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Background: Anaphylactic shock occurs frequently in patients with wheat-dependent exercise-inducedanaphylaxis (WDEIA), so avoidance of wheat products is advised. The purpose of this study was to assess the efficacyand safety of long-term omalizumab treatment in adult patients with WDEIA [1, 2].
Methods: Twenty adult patients with WDEIA were enrolled in this phase 2 multicenter single-arm trial (UMIN 000019250). All patients received 150-600 mg of omalizumab subcutaneously, and assessments (basophil activation and blood examination) were performed at regular intervals during the administration (0-48 weeks) and observation periods (48–68 weeks). The primary endpoint was the proportion of patients who achieved a basophil activation rate of less than 10% with fractionated wheat preparations, and the secondary endpoint was the proportion of patients who had no allergic reactions after consuming wheat products [3].
Results: During treatment with omalizumab, more than 80% of patients had a basophil activation rate of less than 10% against all fractionated wheat preparations, and 68.8% of patients who met the primary endpoint had no allergic reaction. During the observation period, the proportion of patients with basophil activation rates less than 10% gradually decreased, while the proportion of patients with positive allergic reactions increased gradually and reached a maximum of 46.7%. During the study, no severe adverse events were observed [4].
Conclusions: Long-term omalizumab treatment is safe and effective for adult patients with WDEIA, as measured by basophil activation rate with wheat allergens and allergic reactions after removing wheat restrictions. This, however, is insufficient to achieve desensitisation.
