Long-term treatment with egg oral immunotherapy enhances sustained unresponsiveness that persists after cessation of therapy

Long-term treatment with egg oral immunotherapy enhances sustained unresponsiveness that persists after cessation of therapy
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DOI:
10.1016/j.jaci.2015.12.1316
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发表时间:
2016-04-01
影响因子:
14.2
通讯作者:
Sampson, Hugh A.
Sampson, Hugh A.
中科院分区:
医学1区
文献类型:
--
作者:
Jones, Stacie M.;Burks, A. Wesley;Sampson, Hugh A.

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背景资料:我们先前报道了一项鸡蛋口服免疫疗法(eOIT)的随机安慰剂对照研究的结果,其中27.5%的受试者在2年后达到持续无反应(SU)。在这里,我们报告的结果,通过4年的治疗和长期follow.Objective:我们试图评估的有效性和安全性eOIT参与者治疗长达4年。鸡蛋过敏儿童(5-18岁)接受eOIT(n = 40)长达4年或安慰剂(n = 15)关键结果是第4年达到SU的受试者百分比。进行安全性和免疫学评估,并在研究结束后(LFQ-1)和1年后(LFQ-2)进行长期随访问卷调查(LFQ)。结果:40例eOIT治疗受试者中,20例(50.0%)在第4年显示SU。对于第3年和第4年期间仍在给药的受试者,22例受试者中有12例(54.5%)出现轻度症状。在LFQ时,与安慰剂相比,更多接受eOIT的受试者(LFQ-1,23/34 [68%]; LFQ-2,21/33 [64%])食用未烘焙和烘焙鸡蛋(LFQ-1,2/11 [18%],P = .006; LFQ-2,3/12 [25%],P = .04)。在达到SU的受试者中,20名受试者中有18名(90%)完成了LFQ,18名受试者中有18名(100%)报告食用了所有形式的鸡蛋。与未达到SU的受试者相比,达到SU的受试者的IgG 4值更高(P = .001)和较低的鸡蛋皮肤点刺试验评分(P = .0002)随着时间的推移,鸡蛋特异性IgE与总IgE的中位基线比值较低结论:eOIT后的SU随着治疗持续时间的延长而增强,并增加了饮食中耐受未烘焙鸡蛋的可能性。
Background: We previously reported the results of a randomized placebo-controlled study of egg oral immunotherapy (eOIT) in which 27.5% of subjects achieved sustained unresponsiveness (SU) after 2 years. Here we report the results of treatment through 4 years and long-term follow-up.Objective: We sought to evaluate the efficacy and safety of eOIT in participants treated up to 4 years.Methods: Children with egg allergy (5-18 years old) received eOIT (n = 40) for up to 4 years or placebo (n = 15) for 1 year or less. The key outcome was the percentage of subjects achieving SU by year 4. Safety and immunologic assessments were performed, and long-term follow-up questionnaires (LFQs) were administered after study conclusion (LFQ-1) and 1 year later (LFQ-2).Results: Of 40 eOIT-treated subjects, 20 (50.0%) of 40 demonstrated SU by year 4. For those subjects still dosing during years 3 and 4, mild symptoms were present in 12 (54.5%) of 22 subjects. At the time of the LFQ, more subjects receiving eOIT (LFQ-1, 23/34 [68%]; LFQ-2, 21/33 [64%]) were consuming unbaked and baked egg versus placebo (LFQ-1, 2/11 [18%], P = .006; LFQ-2, 3/12 [25%], P = .04). Of subjects achieving SU, 18 (90%) of 20 completed the LFQ, with 18 (100%) of 18 reporting consumption of all forms of egg. When compared with subjects not achieving SU, subjects achieving SU had higher IgG4 values (P = .001) and lower egg skin prick test scores (P = .0002) over time and a lower median baseline ratio of egg-specific IgE to total IgE (1.1% vs 2.7%, P = .04).Conclusions: SU after eOIT is enhanced with longer duration of therapy and increases the likelihood of tolerating unbaked egg in the diet.