Sivridaş Merve, Creemers Rob H, Wong Dennis R, Boekema Paul J, Römkens Tessa E H, Gilissen Lennard P L, van Bodegraven Adriaan A, Loeff Floris C, Rispens Theo, Derijks Luc J J
Department of Clinical Pharmacy, Máxima Medical Center, 5504 DB Veldhoven, The Netherlands.
Department of Gastroenterology, Geriatrics, Internal, and Intensive Care Medicine (COMIK), Zuyderland Medical Center, 6130 MB Sittard-Geleen, The Netherlands.
Pharmaceutics. 2023 Mar 17;15(3):972. doi: 10.3390/pharmaceutics15030972.
There are limited data on therapeutic drug monitoring (TDM) in inflammatory bowel disease (IBD) patients treated with vedolizumab (VDZ). Although an exposure-response relation has been demonstrated in the post-induction phase, this relationship is more uncertain in the maintenance phase of treatment. The aim of our study was to determine whether there is an association between VDZ trough concentration and clinical and biochemical remission in the maintenance phase. A prospective, observational multicenter study has been performed on patients with IBD on VDZ in the maintenance treatment (≥14 weeks). Patient demographics, biomarkers, and VDZ serum trough concentrations were collected. Clinical disease activity was scored by the Harvey Bradshaw Index (HBI) for Crohn's disease (CD) and the Simple Clinical Colitis Activity Index (SCCAI) for ulcerative colitis (UC). Clinical remission was determined as HBI < 5 and SCCAI < 3. Biochemical remission was defined as fecal calprotectin <250 mg/kg and serum CRP <5 mg/L. A total of 159 patients (59 CD, 100 UC) were included. In none of the patient groups, a statistically significant correlation between trough VDZ concentration and clinical remission was observed. Patients in biochemical remission had higher VDZ trough concentrations ( = 0.019). In this population, higher trough VDZ concentrations were associated with biochemical remission but not with clinical remission.
关于接受维多珠单抗（VDZ）治疗的炎症性肠病（IBD）患者的治疗药物监测（TDM）数据有限。尽管在诱导期后已证明存在暴露-反应关系，但在治疗维持期这种关系更不确定。我们研究的目的是确定在维持期VDZ谷浓度与临床和生化缓解之间是否存在关联。对接受VDZ维持治疗（≥14周）的IBD患者进行了一项前瞻性、观察性多中心研究。收集了患者的人口统计学资料、生物标志物和VDZ血清谷浓度。通过哈维·布拉德肖指数（HBI）对克罗恩病（CD）进行临床疾病活动评分，通过简单临床结肠炎活动指数（SCCAI）对溃疡性结肠炎（UC）进行评分。临床缓解定义为HBI<5且SCCAI<3。生化缓解定义为粪便钙卫蛋白<250mg/kg且血清CRP<5mg/L。共纳入159例患者（59例CD，100例UC）。在所有患者组中，均未观察到VDZ谷浓度与临床缓解之间存在统计学显著相关性。生化缓解的患者VDZ谷浓度较高（P = 0.019）。在该人群中，较高的VDZ谷浓度与生化缓解相关，但与临床缓解无关。
