背景:在小麦依赖性运动诱发过敏反应(WDEIA)的患者中,过敏性休克经常发生,因此,建议避免使用小麦产品。我们旨在评估长期奥马珠单抗治疗成人WDEIA患者的疗效和安全性。
方法:在本阶段2,多中心单臂试验,纳入20例WDEIA成人患者(UMIN000019250)。所有患者皮下施用150-600mg奥马珠单抗,并且在施用期(0-48周)和观察期(48-68周)期间定期进行评价(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实现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产品后无过敏反应的患者比例。
结果: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没有出现过敏反应.在观察期间,嗜碱性粒细胞激活率低于10%的患者比例逐渐下降,此后,过敏反应阳性的患者比例逐渐增加,最高达到46.7%。在研究期间未观察到严重不良事件。
结论:通过小麦过敏原的嗜碱性粒细胞激活率以及解除小麦摄入限制后的过敏反应评估,长期奥马珠单抗治疗对成年WDEIA患者是安全有效的。然而,这不足以实现脱敏。
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.