Oral beclomethasone dipropionate as an add-on therapy and response prediction in Korean patients with ulcerative colitis
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Background/Aims: We aimed to investigate the oral beclomethasone dipropionate’s (BDP) efficacy as an add-on therapy and to clarify the predictive factor for response to oral BDP in Korean ulcerative colitis (UC) patients. Methods: Patients with a stable concomitant drug regimen with exposure to oral BDP (5 mg/day) within 30 days before BDP initiation were included. Partial Mayo score (pMS) was used to evaluate response to oral BDP. Clinical remission (CREM) was defined as a post-treatment pMS ≤ 1 point. Clinical response (CRES) was defined as an at least 2-point decrease in post-treatment pMS and an at least 30% decrease from baseline pMS. Patients without CREM or CRES were considered nonresponders (NRs). Results: Of all, 37 showed CREM, 19 showed CRES, and 44 were NRs. The CREM group included more patients with mild disease activity (75.7% vs. 43.2%, p = 0.011) than NRs. In contrast to NRs, CREM and CRES patients showed significant improvement of post-treatment erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) (ESR with p = 0.001, CRP with p = 0.004, respectively). Moreover, the initial rectal bleeding subscore (RBS) was significantly different between CREM and CRES, or NR (both with p < 0.001). In multivariate analyses, initial stool frequency subscore (SFS) of 0 and RBS of 0 were predictive factors for CREM (odds ratio [OR], 15.359; 95% confidence interval [CI], 1.085 to 217.499; p = 0.043 for SFS, and OR, 11.434; 95% CI, 1.682 to 77.710; p = 0.013 for RBS). Conclusions: Oral BDP is an efficacious add-on therapy in Korean UC patients. Patients with initial SFS or RBS of 0 may be particularly good candidates for oral BDP.
Abstract
Background/Aims: We aimed to investigate the oral beclomethasone dipropionate’s (BDP) efficacy as an add-on therapy and to clarify the predictive factor for response to oral BDP in Korean ulcerative colitis (UC) patients. Methods: Patients with a stable concomitant drug regimen with exposure to oral BDP (5 mg/day) within 30 days before BDP initiation were included. Partial Mayo score (pMS) was used to evaluate response to oral BDP. Clinical remission (CREM) was defined as a post-treatment pMS ≤ 1 point. Clinical response (CRES) was defined as an at least 2-point decrease in post-treatment pMS and an at least 30% decrease from baseline pMS. Patients without CREM or CRES were considered nonresponders (NRs). Results: Of all, 37 showed CREM, 19 showed CRES, and 44 were NRs. The CREM group included more patients with mild disease activity (75.7% vs. 43.2%, p = 0.011) than NRs. In contrast to NRs, CREM and CRES patients showed significant improvement of post-treatment erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) (ESR with p = 0.001, CRP with p = 0.004, respectively). Moreover, the initial rectal bleeding subscore (RBS) was significantly different between CREM and CRES, or NR (both with p < 0.001). In multivariate analyses, initial stool frequency subscore (SFS) of 0 and RBS of 0 were predictive factors for CREM (odds ratio [OR], 15.359; 95% confidence interval [CI], 1.085 to 217.499; p = 0.043 for SFS, and OR, 11.434; 95% CI, 1.682 to 77.710; p = 0.013 for RBS). Conclusions: Oral BDP is an efficacious add-on therapy in Korean UC patients. Patients with initial SFS or RBS of 0 may be particularly good candidates for oral BDP.
참고문헌 (38)
- 홍승욱, "The first step to unveil the epidemiology of inflammatory bowel disease in Central Asia", Intestinal research, 18(4), pp.345~346 (2020), 대한장연구학회[DOI]
- Jamilya Kaibullayeva, "Prevalence and patient awareness of inflammatory bowel disease in Kazakhstan: a cross-sectional study", Intestinal research, 18(4), pp.430~437 (2020), 대한장연구학회[DOI]
- Satimai Aniwan, "Temporal trend in the natural history of ulcerative colitis in a country with a low incidence of ulcerative colitis from 2000 through 2018", Intestinal research, 19(2), pp.186~193 (2021), 대한장연구학회[DOI]
- Ajit Sood, "Trends of inflammatory bowel disease at a tertiary care center in northern India", Intestinal research, 19(3), pp.282~290 (2021), 대한장연구학회[DOI]
- Magro F, "Third European Evidence-based Consensus on diagnosis and management of ulcerative colitis. Part 1 : definitions, diagnosis, extra-intestinal manifestations, pregnancy, cancer surveillance, surgery, and ileo-anal pouch disorders", J Crohns Colitis, 11, pp.649~670 (2017)
- Bressler B, "Clinical practice guidelines for the medical management of nonhospitalized ulcerative colitis : the Toronto consensus", Gastroenterology, 148, pp.1035~1058 (2015)
- Tomohiro Fukuda, "Current new challenges in the management of ulcerative colitis", Intestinal research, 17(1), pp.36~44 (2019), 대한장연구학회[DOI]
- Choon Jin Ooi, "Best practices on immunomodulators and biologic agents for ulcerative colitis and Crohn’s disease in Asia", Intestinal research, 17(3), pp.285~310 (2019), 대한장연구학회[DOI]
