University of Wisconsin School of Medicine and Public Health, Madison, Wis.
Rho Federal Systems Division, Inc, Chapel Hill, NC.
J Allergy Clin Immunol Pract. 2013 Mar;1(2):163-71. doi: 10.1016/j.jaip.2013.01.011. Epub 2013 Feb 26.
Treatment regimens for omalizumab are guided by a dosing table that is based on total serum IgE and body weight. Limited data exist about onset and offset of omalizumab efficacy in children and adolescents or subgroups that most benefit from treatment.
Post hoc analyses were conducted to (1) examine patient characteristics of those eligible and ineligible for omalizumab, (2) describe onset of effect after initiation of omalizumab and offset of treatment effect after stopping therapy, and (3) determine whether the efficacy differs by age, asthma severity, dosing regimen, and prespecified biomarkers.
Inner-city children and adolescents with persistent allergic asthma were enrolled in the Inner-City Anti-IgE Therapy for Asthma trial that compared omalizumab with placebo added to guidelines-based therapy for 60 weeks.
Two hundred ninety-three of 889 participants (33%) clinically suitable for omalizumab were ineligible for dosing according to a modified dosing table specifying IgE level and body weight criteria. Baseline symptoms were comparable among those eligible and ineligible to receive omalizumab, but other characteristics (rate of health care utilization and skin test results) differed. The time of onset of omalizumab effect was <30 days and time of offset was between 30 and 120 days. No difference in efficacy was noted by age or asthma severity, but high exhaled nitric oxide, blood eosinophils, and body mass index predicted efficacy.
A significant portion of children and adolescents particularly suited for omalizumab because of asthma severity status may be ineligible due to IgE >1300 IU/mL. Omalizumab reduced asthma symptoms and exacerbations rapidly; features associated with efficacy can be identified to guide patient selection.
奥马珠单抗的治疗方案是根据总血清 IgE 和体重制定的剂量表来指导的。关于奥马珠单抗在儿童和青少年或最受益于治疗的亚组中的疗效的起始和消退，数据有限。
进行事后分析以（1）检查有资格和无资格接受奥马珠单抗治疗的患者特征，（2）描述奥马珠单抗起始治疗后效果的出现和停止治疗后治疗效果的消退，以及（3）确定疗效是否因年龄、哮喘严重程度、剂量方案和预定生物标志物而有所不同。
患有持续性过敏性哮喘的城市内儿童和青少年参加了城市内抗 IgE 治疗哮喘试验，该试验比较了奥马珠单抗与安慰剂，安慰剂添加到基于指南的治疗方案中 60 周。
在 889 名符合奥马珠单抗临床条件的参与者中，有 293 名（33%）根据修改后的剂量表（规定 IgE 水平和体重标准）不适合剂量。有资格和无资格接受奥马珠单抗治疗的患者的基线症状相当，但其他特征（医疗保健利用率和皮肤试验结果）不同。奥马珠单抗疗效的起始时间<30 天，消退时间在 30 至 120 天之间。年龄或哮喘严重程度对疗效无差异，但呼气一氧化氮、血嗜酸性粒细胞和体重指数高可预测疗效。
由于哮喘严重程度，有相当一部分特别适合奥马珠单抗的儿童和青少年可能由于 IgE >1300 IU/mL 而无资格接受奥马珠单抗治疗。奥马珠单抗迅速减轻哮喘症状和加重；可以确定与疗效相关的特征来指导患者选择。
