炎性肠病患者序贯使用第二种和第三种抗TNF药物的有效性和安全性：来自埃内达注册研究的结果
Effectiveness and Safety of the Sequential Use of a Second and Third Anti-TNF Agent in Patients With Inflammatory Bowel Disease: Results From the Eneida Registry.
作者信息
Casanova María José, Chaparro María, Mínguez Miguel, Ricart Elena, Taxonera Carlos, García-López Santiago, Guardiola Jordi, López-San Román Antonio, Iglesias Eva, Beltrán Belén, Sicilia Beatriz, Vera María Isabel, Hinojosa Joaquín, Riestra Sabino, Domènech Eugeni, Calvet Xavier, Pérez-Calle José Lázaro, Martín-Arranz María Dolores, Aldeguer Xavier, Rivero Montserrat, Monfort David, Barrio Jesús, Esteve María, Márquez Lucía, Lorente Rufo, García-Planella Esther, de Castro Luisa, Bermejo Fernando, Merino Olga, Rodríguez-Pérez Antonio, Martínez-Montiel Pilar, Van Domselaar Manuel, Alcaín Guillermo, Domínguez-Cajal Manuel, Muñoz Carmen, Gomollón Fernando, Fernández-Salazar Luis, García-Sepulcre Mariana Fe, Rodríguez-Lago Iago, Gutiérrez Ana, Argüelles-Arias Federico, Rodriguez Cristina, Rodríguez Gloria Esther, Bujanda Luis, Llaó Jordina, Varela Pilar, Ramos Laura, Huguet José María, Almela Pedro, Romero Patricia, Navarro-Llavat Mercè, Abad Águeda, Ramírez-de la Piscina Patricia, Lucendo Alfredo J, Sesé Eva, Madrigal Rosa Eva, Charro Mara, García-Herola Antonio, Pajares Ramón, Khorrami Sam, Gisbert Javier P
机构信息
Gastroenterology Department at Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.
Gastroenterology Department at Hospital Clínico Valencia, Valencia, Spain.
出版信息
Inflamm Bowel Dis. 2020 Mar 4;26(4):606-616. doi: 10.1093/ibd/izz192.
BACKGROUND
The effectiveness of the switch to another anti-tumor necrosis factor (anti-TNF) agent is not known. The aim of this study was to analyze the effectiveness and safety of treatment with a second and third anti-TNF drug after intolerance to or failure of a previous anti-TNF agent in inflammatory bowel disease (IBD) patients.
METHODS
We included patients diagnosed with IBD from the ENEIDA registry who received another anti-TNF after intolerance to or failure of a prior anti-TNF agent.
RESULTS
A total of 1122 patients were included. In the short term, remission was achieved in 55% of the patients with the second anti-TNF. The incidence of loss of response was 19% per patient-year with the second anti-TNF. Combination therapy (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.8-3; P < 0.0001) and ulcerative colitis vs Crohn's disease (HR, 1.6; 95% CI, 1.1-2.1; P = 0.005) were associated with a higher probability of loss of response. Fifteen percent of the patients had adverse events, and 10% had to discontinue the second anti-TNF. Of the 71 patients who received a third anti-TNF, 55% achieved remission. The incidence of loss of response was 22% per patient-year with a third anti-TNF. Adverse events occurred in 7 patients (11%), but only 1 stopped the drug.
CONCLUSIONS
Approximately half of the patients who received a second anti-TNF achieved remission; nevertheless, a significant proportion of them subsequently lost response. Combination therapy and type of IBD were associated with loss of response. Remission was achieved in almost 50% of patients who received a third anti-TNF; nevertheless, a significant proportion of them subsequently lost response.
背景
换用另一种抗肿瘤坏死因子（抗TNF）药物的疗效尚不清楚。本研究的目的是分析炎症性肠病（IBD）患者在对先前的抗TNF药物不耐受或治疗失败后，使用第二种和第三种抗TNF药物治疗的有效性和安全性。
方法
我们纳入了来自ENEIDA注册库中被诊断为IBD且在对先前的抗TNF药物不耐受或治疗失败后接受另一种抗TNF药物治疗的患者。
结果
共纳入1122例患者。短期内，55%接受第二种抗TNF药物治疗的患者实现缓解。接受第二种抗TNF药物治疗的患者每年反应丧失发生率为19%。联合治疗（风险比[HR]，2.4；95%置信区间[CI]，1.8 - 3；P < 0.0001）以及溃疡性结肠炎与克罗恩病相比（HR，1.6；95%CI，1.1 - 2.1；P = 0.005）与反应丧失的较高概率相关。15%的患者出现不良事件，10%的患者不得不停用第二种抗TNF药物。在接受第三种抗TNF药物治疗的71例患者中，55%实现缓解。接受第三种抗TNF药物治疗的患者每年反应丧失发生率为22%。7例患者（11%）出现不良事件，但只有1例停药。
结论
接受第二种抗TNF药物治疗的患者中约一半实现缓解；然而，其中很大一部分随后失去反应。联合治疗和IBD类型与反应丧失有关。接受第三种抗TNF药物治疗的患者中近50%实现缓解；然而，其中很大一部分随后失去反应。
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