Department of Pediatrics, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea.
Department of Pediatrics, Samsung Medical Center, School of Medicine, Sungkyunkwan University, Seoul, Korea.
J Korean Med Sci. 2020 Apr 27;35(16):e114. doi: 10.3346/jkms.2020.35.e114.
Limited data exist regarding mucosal healing (MH) and therapeutic drug monitoring (TDM) in pediatric Crohn's disease (CD) patients treated with adalimumab (ADL). We aimed to investigate the associations between ADL trough levels (TLs) and MH, and between ADL TLs and histologic remission (HR) at 16 weeks from ADL treatment in pediatric CD patients.
This was a prospective study on moderate-to-severe luminal pediatric CD patients receiving ADL. Ileocolonoscopies and biopsies, as well as clinical activity assessments, laboratory examinations, including tests for ADL TLs and antibody to ADL, were performed 16 weeks after ADL initiation. MH was defined as a Simple Endoscopic Score for CD of 0. HR was defined as the complete absence of microscopic inflammation.
Seventeen subjects (13 males, 4 females) were included. At 16 weeks from ADL initiation, 14 (82.4%), 8 (47.1%), and 4 (23.5%) patients achieved clinical remission, MH, and HR, respectively. ADL TLs were significantly higher in patients who achieved MH compared to those who did not (13.0 ± 6.5 vs. 6.2 ± 2.6 μ/mL, respectively; = 0.023) and also significantly higher in patients who achieved HR compared to those who did not (17.9 ± 5.3 vs. 6.8 ± 2.5 μ/mL, respectively; = 0.02). The optimal TL for predicting MH was 8.76 μ/mL.
Serum ADL TLs at 16 weeks were significantly higher in pediatric patients with CD who achieved MH and HR, respectively. TDM may guide in optimizing treatment efficacy and better target MH in the era of treat-to-target.
在接受阿达木单抗（ADL）治疗的儿童克罗恩病（CD）患者中，关于黏膜愈合（MH）和治疗药物监测（TDM）的数据有限。我们旨在研究 ADL 谷浓度（TL）与 MH 之间以及 ADL 治疗 16 周后与组织学缓解（HR）之间的关联。
这是一项针对接受 ADL 治疗的中重度腔型儿童 CD 患者的前瞻性研究。ADL 起始后 16 周，进行回结肠镜检查和活检，以及临床活动评估、实验室检查，包括 ADL TL 和 ADL 抗体检测。MH 定义为 CD 简单内镜评分 0。HR 定义为无微观炎症的完全缺失。
共纳入 17 例患者（男 13 例，女 4 例）。ADL 起始后 16 周，14 例（82.4%）、8 例（47.1%）和 4 例（23.5%）患者分别达到临床缓解、MH 和 HR。达到 MH 的患者 ADL TL 明显高于未达到 MH 的患者（分别为 13.0 ± 6.5 vs. 6.2 ± 2.6 μ/mL， = 0.023），达到 HR 的患者 ADL TL 也明显高于未达到 HR 的患者（分别为 17.9 ± 5.3 vs. 6.8 ± 2.5 μ/mL， = 0.02）。预测 MH 的最佳 TL 为 8.76 μ/mL。
CD 患儿 MH 和 HR 分别达到时，血清 ADL TL 明显升高。TDM 可能有助于优化治疗效果，并在治疗目标时代更好地针对 MH。
