DOP73 比利时前瞻性炎症性肠病患者队列:PANTHER 队列中的早期生物制剂使用情况

S Verstockt, E Glorieus, M De Wolf, M Lenfant, M Barbaraci, J Sabino, M Ferrante, J Geldof, B Verstockt, D Laukens, I Cleynen, L Vandermeulen, T Lobaton, S Vermeire
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Treatment use and outcomes are prospectively collected, and time trends for biological use were analysed using log-rank tests and Cox regression (R 4.3.2). Results Between 2015 and 2023, a total of 473 newly-diagnosed IBD patients were recruited (270 Crohn’s disease (CD) [57%]; 199 ulcerative colitis (UC) [42%]; 4 [1%] IBD type unclassified) (Table 1). During a median (IQR) follow-up of 2.6 (1.3-4.3) years, 64 patients (14%) required surgery (n=10 colectomy; n=54 ileocecal/small bowel resection); and 250 patients (53%) received biological therapy within the 1st year after diagnosis. Most patients were treated with anti-TNF (CD 67%; UC 55%) as first-line biological, followed by anti-integrins (CD 24%; UC 43%) and anti-IL12/23 (CD 9%; UC 2%). Time series analysis showed a significant increase in biological use within the 1st year after diagnosis when comparing patients diagnosed between 2015-2017 (44%) to those between 2018-2020 (57%), and to 2021-2023 (66%) (p=0.03) (Fig. 1A). Factors associated to this early biological use were younger age (HR=0.99 [95%CI: 0.98-0.99]), a diagnosis of CD (HR=2.2 [95%CI: 1.6-2.8]); and perianal disease in CD (HR=2.8 [95%CI: 1.8-12.8]). Within this early biological exposure group, 26 patients (10%) needed a resection later on. Therapy persistence over time was higher with early exposure rates in patients diagnosed in 2021-2023 (82%) and 2018-2021 (71%), as compared to 2015-2017 (63%) (p=0.08) (Fig.1B). The mode-of-action of first-line biological did not show any association with persistence (HR=1.0 [95%CI: 0.4-3.0]). Overall, only 26% of patients had to switch to a second-line, with a switch [anti-TNF >anti-IL12/23] being the most frequent in CD (50%); and from [anti-TNF >anti-integrins] (46%) or vice versa (40%) in UC. Conclusion In this Belgian inception cohort, two thirds of patients are currently initiated with biological therapy within the first year after diagnosis. 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引用次数: 0

