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Review Article

帮助决定治疗选择的新范式:炎症性肠病生物疗法的面对面试验

卷 22, 期 4, 2021

发表于: 11 December, 2020

页: [370 - 378] 页: 9

弟呕挨: 10.2174/1389450121666201211162527

价格: $65

摘要

随着炎症性肠病(IBD)药物装备的不断增加，需要对不同的治疗方案进行直接比较，以便指导医生为患者选择最合适的治疗方案。面对面试验被认为是IBD比较研究的黄金标准，它允许在相同的人群和环境中比较不同的治疗方法，但也可以评估不同的治疗策略。尽管包括生物制剂和免疫抑制治疗在内的对IBD的面对面试验早在几十年前就已经进行了，但自从第一个直接比较生物制剂与不同分子靶点的随机对照试验发表以来，人们对这些直接比较的兴趣越来越大。这篇综述提供了过去和当前IBD面对面试验的概述，考虑了他们各自在现实生活中的优势和局限性。

关键词: 炎症性肠病，面对面试验，随机临床试验，直接比较，治疗策略

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图形摘要

[1]
Colombel JF, Narula N, Peyrin-Biroulet L. Management strategies to improve outcomes of patients with inflammatory bowel diseases. Gastroenterology 2017; 152(2): 351-61.
[http://dx.doi.org/10.1053/j.gastro.2016.09.046] [PMID: 27720840]
[2]
Neurath MF. Current and emerging therapeutic targets for IBD. Nat Rev Gastroenterol Hepatol 2017; 14(5): 269-78.
[http://dx.doi.org/10.1038/nrgastro.2016.208] [PMID: 28144028]
[3]
Pouillon L, Travis S, Bossuyt P, Danese S, Peyrin-Biroulet L. Head-to-head trials in inflammatory bowel disease: past, present and future. Nat Rev Gastroenterol Hepatol 2020; 17(6): 365-76.
[http://dx.doi.org/10.1038/s41575-020-0293-9] [PMID: 32303700]
[4]
Sands BE, Peyrin-Biroulet L, Loftus EV Jr, et al. VARSITY Study Group. Vedolizumab versus Adalimumab for moderate-to-severe ulcerative colitis. N Engl J Med 2019; 381(13): 1215-26.
[http://dx.doi.org/10.1056/NEJMoa1905725] [PMID: 31553834]
[5]
D’Haens G, Baert F, van Assche G, et al. Belgian inflammatory bowel disease research group; north-holland gut club. early combined immunosuppression or conventional management in patients with newly diagnosed crohn’s disease: an open randomised trial. Lancet 2008; 371(9613): 660-7.
[http://dx.doi.org/10.1016/S0140-6736(08)60304-9] [PMID: 18295023]
[6]
Feuerstein JD, Isaacs KL, Schneider Y, Siddique SM, Falck-Ytter Y, Singh S. AGA institute clinical guidelines committee. aga clinical practice guidelines on the management of moderate to severe ulcerative colitis. Gastroenterology 2020; 158(5): 1450-61.
[http://dx.doi.org/10.1053/j.gastro.2020.01.006] [PMID: 31945371]
[7]
Torres J, Bonovas S, Doherty G, et al. ECCO guidelines on therapeutics in Crohn’s disease: Medical treatment. J Crohn’s Colitis 2020; 14(1): 4-22.
[http://dx.doi.org/10.1093/ecco-jcc/jjz180] [PMID: 31711158]
[8]
Colombel JF, Sandborn WJ, Reinisch W, et al. SONIC Study Group. Infliximab, azathioprine, or combination therapy for Crohn’s disease. N Engl J Med 2010; 362(15): 1383-95.
[http://dx.doi.org/10.1056/NEJMoa0904492] [PMID: 20393175]
[9]
Peyrin-Biroulet L, Reinisch W, Colombel JF, et al. Clinical disease activity, C-reactive protein normalisation and mucosal healing in Crohn’s disease in the SONIC trial. Gut 2014; 63(1): 88-95.
[http://dx.doi.org/10.1136/gutjnl-2013-304984] [PMID: 23974954]
[10]
Colombel JF, Reinisch W, Mantzaris GJ, et al. Randomised clinical trial: deep remission in biologic and immunomodulator naïve patients with Crohn’s disease - a SONIC post hoc analysis. Aliment Pharmacol Ther 2015; 41(8): 734-46.
[http://dx.doi.org/10.1111/apt.13139] [PMID: 25728587]
[11]
Panaccione R, Ghosh S, Middleton S, et al. Combination therapy with infliximab and azathioprine is superior to monotherapy with either agent in ulcerative colitis. Gastroenterology 2014; 146(2): 392-400.
[http://dx.doi.org/10.1053/j.gastro.2013.10.052] [PMID: 24512909]
[12]
