Clinical Efficacy of Beclomethasone Dipropionate in Korean Patients with Ulcerative Colitis

Purpose Our aim was to evaluate the efficacy and safety of oral beclomethasone dipropionate (BDP) in Korean patients with ulcerative colitis (UC). Materials and Methods The medical records of patients with active UC who were treated with BDP were retrospectively reviewed. Partial Mayo Clinic score (pMS) was calculated to determine disease activity. After 4 weeks of therapy, clinical remission, clinical response, and response failure rates were evaluated. Clinical remission was defined as a post-treatment pMS of 0 or 1, clinical response as a decrease of two of three points in pMS and >30% from baseline, and response failure as a lack of clinical response. Also, we considered that clinical remission was included in clinical response. Results Between July 2013 and April 2015, 95 patients with UC received BDP therapy at our institution (median age, 44 years; range, 12–81 years). After 4 weeks of therapy, clinical remission and clinical response rates were 50.5% and 73.7%, respectively. Mean change of pMS before and after BDP therapy was 2.4. There was no significant side effect reported. In multivariate analysis, disease activity was the only factor associated with a favorable response. Clinical remission rate was significantly higher in the mild disease activity group (66.7%) than that in the moderate or severe disease activity group (41.9%) (p=0.024). Conclusion BDP is efficacious in inducing a clinical response or remission in Korean patients with UC. Patients with mild UC were more likely to be in remission than those with moderate or severe UC after receiving BDP for 4 weeks. BDP exhibited a good safety profile.

[1]  S. Jeon,et al.  Is Long-Term Therapy With Thiopurines Effective for Maintaining Remission in Patients With Moderate-To-Severe Ulcerative Colitis? , 2015, Intestinal research.

[2]  M. Matsuura,et al.  Efficacy and Safety of Long-Term Thiopurine Maintenance Treatment in Japanese Patients With Ulcerative Colitis , 2015, Intestinal research.

[3]  F. Manguso,et al.  Oral Prolonged Release Beclomethasone Dipropionate and Prednisone in the Treatment of Active Ulcerative Colitis: Results From a Double-Blind, Randomized, Parallel Group Study , 2015, The American Journal of Gastroenterology.

[4]  Eun Soo Kim,et al.  Old Age at Diagnosis Is Associated With Favorable Outcomes in Korean Patients With Inflammatory Bowel Disease , 2015, Intestinal research.

[5]  G. Manes,et al.  Low bioavailability steroids in inflammatory bowel disease: an old chestnut or a whole new ballgame? , 2014, Expert review of gastroenterology & hepatology.

[6]  J. Cheon,et al.  Clinical characteristics and treatment of inflammatory bowel disease: a comparison of Eastern and Western perspectives. , 2014, World journal of gastroenterology.

[7]  T. Kim,et al.  Effect of Follow-Up Endoscopy on the Outcomes of Patients with Inflammatory Bowel Disease , 2014, Digestive Diseases and Sciences.

[8]  T. Kim,et al.  Long-term clinical outcomes and factors predictive of relapse after 5-aminosalicylate or sulfasalazine therapy in patients with mild-to-moderate ulcerative colitis. , 2012, Hepato-gastroenterology.

[9]  C. Papi,et al.  Oral beclomethasone dipropionate: a critical review of its use in the management of ulcerative colitis and Crohn's disease. , 2012, Current clinical pharmacology.

[10]  D. Hwang,et al.  Practical usefulness of minor grooves of the hepatic surface for liver resection. , 2012, Hepato-gastroenterology.

[11]  C. Choi,et al.  [Guidelines for the management of ulcerative colitis]. , 2012, The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi.

[12]  M. Sans,et al.  Usefulness of oral beclometasone dipropionate in the treatment of active ulcerative colitis in clinical practice: the RECLICU Study. , 2010, Journal of Crohn's & colitis.

[13]  Eun Soo Kim,et al.  Inflammatory bowel disease in Korea: epidemiological, genomic, clinical, and therapeutic characteristics. , 2010, Gut and liver.

[14]  C. O'Morain,et al.  The second European evidence-based Consensus on the diagnosis and management of Crohn's disease: Current management. , 2010, Journal of Crohn's & colitis.

[15]  C. Papi,et al.  Oral Beclomethasone Dipropionate as an Alternative to Systemic Steroids in Mild to Moderate Ulcerative Colitis Not Responding to Aminosalicylates , 2010, Digestive Diseases and Sciences.

[16]  J. Ellenberg,et al.  Use of the noninvasive components of the mayo score to assess clinical response in Ulcerative Colitis , 2008, Inflammatory bowel diseases.

[17]  J. Satsangi,et al.  Toward an integrated clinical, molecular and serological classification of inflammatory bowel disease: report of a Working Party of the 2005 Montreal World Congress of Gastroenterology. , 2005, Canadian journal of gastroenterology = Journal canadien de gastroenterologie.

[18]  F. Manguso,et al.  Oral beclometasone dipropionate in the treatment of extensive and left‐sided active ulcerative colitis: a multicentre randomised study , 2003, Alimentary pharmacology & therapeutics.

[19]  F. Manguso,et al.  Oral beclometasone dipropionate in the treatment of active ulcerative colitis: a double‐blind placebo‐controlled study , 2002, Alimentary pharmacology & therapeutics.

[20]  W. Tremaine,et al.  Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. , 1987, The New England journal of medicine.

[21]  D. Levine,et al.  Coating of oral beclomethasone dipropionate capsules with cellulose acetate phthalate enhances delivery of topically active antiinflammatory drug to the terminal ileum. , 1987, Gastroenterology.

[22]  Harris Dm Some properties of beclomethasone dipropionate and related steroids in man. , 1975 .

[23]  D. Harris Some properties of beclomethasone dipropionate and related steroids in man. , 1975, Postgraduate medical journal.