible were patients >18 years, with active mild and/or moderate extensive (E-UC) or left-sided (LS-UC) UC. Patients with proctitis were excluded. Patients with mild UC received 2.4g/day and patients with moderate UC received 4.8g/day MMX-M for 8 weeks. Clinical response and remission rates were assessed by the partial Mayo score at weeks 2 and 6 and the full Mayo score at weeks 4 and 8. Faecal Calprotectin (FC) tests (Quantum Blue, Bühlmann, normal values <50microg/g faeces) were performed at weeks 0, 4 and 8.
Twenty six patients [15 male - 11female, mean age 28 (range 18-65) years, 5 smokers, 14 with LS-UC and 12 with E-UC, and Mayo score 6.5 (5-9)] received 2.4g MMX-M for mild (n=15) and 4.8g/day MMX-M for moderate (n=11) UC. After 8 weeks, 21/26 (81%) patients were in clinical and endoscopic remission (Mayo score=0). There were no significant differences in remission rates between patients with E-UC and LS-UC. Remission rates increased progressively by week 8 (31%, 54%, 69% and 81% at weeks 2, 4, 6 and 8, respectively) and are comparable to the known remission rates achieved by COTP. FC ranged from 72 to >300 microg/g of faeces at baseline but decreased gradually to < 50microg/g in the 21 patients in remission at week 8. Five of 26 (19%) patients did not achieve clinical remission (Mayo score 5-8, FC levels >100microg/g faeces). A significantly higher correlation was seen for FC than CRP with Mayo scores (P<0.001).
High levels of clinical remission were achieved by MMX-M monotherapy in this single-center pilot study in E-/LS-UC patients with mild and moderate disease without any differences between E-UC and LS-UC. FC may be used to follow clinical response. Adding topical therapy may not further increase remission rates at a clinically meaningful (cost-effective) difference than MMX-M monotherapy but this should be better addressed in large scale clinical trials.