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      Maintaining infliximab induced clinical remission with azathioprine and 5-aminosalicylates in acute severe steroid-refractory ulcerative colitis has lower cost and high efficacy (MIRACLE): a multicenter study = Maintaining infliximab induced clinical remission with azathioprine and 5-aminosalicylates in acute severe steroid-refractory ulcerative colitis has lower cost and high efficacy (MIRACLE): a multicenter study

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      https://www.riss.kr/link?id=A108014547

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      다국어 초록 (Multilingual Abstract)

      Background/Aims: Infliximab (IFX) has been used to induce and maintain remission in patients with severe steroid-refractory ulcerative colitis (UC). Long-term use of biologics in developing countries is limited by high cost and frequent side effects. ...

      Background/Aims: Infliximab (IFX) has been used to induce and maintain remission in patients with severe steroid-refractory ulcerative colitis (UC). Long-term use of biologics in developing countries is limited by high cost and frequent side effects. An optimal maintenance strategy in these patients needs to be established. Methods: A retrospective analysis of maintenance of clinical remission with combination of azathioprine (AZA) and 5-aminosalicylates (5-ASA) in patients with severe steroid-refractory UC where IFX (5 mg/kg intravenously at weeks 0, 2, 6) had been used only as an induction therapy was done at 2 centers in India. Primary outcome was the proportion of patients maintaining corticosteroid-free sustained clinical remission (SCR) at the end of study period. Rates of relapse and cost of therapy were also analyzed. Results: Of the 137 patients who received rescue IFX induction therapy, 77 (56.2%) achieved clinical remission (mean age 34.81±13.32 years, 68.83% males, median follow-up 4 years, range 3 months to 6 years) and were included. Cumulative corticosteroid-free SCR was maintained in 68%, 59%, 42%, and 35% patients at 1, 2, 4, and 6 years respectively. Sixty-seven relapses were observed in 33 patients. Majority of the relapses (45/67, 67.16%) occurred within first 2 years of follow-up. Two relapses were managed with re-induction with IFX, one required colectomy, whereas all other responded to repeat course(s) of corticosteroids. Annual per capita maintenance therapy with 5-ASA and AZA was cheaper by US$ 4,526 compared to maintaining remission with IFX. Conclusions: Clinical remission achieved with IFX induction therapy in severe steroid-refractory UC can be sustained over long time with a combination of AZA and 5-ASA. (Intest Res 2022;20:64-71)

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      참고문헌 (Reference)

      1 Refojo D, "Transcription factor-mediated molecular mechanisms involved in the functional cross-talk between cytokines and glucocorticoids" 79 : 385-394, 2001

      2 Harbord M, "Third European evidence-based consensus on diagnosis and management of ulcerative colitis. Part 2: current management" 11 : 769-784, 2017

      3 Gisbert JP, "The risk of relapse after anti-TNF discontinuation in inflammatory bowel disease : systematic review and meta-analysis" 111 : 632-647, 2016

      4 Kang B, "Subtherapeutic infliximab trough levels and complete mucosal healing are associated with sustained clinical remission after infliximab cessation in paediatric-onset Crohn’s disease patients treated with combined immunosuppressive therapy" 12 : 644-652, 2018

      5 Nasuno M, "Short-and long-term outcomes of infliximab treatment for steroid-refractory ulcerative colitis and related prognostic factors : a single-center retrospective study" 95 : 67-71, 2017

      6 Turner D, "Response to corticosteroids in severe ulcerative colitis : a systematic review of the literature and a meta-regression" 5 : 103-110, 2007

      7 Travis SP, "Predicting outcome in severe ulcerative colitis" 38 : 905-910, 1996

      8 Nikolaus S, "Mechanisms in failure of infliximab for Crohn’s disease" 356 : 1475-1479, 2000

      9 Louis E, "Maintenance of remission among patients with Crohn’s disease on antimetabolite therapy after infliximab therapy is stopped" 142 : 63-70, 2012

      10 Roda G, "Loss of response to anti-TNFs : definition, epidemiology, and management" 7 : e135-, 2016

      1 Refojo D, "Transcription factor-mediated molecular mechanisms involved in the functional cross-talk between cytokines and glucocorticoids" 79 : 385-394, 2001

      2 Harbord M, "Third European evidence-based consensus on diagnosis and management of ulcerative colitis. Part 2: current management" 11 : 769-784, 2017

      3 Gisbert JP, "The risk of relapse after anti-TNF discontinuation in inflammatory bowel disease : systematic review and meta-analysis" 111 : 632-647, 2016

      4 Kang B, "Subtherapeutic infliximab trough levels and complete mucosal healing are associated with sustained clinical remission after infliximab cessation in paediatric-onset Crohn’s disease patients treated with combined immunosuppressive therapy" 12 : 644-652, 2018

      5 Nasuno M, "Short-and long-term outcomes of infliximab treatment for steroid-refractory ulcerative colitis and related prognostic factors : a single-center retrospective study" 95 : 67-71, 2017

      6 Turner D, "Response to corticosteroids in severe ulcerative colitis : a systematic review of the literature and a meta-regression" 5 : 103-110, 2007