Feagan BG, McDonald JWD, Panaccione R, et al. Methotrexate in combination with infliximab is no more effective than infliximab alone in patients with Crohn’s disease. Gastroenterology 2014; 146(3): 681-8.
[http://dx.doi.org/10.1053/j.gastro.2013.11.024] [PMID: 24269926]
[13]
Laharie D, Bourreille A, Branche J, et al. Groupe d’Etudes Thérapeutiques des Affections Inflammatoires Digestives. Ciclosporin versus infliximab in patients with severe ulcerative colitis refractory to intravenous steroids: a parallel, open-label randomised controlled trial. Lancet 2012; 380(9857): 1909-15.
[http://dx.doi.org/10.1016/S0140-6736(12)61084-8] [PMID: 23063316]
[14]
Williams JG, Alam MF, Alrubaiy L, et al. Infliximab versus ciclosporin for steroid-resistant acute severe ulcerative colitis (CONSTRUCT): a mixed methods, open-label, pragmatic randomised trial. Lancet Gastroenterol Hepatol 2016; 1(1): 15-24.
[http://dx.doi.org/10.1016/S2468-1253(16)30003-6] [PMID: 27595142]
[15]
Sandborn WJ, Baert F, Danese S, et al. Efficacy and safety of vedolizumab subcutaneous formulation in a randomized trial of patients with ulcerative colitis. Gastroenterology 2020; 158(3): 562-572.e12.
[http://dx.doi.org/10.1053/j.gastro.2019.08.027] [PMID: 31470005]
[16]
Peyrin-Biroulet L, Danese S, Argollo M, et al. Loss of response to vedolizumab and ability of dose intensification to restore response in patients with crohn’s disease or ulcerative colitis: a systematic review and meta-analysis. Clin Gastroenterol Hepatol 2019; 17(5): 838-846.e2.
[http://dx.doi.org/10.1016/j.cgh.2018.06.026] [PMID: 29935327]
[17]
Paul S, Moreau AC, Del Tedesco E, et al. Pharmacokinetics of adalimumab in inflammatory bowel diseases: a systematic review and meta-analysis. Inflamm Bowel Dis 2014; 20(7): 1288-95.
[http://dx.doi.org/10.1097/MIB.0000000000000037] [PMID: 24831559]
[18]
Ponsioen CY, de Groof EJ, Eshuis EJ, et al. LIR!C study group. Laparoscopic ileocaecal resection versus infliximab for terminal ileitis in Crohn’s disease: a randomised controlled, open-label, multicentre trial. Lancet Gastroenterol Hepatol 2017; 2(11): 785-92.
[http://dx.doi.org/10.1016/S2468-1253(17)30248-0] [PMID: 28838644]
[19]
Vuitton L, Peyrin-Biroulet L. Pharmacological prevention of postoperative recurrence in crohn’s disease. Drugs 2020; 80(4): 385-99.
[http://dx.doi.org/10.1007/s40265-020-01266-3] [PMID: 32056142]
[20]
De Cruz P, Kamm MA, Hamilton AL, et al. Crohn’s disease management after intestinal resection: a randomised trial. Lancet 2015; 385(9976): 1406-17.
[http://dx.doi.org/10.1016/S0140-6736(14)61908-5] [PMID: 25542620]
[21]
Gionchetti P, Dignass A, Danese S, et al. ECCO. 3rd European evidence-based consensus on the diagnosis and management of Crohn’s disease 2016: Part 2: Surgical management and special situations. J Crohn’s Colitis 2017; 11(2): 135-49.
[http://dx.doi.org/10.1093/ecco-jcc/jjw169] [PMID: 27660342]
[22]
De Cruz P, Kamm MA, Hamilton AL, et al. Efficacy of thiopurines and adalimumab in preventing Crohn’s disease recurrence in high-risk patients - a POCER study analysis. Aliment Pharmacol Ther 2015; 42(7): 867-79.
[http://dx.doi.org/10.1111/apt.13353] [PMID: 26314275]
[23]
Hoekman DR, Stibbe JA, Baert FJ, et al. Belgian Inflammatory Bowel Disease Research and Development (BIRD) Group; North-Holland Gut Club. Long-term outcome of early combined immunosuppression versus conventional management in newly diagnosed Crohn’s disease. J Crohn’s Colitis 2018; 12(5): 517-24.
