Department of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, The Netherlands.
Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands.
United European Gastroenterol J. 2021 Oct;9(8):919-928. doi: 10.1002/ueg2.12107. Epub 2021 Jun 2.
Only limited data is available on the extent and burden of adverse drug reactions (ADRs) to biological therapy in inflammatory bowel disease (IBD) patients in daily practice, especially from a patient's perspective.
The aim of this study was to systematically assess patient-reported ADRs during biological therapy in IBD patients and compare these with healthcare provider (HCP)-reported ADRs.
This multicentre, prospective, event monitoring study enrolled IBD patients on biological therapy. Patients completed bimonthly comprehensive web-based questionnaires regarding description of biological induced ADRs, follow-up of previous ADRs and experienced burden of the ADR using a five-point Likert scale. The relationship between patient-reported ADRs and biological therapy was assessed. HCP-reported ADRs were extracted from the electronic healthcare records.
In total, 182 patients (female 51%, mean age 42.2 [standard deviation 14.2] years, Crohn's disease 77%) were included and completed 728 questionnaires. At baseline, 60% of patients used infliximab, 30% adalimumab, 9% vedolizumab and 1% ustekinumab. Fifty percent of participants reported at least one ADR with a total of 239 unique ADRs. Fatigue (n = 26) and headache (n = 20) resulted in the highest burden and a correlation in time with the administration of the biological was described in 56% and 85% respectively. Out of 239 ADRs, 115 were considered biological-related. HCPs reported 119 ADRs. Agreement between patient-reported ADRs and HCP-reported ADRs was only 13%.
IBD patients often report ADRs during biological therapy. We observed an important significant difference between the type and frequency of patient-reported ADRs versus HCP-reported ADRs, leading to an underestimation of more subjective ADRs and patients' ADR-related burden.
在炎症性肠病（IBD）患者的日常实践中，仅有有限的数据可用于评估生物治疗相关的不良反应（ADR）的程度和负担，尤其是从患者角度来看。
本研究旨在系统评估生物治疗期间 IBD 患者报告的药物不良反应，并将其与医疗保健提供者（HCP）报告的药物不良反应进行比较。
这是一项多中心、前瞻性、事件监测研究，纳入正在接受生物治疗的 IBD 患者。患者每两个月通过综合网络问卷报告生物治疗引起的药物不良反应描述、以前药物不良反应的随访情况以及药物不良反应的负担（采用五分制量表）。评估患者报告的药物不良反应与生物治疗之间的关系。从电子医疗记录中提取 HCP 报告的药物不良反应。
共纳入 182 例患者（女性占 51%，平均年龄 42.2 [14.2] 岁，克罗恩病占 77%），并完成了 728 份问卷。基线时，60%的患者使用英夫利昔单抗，30%的患者使用阿达木单抗，9%的患者使用维得利珠单抗，1%的患者使用乌司奴单抗。50%的参与者报告了至少一种药物不良反应，共报告了 239 种独特的药物不良反应。疲劳（n=26）和头痛（n=20）导致的负担最高，分别有 56%和 85%的药物不良反应与生物治疗的时间相关。在 239 种药物不良反应中，有 115 种被认为与生物治疗相关。HCP 报告了 119 种药物不良反应。患者报告的药物不良反应与 HCP 报告的药物不良反应之间的一致性仅为 13%。
IBD 患者在接受生物治疗期间经常报告药物不良反应。我们观察到患者报告的药物不良反应与 HCP 报告的药物不良反应在类型和频率上存在显著差异，导致更主观的药物不良反应和患者药物不良反应相关负担被低估。
