Arasi Stefania, Lo Scalzo Lucia, Sciannamea Maddalena, Klimek Ludger, Fiocchi Alessandro
Translational Research in Paediatric Specialities Area, Division of Allergy, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.
Center for Rhinology and Allergology, Wiesbaden, Germany.
Curr Opin Allergy Clin Immunol. 2025 Jun 1;25(3):199-204. doi: 10.1097/ACI.0000000000001072. Epub 2025 Apr 3.
To explore the potential applicability in clinical trials of the groundbreaking international consensus named DEFASE (DEfinition of Food Allergy SEverity) as the unique grading system for IgE-mediated food allergy (FA) severity embracing the different aspects of the disease in a holistic approach. Herein, we discuss its relevance in clinical trials and potential applications in research and clinical settings through a few clinical scenarios.
The DEFASE score has been developed to be used in research settings as a comprehensive scoring system. Researchers are currently focusing on internal and external validation of the scoring system, targeting these models to various food allergenic sources, populations, and settings.
Implementing the DEFASE score in clinical trials could improve patient stratification, guide therapeutic decisions, and support regulatory assessments. Future research will focus on its external validation and integration with biomarker data to refine its predictive accuracy and make this tool applicable in the near future.
探讨具有开创性的国际共识“DEFASE(食物过敏严重程度定义)”作为IgE介导的食物过敏(FA)严重程度的独特分级系统在临床试验中的潜在适用性,该系统以整体方法涵盖了该疾病的不同方面。在此,我们通过一些临床案例讨论其在临床试验中的相关性以及在研究和临床环境中的潜在应用。
DEFASE评分已被开发用于研究环境中作为综合评分系统。研究人员目前正专注于该评分系统的内部和外部验证,将这些模型应用于各种食物过敏原来源、人群和环境。
在临床试验中实施DEFASE评分可改善患者分层、指导治疗决策并支持监管评估。未来的研究将专注于其外部验证以及与生物标志物数据的整合,以提高其预测准确性,并使该工具在不久的将来适用。