[http://dx.doi.org/10.1093/ecco-jcc/jjy014] [PMID: 29401297]
[24]
Baert F, Moortgat L, Van Assche G, et al. Belgian inflammatory bowel disease research group; north-holland gut club. mucosal healing predicts sustained clinical remission in patients with early-stage crohn’s disease. Gastroenterology 2010; 138(2): 463-8.
[http://dx.doi.org/10.1053/j.gastro.2009.09.056] [PMID: 19818785]
[25]
Khanna R, Bressler B, Levesque BG, et al. REACT Study Investigators. Early combined immunosuppression for the management of Crohn’s disease (REACT): a cluster randomised controlled trial. Lancet 2015; 386(10006): 1825-34.
[http://dx.doi.org/10.1016/S0140-6736(15)00068-9] [PMID: 26342731]
[26]
US National Library of Medicine NCT01698307, Available from:https://clinicaltrials.gov/ct2/show/NCT01698307
[27]
Colombel JF, Panaccione R, Bossuyt P, et al. Effect of tight control management on Crohn’s disease (CALM): a multicentre, randomised, controlled phase 3 trial. Lancet 2018; 390(10114): 2779-89.
[http://dx.doi.org/10.1016/S0140-6736(17)32641-7] [PMID: 29096949]
[28]
Peyrin-Biroulet L, Sandborn W, Sands BE, et al. Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE): Determining Therapeutic Goals for Treat-to-Target. Am J Gastroenterol 2015; 110(9): 1324-38.
[http://dx.doi.org/10.1038/ajg.2015.233] [PMID: 26303131]
[29]
Ungaro RC, Yzet C, Bossuyt P, et al. Deep Remission at 1 Year Prevents Progression of Early Crohn’s Disease Gastroenterology 2020; 159(1): 139-47.
[30]
D’Haens G, Vermeire S, Lambrecht G, et al. GETAID. Increasing Infliximab Dose Based on Symptoms, Biomarkers, and Serum Drug Concentrations Does Not Increase Clinical, Endoscopic, and Corticosteroid-Free Remission in Patients With Active Luminal Crohn’s Disease. Gastroenterology 2018; 154(5): 1343-51.
[http://dx.doi.org/10.1053/j.gastro.2018.01.004] [PMID: 29317275]
[31]
Vande Casteele N, Ferrante M, Van Assche G, et al. Trough concentrations of infliximab guide dosing for patients with inflammatory bowel disease. Gastroenterology 2015; 148(7): 1320-9.
[http://dx.doi.org/10.1053/j.gastro.2015.02.031] [PMID: 25724455]
[32]
Pouillon L, Ferrante M, Van Assche G, et al. Mucosal healing and long-term outcomes of patients with inflammatory bowel diseases receiving clinic-based vs trough concentration-based dosing of infliximab. Clin Gastroenterol Hepatol 2018; 16(8): 1276-83.
[http://dx.doi.org/10.1016/j.cgh.2017.11.046] [PMID: 29203225]
[33]
US National Library of Medicine NCT03464136, Available from:https://clinicaltrials.gov/ct2/show/NCT03464136
[34]
US National Library of Medicine NCT03759288, Available from:https://clinicaltrials.gov/ct2/show/NCT03759288
[35]
US National Library of Medicine NCT03926130, Available from:https://clinicaltrials.gov/ct2/show/NCT03926130
[36]
US National Library of Medicine NCT03466411, Available from:https://clinicaltrials.gov/ct2/show/NCT03466411
[37]
US National Library of Medicine NCT03662542, Available from:https://clinicaltrials.gov/ct2/show/NCT03662542
[38]
US National Library of Medicine NCT02136069, Available from:https://clinicaltrials.gov/ct2/show/NCT02136069
[39]
US National Library of Medicine NCT02163759, Available from:https://clinicaltrials.gov/ct2/show/NCT02163759
[40]
US National Library of Medicine NCT02171429, Available from:https://clinicaltrials.gov/ct2/show/NCT02171429
[41]
US National Library of Medicine NCT03616821, Available from:https://clinicaltrials.gov/ct2/show/NCT03616821

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