Abstract
Backgroud
Aminosalicylates (5-ASA) are first-line treatment for mild-moderate ulcerative colitis (UC). Systemic corticosteroids (CS) are considered for patients in whom 5-ASA has been unsuccessful, but their use is limited by adverse effects. Beclomethasone dipropionate (BDP), a topically acting steroid with low systemic bioavailability, has a more favorable safety profile, but its role in clinical practice is not yet well established.
Aim
The aim of the present study is to assess whether oral BDP can be an alternative treatment to systemic CS for patients with mild-moderate UC not responding to first-line therapy with 5-ASA.
Methods
From 2003 to 2006, all consecutive patients with mild-moderate UC unresponsive to oral and topical 5-ASA (±topical CS) administered for at least 3 weeks received an 8-week course of oral BDP (10 mg/day for 4 weeks and 5 mg/day for an additional 4 weeks). Co-primary end-points were: (1) clinical remission within 8 weeks, without need of systemic CS; (2) steroid-free remission for 12 months.
Results
Sixty-four patients were included. In this study, within 8 weeks, 48/64 patients (75%) entered remission without systemic CS, while 16/64 (25%) failed to enter remission. Within 12 months, 37/64 patients (58%) had prolonged steroid-free remission, while 11/64 (17%) relapsed. During 1 year, 75% of patients receiving oral BDP could avoid systemic CS.
Conclusions
Oral BDP can avoid the use of systemic CS in the vast majority of patients with mild-moderate UC not responding to 5-ASA and could be considered as a second-line treatment for these patients.
Similar content being viewed by others
References
Carter MJ, Lobo AJ, Travis SPL, On behalf of the IBD Section of the British Society of Gastroenterology. Guidelines for the management of inflammatory bowel disease in adults. Gut. 2004;53(Suppl V):v1–v16.
Kornbluth A, Sachar DB. Ulcerative colitis practice guidelines in adults (update). Am J Gastroenterol. 2004;99(7):1371–1385.
Travis SPL, Stange EF, Lémann M, For the European Crohn’s and Colitis Organisation (ECCO), et al. European evidence-based consensus on the management of ulcerative colitis: current management. J Crohn’s Colitis. 2008;2(1):24–62.
Sutherland L, MacDonald JK. Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis. Cochrane Database Syst Rev. 2006;19(2):CD000543.
Marshall JK, Irvine EJ. Rectal aminosalicylates therapy for distal ulcerative colitis: a meta-analysis. Aliment Pharmacol Ther. 1995;9(3):293–300.
Marshall JK, Irvine EJ. Putting rectal 5-aminosalicylic acid in its place: the role in distal ulcerative colitis. Am J Gastroenterol. 2000;95(7):1628–1636.
Cohen RD, Woseth DM, Thisted RA, et al. A meta-analysis and overview of the literature on treatment options for left-sided ulcerative colitis and ulcerative proctitis. Am J Gastroenterol. 2000;95(5):1263–1276.
Safdi M, DeMicco M, Sninsky C, et al. A double-blind comparison of oral versus rectal mesalamine versus combination therapy in the treatment of distal ulcerative colitis. Am J Gastroenterol. 1997;92(10):1867–1871.
Marteau P, Probert CS, Lindgren S, et al. Combined oral and enema treatment with Pentasa (mesalazine) is superior to oral therapy alone in patients with extensive mild/moderate active ulcerative colitis: a randomised, double blind, placebo controlled study. Gut. 2005;54(7):960–965.
Vecchi M, Meucci G, Gionchetti P, et al. Oral versus combination mesalazine therapy in active ulcerative colitis: a double-blind, double-dummy, randomized multicentre study. Aliment Pharmacol Ther. 2001;15(2):251–256.
Regueiro M, Loftus EV Jr, Steinhart AH, et al. Medical management of left-sided ulcerative colitis and ulcerative proctitis: critical evaluation of therapeutic trials. Inflamm Bowel Dis. 2006;12(10):979–994.
Travis SPL. Review article: induction therapy for patients with active ulcerative colitis. Aliment Pharmacol Ther. 2006;15(1):10–16.
Faubion WA, Loftus EV, Harmsen WS, et al. The natural history of corticosteroid therapy for inflammatory bowel disease: a population-based study. Gastroenterology. 2001;121:255–260.
Ho GT, Chiam P, Drummond H, et al. The efficacy of corticosteroid therapy in inflammatory bowel disease: analysis of a 5-year UK inception cohort. Aliment Pharmacol Ther. 2006;24:319–330.
Plevy SE. Corticosteroid-sparing treatments in patients with Crohn’s disease. Am J Gastroenterol. 2002;97:1607–1617.
Harris DM. Some properties of beclomethasone dipropionate and related steroids in man. Postgrad Med J. 1975;51:20–25.
