A231 EFFECTIVENESS OF DUAL BIOLOGIC THERAPY IN PEDIATRIC INFLAMMATORY BOWEL DISEASE: A MULTICENTRE CANADIAN STUDY

F. Diaz, R. Belaghi, T. Walters, E. Chea, D. Friedland, E. Wine, C. Deslandres, H. Huynh, J. deBruyn, D. Mack, A. Otley, A. Ricciuto, E. I. Benchimol, M. Carroll, P. Church, N. Carman, A. Shaikh, A. Griffiths, W. El-Matary
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Abstract

Abstract Background The effectiveness of combining biologics for pediatric inflammatory bowel disease (IBD) is under-investigated. Aims To evaluate the effectiveness of dual biologic therapy in children with IBD. Methods Children and adolescents ampersand:003C 17 years old with IBD enrolled in the Canadian Children IBD Network (CIDsCANN) who received any biologic therapy were included. Patients were classified as cases if they received two biologics simultaneously, and controls if they were switched from one biologic to another. All cases and controls who met inclusion criteria were analyzed. Baseline demographic and disease-specific data were collected. The primary outcome was clinical activity indices at the end of the 1-year period following the start of dual biologic therapy or the switch to a different biologic. The Wilcoxon signed rank test (for continuous variables) and the Fisher exact test (for nominal variables) were used to compare demographic data. A multivariable Cox proportional hazard model was used to infer about disease activity reduction between the two groups. p ampersand:003C 0.05 was used to determine statistical significance. Results Twenty-six cases and 194 controls fulfilled the inclusion criteria. Demographic and disease-specific data are summarized in Table 1. The most common combination was ustekinumab with vedolizumab in 11 (42.3%) patients; while the most common first biologic in the control group was infliximab (104, 54.1%) and the second was ustekinumab (109, 56.2%). The most common indication for the biologic therapy addition or switch was unsatisfactory clinical response. No differences between cases and controls in reductions of disease activity indices were seen at the end of the 1-year period (Figure 1). Conclusions In children with IBD, dual biologic therapy was not more effective than switching from one biologic to another. We are currently investigating the safety of this approach. Baseline data Dual biologic (n=26) Control (n=194) Sex Male 18 (69%) 103 (53%) Female 8 (31%) 91 (47%) Age at diagnosis (years) Mean (SD) 10.9 (3.11) 11.5 (3.46) Diagnosis Ulcerative colitis 12 (46%) 107 (55%) Crohn's disease 14 (54%) 87 (45%) Disease duration (years) Mean (SD) 4.47 (2.43) 4.34 (2.31) Baseline disease activity index PUCAI mean (SD) 25.0 (21.3) 25.3 (23.8) PCDAI mean (SD) 29.0 (22.2) 29.3 (23.0) Proportion of patients with 10- and 20-point reduction in clinical activity indices at the end of the 1-year period Funding Agencies None
A231 双重生物疗法对小儿炎症性肠病的疗效:加拿大多中心研究
摘要 背景 对联合使用生物制剂治疗小儿炎症性肠病(IBD)的有效性研究不足。目的 评估双重生物制剂疗法对儿童 IBD 患者的疗效。方法 纳入加拿大儿童 IBD 网络(CIDsCANN)中接受过任何生物制剂治疗的 17 岁 IBD 儿童和青少年。同时接受两种生物制剂治疗的患者被列为病例,从一种生物制剂转为另一种生物制剂的患者被列为对照。对符合纳入标准的所有病例和对照组进行了分析。研究人员收集了基线人口统计学数据和疾病特异性数据。主要结果是在开始接受双重生物制剂治疗或改用另一种生物制剂后的 1 年期末的临床活动指数。在比较人口统计学数据时使用了Wilcoxon符号秩检验(连续变量)和Fisher精确检验(名义变量)。采用多变量 Cox 比例危险模型推断两组患者的疾病活动性降低情况。结果 符合纳入标准的病例有 26 例,对照组有 194 例。人口统计学和疾病特异性数据汇总于表 1。11例(42.3%)患者最常见的联合用药是乌司他单抗和维多珠单抗;而对照组最常见的第一种生物制剂是英夫利西单抗(104例,54.1%),第二种是乌司他单抗(109例,56.2%)。增加或更换生物制剂疗法最常见的原因是临床反应不满意。在为期 1 年的治疗结束时,病例与对照组在疾病活动指数的降低方面没有差异(图 1)。结论 在 IBD 儿童患者中,双重生物制剂疗法并不比从一种生物制剂转换到另一种生物制剂更有效。我们目前正在研究这种方法的安全性。基线数据 双生物制剂(n=26) 对照组(n=194) 性别 男性 18(69%) 103(53%) 女性 8(31%) 91(47%) 诊断年龄(岁) 平均(标清) 10.9(3.11) 11.5(3.46) 诊断溃疡性结肠炎 12(46%) 107(55%) 克罗恩病 14(54%) 87(45%) 病程(年) 平均(标清) 4.47 (2.43) 4.34 (2.31) 基线疾病活动指数 PUCAI 平均 (SD) 25.0 (21.3) 25.3 (23.8) PCDAI 平均 (SD) 29.0 (22.2) 29.3 (23.0) 1 年期末临床活动指数降低 10 分和 20 分的患者比例 资助机构 无
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