ADALIMUMAB FOR ULCERATIVE COLITIS: RESULTS OF A BRAZILIAN MULTICENTER OBSERVATIONAL STUDY.

ADALIMUMAB FOR ULCERATIVE COLITIS: RESULTS OF A BRAZILIAN MULTICENTER OBSERVATIONAL STUDY.
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阿达木单抗治疗溃疡性结肠炎:巴西多中心观察研究的结果。

DOI:
10.1590/s0004-2803.201700000-51
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发表时间:
2017
影响因子:
--
通讯作者:
P. Kotze
P. Kotze
中科院分区:
--
文献类型:
--
作者:
P. Zacharias;A. Damião;A. Moraes;F. Teixeira;J. Ludvig;R. Nones;R. Saad;L. Sassaki;Rosemary da Silva;L. Facchin;M. Olandoski;P. Kotze

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背景 阿达单抗是一种抗肿瘤坏死因子-α(α)的单抗,对中、重度溃疡性结肠炎有诱导和维持缓解的作用。在拉丁美洲溃疡性结肠炎患者中使用阿达利单抗的真实研究很少。 客观化 目的:评价阿达利单抗治疗溃疡性结肠炎的诱导和维持治疗的临床缓解率。 方法 阿达利单抗治疗中重度溃疡性结肠炎病例系列的观察、多中心和回顾性研究。分析的变量是:人口统计数据,英夫利昔单抗的先前状态,伴随药物,蒙特利尔分类,0,8,26和52周的疾病活动(Mayo评分),或直到最后一次随访。临床缓解定义为部分Mayo评分,≤-2,最后观察结转(LOCF值)和无应答(NRI)分析。 结果 36名患者参与了这项研究。经LOCF分析,8周、26周、52周缓解率分别为41.7%、47.2%、47.2%。经NRI分析,8、26、52周的缓解率分别为41.7%、41.7%、27.8%。 结论 阿达利单抗治疗中重度溃疡性结肠炎有效。大约40%的患者在8周和26周观察到临床缓解,近四分之一的患者在一年的随访后观察到临床缓解。
BACKGROUND Adalimumab is a monoclonal antibody, tumor necrosis factor-alpha (TNFα) inhibitor that has efficacy for inducing and maintaining remission in moderate-to-severe ulcerative colitis. Real world studies with adalimumab in Latin American ulcerative colitis patients are scarce. OBJECTIVE To assess the clinical remission rates in induction and maintenance with adalimumab therapy in ulcerative colitis. METHODS Observational, multicenter and retrospective study on a case series of patients with moderate-to-severe ulcerative colitis under adalimumab therapy. The variables analyzed were: demographic data, previous infliximab status, concomitant drugs, the Montreal Classification, disease activity (Mayo score) at weeks 0, 8, 26 and 52, or until the last follow-up. Clinical remission was defined as a partial Mayo score ≤2 and Last observation carried forward (LOCF) and Non responder imputation (NRI) analysis were used. RESULTS Thirty-six patients were included in the study. With LOCF analysis, remission rates at weeks 8, 26 e 52 were of 41.7%, 47.2% and 47.2%, respectively. With NRI analysis, remission rates at weeks 8, 26 and 52 were of 41.7%, 41.7% and 27.8%, respectively. CONCLUSION Adalimumab was effective in the treatment of moderate-to-severe ulcerative colitis. Clinical remission was observed in approximately 40% of the patients at weeks 8 and 26, and in almost a quarter of the patients after 1 year of follow up.
DOI: 10.1056/nejmoa050516
发表时间: 2005-12-08
影响因子: 158.5
作者:
Rutgeerts, P;Sandborn, WJ;Colombel, JF
通讯作者: Colombel, JF