《来自 epi-IIRN 的全国性研究：克罗恩病患者的首个生物制剂的耐久性》。
Durability of the First Biologic in Patients with Crohn's Disease: A Nationwide Study from the epi-IIRN.
机构信息
Juliet Keidan Institute of Pediatric Gastroenterology Hepatology and Nutrition, Shaare Zedek Medical Center, Hebrew University of Jerusalem, Jerusalem, Israel.
Pediatric Gastroenterology & Nutrition Institute, Ruth Rappaport Children's Hospital, Rambam Health Care Campus and the Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.
出版信息
J Crohns Colitis. 2024 Jan 27;18(1):38-46. doi: 10.1093/ecco-jcc/jjad121.
BACKGROUND
In this nationwide study we aimed to compare the durability of the first initiated biologic in Crohn's disease [CD], stratified by monotherapy and combotherapy.
METHODS
We used data from the epi-IIRN cohort, which includes 98% of the Israeli inflammatory bowel disease population [2005-2020]. Durability was defined as consistent treatment without surgery or added medications [except for combination therapy with thiopurines or methotrexate]. All comparisons were based on stringent propensity-score matching and paired time-to-event analyses.
RESULTS
A total of 19 264 patients with CD were included, of whom 7452 [39%] received biologics with a median follow-up of 6.8 years (interquartile range [IQR] 3.6-10.7). Time to biologics decreased gradually from 6.7 years [IQR 2.7-10.4] in 2005 to 0.2 years [0.07-0.23] in 2020. The durability of the first biologic after 1 and 3 years was higher with adalimumab monotherapy [88%/61%] than vedolizumab monotherapy [81%/59%; n = 394 matched patients, p = 0.04] and similar between infliximab monotherapy and vedolizumab monotherapy [65%/43%; n = 182 matched patients, p = 0.1]. Durability was higher in adalimumab monotherapy vs infliximab monotherapy [83%/62% vs 71%/48% at 1/3 years; p <0.001] and it was similar in adalimumab monotherapy vs infliximab combotherapy [87%/63% vs 80%/58%, respectively; p = 0.1]. Durability was higher in combotherapy compared with monotherapy for both infliximab [85%/64% vs 67%/43%, respectively; n = 496 matched pairs, p <0.001], and adalimumab [93%/76% vs 82%/62%, respectively; n = 540 matched pairs, p <0.001].
CONCLUSION
Durability of the first biologic in CD was highest for adalimumab monotherapy. Combotherapy further increased the durability of adalimumab and infliximab. Unless otherwise indicated, our data may support using anti-tumour necrosis factors [TNFs] as first-line biologics in CD, particularly adalimumab if monotherapy is advised.
背景
在这项全国性研究中，我们旨在比较克罗恩病 [CD] 中首次使用的生物制剂的耐久性，分为单药治疗和联合治疗。
方法
我们使用了 epi-IIRN 队列的数据，该队列包括了 98%的以色列炎症性肠病患者[2005-2020 年]。耐久性定义为持续治疗而无需手术或添加药物[除了与硫嘌呤或甲氨蝶呤联合治疗]。所有比较均基于严格的倾向评分匹配和配对的时间事件分析。
结果
共纳入 19264 例 CD 患者，其中 7452 例[39%]接受生物制剂治疗，中位随访时间为 6.8 年（四分位距 [IQR] 3.6-10.7）。从 2005 年的 6.7 年 [IQR 2.7-10.4]到 2020 年的 0.2 年 [0.07-0.23]，生物制剂的使用时间逐渐减少。在 1 年和 3 年后，阿达木单抗单药治疗的首个生物制剂的耐久性更高[88%/61%]，而维得利珠单抗单药治疗[81%/59%；n=394 例匹配患者，p=0.04]，与英夫利昔单抗单药治疗相似[65%/43%；n=182 例匹配患者，p=0.1]。阿达木单抗单药治疗的耐久性高于英夫利昔单抗单药治疗[83%/62%比 71%/48%在 1/3 年；p<0.001]，阿达木单抗单药治疗与英夫利昔单抗联合治疗的耐久性相似[87%/63%比 80%/58%，分别；p=0.1]。与单药治疗相比，英夫利昔单抗[85%/64%比 67%/43%，分别；n=496 对匹配对，p<0.001]和阿达木单抗[93%/76%比 82%/62%，分别；n=540 对匹配对，p<0.001]联合治疗的耐久性更高。
结论
在 CD 中，首个生物制剂的耐久性以阿达木单抗单药治疗最高。联合治疗进一步提高了阿达木单抗和英夫利昔单抗的耐久性。除非另有说明，否则我们的数据可能支持在 CD 中使用抗肿瘤坏死因子 [TNFs] 作为一线生物制剂，特别是如果建议单药治疗，则使用阿达木单抗。
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