Observational long-term follow-up study of rapid food oral immunotherapy with omalizumab.
Observational long-term follow-up study of rapid food oral immunotherapy with omalizumab.
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DOI：
10.1186/s13223-017-0223-8
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发表时间：
2017
期刊：
影响因子：
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通讯作者：
Nadeau KC
中科院分区：
文献类型：
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作者：
Andorf S;Manohar M;Dominguez T;Block W;Tupa D;Kshirsagar RA;Sampath V;Chinthrajah RS;Nadeau KC
已经发表了许多临床研究，这些研究集中于通过口服免疫疗法（OIT）与抗奥马珠单抗治疗来治疗单一食物过敏。我们之前在一项I期研究中证明了使用奥马珠单抗的快速OIT方案的安全性和耐受性，以快速（7-36周;中位数= 18周）平行实现对多种（最多5种）食物过敏原的脱敏。在目前的长期观察性研究中，我们跟踪了34名食物过敏参与者超过5年，他们最初接受了1期快速OIT方案。作为1期研究的一部分，在达到每种食物过敏原2 g蛋白质的维持剂量后，根据务实的团队决定，一些参与者的长期维持剂量减少。参与者通过标准口服食物挑战（OFC），皮肤点刺试验和血液测试进行了长达62个月的随访。在长期随访（LTFU）研究结束时，每位参与者将2 g OFC传递给他们的每种冒犯性食物过敏原（总共最多5种食物过敏原）。我们的数据证明了长期维持食物过敏原剂量的可行性，而不影响通过快速OIT赋予的脱敏状态。 试验注册登记处：Clinicaltrials. gov。注册编号：NCT 01510626（原始研究），NCT 03234764（LTFU研究）。登记日期：2011年11月29日（原始研究）; 2017年7月26日（LTFU研究，回顾性注册）本文的在线版本（10.1186/s13223-017-0223-8）包含补充材料，可供授权用户使用。
A number of clinical studies focused on treating a single food allergy through oral immunotherapy (OIT) with adjunctive omalizumab treatment have been published. We previously demonstrated safety and tolerability of a rapid OIT protocol using omalizumab in a phase 1 study to achieve desensitization to multiple (up to 5) food allergens in parallel, rapidly (7–36 weeks; median = 18 weeks). In the current long-term, observational study, we followed 34 food allergic participants for over 5 years, who had originally undergone the phase 1 rapid OIT protocol. After reaching the maintenance dose of 2 g protein for each of their respective food allergens as a part of the phase 1 study, the long-term maintenance dose was reduced for some participants based on a pragmatic team-based decision. Participants were followed up to 62 months through standard oral food challenges (OFCs), skin prick tests, and blood tests. Each participant passed the 2 g OFC to each of their offending food allergens (up to 5 food allergens in total) at the end of the long-term follow-up (LTFU) study. Our data demonstrate the feasibility of long-term maintenance dosing of a food allergen without compromising the desensitized status conferred through rapid-OIT. Trial registration Registry: Clinicaltrials.gov. Registration numbers: NCT01510626 (original study), NCT03234764 (LTFU study). Date of registration: November 29, 2011 (original study); July 26, 2017 (LTFU study, retrospectively registered) The online version of this article (10.1186/s13223-017-0223-8) contains supplementary material, which is available to authorized users.
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影响因子：
14.2
作者：
Jones, Stacie M.;Burks, A. Wesley;Sampson, Hugh A.
通讯作者：
Sampson, Hugh A.
影响因子：
14.2
作者：
Jones, Stacie M.;Burks, A. Wesley;Dupont, Christophe
通讯作者：
Dupont, Christophe
影响因子：
5.9
作者：
Goetz, DW;Whisman, BA;Goetz, AD
通讯作者：
Goetz, AD
影响因子：
14.2
作者：
Grundy, J;Matthews, S;Arshad, SH
通讯作者：
Arshad, SH
影响因子：
64.8
作者：
通讯作者：
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