Clinical Pharmacology and Pharmacometrics, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen am Rhein, Germany.
Health Economics & Outcomes Research, AbbVie, North Chicago, Illinois, USA.
CPT Pharmacometrics Syst Pharmacol. 2021 Jan;10(1):40-47. doi: 10.1002/psp4.12570. Epub 2020 Dec 18.
Selection of a personalized dose for an individual patient can be informed by the patient's preferences, translated as weights on each of the clinically relevant safety and efficacy drug attributes, based on results from a brief patient preference elicitation questionnaire. In this analysis, the weighted attributes were simulated to represent various endometriosis patient profiles. Exposure-response simulations were performed for elagolix, a drug approved for management of moderate to severe pain associated with endometriosis, across a range of plasma exposures corresponding to a range of doses. The results were combined to calculate a personalized clinical utility index. An interactive user-friendly online application was developed and envisioned as a physician's desk tool to personalize the dose selection process based on individual patient preferences. This demonstration should serve as an example of how patient/physician conversation can be facilitated with quantitative tools for personalizing the dose.
为个体患者选择个性化剂量可以参考患者的偏好，将其转化为每个具有临床相关性的安全性和疗效药物属性的权重，这是基于简短的患者偏好征询问卷的结果。在这项分析中，对加权属性进行了模拟，以代表各种子宫内膜异位症患者的特征。对获批用于治疗与子宫内膜异位症相关的中度至重度疼痛的药物 Elagolix 进行了暴露-反应模拟，模拟范围涵盖了与一系列剂量相对应的各种血浆暴露水平。将结果进行组合，以计算个性化临床效用指数。开发了一个互动式用户友好型在线应用程序，并将其设想为医生的桌面工具，以根据个体患者的偏好来个性化剂量选择过程。本演示应作为如何使用定量工具来个性化剂量从而促进医患对话的一个示例。