      7 Travis SP, "Predicting outcome in severe ulcerative colitis" 38 : 905-910, 1996

      8 Nikolaus S, "Mechanisms in failure of infliximab for Crohn’s disease" 356 : 1475-1479, 2000

      9 Louis E, "Maintenance of remission among patients with Crohn’s disease on antimetabolite therapy after infliximab therapy is stopped" 142 : 63-70, 2012

      10 Roda G, "Loss of response to anti-TNFs : definition, epidemiology, and management" 7 : e135-, 2016

      11 Papamichael K, "Long-term outcome of patients with Crohn’s disease who discontinued infliximab therapy upon clinical remission" 13 : 1103-1110, 2015

      12 Ferrante M, "Long-term outcome after infliximab for refractory ulcerative colitis" 2 : 219-225, 2008

      13 Reinisch W, "Long-term infliximab maintenance therapy for ulcerative colitis : the ACT-1 and-2 extension studies" 18 : 201-211, 2012

      14 Yamada S, "Long-term efficacy of infliximab for refractory ulcerative colitis : results from a single center experience" 14 : 80-, 2014

      15 Gustavsson A, "Long-term colectomy rate after intensive intravenous corticosteroid therapy for ulcerative colitis prior to the immunosuppressive treatment era" 102 : 2513-2519, 2007

      16 Puri AS, "Infliximab-induced tuberculosis in patients with UC : experience from India-a country with high prevalence of tuberculosis" 32 : 1191-1194, 2017

      17 Sood A, "Infliximab in patients with severe steroid-refractory ulcerative colitis : Indian experience" 33 : 31-34, 2014

      18 Yokoyama Y, "Inflammatory bowel disease patients experiencing a loss of response to infliximab regain long-term response after undergoing granulocyte/monocyte apheresis : a case series" 103 : 25-28, 2018

      19 Baumgart DC, "Inflammatory bowel disease : cause and immunobiology" 369 : 1627-1640, 2007

      20 Ozaki R, "Histological risk factors to predict clinical relapse in ulcerative colitis with endoscopically normal mucosa" 12 : 1288-1294, 2018

      21 Bach JF, "Frontiers of biology" North-Holland Publishing Co 1975

      22 Huang G, "Effect of azathioprine upon inflammation in rats with ulcerative colitis induced by immune complex-combined TNBS/ethanol" 28 : 2604-2608, 2017

      23 Roda G, "Cytokine networks in ulcerative colitis" 2011 : e391787-, 2011

      24 Sood A, "Cyclosporine in the treatment of severe steroid refractory ulcerative colitis : a retrospective analysis of 24 cases" 27 : 232-235, 2008

      25 Lichtiger S, "Cyclosporine in severe ulcerative colitis refractory to steroid therapy" 330 : 1841-1845, 1994

      26 Reinink AR, "Cost-effectiveness analysis of azathioprine vs. infliximab vs. combination therapy for Crohn’s disease" 5 (5): 175-176, 2011

      27 Gustavsson A, "Clinical trial : colectomy after rescue therapy in ulcerative colitis : 3-year follow-up of the Swedish-Danish controlled infliximab study" 32 : 984-989, 2010

      28 Laharie D, "Ciclosporin versus infliximab in patients with severe ulcerative colitis refractory to intravenous steroids: a parallel, open-label randomised controlled trial" 380 : 1909-1915, 2012

      29 Lamers CB, "Azathioprine : an update on clinical efficacy and safety in inflammatory bowel disease" 230 : 111-115, 1999

      30 Hindryckx P, "Acute severe ulcerative colitis : from pathophysiology to clinical management" 13 : 654-664, 2016

      31 Bantel H, "Abnormal activation of transcription factor NF-kappaB involved in steroid resistance in chronic inflammatory bowel disease" 95 : 1845-1846, 2000

      32 Rubin DT, "ACG clinical guideline : ulcerative colitis in adults" 114 : 384-413, 2019

      33 Turner D, "A systematic prospective comparison of noninvasive disease activity indices in ulcerative colitis" 7 : 1081-1088, 2009

      34 Goleva E, "A role for STAT5 in the pathogenesis of IL-2-induced glucocorticoid resistance" 169 : 5934-5940, 2002

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      학술지 이력
      연월일 이력구분 이력상세 등재구분
      2023 평가예정 해외DB학술지평가 신청대상 (해외등재 학술지 평가)
      2020-01-01 평가 등재학술지 유지 (해외등재 학술지 평가) KCI등재
      2015-03-30 학회명변경 영문명 : 미등록 -> KASID KCI등재
      2015-03-30 학회명변경 영문명 : KASID -> Korean Association for the Study of Intestinal Disease KCI등재
      2015-01-01 평가 등재학술지 유지 (등재유지) KCI등재
      2011-01-01 평가 등재학술지 선정 (등재후보2차) KCI등재
      2010-01-01 평가 등재후보 1차 PASS (등재후보1차) KCI등재후보
      2008-01-01 평가 등재후보학술지 선정 (신규평가) KCI등재후보
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      학술지 인용정보
      기준연도 WOS-KCI 통합IF(2년) KCIF(2년) KCIF(3년)
      2016 0.54 0.54 0.46
      KCIF(4년) KCIF(5년) 중심성지수(3년) 즉시성지수
      0.4 0.35 0.652 0.08
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