摘要

背景 越来越多的先进疗法彻底改变了炎症性肠病(IBD)的治疗方法。虽然早期使用生物疗法可获得更好的长期疗效,但目前尚无比利时人群的相关数据。为此,我们对比利时初始队列中生物疗法的使用和持续治疗模式进行了评估。方法 PANTHER(早期慢性结肠炎或结肠炎患者预后生物分析)队列由比利时 3 个 IBD 转诊中心招募的成年 IBD 患者组成。患者在确诊后 3 个月内入组,初次使用免疫抑制剂和生物制剂,既往未接受过 IBD 相关手术。前瞻性地收集了治疗使用情况和结果,并使用对数秩检验和 Cox 回归(R 4.3.2)分析了生物制剂使用的时间趋势。结果 2015 年至 2023 年间,共招募了 473 名新确诊的 IBD 患者(270 名克罗恩病 (CD) [57%];199 名溃疡性结肠炎 (UC) [42%];4 名 IBD 类型未分类 [1%])(表 1)。在中位数(IQR)为 2.6(1.3-4.3)年的随访期间,64 名患者(14%)需要进行手术(10 人接受结肠切除术;54 人接受回盲部/小肠切除术);250 名患者(53%)在确诊后第一年内接受了生物疗法。大多数患者接受了抗肿瘤坏死因子(CD 67%;UC 55%)作为一线生物治疗,其次是抗整合素(CD 24%;UC 43%)和抗IL12/23(CD 9%;UC 2%)。时间序列分析显示,与 2015-2017 年间(44%)和 2018-2020 年间(57%)以及 2021-2023 年间(66%)确诊的患者相比,确诊后第一年内使用生物制剂的患者明显增加(P=0.03)(图 1A)。与早期使用生物制剂相关的因素有:年龄较小(HR=0.99 [95%CI:0.98-0.99])、诊断为CD(HR=2.2 [95%CI:1.6-2.8]);CD中的肛周疾病(HR=2.8 [95%CI:1.8-12.8])。在这一早期生物暴露组中,有26名患者(10%)后来需要进行切除手术。与2015-2017年(63%)相比,在2021-2023年(82%)和2018-2021年(71%)确诊的患者中,早期暴露率的治疗持续时间更高(P=0.08)(图1B)。一线生物制剂的作用模式与持续性没有任何关联(HR=1.0 [95%CI:0.4-3.0])。总体而言,仅有 26% 的患者需要转用二线药物,其中 CD 最常转用[抗肿瘤坏死因子 >anti-IL12/23] (50%);UC 最常转用[抗肿瘤坏死因子 >anti-integrins] (46%),反之亦然(40%)。结论 在比利时的这一初始队列中,目前有三分之二的患者在确诊后第一年内开始接受生物治疗。在中位随访 1.5 年后,生物疗法的使用率上升至 80%,且手术切除率较低。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
DOP73 Early biological use in a Belgian, prospective inception cohort of patients with Inflammatory Bowel Disease: the PANTHER cohort
Background The growing number of advanced therapies has revolutionized the management of inflammatory bowel disease (IBD). Although early use of biological therapies is associated with better long-term outcomes, no data exist for the Belgian population. To this end, we evaluated treatment patterns in biological use and persistence in a Belgian inception cohort. Methods The PANTHER (Prognostic biobANk of paTients witH Early cRohn’s or colitis) cohort consists of adult IBD patients recruited in 3 Belgian IBD referral centres. Patients are included within 3 months after diagnosis and are naïve for immunosuppressives and biologicals, and without previous IBD-related surgery. Treatment use and outcomes are prospectively collected, and time trends for biological use were analysed using log-rank tests and Cox regression (R 4.3.2). Results Between 2015 and 2023, a total of 473 newly-diagnosed IBD patients were recruited (270 Crohn’s disease (CD) [57%]; 199 ulcerative colitis (UC) [42%]; 4 [1%] IBD type unclassified) (Table 1). During a median (IQR) follow-up of 2.6 (1.3-4.3) years, 64 patients (14%) required surgery (n=10 colectomy; n=54 ileocecal/small bowel resection); and 250 patients (53%) received biological therapy within the 1st year after diagnosis. Most patients were treated with anti-TNF (CD 67%; UC 55%) as first-line biological, followed by anti-integrins (CD 24%; UC 43%) and anti-IL12/23 (CD 9%; UC 2%). Time series analysis showed a significant increase in biological use within the 1st year after diagnosis when comparing patients diagnosed between 2015-2017 (44%) to those between 2018-2020 (57%), and to 2021-2023 (66%) (p=0.03) (Fig. 1A). Factors associated to this early biological use were younger age (HR=0.99 [95%CI: 0.98-0.99]), a diagnosis of CD (HR=2.2 [95%CI: 1.6-2.8]); and perianal disease in CD (HR=2.8 [95%CI: 1.8-12.8]). Within this early biological exposure group, 26 patients (10%) needed a resection later on. Therapy persistence over time was higher with early exposure rates in patients diagnosed in 2021-2023 (82%) and 2018-2021 (71%), as compared to 2015-2017 (63%) (p=0.08) (Fig.1B). The mode-of-action of first-line biological did not show any association with persistence (HR=1.0 [95%CI: 0.4-3.0]). Overall, only 26% of patients had to switch to a second-line, with a switch [anti-TNF >anti-IL12/23] being the most frequent in CD (50%); and from [anti-TNF >anti-integrins] (46%) or vice versa (40%) in UC. Conclusion In this Belgian inception cohort, two thirds of patients are currently initiated with biological therapy within the first year after diagnosis. This increased biological use is associated with high therapy persistence rates of >80% after a median follow-up of 1.5 years, and with low rates of surgical resections.
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