- Ajit Sood, "Colitis and Crohn’s Foundation (India) consensus statements on use of 5-aminosalicylic acid in inflammatory bowel disease", Intestinal research, 18(4), pp.355~378 (2020), 대한장연구학회[DOI]
- Toshifumi Hibi, "Efficacy of biologic therapies for biologic-naïve Japanese patients with moderately to severely active ulcerative colitis: a network meta-analysis", Intestinal research, 19(1), pp.53~61 (2021), 대한장연구학회[DOI]
- Choon Jin Ooi, "Efficacy and safety of vedolizumab in ulcerative colitis in patients from Asian countries in the GEMINI 1 study", Intestinal research, 19(1), pp.71~82 (2021), 대한장연구학회[DOI]
- Hiromichi Shimizu, "Rapid prediction of 1-year efficacy of tofacitinib for treating refractory ulcerative colitis", Intestinal research, 19(1), pp.115~118 (2021), 대한장연구학회[DOI]
- 오신주, "Long-term outcomes of infliximab in a real-world multicenter cohort of patients with acute severe ulcerative colitis", Intestinal research, 19(3), pp.323~331 (2021), 대한장연구학회[DOI]
- Harbord M, "Third European Evidence-based Consensus on diagnosis and management of ulcerative colitis. Part 2 : current management", J Crohns Colitis, 11, pp.769~784 (2017)
- Lamb CA, "British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults", Gut, 68(Suppl 3), pp.s1~s106 (2019)
- Ko CW, "AGA clinical practice guidelines on the management of mild-to-moderate ulcerative colitis", Gastroenterology, 156, pp.748~764 (2019)
- Fumery M, "Natural history of adult ulcerative colitis in population-based cohorts : a systematic review", Clin Gastroenterol Hepatol, 16, pp.343~356 (2018)
- Brattsand R, "Cytokine modulation by glucocorticoids:mechanisms and actions in cellular studies", Aliment Pharmacol Ther, 10(Suppl 2), pp.81~92 (1996)
- Manso G, "In vivo and in vitro effects of glucocorticosteroids on arachidonic acid metabolism and monocyte function in nonasthmatic humans", Eur Respir J, 5, pp.712~716 (1992)
- Curkovic I, "Risks of inflammatory bowel disease treatment with glucocorticosteroids and aminosalicylates", Dig Dis, 31, pp.368~373 (2013)
- Curtis JR, "Population-based assessment of adverse events associated with long-term glucocorticoid use", Arthritis Rheum, 55, pp.420~426 (2006)
- Toruner M, "Risk factors for opportunistic infections in patients with inflammatory bowel disease", Gastroenterology, 134, pp.929~936 (2008)
- Steed KP, "The in vivo behaviour of a colonic delivery system : a pilot study in man", Int J Pharm, 112, pp.199~206 (1994)
- Daley-Yates PT, "Beclomethasone dipropionate : absolute bioavailability, pharmacokinetics and metabolism following intravenous, oral, intranasal and inhaled administration in man", Br J Clin Pharmacol, 51, pp.400~409 (2001)
- Roberts JK, "Metabolism of beclomethasone dipropionate by cytochrome P450 3A enzymes", J Pharmacol Exp Ther, 345, pp.308~316 (2013)
- 최창환, "Second Korean guidelines for the management of ulcerative colitis", Intestinal research, 15(1), pp.7~37 (2017), 대한장연구학회
- Rizzello F, "Oral beclomethasone dipropionate in patients with mild to moderate ulcerative colitis : a dose-finding study", Adv Ther, 18, pp.261~271 (2001)
- Rizzello F, "Oral beclometasone dipropionate in the treatment of active ulcerative colitis : a double-blind placebo-controlled study", Aliment Pharmacol Ther, 16, pp.1109~1116 (2002)
- Campieri M, "Oral beclometasone dipropionate in the treatment of extensive and left-sided active ulcerative colitis : a multicentre randomised study", Aliment Pharmacol Ther, 17, pp.1471~1480 (2003)
- Van Assche G, "Oral prolonged release beclomethasone dipropionate and prednisone in the treatment of active ulcerative colitis : results from a double-blind, randomized, parallel group study", Am J Gastroenterol, 110, pp.708~715 (2015)
- Lewis JD, "Use of the noninvasive components of the Mayo score to assess clinical response in ulcerative colitis", Inflamm Bowel Dis, 14, pp.1660~1666 (2008)
- Rutgeerts P, "Infliximab for induction and maintenance therapy for ulcerative colitis", N Engl J Med, 353, pp.2462~2476 (2005)
- Manguso F, "Efficacy and safety of oral beclomethasone dipropionate in ulcerative colitis : a systematic review and meta-analysis", PLoS One, 11, pp.e0166455~ (2016)
- Papi C, "Oral beclomethasone dipropionate as an alternative to systemic steroids in mild to moderate ulcerative colitis not responding to aminosalicylates", Dig Dis Sci, 55, pp.2002~2007 (2010)
- Nunes T, "Usefulness of oral beclometasone dipropionate in the treatment of active ulcerative colitis in clinical practice : the RECLICU Study", J Crohns Colitis, 4, pp.629~636 (2010)
- 이윤지, "Clinical Efficacy of Beclomethasone Dipropionate in Korean Patients with Ulcerative Colitis", Yonsei Medical Journal, 58(1), pp.144~149 (2017), 연세대학교의과대학[DOI]
- Romano C, "Oral beclomethasone dipropionate in pediatric active ulcerative colitis : a comparison trial with mesalazine", J Pediatr Gastroenterol Nutr, 50, pp.385~389 (2010)
- Nugent SG, "Intestinal luminal pH in inflammatory bowel disease : possible determinants and implications for therapy with aminosalicylates and other drugs", Gut, 48, pp.571~577 (2001)
