Abstract

Anaphylactic shock usually occurs in people with wheat-dependent exercise-induced anaphylaxis (WDEIA), hence avoiding wheat products is advised. For adult patients with WDEIA, our goal was to assess the effectiveness and safety of long-term omalizumab treatment. 20 adult WDEIA patients were enrolled in this phase 2, multicenter, single-arm experiment (UMIN 000019250). Every patient received 150-600 mg of omalizumab subcutaneously, and during the administration period (0-48 weeks) and observation period, assessments (basophil activation and blood testing) were carried out at regular intervals (48–68 weeks). The proportion of patients who reached a basophil activation rate of less than 10% with fractionated wheat preparations served as the primary endpoint, while the proportion of patients who experienced no allergic reactions after consuming wheat products served as the secondary endpoint.