P749 A comparative analysis of low bioavailability steroids in inducing clinical response and remission in ulcerative colitis: Budesonide MMX as the safest option

• Published in: Journal of Crohn's and colitis 2018-01, Vol.12 (supplement_1), p.S489-S490
• Main Authors: Scrivo, B, Giuffrida, E, Calvaruso, V, Cappello, M
• Format: Article
• Language: English
• ISSN: 1873-9946; 1876-4479
• DOI: 10.1093/ecco-jcc/jjx180.876

Abstract Background 5-Aminosalicylates (5-ASA) are first-line treatment for induction of remission in mild to moderate ulcerative colitis (UC). When 5-ASA fails, systemic corticosteroids are the next step, but they cause significant adverse effects. An alternative option is the use of corticosteroids with low bioavailability: beclomethasone dipropionate (BDP) and budesonide with a multi-matrix system (MMX) technology. Our aim was to compare in a real-life setting efficacy and safety of oral budesonide and BDP for the induction of remission in UC. Methods We analysed a prospective cohort of patients with mild to moderate UC resistant to the treatment with 5-ASA, from September 2016 to September 2017. We enrolled 43 consecutive UC patients, 22 were treated with budesonide MMX (9 mg daily for 4 weeks, then every other day for other 4 weeks), 21 with BDP (at a dose of 5 mg daily for 8 weeks). Disease activity was assessed by Partial Mayo Score (PMS) and endoscopic Mayo score. Clinical response and/or remission were evaluated at baselines (T0), at week 4 (T1) and at the end of treatment (T2). When lack of response to both drugs occurred, systemic corticosteroids were used (prednisone 0.75 -1 mg/kg). Results Mean age was 42.7 ± 15.3, 16 were males, mean PMS was 6 ± 1.3, mean C-reactive protein was 10 ± 7.5 mg/l; no significant difference was present in baseline characteristics (age, extent of disease, endoscopic activity), except disease activity which was more severe in patients (patients) treated with budesonide MMX (p = 0.006). At week 4, 50% (11/22) of patients treated with budesonide MMX achieved clinical response, mean PMS was 4 ± 2.3; among them, 87% were in clinical remission at week 8. In the population treated with BDP, 43% of patients (9/21) reached clinical response, mean PMS was 3.4 ± 1.7; among them, 100% were in clinical remission at the end of treatment. Differences observed between the two treatment groups were not significant. Among the 43 (17/43) patients, 40% were switched to systemic corticosteroids for lack of response. Extensive disease, higher Mayo Score at baseline, reduction in PMS at T1 lower than 30%, were predictive of treatment failure. No steroid-related side effects were found in the group treated with budesonide-MMX; 2 patients in the BDP group stopped therapy because of adverse effects (headache, muscle pain and hypertension). Conclusions This single-center study shows that efficacy of Budesonide MMX and BDP is comparable in the