BackgroundPredose trough concentrations (Ctrough) 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 Ctrough values due to its favourable pharmacokinetics.AimsTo evaluate the association of Ctrough of SC‐IFX with therapeutic outcomes and the threshold of SC‐IFX Ctrough for achieving mucosal healing (MH) and transmural healing (TH) in patients with CD.MethodsWe performed this cross‐sectional study in patients with CD who had received SC‐IFX maintenance therapy for ≥ 6 months. We measured SC‐IFX Ctrough immediately before SC‐IFX injection. We performed ileocolonoscopy/single‐balloon enteroscopy and/or magnetic resonance enterography within 3 months of SC‐IFX Ctrough measurement. MH was defined as SES‐CD–ulcerated surface subscore of 0. TH was defined as simplified MaRIA score of 0.ResultsWe enrolled 124 patients with MH in 77.9% (74/95) and TH in 36.3% (37/102). SC‐IFX Ctrough 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 Ctrough for MH and TH were 17.5 and 30.3 μg/mL, respectively. Multivariate logistic regression showed that SC‐IFX Ctrough 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).ConclusionsSC‐IFX Ctrough 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.

中文翻译：

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克罗恩病患者粘膜和透壁愈合的皮下英夫利昔单抗浓度阈值


背景维持治疗期间静脉注射英夫利昔单抗 （IV-IFX） 的给药前谷浓度 （Ctrough） 与克罗恩病 （CD） 患者的治疗结果相关。英夫利昔单抗 （SC-IFX） 的皮下制剂由于其良好的药代动力学而显示出高 Ctrough 值。目的评价 SC-IFX Ctrough 与 CD-IFX 患者治疗结局的相关性以及 SC-IFX Ctrough 实现粘膜愈合 （MH） 和透壁愈合 （TH） 的阈值≥。我们在 SC-IFX 注射前立即测量了 SC-IFX Ctrough。我们在 SC-IFX Ctrough 测量后 3 个月内进行了回肠结肠镜检查/单球囊小肠镜检查和/或磁共振小肠造影。MH 定义为 SES-CD 溃疡表面分项评分为 0。TH 定义为简化的 MaRIA 评分为 0.结果我们招募了 124 例 MH 患者，占 77.9% （74/95），TH 占 36.3% （37/102）。MH 患者 （24.1 vs. 16.9 μg/mL;p = 0.001） 和 TH （26.0 vs. 20.5 μg/mL;p = 0.007） 的 SC-IFX Ctrough 显著高于无患者。ROC 分析发现 MH 和 TH 的 SC-IFX Ctrough 阈值分别为 17.5 和 30.3 μg/mL。多因素logistic回归分析显示，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，这可能指导治疗决策，以优化治疗目标时代的治疗反应。