Manguso F, Balzano A. Meta-analysis: the efficacy of rectal beclomethasone dipropionate vs. 5-aminosalicylic acid in mild to moderate distal ulcerative colitis. Aliment Pharmacol Ther. 2007;26(1):21–29.
Biancone L, Gionchetti P, del Vecchio Blanco G, et al. Beclomethasone dipropionate versus mesalazine in distal ulcerative colitis: a multicenter, randomized, double-blind study. Dig Liver Dis. 2007;39(4):329–337.
Gionchetti P, D’Arienzo A, Rizzello F, Italian BDP Study Group, et al. Topical treatment of distal active ulcerative colitis with beclomethasone dipropionate or mesalamine: a single-blind randomized controlled trial. J Clin Gastroenterol. 2005;39(4):291–297.
D’Arienzo A, Manguso F, Castiglione GN, et al. Beclomethasone dipropionate (3 mg) enemas combined with oral 5-ASA (2.4 g) in the treatment of ulcerative colitis not responsive to oral 5-ASA alone. Ital J Gastroenterol Hepatol. 1998;30(3):254–257.
Campieri M, Cottone M, Miglio F, et al. Beclomethasone dipropionate enemas versus prednisolone sodium phosphate enemas in the treatment of distal ulcerative colitis. Aliment Pharmacol Ther. 1998;12(4):361–366.
Steed KP, Hooper G, Ventura P, et al. The in vivo behaviour of a colonic delivery system. Pharmaceutical Profiles Limited study no. PPL-015. Nottingham, 3rd April 1992. Int J Pharm. 1994;112:199–206.
Campieri M, Adamo S, Valpiani D, et al. Oral beclomethasone dipropionate in the treatment of extensive and left-sided active ulcerative colitis: a multicenter randomised study. Aliment Pharmacol Ther. 2003;17(12):1471–1480.
Rizzello F, Gionchetti P, D’Arienzo A, et al. Oral beclomethasone dipropionate in the treatment of active ulcerative colitis: a double-blind placebo-controlled study. Aliment Pharmacol Ther. 2002;16(6):1109–1116.
Rachmilewitz D. Coated mesalazine (5-aminosalicylic acid) versus sulphasalazine in the treatment of active ulcerative colitis: a randomised trial. BMJ. 1989;298(6666):82–86.
Travis S. Review article: the management of mild to severe acute ulcerative colitis. Aliment Pharmacol Ther. 2004;20(Suppl. 4):88–92.
Hanauer SB, Sandborn WJ, Kornbluth A, et al. Delayed-release oral mesalamine at 4.8 g/day (800 mg tablet) for the treatment of moderately active ulcerative colitis: the ASCEND II trial. Am J Gastroenterol. 2005;100(11):2478–2485.
Hanauer SB, Sandborn WJ, Dallaire C, et al. Delayed-release oral mesalamine 4.8 g/day (800 mg tablets) compared to 2.4 g/day (400 mg tablets) for the treatment of mildly to moderately active ulcerative colitis: the ASCEND I trial. Can J Gastroenterol. 2007;21(12):827–834.
Hanauer SB. Review article: high-dose aminosalicylates to induce and maintain remissions in ulcerative colitis. Aliment Pharmacol Ther. 2006;24(Suppl 3):37–40.
Kruis W, Bar-Meir S, Feher J, et al. The optimal dose of 5-aminosalicylic acid in active ulcerative colitis: a dose-finding study with newly developed mesalamine. Clin Gastroenterol Hepatol. 2003;1(1):36–43.
Safdi AV, Cohen RD. Review article: increasing the dose of oral mesalazine therapy for active ulcerative colitis does not improve remission rates. Aliment Pharmacol Ther. 2007;26(9):1179–1186.
Bergman R, Parkes M. Systematic review: the use of mesalazine in inflammatory bowel disease. Aliment Pharmacol Ther. 2006;23(7):841–855.
Rizzello F, Gionchetti P, Galeazzi R, et al. Oral beclomethasone dipropionate in patients with mild to moderate ulcerative colitis: a dose-finding study. Adv Ther. 2001;18(6):261–271.
Manes G, Imbesi V, Ardizzone S, et al. Appropriateness and diagnostic yield of colonoscopy in the management of patients with ulcerative colitis: a prospective study in an open access endoscopy service. Inflamm Bowel Dis. 2008;14(8):1133–1138.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Papi, C., Aratari, A., Moretti, A. et al. Oral Beclomethasone Dipropionate as an Alternative to Systemic Steroids in Mild to Moderate Ulcerative Colitis Not Responding to Aminosalicylates. Dig Dis Sci 55, 2002–2007 (2010). https://doi.org/10.1007/s10620-009-0962-6
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10620-009-0962-6