Section of Pediatric Gastroenterology, Department of Pediatrics, Max Rady Faculty of Medicine, University of Manitoba, Winnipeg, MB, Canada.
Division of Pediatric Gastroenterology, Department of Pediatrics, Faculty of Medicine, University of Alberta, Edmonton, AB, Canada.
Acta Paediatr. 2017 Nov;106(11):1863-1867. doi: 10.1111/apa.14008. Epub 2017 Aug 24.
This study examined the impact of therapeutic drug monitoring (TDM) on clinical decision-making for children receiving infliximab for inflammatory bowel disease (IBD).
The medical records of children with IBD who had infliximab trough levels (ITLs) measured between January 2013 and December 2015 at two Canadian tertiary-care centres were examined. The indications for TDM, clinical and laboratory disease activity indices and TDM-driven treatment changes to infliximab therapy were documented.
We included 107 consecutive serum measurements of ITLs in 73 children (40 boys), with a median age of 16.1 years, including 52 with Crohn's disease. TDM was performed due to concerns about clinical disease activity in 24/107 (22.4%) measurements and 83 (77.6%) were ordered as routine tests. Of these, 38 (35.5%) ITLs were suboptimal (<3.5 μg/mL) and 36 (34.0%) resulted in more frequent doses of infliximab, with subsequent improvements in disease biomarkers. Interval changes were implemented as a result of 34 (32.0%) ITLs, with shorter intervals in 19 (17.0%) cases, and seven (6.5%) ITLs resulted in adding or increasing doses of immunomodulators. In addition, four children were switched to adalimumab.
Therapeutic drug monitoring was helpful in guiding the decision-making process for children with IBD on infliximab.
本研究旨在探讨治疗药物监测(TDM)对接受英夫利昔单抗治疗炎症性肠病(IBD)儿童临床决策的影响。
研究人员对 2013 年 1 月至 2015 年 12 月期间在加拿大两家三级保健中心接受英夫利昔单抗治疗的 IBD 儿童的病历进行了检查。记录了 TDM 的适应证、临床和实验室疾病活动指数以及 TDM 驱动的英夫利昔单抗治疗方案改变。
本研究纳入了 73 例儿童(40 名男性)共 107 次血清英夫利昔单抗谷浓度(ITL)检测结果,中位数年龄为 16.1 岁,其中 52 例为克罗恩病。24/107(22.4%)次检测是由于对临床疾病活动的担忧而进行 TDM,83(77.6%)次是常规检测。其中 38(35.5%)次 ITL 结果不理想(<3.5μg/mL),36(34.0%)次结果导致更频繁地使用英夫利昔单抗,随后疾病生物标志物得到改善。34(32.0%)次 ITL 结果导致了间隔时间的改变,其中 19(17.0%)次缩短了间隔时间,7(6.5%)次导致添加或增加免疫调节剂剂量。此外,4 名儿童转为使用阿达木单抗。
治疗药物监测有助于指导接受英夫利昔单抗治疗的 IBD 儿童的决策过程。