Subcutaneous Infliximab Concentration Thresholds for Mucosal and Transmural Healing in Patients With Crohn's Disease.

IF 6.6 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Alimentary Pharmacology & Therapeutics Pub Date : 2024-11-18 DOI:10.1111/apt.18354

Sung Noh Hong, Joo Hye Song, Sung Jin Kim, Yoon Ha Park, Chang Wan Choi, Ji Eun Kim, Eun Ran Kim, Dong Kyung Chang, Young-Ho Kim

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引用次数: 0

Abstract

Background: Predose trough concentrations (C_trough) of intravenous infliximab (IV-IFX) during maintenance therapy are associated with therapeutic outcomes in patients with Crohn's disease (CD). A subcutaneous formulation of infliximab (SC-IFX) has shown high C_trough values due to its favourable pharmacokinetics.

Aims: To evaluate the association of C_trough of SC-IFX with therapeutic outcomes and the threshold of SC-IFX C_trough for achieving mucosal healing (MH) and transmural healing (TH) in patients with CD.

Methods: We performed this cross-sectional study in patients with CD who had received SC-IFX maintenance therapy for ≥ 6 months. We measured SC-IFX C_trough immediately before SC-IFX injection. We performed ileocolonoscopy/single-balloon enteroscopy and/or magnetic resonance enterography within 3 months of SC-IFX C_trough measurement. MH was defined as SES-CD-ulcerated surface subscore of 0. TH was defined as simplified MaRIA score of 0.

Results: We enrolled 124 patients with MH in 77.9% (74/95) and TH in 36.3% (37/102). SC-IFX C_trough was significantly higher in patients with MH (24.1 vs.16.9 μg/mL; p = 0.001) and TH (26.0 vs. 20.5 μg/mL; p = 0.007) than in those without. ROC analysis identified that the threshold of SC-IFX C_trough for MH and TH were 17.5 and 30.3 μg/mL, respectively. Multivariate logistic regression showed that SC-IFX C_trough was significantly associated with MH (OR 1.16; 95% CI 1.05-1.27; p = 0.002) and TH (OR 1.08; 95% CI 1.02-1.14; p = 0.005).

Conclusions: SC-IFX C_trough was positively associated with MH (≥ 18 μg/mL) and TH (≥ 30 μg/mL) in patients with CD, which may guide treatment decisions to optimise therapeutic response in the era of treat-to-target.

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克罗恩病患者皮下注射英夫利西单抗浓度阈值可促进黏膜和壁间愈合

背景：维持治疗期间静脉注射英夫利昔单抗（IV-IFX）的剂量前谷浓度（Ctrough）与克罗恩病（CD）患者的治疗效果有关。目的：评估英夫利昔单抗皮下制剂（SC-IFX）的Ctrough值与治疗效果的关系，以及SC-IFX Ctrough值达到CD患者粘膜愈合（MH）和透壁愈合（TH）的阈值：我们对接受SC-IFX维持治疗≥6个月的CD患者进行了横断面研究。我们在注射 SC-IFX 前立即测量了 SC-IFX Ctrough。我们在测量 SC-IFX Ctrough 后 3 个月内进行了回结肠镜/单球囊肠镜和/或磁共振肠造影检查。MH定义为SES-CD-溃疡面子评分为0分，TH定义为简化MaRIA评分为0分：我们共招募了 124 名患者，其中 77.9% 的患者（74/95）患有 MH，36.3% 的患者（37/102）患有 TH。MH（24.1 对 16.9 μg/mL；p = 0.001）和 TH（26.0 对 20.5 μg/mL；p = 0.007）患者的 SC-IFX Ctrough 明显高于非 MH 患者。ROC分析确定，MH和TH的SC-IFX Ctrough阈值分别为17.5和30.3微克/毫升。多变量逻辑回归显示，SC-IFX Ctrough与MH（OR 1.16; 95% CI 1.05-1.27; p = 0.002）和TH（OR 1.08; 95% CI 1.02-1.14; p = 0.005）显著相关：结论：SC-IFX Ctrough与CD患者的MH（≥ 18 μg/mL）和TH（≥ 30 μg/mL）呈正相关，可指导治疗决策以优化靶向治疗时代的治疗反应。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Alimentary Pharmacology & Therapeutics 医学-胃肠肝病学

CiteScore

15.60

自引率

7.90%

发文量

527

审稿时长

3-6 weeks

期刊介绍： Alimentary Pharmacology & Therapeutics is a global pharmacology journal focused on the impact of drugs on the human gastrointestinal and hepato-biliary systems. It covers a diverse range of topics, often with immediate clinical relevance to its readership.