본문 바로가기
KERD
논문KCI 등재

Oral beclomethasone dipropionate as an add-on therapy and response prediction in Korean patients with ulcerative colitis

1

조회

0

다운로드

0

인용

0

참고문헌

키워드

주제분류내과학

초록

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)

  1. 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]
  2. 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]
  3. 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]
  4. 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]
  5. 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)
  6. Bressler B, "Clinical practice guidelines for the medical management of nonhospitalized ulcerative colitis : the Toronto consensus", Gastroenterology, 148, pp.1035~1058 (2015)
  7. Tomohiro Fukuda, "Current new challenges in the management of ulcerative colitis", Intestinal research, 17(1), pp.36~44 (2019), 대한장연구학회[DOI]
  8. 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]
  9. 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]
  10. 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]
  11. 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]
  12. 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]
  13. 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]
  14. 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)
  15. 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)
  16. Ko CW, "AGA clinical practice guidelines on the management of mild-to-moderate ulcerative colitis", Gastroenterology, 156, pp.748~764 (2019)
  17. Fumery M, "Natural history of adult ulcerative colitis in population-based cohorts : a systematic review", Clin Gastroenterol Hepatol, 16, pp.343~356 (2018)
  18. Brattsand R, "Cytokine modulation by glucocorticoids:mechanisms and actions in cellular studies", Aliment Pharmacol Ther, 10(Suppl 2), pp.81~92 (1996)
  19. 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)
  20. Curkovic I, "Risks of inflammatory bowel disease treatment with glucocorticosteroids and aminosalicylates", Dig Dis, 31, pp.368~373 (2013)
  21. Curtis JR, "Population-based assessment of adverse events associated with long-term glucocorticoid use", Arthritis Rheum, 55, pp.420~426 (2006)
  22. Toruner M, "Risk factors for opportunistic infections in patients with inflammatory bowel disease", Gastroenterology, 134, pp.929~936 (2008)
  23. Steed KP, "The in vivo behaviour of a colonic delivery system : a pilot study in man", Int J Pharm, 112, pp.199~206 (1994)
  24. 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)
  25. Roberts JK, "Metabolism of beclomethasone dipropionate by cytochrome P450 3A enzymes", J Pharmacol Exp Ther, 345, pp.308~316 (2013)
  26. 최창환, "Second Korean guidelines for the management of ulcerative colitis", Intestinal research, 15(1), pp.7~37 (2017), 대한장연구학회
  27. Rizzello F, "Oral beclomethasone dipropionate in patients with mild to moderate ulcerative colitis : a dose-finding study", Adv Ther, 18, pp.261~271 (2001)
  28. 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)
  29. 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)
  30. 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)
  31. 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)
  32. Rutgeerts P, "Infliximab for induction and maintenance therapy for ulcerative colitis", N Engl J Med, 353, pp.2462~2476 (2005)
  33. Manguso F, "Efficacy and safety of oral beclomethasone dipropionate in ulcerative colitis : a systematic review and meta-analysis", PLoS One, 11, pp.e0166455~ (2016)
  34. 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)
  35. 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)
  36. 이윤지, "Clinical Efficacy of Beclomethasone Dipropionate in Korean Patients with Ulcerative Colitis", Yonsei Medical Journal, 58(1), pp.144~149 (2017), 연세대학교의과대학[DOI]
  37. Romano C, "Oral beclomethasone dipropionate in pediatric active ulcerative colitis : a comparison trial with mesalazine", J Pediatr Gastroenterol Nutr, 50, pp.385~389 (2010)
  38. 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)

관련 논문AI추천

Clinical Efficacy of Beclomethasone Dipropionate in Korean Patients with Ulcerative Colitis김원호, 김재현, 김태일, 박수정, 유선호, 이윤지, 이현정, 천재희, 홍성필연세대학교의과대학 · Yonsei Medical Journal2017 · 제58권 제1호Clinical Outcomes and Predictive Factors for Response after the First Course of Corticosteroid Therapy in Patients with Crohn’s Disease김덕환, 김원호, 김태일, 문창모, 박재준, 윤진영, 천재희, 홍성필거트앤리버 소화기연관학회협의회 · Gut and Liver2013 · 제7권 제1호Long-term Outcomes of Adalimumab Therapy in Korean Patients with Ulcerative Colitis: A Hospital-Based Cohort StudyByong Duk Ye, Dong-Hoon Yang, Eun Hye Oh, Jeongseok Kim, Jeong-Sik Byeon, Namseok Ham, Sang Hyoung Park, Seung-Jae Myung, Suk-Kyun Yang, Sung Wook Hwang거트앤리버 소화기연관학회협의회 · Gut and Liver2020 · 제14권 제3호Quality of Life in Newly Diagnosed Moderate-to-Severe Ulcerative Colitis: Changes in the MOSAIK Cohort Over 1 Year이준, 김현수, 이유진, 진윤태, 홍성노, Jo Ik Hyun, Kim Dae Bum, Kim Ji Won, Kim Joo Sung, Kim Tae-Oh, Kim Youngdoe, Lee Kang-Moon, Park Dong Il, Park Jae Jun거트앤리버 소화기연관학회협의회 · Gut and Liver2022 · 제16권 제3호Real-world effectiveness and safety of adalimumab in Korean patients with intestinal Behcet’s disease: a Korean Association for the Study of Intestinal Diseases (KASID) multicenter studyBo-In Lee, Byong Duk Ye, Chang Kyun Lee, Hee Seung Hong, Hosun Yu, Jung-Bin Park, on behalf of the IBD Research Group of the Korean Association for the Study of Intestinal Diseases (KASID), Sang Hyoung Park, Seong-Joon Koh, Seung Bum Lee, Sol Kim, Suk-Kyun Yang, Sung Wook Hwang대한내과학회 · The Korean Journal of Internal Medicine2023 · 제38권 제5호Clinical Significance of Residual Nonrectal Inflammation in Ulcerative Colitis Patients in Clinical Remission김영호, Chang Dong Kyung, Hong Sung Noh, Kim Eun Ran, Kim Tae Jun, Kong Sung Min, Shin Jongbeom거트앤리버 소화기연관학회협의회 · Gut and Liver2021 · 제15권 제3호

이 간행물의 다른 논문 (20건)