不同的英夫利西单抗诱导给药方案不会影响克罗恩病患儿一年内的缓解率。

IF 2.4 3区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Journal of Pediatric Gastroenterology and Nutrition Pub Date : 2024-09-01 Epub Date: 2024-07-09 DOI:10.1002/jpn3.12307
Tal Marshanski, Eliana Fanous, Noa Tal, Tsachi T Perets, Manar Matar, Yael Weintraub, Raanan Shamir, Dror S Shouval
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引用次数: 0

摘要

目的:对接受抗肿瘤坏死因子α药物治疗的克罗恩病(CD)患者进行的多项研究表明,在维持治疗阶段主动进行治疗药物监测(TDM)可改善疗效。我们的目的是评估在诱导期加速英夫利西单抗用药是否能改善疗效:这项回顾性研究纳入了接受英夫利西单抗治疗的 5-17.9 岁 CD 患者。我们比较了诱导期患者在第 0、2、6 和 14 周使用 5-8 mg/kg 剂量(第 1 组)与加速使用英夫利西单抗(≥8 mg/kg 和/或 >4 次输注直至第 14 周,第 2 组)的疗效。主要结果是第52周时无类固醇临床缓解:结果:共纳入68例患者,其中7例在第14周前因输注反应、免疫原性失败或原发性无应答而停用英夫利西单抗。第一组(25 人)和第二组(36 人)的比较显示,开始使用英夫利西单抗时的临床特征和炎症指标相似。尽管第1组接受的英夫利西单抗明显更多,并且在第14周达到了更高的谷值水平(10.3 ± 1.2 vs. 3.3 ± 0.7,P 结论:英夫利西单抗的加速治疗效果更好:在诱导期间加快英夫利西单抗剂量并不能改善随访12个月的疗效。需要进行前瞻性研究,以确定应用主动TDM的确切时间。
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Different infliximab induction dosing regimens do not affect remission rates up to 1 year in children with Crohn's disease.

Objectives: Multiple studies in patients with Crohn's disease (CD) treated with anti-tumor necrosis factor alpha agents have shown that proactive therapeutic drug monitoring (TDM) during the maintenance phase leads to improved outcomes. We aimed to assess whether accelerated (IFX) administration during induction resulted in improved outcomes.

Methods: This retrospective study included CD patients aged 5-17.9 years that were treated with IFX. We compared outcomes of patients treated during induction with 5-8 mg/kg dosing at Weeks 0, 2, 6, and 14 (Group 1), versus accelerated dosing (≥8 mg/kg and/or >4 infusions until Week 14, Group 2) of IFX. Primary outcome was steroid-free clinical remission by Week 52.

Results: Sixty-eight patients were included, of whom seven discontinued IFX before Week 14, due to infusion reactions, immunogenic failure, or primary nonresponse. Comparison of Group 1 (n = 25) and Group 2 (n = 36) showed similar clinical characteristics, as well as inflammatory markers, at IFX initiation. Despite receiving significantly more IFX, and reaching a higher trough level by Week 14 (10.3 ± 1.2 vs. 3.3 ± 0.7, p < 0.001), the median Pediatric Crohn's disease Activity Index (PCDAI) was slightly higher in Group 2 versus Group 1 (14 [5-20] vs. 5 [0-15], p = 0.02). However, at Weeks 26 and 52 the PCDAI and inflammatory markers were comparable between the groups. Moreover, about 70% in both groups achieved the desirable trough IFX levels by Week 52.

Conclusion: Accelerated IFX dosing during induction did not result in improved outcomes up to 12 months follow-up. Prospective studies are required to determine the exact timing in which proactive TDM should be applied.

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来源期刊
CiteScore
5.30
自引率
13.80%
发文量
467
审稿时长
3-6 weeks
期刊介绍: ​The Journal of Pediatric Gastroenterology and Nutrition (JPGN) provides a forum for original papers and reviews dealing with pediatric gastroenterology and nutrition, including normal and abnormal functions of the alimentary tract and its associated organs, including the salivary glands, pancreas, gallbladder, and liver. Particular emphasis is on development and its relation to infant and childhood nutrition.
期刊最新文献
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