Department of Allergy, Hospital Infantil Universitario Niño Jesús and ARADyAL- RETICs network RD16/0006/0026, Instituto de Salud Carlos III, IIS-P, FibHNJ, Madrid, Spain.
Department of Allergy, Hospital General La Mancha Centro, Alcázar de San Juan, Spain.
Pediatr Allergy Immunol. 2021 Aug;32(6):1287-1295. doi: 10.1111/pai.13517. Epub 2021 Apr 27.
Oral immunotherapy is a frequent treatment for the management of food allergies, but adverse events (AE) are common. This study assessed the outcome of cow's milk oral immunotherapy (MOIT) in severe cow`s milk-allergic patients treated with omalizumab in a real-life setting.
OmaBASE was a national, multicenter, open, and observational registry that collected clinical, immunologic, and treatment from patients with food allergy receiving omalizumab.
Data derived from 58 patients aged 10.3 years (IQR 6.3-13.2) and median milk-specific IgE 100 kU /L at the start of omalizumab treatment. Most had experienced anaphylaxis by accidental exposures (70.7%) and had asthma (81.0%). Omalizumab in monotherapy induced tolerance to ≥6000 mg of cow's milk protein (CMP) to 34.8% of patients tested by oral food challenge. Omalizumab combined with MOIT conferred desensitization to ≥6000 mg of CMP to 83.0% of patients. Omalizumab withdrawal triggered more AE (P = .013) and anaphylaxis (P = .001) than no discontinuation. Anaphylaxis was observed in 36.4% of patients who discontinued omalizumab, and more in those with sudden (50.0%) rather than progressive (12.5%) discontinuation. At database closure, 40.5% of patients who had completed follow-up tolerated CMP without omalizumab (7.2% 1500-4500 mg; 33.3% ≥6000 mg).
Milk oral immunotherapy initiated under omalizumab allows the desensitization of subjects with severe cow's milk allergy even after omalizumab discontinuation. However, discontinuation of omalizumab can lead to severe AE and should be carefully monitored.
口服免疫疗法是治疗食物过敏的常用方法,但不良反应(AE)很常见。本研究评估了奥马珠单抗治疗下严重牛奶过敏患者进行牛奶口服免疫疗法(MOIT)的结果,这是在真实环境中进行的。
OmaBASE 是一项全国性、多中心、开放和观察性登记研究,收集了接受奥马珠单抗治疗的食物过敏患者的临床、免疫和治疗数据。
数据来自 58 名年龄为 10.3 岁(IQR 6.3-13.2)的患者,在开始奥马珠单抗治疗时中位牛奶特异性 IgE 为 100 kU/L。大多数患者因意外暴露而发生过敏反应(70.7%),且患有哮喘(81.0%)。奥马珠单抗单药治疗诱导 34.8%的患者经口服食物挑战可耐受≥6000mg 牛奶蛋白(CMP)。奥马珠单抗联合 MOIT 使 83.0%的患者可耐受≥6000mg CMP。奥马珠单抗停药比不停药更易引发不良反应(P=.013)和过敏反应(P=.001)。奥马珠单抗停药后,36.4%的患者出现过敏反应,且突然停药(50.0%)比逐渐停药(12.5%)的患者更多。在数据库关闭时,40.5%完成随访的患者可耐受不含奥马珠单抗的 CMP(7.2%为 1500-4500mg;33.3%为≥6000mg)。
在奥马珠单抗的基础上启动牛奶口服免疫疗法可以使严重牛奶过敏患者脱敏,即使在奥马珠单抗停药后也是如此。然而,奥马珠单抗的停药可能导致严重的不良反应,应密切监测。