iMed.ULisboa-Research Institute for Medicines, Faculty of Pharmacy, Universidade de Lisboa, Lisbon, Portugal.
Pharmacy Service, Centro Hospitalar Lisboa Norte/Hospital de Santa Maria, Lisbon, Portugal.
BioDrugs. 2019 Dec;33(6):683-691. doi: 10.1007/s40259-019-00387-w.
The aim of this analysis was to evaluate whether the current unsystematic assessment leads to sufficient reporting of immunogenicity-related information in the Summary of Product Characteristics (SmPCs) of biological products approved in the European market.
Immunogenicity-related information was identified and extracted from a group of 72 biological drugs that complied with drug-selection criteria. Afterwards, 12 dichotomous questions were proposed to evaluate whether any issues are being commonly neglected.
Most SmPCs (92%) do not have any recommendations on how to report immunogenicity-related adverse drug reactions by patients or healthcare professionals. Furthermore, 80% of SmPCs do not identify the assay used to assess the reported immunogenicity rates, while 81% do not address the possible impact of immunogenicity on their drug's pharmacokinetics. It was also identified that a group factor (i.e. older drugs' SmPCs) could be influencing how/which issues were being addressed by newer drugs' SmPCs. To transform SmPCs into useful tools when an immunogenic response occurs, a proposal on how to report immunogenicity-related information in the SmPCs of biological products is advanced. This decision tree should contribute towards increasing the quality and transparency of the immunogenicity-related information being reported in the SmPCs, thus leading to better informed medical decisions.
Based on these results, an unsystematic assessment does not yield enough reporting across products and thus immunogenicity-related information should be reported in a systematic way. Further guidance about reporting immunogenicity-related information is required, otherwise SmPCs will not be the basis of information for healthcare professionals on how to use a biological product safely and effectively.
本分析旨在评估当前非系统性评估是否导致在欧洲市场批准的生物制品的产品特性摘要（SmPC）中充分报告与免疫原性相关的信息。
从符合药物选择标准的 72 种生物药物中确定并提取了与免疫原性相关的信息。之后，提出了 12 个二项式问题来评估是否普遍忽略了任何问题。
大多数 SmPC（92%）没有任何关于如何报告患者或医疗保健专业人员与免疫原性相关的不良药物反应的建议。此外，80%的 SmPC 未识别用于评估报告的免疫原性率的检测方法，而 81%的 SmPC 未解决免疫原性对其药物药代动力学的可能影响。还发现，组因素（即较老药物的 SmPC）可能会影响新药的 SmPC 如何/解决哪些问题。为了在发生免疫反应时将 SmPC 转化为有用的工具，提出了在生物制品的 SmPC 中报告与免疫原性相关信息的建议。该决策树应有助于提高 SmPC 中报告的与免疫原性相关信息的质量和透明度，从而做出更明智的医疗决策。
基于这些结果，非系统性评估并不能在产品之间产生足够的报告，因此应该系统地报告与免疫原性相关的信息。需要进一步报告与免疫原性相关信息的指导，否则 SmPC 将不会成为医疗保健专业人员如何安全有效地使用生物产品的信息基础。
