Efficacy and safety of omalizumab in adult patients with wheat-dependent exercise-induced anaphylaxis: Reduction of in vitro basophil activation and allergic reaction to wheat
Efficacy and safety of omalizumab in adult patients with wheat-dependent exercise-induced anaphylaxis: Reduction of in vitro basophil activation and allergic reaction to wheat
复制标题
奥马珠单抗对小麦依赖性运动诱发过敏反应成年患者的疗效和安全性：减少体外嗜碱性粒细胞活化和对小麦的过敏反应
DOI：
10.1016/j.alit.2022.11.013
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发表时间：
2023
影响因子：
6.8
通讯作者：
Morita Eishin
中科院分区：
文献类型：
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作者：
Chinuki Yuko;Kohno Kunie;Hide Michihiro;Hanaoka Keiko;Okabe Takahiro;Fukunaga Atsushi;Oda Yoshiko;Adachi Atsuko;Ugajin Tsukasa;Yokozeki Hiroo;Suzuki Ritsuro;Sugiyama Akiko;Kishikawa Reiko;Yamasaki Osamu;Morita Eishin
背景资料：在小麦依赖性运动诱导过敏反应（WDEIA）患者中，过敏性休克经常发生，因此建议避免使用小麦产品。我们的目的是评估长期奥马珠单抗治疗成人患者WDEIA.Methods的疗效和安全性：在这个2期，多中心单臂试验，20例成人患者WDEIA入组（UMIN 000019250）。所有患者皮下给予150-600 mg奥马珠单抗，并在给药期（0-48周）和观察期（48-68周）定期进行评价（嗜碱性粒细胞活化和血液检查）。主要终点是使用分级小麦制剂后嗜碱性粒细胞活化率低于10%的患者比例，次要终点是摄入小麦制品后无过敏反应的患者比例。在奥马珠单抗治疗期间，超过80%的患者对所有分级小麦制剂的嗜碱性粒细胞活化率低于10%，68.8%达到主要终点的患者未发生过敏反应。观察期间，嗜碱性粒细胞活化率低于10%的患者比例逐渐下降，此后过敏反应阳性患者比例逐渐增加，最高达46.7%。严重的不良事件没有观察到在study.Conclusions：长期omalizumab治疗是安全和有效的成人患者WDEIA评估时，嗜碱性粒细胞活化率与小麦过敏原以及过敏反应后解除限制小麦摄入量。然而，这还不足以实现脱敏。
Background: In patients with wheat-dependent exercise-induced anaphylaxis (WDEIA), anaphylactic shock occurs frequently, therefore avoidance of wheat products is recommended. We aimed to evaluate efficacy and safety of long-term omalizumab treatment for adult patients with WDEIA.Methods: In this phase 2, multicentre single-arm trial, 20 adult patients with WDEIA were enrolled (UMIN 000019250). All patients were administered 150-600 mg of omalizumab subcutaneously and evaluations (basophil activation and blood examination) were performed at regular intervals during administration period (0-48 weeks) and observation period (48-68 weeks). Primary endpoint was proportion of the patients who achieved a basophil activation rate below 10% with fractionated wheat preparations, and secondary endpoint was proportion of the patients with no allergic reactions after wheat products ingestion.Results: During the omalizumab treatment, more than 80% of the patients achieved the basophil activation rate less than 10% against all fractionated wheat preparations, and 68.8% of the patients who achieved the primary endpoint experienced no allergic reaction. During the observation period, the proportion of the patients who achieved a basophil activation rate below 10% decreased gradually, and the proportion of patients with positive allergic reactions increased gradually thereafter and reached maximum of 46.7%. Severe adverse events were not observed during the study.Conclusions: Long-term omalizumab treatment is safe and effective for adult patients with WDEIA when assessed by basophil activation rate with wheat allergens as well as allergic reactions after lifting of restrictions on wheat intake. However, this is not enough to achieve desensitization.