Brandström J, Vetander M, Lilja G, Johansson S G O, Sundqvist A-C, Kalm F, Nilsson C, Nopp A
Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
Sachs' Children and Youth Hospital, Södersjukhuset, Stockholm, Sweden.
Clin Exp Allergy. 2017 Apr;47(4):540-550. doi: 10.1111/cea.12862. Epub 2017 Jan 10.
Treatment with omalizumab has shown a positive effect on food allergies, but no dosages are established. Basophil allergen threshold sensitivity (CD-sens) can be used to objectively measure omalizumab treatment efficacy and correlates with the outcome of double-blind placebo-controlled food challenge to peanut.
To evaluate whether individualized omalizumab treatment monitored by CD-sens could be an effective intervention for suppression of allergic reactions to peanut.
Severely peanut allergic adolescents (n = 23) were treated with omalizumab for 8 weeks, and CD-sens was analysed before and after. Based on whether CD-sens was suppressed after 8 weeks, the patients either were subject to a peanut challenge or received eight more weeks with increased dose of omalizumab, followed by peanut challenge or another 8-week cycle of omalizumab. IgE and IgE-antibodies to peanut and its components were analysed before treatment.
After individualized omalizumab treatment (8-24 weeks), all patients continued with an open peanut challenge with no (n = 18) or mild (n = 5) objective allergic symptoms. Patients (n = 15) needing an elevated omalizumab dose (ED) to suppress CD-sens had significantly higher CD-sens values at baseline 1.49 (0.44-20.5) compared to those (n = 8) who managed with normal dose (ND) 0.32 (0.24-5.5) (P < 0.01). Median ratios for Ara h 2 IgE-ab/IgE were significantly higher in the ED group (17%) compared to the ND group (11%).
Individually dosed omalizumab, monitored by CD-sens, is an effective and safe treatment for severe peanut allergy. The ratio of IgE-ab to storage protein Ara h 2/IgE as well as CD-sens to peanut may predict the need of a higher omalizumab dose. Clinical trials numbers: EudraCT; 2012-005625-78, ClinicalTrials.gov; NCT02402231.
奥马珠单抗治疗已显示出对食物过敏有积极作用,但尚未确定剂量。嗜碱性粒细胞过敏原阈值敏感性(CD-sens)可用于客观测量奥马珠单抗的治疗效果,并与花生双盲安慰剂对照食物激发试验的结果相关。
评估通过CD-sens监测的个体化奥马珠单抗治疗是否可能是抑制花生过敏反应的有效干预措施。
对23名严重花生过敏的青少年进行8周的奥马珠单抗治疗,并在治疗前后分析CD-sens。根据8周后CD-sens是否受到抑制,患者要么接受花生激发试验,要么接受另外8周更高剂量的奥马珠单抗治疗,随后进行花生激发试验或另一个8周的奥马珠单抗治疗周期。在治疗前分析花生及其成分的IgE和IgE抗体。
经过个体化奥马珠单抗治疗(8 - 24周)后,所有患者继续进行开放性花生激发试验,无(n = 18)或有轻度(n = 5)客观过敏症状。与那些使用正常剂量(ND)0.32(0.24 - 5.5)的患者(n = 8)相比,需要提高奥马珠单抗剂量(ED)以抑制CD-sens的患者(n = 15)在基线时的CD-sens值显著更高,为1.49(0.44 - 20.5)(P < 0.01)。与ND组(11%)相比,ED组中Ara h 2 IgE-ab/IgE的中位比值显著更高(17%)。
通过CD-sens监测的个体化剂量奥马珠单抗是治疗严重花生过敏的有效且安全的方法。IgE抗体与储存蛋白Ara h 2/IgE的比值以及对花生的CD-sens可能预测更高剂量奥马珠单抗的需求。临床试验编号:欧洲药品临床试验数据库(EudraCT);2012 - 005625 - 78,美国国立医学图书馆临床试验数据库(ClinicalTrials.gov);NCT02402231。