P562 Role, efficacy and safety of budesonide multi-matrix in ulcerative colitis in real life: A study in three Italian third-level centres. (16th January 2018)

• Record Type: Journal Article
• Authors: Landi, S; Mezzina, N; Carmagnola, S; Bosani, M; Filippi, E; Pastorelli, L; Grillo, S; Massari, A; Cassinotti, A; Moulteni, P; Dell'Era, A; Ardizzone, S; Maconi, G
• Is Part Of: Journal of Crohn's and colitis. Volume 12:Number 1(2018:Jan.)Supplement 1
• Page Start: S390
• Page End: S391
• Publication Date: 2018-01-16
• Subjects: Inflammatory bowel diseases -- Periodicals; 616.344005
• DOI: 10.1093/ecco-jcc/jjx180.689
• Languages: English
• ISSNs: 1873-9946

Abstract

Abstract: Background: First-line therapy of mild–moderate ulcerative colitis (UC) is based usually on mesalamine and, most recently, on low-bioavailable steroids such as Budesonide MMX (BDMMX). Controlled clinical trial have shown that BDMMX is effective in mild to moderate UC in approximately one of four of patients. However, its role in clinical practice is still not well-defined. The present study evaluated the indications, efficacy and safety of BDMMX therapy in real clinical practice in patients with UC. Methods: This retrospective study included all patients with mild-to-moderate UC who had been prescribed BDMMX therapy from August 2016 to October 2017 at three tertiary IBD referral centres in Italy. We evaluated the clinical activity of disease at baseline (assessed with Partial Mayo Score, PMS) indications for therapy, previous and concomitant treatments and adverse effects. The clinical end point was evaluated at the end of therapy and, when possible, at 6 months after the treatment. We defined as clinical response a decrease in PMS ≥2, whereas clinical remission as PMS <2. Results: Fifty-seven patients were included in the study (29 male, mean age 44 years). Twenty-eight patients had pancolitis, 22 left sided colites and 7 proctitis. The main indication for treatment was an inadequate response to ongoing therapy (53%), represented by mesalamine alone (44%) in most of cases. However, nine patients were in treatment with biologic drugs (16%) and six patients with immunosuppressants. Thirty-eight patients (67%) continued therapy over 8 weeks. At the end of treatment 20 (35%) were in clinical remission, and 5 patients (9%) achieved a clinical response, whereas 32 patients (56 %) had an absent or inadequate response. Stratifying patients based on PMS pre-treatment (PMS<4 vs. ≥4) resulted in no statistically significant difference in term of no response between the two groups (50% vs. 56% p = 0.86). Only 2 patients out of 15 (13%) under treatment with biologics or immunosuppressants achieved a clinical response. Excluding these patients, the clinical response was achieved in 55% (23 of 42) of patients. Three patients had adverse effects (fluid retention, hypertension and headache) but only one of them discontinued therapy. Conclusions: BDMMX in real life was used with indications beyond those reported in controlled trials without severe side effects. Moreover, excluding patients with severe diseases, under biologics and immunosuppresants, the response rate seems to be greater than that reported in clinical trials.