Department of Gastroenterology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, P.R. China.
Department of Gastroenterology, Sheba Medical Center & Sackler School of Medicine, Tel-Aviv University, Tel Hashomer, Israel.
Inflamm Bowel Dis. 2019 Oct 18;25(11):1813-1821. doi: 10.1093/ibd/izz061.
Infliximab levels have been reported to be associated with mucosal healing (MH) in Crohn's disease (CD). However, whether the association differs between postinduction (week 14) and maintenance (week 30) has seldom been investigated. We aimed to analyze the association between serum infliximab trough levels and MH at the 2 different time points.
A retrospective study of CD patients treated with infliximab in a tertiary referral center between January 2012 and May 2018 was conducted. MH was defined as absence of ulceration by endoscopy. Correlations between infliximab level and MH were investigated at 2 specific time points, weeks 14 and 30.
Median infliximab levels were higher in patients with MH than those without at weeks 14 (7.5 vs 1.5 μg/mL; P < 0.001) and 30 (5.9 vs 0.5 μg/mL; P < 0.001). The median levels in patients with MH at week 14 were higher than at week 30 (7.5 vs 5.9 μg/mL; P < 0.05). Multivariate analysis showed that infliximab level was independently associated with MH (both P < 0.001 at weeks 14 and 30). Infliximab level above 4.85 μg/mL and 2.85 μg/mL identified patients with MH at week 14 (area under the curve [AUC], 0.796; P < 0.001) and week 30 (AUC, 0.780; P < 0.001) with 80% specificity. The rates of MH reached a plateau (>85%) when infliximab levels were above 10 and 6 μg/mL at weeks 14 and 30, respectively.
Infliximab levels correlated with MH at weeks 14 and 30 in CD patients. Higher levels might be required to achieve MH at postinduction than during maintenance treatment.
已有研究报道英夫利昔单抗（IFX）水平与克罗恩病（CD）的黏膜愈合（MH）相关。然而，诱导期（第 14 周）和维持期（第 30 周）的 IFX 水平与 MH 的相关性是否存在差异，尚未见报道。本研究旨在分析 CD 患者在这两个不同时间点的 IFX 谷浓度与 MH 之间的相关性。
本研究为回顾性队列研究，纳入 2012 年 1 月至 2018 年 5 月期间在我院接受 IFX 治疗的 CD 患者。内镜下无溃疡定义为 MH。分析患者在第 14 周和第 30 周时 IFX 水平与 MH 的相关性。
第 14 周和第 30 周时，MH 患者的 IFX 谷浓度中位数均高于无 MH 患者（7.5μg/ml 比 1.5μg/ml，P<0.001；5.9μg/ml 比 0.5μg/ml，P<0.001）。第 14 周 MH 患者的 IFX 浓度中位数高于第 30 周（7.5μg/ml 比 5.9μg/ml，P<0.05）。多因素分析显示，IFX 水平与 MH 独立相关（第 14 周和第 30 周 P<0.001）。第 14 周时 IFX 浓度>4.85μg/ml 和>2.85μg/ml 可识别出 MH 患者（曲线下面积 AUC 分别为 0.796 和 0.780，P<0.001），第 30 周时 IFX 浓度>4.85μg/ml 和>2.85μg/ml 可识别出 MH 患者（AUC 分别为 0.780 和 0.780，P<0.001），特异度均为 80%。第 14 周和第 30 周时，IFX 浓度分别高于 10μg/ml 和 6μg/ml 时，MH 比例达到平台期（>85%）。
CD 患者第 14 周和第 30 周的 IFX 水平与 MH 相关，诱导期比维持期可能需要更高的 IFX 水平来实现 MH。
