奥马珠单抗治疗多食物过敏患者疗效的预测因子及相关因素的探索性分析
2026/03/05
摘要
背景：在食物过敏儿童及成人中进行的奥马珠单抗单药治疗及作为多过敏原口服免疫疗法辅助治疗（OUtMATCH）研究的第1阶段已证明，接受16至20周的奥马珠单抗治疗能显著提高多种食物过敏参与者对花生及其他常见食物过敏原的反应阈值。然而，这种保护程度在参与者之间存在差异，并且目前尚无已知的标志物可用于预测或评估个体对奥马珠单抗的反应。我们的目的是评估临床和实验室变量作为奥马珠单抗治疗反应的预测因子或相关因素。
方法：选择累积耐受剂量作为连续变量，以及个体食物蛋白444毫克和1044毫克的阈值作为阳性治疗反应的定义标准。我们评估了临床和免疫学变量作为反应预测因子的价值。
结果：奥马珠单抗治疗降低了游离IgE水平。在此项探索性分析中，尽管结论并非最终定论，但基线时较高的总IgE水平是与奥马珠单抗治疗阳性反应最一致的预测因子（花生累积耐受剂量：r = 0.25；q = 0.047）。奥马珠单抗的给药频率（每2周一次）也与较高的花生累积耐受剂量结果相关（r = 0.25；q = 0.047）。过敏史、过敏原特异性IgE水平、皮肤点刺试验结果和嗜碱性粒细胞活化情况与奥马珠单抗治疗反应均未呈现一致相关性。同时存在花生和牛奶过敏与奥马珠单抗治疗效果呈正相关（r = 0.34；q = 0.003），而花生过敏同时伴有腰果过敏（r = -0.43；q = 0.003）或核桃过敏（r = -0.26；q = 0.042）则与奥马珠单抗治疗效果呈负相关。
结论：在本分析所评估的食物过敏生物标志物和奥马珠单抗给药方案中，较高的基线总IgE水平是奥马珠单抗治疗成功实现对花生阈值保护的最一致（尽管程度有限）的预测因子，值得进一步研究。
Exploratory analyses of predictors and correlates of response to omalizumab therapy in patients with multiple food allergies
Chinthrajah RS, Kulis M, Jones SM, Sicherer S, Wang J, Shreffler W, Burk CM, Kim E, Keet C, Sindher S, Long AJ, Scurlock AM, Lanser BJ, Hui-Beckman JW, Vickery B, Ezhuthachan ID, Bird JA, Parrish C, Spergel JM, Brown-Whitehorn T, Dantzer J, Ligueros-Saylan M, Tassinari P, Olsson J, Iqbal A, Ozanne M, Huckabee C, Rogers N, Yovetich N, Lin A, Brittain E, Wheatley LM, Togias A, Wood RA.
Abstract
Abstract
BACKGROUND:
Stage 1 of the Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults (OUtMATCH) study demonstrated that treatment with omalizumab for 16 to 20 weeks significantly increased the reaction threshold for peanut and other common food allergens in participants with multiple food allergies. However, the degree of this protection is variable across participants, and there are no known markers to predict or assess individual response to omalizumab. Our aim was to evaluate clinical and laboratory-based variables as predictors or correlates of response to omalizumab treatment.
METHODS:
Cumulative tolerated dose (CTD) as a continuous variable and thresholds of 444 mg and 1044 mg of individual food proteins were selected as definitions of positive treatment response. Clinical and immunologic variables were evaluated as predictors of response.
RESULTS:
Omalizumab treatment reduced the level of free IgE. In this exploratory analysis (N = 116), although not definitive, higher total IgE level at baseline was the most consistent predictor of a positive response to omalizumab treatment (peanut CTD: r = 0.25; q = 0.047). Omalizumab dosing frequency (every 2 weeks) was also associated with higher peanut CTD outcomes (r = 0.25; q = 0.047). Medical history of allergy, level of allergen-specific IgE, skin prick test result, and basophil activation did not consistently correlate with response to omalizumab treatment. Concomitant peanut and milk allergy was positively correlated with outcomes of omalizumab treatment (r = 0.34; q = 0.003), whereas peanut allergy concomitant with either cashew allergy (r = -0.43; q = 0.003) or walnut allergy (r = -0.26; q = 0.042) was inversely correlated with outcomes of omalizumab treatment.
CONCLUSION:
Of the food allergy biomarkers and omalizumab dosing assessed in this analysis, a higher baseline total IgE level was the most consistent, albeit modest, predictor of successful peanut threshold protection with omalizumab treatment, thus warranting further study.
