Study of the mechanism and therapeutic biomarkers for sublingual immunotherapy by using the EXiLE method

2018 Fiscal Year Final Research Report

• Project/Area Number: 16H05483
• Research Category: Grant-in-Aid for Scientific Research (B)
• Allocation Type: Single-year Grants
• Section: 一般
• Research Field: Otorhinolaryngology
• Research Institution: National Institute of Health Sciences
• Principal Investigator: Nakamura Ryosuke 国立医薬品食品衛生研究所, 医薬安全科学部, 室長 (50333357)
• Co-Investigator(Kenkyū-buntansha): 岡本 美孝 千葉大学, 大学院医学研究院, 教授 (40169157) ; 秋山 晴代 帝京平成大学, 薬学部, 講師 (50420229) ; 岡本 好海 (内田) 国立医薬品食品衛生研究所, 医薬安全科学部, 任期付研究員 (40716792)
• Project Period (FY): 2016-04-01 – 2019-03-31
• Keywords: アレルゲン舌下免疫療法 / EXiLE法 / IgE / IgG / バイオマーカー / ルシフェラーゼ

Outline of Final Research Achievements

In this study we aimed to explore a biomarker that can predict the clinical response to sublingual immunotherapy (SLIT). Patients allergic to Japanese cedar pollen (JCP) were administered with JCP SLIT for more than 2 seasons. The severity of symptoms of pollinosis was represented by an averaged total nasal symptoms medication score (TNSMS) in the peak season. Crosslinking ability of patients’ serum IgE on the addition of JCP extract was determined by our original cell-based allergy test; IgE crosslinking-induced luciferase expression (EXiLE) method. When the reporter cells were sensitized with patients’ sera collected before starting SLIT, JCP-induced EXiLE response of more than 2.0 fold was an effective threshold to distinguish good and poor responders in SLIT judged by TNSMS diference (P<0.001). These results suggest that specific IgE crosslinking ability at SLIT entry would be a good biomarker candidate to predict the clinical response to SLIT.

Free Research Field

アレルギー学

Academic Significance and Societal Importance of the Research Achievements

近年、舌下免疫療法（SLIT）という画期的なアレルギーの治療法が開発された。しかしこの治療法は長期（数年）にわたって実施する必要があるため、治療開始時にSLITがよく効く患者とそうでない患者を見分ける手法の開発が求められていた。我々が近年開発した「EXiLE法」という手法を用いると、治療開始前にEXiLE法の応答性が高い患者ほど、SLITがよく効いていることが分かった。この方法により、SLITがよく効く患者を事前に見分けてから長期にわたるSLITを実施するという個別化医療が実現できるかもしれない。