Department of Life, Health and Environmental Sciences, University of L'Aquila, L'Aquila, Italy.
Allergology and Clinical Immunology Unit, Teramo, Italy.
Int J Immunopathol Pharmacol. 2021 Jan-Dec;35:20587384211065870. doi: 10.1177/20587384211065870.
Omalizumab is shown to be effective in the treatment of chronic spontaneous urticaria (CSU), a disease with high personal and social impact. Sex differences in CSU are recognized with women more frequently affected. Scarce is the knowledge about response to omalizumab between sex groups. We sought to identify any differences based on the sex of patients receiving omalizumab.
We evaluated data of patients diagnosed with CSU refractory to high-dose second-generation H1 antihistamines and treated with 300 mg omalizumab every 4 weeks for 6 months and then at relapse.
Discussion: All patients, regardless of sex, age, or any other factor, achieved the clinical remission of the disease after the first 3 doses with a reduction of the disease activity indices and impact on the quality of life. Recurrences predominate in men, two months after the suspension of the drug. Respect to sex and recurrence we did not find any correlation with age, body mass index, peripheral eosinophil counts, total IgE levels, D-dimer, plasma prothrombine level or C-reactive protein. We found no sex differences in tolerability and safety. CSU in girls may persist longer and have worse prognosis, but no one has so far noted sex differences in response to omalizumab.
Although there are no certainties on the mechanism of action of omalizumab in CSU, the noticeable difference in response between males and females lead us to suppose a role of the hormonal balance both on the pathogenesis of the CSU and on the efficacy of OmAb.
奥马珠单抗已被证明可有效治疗慢性自发性荨麻疹（CSU），这是一种对个人和社会影响较大的疾病。CSU 存在性别差异，女性患者更为常见。关于奥马珠单抗治疗不同性别患者的效果差异，目前的了解非常有限。我们旨在确定基于患者性别接受奥马珠单抗治疗的任何差异。
我们评估了诊断为 CSU 的患者数据，这些患者对高剂量第二代 H1 抗组胺药难治，接受 300mg 奥马珠单抗每 4 周治疗 6 个月，然后在复发时再进行治疗。
讨论：所有患者，无论性别、年龄或任何其他因素如何，在接受前 3 剂治疗后均实现了疾病的临床缓解，疾病活动指数和生活质量影响均得到降低。停药后两个月，男性复发更为常见。关于性别和复发，我们未发现年龄、体重指数、外周嗜酸性粒细胞计数、总 IgE 水平、D-二聚体、血浆凝血酶原水平或 C 反应蛋白与复发之间存在任何相关性。我们未发现奥马珠单抗治疗的耐受性和安全性存在性别差异。女孩的 CSU 可能持续时间更长，预后更差，但迄今为止，尚未有人注意到奥马珠单抗治疗效果的性别差异。
尽管奥马珠单抗治疗 CSU 的作用机制尚不确定，但男性和女性之间对奥马珠单抗的反应存在显著差异，这使我们推测，激素平衡在 CSU 的发病机制和奥马珠单抗的疗效中都发挥了作用。