背景：在食物过敏儿童及成人中进行的奥马珠单抗单药治疗及作为多过敏原口服免疫疗法辅助治疗（OUtMATCH）研究的第1阶段已证明，接受16至20周的奥马珠单抗治疗能显著提高多种食物过敏参与者对花生及其他常见食物过敏原的反应阈值。然而，这种保护程度在参与者之间存在差异，并且目前尚无已知的标志物可用于预测或评估个体对奥马珠单抗的反应。我们的目的是评估临床和实验室变量作为奥马珠单抗治疗反应的预测因子或相关因素。
方法：选择累积耐受剂量作为连续变量，以及个体食物蛋白444毫克和1044毫克的阈值作为阳性治疗反应的定义标准。我们评估了临床和免疫学变量作为反应预测因子的价值。
结果：奥马珠单抗治疗降低了游离IgE水平。在此项探索性分析中，尽管结论并非最终定论，但基线时较高的总IgE水平是与奥马珠单抗治疗阳性反应最一致的预测因子（花生累积耐受剂量：r = 0.25；q = 0.047）。奥马珠单抗的给药频率（每2周一次）也与较高的花生累积耐受剂量结果相关（r = 0.25；q = 0.047）。过敏史、过敏原特异性IgE水平、皮肤点刺试验结果和嗜碱性粒细胞活化情况与奥马珠单抗治疗反应均未呈现一致相关性。同时存在花生和牛奶过敏与奥马珠单抗治疗效果呈正相关（r = 0.34；q = 0.003），而花生过敏同时伴有腰果过敏（r = -0.43；q = 0.003）或核桃过敏（r = -0.26；q = 0.042）则与奥马珠单抗治疗效果呈负相关。
结论：在本分析所评估的食物过敏生物标志物和奥马珠单抗给药方案中，较高的基线总IgE水平是奥马珠单抗治疗成功实现对花生阈值保护的最一致（尽管程度有限）的预测因子，值得进一步研究。
（中日友好医院呼吸与危重症医学科 沈焜路 摘译 林江涛 审校）
（J Allergy Clin Immunol. 2026 Feb; DOI: 10.1016/j.jaci.2025.10.031 ）
（J Allergy Clin Immunol. 2026 Feb; DOI: 10.1016/j.jaci.2025.10.031 ）
Exploratory analyses of predictors and correlates of response to omalizumab therapy in patients with multiple food allergies
Chinthrajah RS, Kulis M, Jones SM, Sicherer S, Wang J, Shreffler W, Burk CM, Kim E, Keet C, Sindher S, Long AJ, Scurlock AM, Lanser BJ, Hui-Beckman JW, Vickery B, Ezhuthachan ID, Bird JA, Parrish C, Spergel JM, Brown-Whitehorn T, Dantzer J, Ligueros-Saylan M, Tassinari P, Olsson J, Iqbal A, Ozanne M, Huckabee C, Rogers N, Yovetich N, Lin A, Brittain E, Wheatley LM, Togias A, Wood RA.
Abstract
Abstract
BACKGROUND:
Stage 1 of the Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults (OUtMATCH) study demonstrated that treatment with omalizumab for 16 to 20 weeks significantly increased the reaction threshold for peanut and other common food allergens in participants with multiple food allergies. However, the degree of this protection is variable across participants, and there are no known markers to predict or assess individual response to omalizumab. Our aim was to evaluate clinical and laboratory-based variables as predictors or correlates of response to omalizumab treatment.
METHODS:
Cumulative tolerated dose (CTD) as a continuous variable and thresholds of 444 mg and 1044 mg of individual food proteins were selected as definitions of positive treatment response. Clinical and immunologic variables were evaluated as predictors of response.
RESULTS:
Omalizumab treatment reduced the level of free IgE. In this exploratory analysis (N = 116), although not definitive, higher total IgE level at baseline was the most consistent predictor of a positive response to omalizumab treatment (peanut CTD: r = 0.25; q = 0.047). Omalizumab dosing frequency (every 2 weeks) was also associated with higher peanut CTD outcomes (r = 0.25; q = 0.047). Medical history of allergy, level of allergen-specific IgE, skin prick test result, and basophil activation did not consistently correlate with response to omalizumab treatment. Concomitant peanut and milk allergy was positively correlated with outcomes of omalizumab treatment (r = 0.34; q = 0.003), whereas peanut allergy concomitant with either cashew allergy (r = -0.43; q = 0.003) or walnut allergy (r = -0.26; q = 0.042) was inversely correlated with outcomes of omalizumab treatment.
CONCLUSION:
Of the food allergy biomarkers and omalizumab dosing assessed in this analysis, a higher baseline total IgE level was the most consistent, albeit modest, predictor of successful peanut threshold protection with omalizumab treatment, thus warranting further study.
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