From the Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Nationwide Children's Hospital.
the Center for Biostatistics, Department of Biomedical Informatics, The Ohio State University College of Medicine.
J Pediatr Gastroenterol Nutr. 2022 Jul 1;75(1):59-63. doi: 10.1097/MPG.0000000000003462. Epub 2022 Apr 20.
Studies assessing adult inflammatory bowel disease (IBD) patient perspectives on biosimilar use revealed that most were unfamiliar with biosimilars and had a negative perception. The objective of this study was to evaluate the perspectives of pediatric patients with IBD and their caregivers regarding biosimilar use and non-medical switches.
A survey was given to a cross section of patients with IBD ages 11-21 years receiving the intravenous anti-tumor necrosis factor originator and caregivers of patients with IBD ages 3-21 years receiving the originator. Recruitment occurred via mail, during clinic visits, and infusions. Fisher exact tests were used to test for statistically significant differences.
Response rate amongst caregivers was 49% (n = 98) and among patients was 35% (n = 67). Sixty-four percent of caregivers and 79% of patients had never heard of biosimilars. There was increased discomfort surrounding the use of biosimilars and switching to a biosimilar amongst caregivers who had previously heard of biosimilars compared to caregivers who had not previously heard of biosimilars ( P < 0.05). Similar concerns were not seen in patient respondents. The length of time on the originator had no effect on patient or caregiver concerns related to biosimilar efficacy, adverse effects, or switches.
The majority of pediatric patients and caregivers had never heard of biosimilars. Caregivers that had heard of biosimilars before the study were more likely to have a negative perception of them. This study highlights the importance of providing thorough and accurate education to pediatric patients and families regarding the safety and efficacy of biosimilars.
评估成人炎症性肠病(IBD)患者对生物类似药使用的看法的研究表明,大多数患者对生物类似药不熟悉,并且对此持负面看法。本研究的目的是评估 IBD 儿科患者及其照顾者对生物类似药使用和非医学转换的看法。
对接受静脉注射抗肿瘤坏死因子原创药的 11-21 岁 IBD 患者和接受原创药的 3-21 岁 IBD 患者的照顾者进行横断面调查。通过邮寄、门诊就诊和输液进行招募。使用 Fisher 精确检验来检验统计学上的显著差异。
照顾者的回应率为 49%(n=98),患者的回应率为 35%(n=67)。64%的照顾者和 79%的患者从未听说过生物类似药。与从未听说过生物类似药的照顾者相比,以前听说过生物类似药的照顾者对使用生物类似药和转换为生物类似药的不适感更强(P<0.05)。在患者受访者中没有看到类似的担忧。使用原创药的时间长短对患者或照顾者对生物类似药疗效、不良反应或转换的担忧没有影响。
大多数儿科患者和照顾者从未听说过生物类似药。在研究之前听说过生物类似药的照顾者更有可能对其产生负面看法。这项研究强调了向儿科患者及其家庭提供关于生物类似药安全性和疗效的全面准确教育的重要性。