2期临床试验“MOTIF”中的虾口服免疫疗法结果
Shrimp oral immunotherapy outcomes in the phase 2 clinical trial: MOTIF.
作者信息
Jiang Shirley Y, Cao Shu, Martinez Kristine, Sharma Reyna, Raeber Olivia, Fernandes Andrea, Bogetic Dinara, Kaushik Abhinav, Gupta Sheena, Manohar Monali, Maeker Holden T, Chin Andrew R, Long Andrew J, Feight Catherine, Woch Margaret, Nadeau Kari C, Chinthrajah R Sharon, Sindher Sayantani B
机构信息
Sean N Parker Center for Allergy and Asthma Research at Stanford University, Stanford University, Stanford, CA, United States.
Institute for Immunity, Transplantation and Infection, Stanford University School of Medicine, Stanford, CA, United States.
出版信息
Front Allergy. 2025 Jul 22;6:1458131. doi: 10.3389/falgy.2025.1458131. eCollection 2025.
INTRODUCTION
Shrimp is a common but understudied food allergen with relatively high rates of emergency department visits. Here we report the shrimp OIT outcomes in the MOTIF (NCT03504774) clinical trial and discuss some of the challenges with performing this study.
METHODS
In this phase 2 clinical trial, 12 shrimp allergic participants aged 7-55 years (median age 21.5 years) were enrolled to receive shrimp OIT. Shrimp OIT was performed up to a maintenance dose of 1,000 mg shrimp protein by week 28 with desensitization to shrimp assessed by double-blind placebo-controlled food challenge at week 52 followed by switching to avoidance and assessing sustained unresponsiveness (SU) at week 58. The primary endpoint was the change in CD28 in CD4+ allergen specific (CD154+) T-cells at baseline and 52 weeks.
RESULTS
Shrimp OIT induced desensitization to a cumulative 4,043 mg shrimp protein in 58.3% (7/12) of the intention to treat and 87.5% (7/8) of the per protocol group after 52 weeks of shrimp OIT. Most shrimp OIT participants who remained in the study after desensitization (87.5%, 7/8) achieved SU. Although adverse events were common during shrimp OIT (75%), most were mild (Bock grade 1, 88%) and there were no severe (Bock grade 3+) reactions or use of epinephrine. No significant differences in CD28 expression were observed after shrimp OIT.
CONCLUSIONS
Shrimp OIT is safe and effective for the treatment of shrimp allergy. Most participants were successful and achieved SU after 6 weeks of avoidance.
引言
虾是一种常见但研究较少的食物过敏原，因食用虾导致急诊就诊的比例相对较高。在此，我们报告了MOTIF（NCT03504774）临床试验中虾口服免疫疗法（OIT）的结果，并讨论了开展该研究面临的一些挑战。
方法
在这项2期临床试验中，招募了12名年龄在7至55岁（中位年龄21.5岁）的虾过敏参与者接受虾OIT治疗。在第28周时，虾OIT治疗的维持剂量高达1000毫克虾蛋白，在第52周时通过双盲安慰剂对照食物激发试验评估对虾的脱敏情况，随后改为避免食用虾，并在第58周评估持续无反应性（SU）。主要终点是基线和52周时CD4 +过敏原特异性（CD154 +）T细胞中CD28的变化。
结果
经过52周的虾OIT治疗后，在意向性治疗组中，58.3%（7/12）的参与者对累计4043毫克虾蛋白产生了脱敏反应；在符合方案组中，87.5%（7/8）的参与者产生了脱敏反应。大多数在脱敏后仍留在研究中的虾OIT参与者（87.5%，7/8）实现了SU。虽然在虾OIT治疗期间不良事件很常见（75%），但大多数为轻度（伯克分级1级，88%），没有严重（伯克分级3级以上）反应或使用肾上腺素的情况。虾OIT治疗后未观察到CD28表达的显著差异。
结论
虾OIT治疗虾过敏安全有效。大多数参与者治疗成功，并在避免食用虾6周后实现了SU。
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