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To the Editor, Standard treatments for chronic spontaneous urticaria (CSU) including the second-generation H1-antihistamines (SGAH) are often ineffective even with four times the FDA-recommended dose. 1,2 Eosinophilic infiltrates and an abundance of interleukin-5 (IL5) in CSU lesions (hives) support a role for IL5 in the pathomechanism(s) of CSU. 3 Thus, the use of biologic therapies, for example, benralizumab targeting IL5-receptor-α, in treating SGAH-resistant CSU was hypothesized.A repeated-measures, 24-week study was designed and conducted at an urticaria clinic to determine clinical efficacy of benralizumab in CSU. Twelve SGAH-unresponsive CSU patients (3 males, 9 females; 2 blacks, 10 whites; between ages 32-65 years) having a median daily Urticaria Activity Score (UAS7) 4 of 4 and pruritus severity ≥2 were enrolled. After a baseline run-in period, subjects were treated with a subcutaneous placebo dose followed by benralizumab 30 mg subcutaneously every month (×3 doses) followed by two off-medication monthly visits. Subject-reported responses to UAS7 and CU-QoL questionnaires were recorded at the monthly visits. The primary and exploratory endpoints were the change in UAS7 and Chronic Urticaria Quality-of-Life Total Score (CUQoLTS) respectively, from 4 weeks after placebo dose (visit 2) to 4 weeks after last dose of benralizumab (visit 5). Nine subjects completed

Purpose of reviewThe current review describes the incidence and risk for anaphylaxis due to allergy injections. Recent findingsThe incidence of fatal anaphylaxis occurs with approximately one in 7.2 million injection visits. Severe anaphylaxis may occur once in every 160 000 visits. The major risk for fatal anaphylaxis is severe and uncontrolled asthma.

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Background. Standard of care for chronic spontaneous urticaria (CSU) includes second-generation H1-antihistamines (SGAH) but is often ineffective even with four-times the FDA-recommended dose. Urticarial lesions are commonly characterized by increased lymphocytes with perivascular eosinophilic infiltrates implying a role for the interleukin-5 (IL5). Objective. This study investigated the effects of benralizumab, an anti-IL5-receptor-alpha monoclonal antibody, in human subjects with SGAHunresponsive CSU that completed all study visits. Methods. A repeated-measures, 24-week study was conducted at an urticaria specialist clinic where SGAH-unresponsive CSU patients (3 males and 9 females; age range, 32-65 years) having a median weekly Urticaria Activity Score (UAS7) of 4 and pruritus severity [?]2 were enrolled. After a baseline run-in period, subjects were treated with a subcutaneous placebo dose followed by benralizumab 30mg subcutaneously every month (×3 doses) followed by two off-medication monthly-visits. The primary and exploratory endpoints were the change from baseline in UAS7 and Chronic Urticaria Quality-of-Life Score (CU-QoLTS) respectively. Secondary endpoints included peripheral blood eosinophils (eos%) and basophils, skin eosinophilia, and differentially expressed genes (DEGs) in blood before-and after benralizumab. Results. UAS7 and CU-QoLTS significantly improved post-benralizumab compared to baseline scores in 7 of 9 subjects completing the study.Clinical improvements correlated with reduction in eos% and inflammatory cell infiltrates in skin lesions. Biologic pathways, regulated by DEGs, involved IL-5R activity, tryptophan metabolism and Siglec-8 expression. Conclusion. Benralizumab was clinically efficacious in the treatment of subjects with SGAH-refractory CSU which correlated with several DEGs in blood. This study supports the use of benralizumab for CSU treatment.