Abstract：
Food allergy (FA) is a potentially life-threatening chronic condition that is becoming an increasing public health problem worldwide. This systematic review (SR) was carried out to inform the development of clinical recommendations on the treatment of IgE-mediated FA with biologics and/or IT for the update of the EAACI guidelines. A SR of randomized-controlled trials or quasi-controlled trials was carried out. Studies were identified via comprehensive search strategies in Medline, Embase, and Cochrane Library, up to April 2022.
METHODS: Human adults, children, and adolescents with IgE-mediated FA.
METHODS: IT and/or biologics.
METHODS: Placebo or standard-of-care (allergen avoidance).
RESULTS: Efficacy (desensitization, sustained unresponsiveness (SU), remission), quality of life, and safety (systemic and local adverse reactions (AR)). The Cochrane RoB tool was used to assess the risk of bias. It was reported according to PRISMA and registered in PROSPERO CRD4202229828. After screening, 121 studies were included (111 for IT and 10 for biologics). Most studies had a high risk of bias and showed high heterogeneity in design and results. Metanalysis showed a positive effect of biologics and IT in terms of relative risk (RR) for achieving tolerance to the culprit food compared to avoidance or placebo. Omalizumab for any FA showed a RR of 2.17 [95% confidence interval: 1.22, 3.85]. For peanut allergy, oral IT (OIT) had a RR of 11.94 [1.76, 80.84] versus avoidance or placebo, sublingual IT (SLIT) had a RR of 3.00 [1.04, 8.66], and epicutaneous IT (EPIT) of 2.16 [1.56, 3.00]. OIT had a RR of 5.88 [2.27, 15.18] for cow\'s milk allergy, and of 3.43 [2.24, 5.27] for egg allergy. There was insufficient data on SLIT or EPIT for the treatment of egg and milk allergies. Most ARs reported were mild. For OIT the most common AR involved the gastrointestinal system and for EPIT, AR\'s most commonly affected the skin. There was limited data on severe or life-threatening ARs. There was limited evidence for long term efficacy and quality of life. In conclusion, biologics and IT, alone or in combination, are effective in achieving desensitization while on active treatment but more evidence is needed on long-term tolerance as current evidence is not of high quality. Adverse events while on therapy are generally mild to moderate but a long-term comprehensive safety profile is missing. There is a critical need to optimize and standardize desensitization protocols and outcome measures to facilitate our understanding of the efficacy and safety as well as to allow for comparison between interventions.
METHODS: Human adults, children, and adolescents with IgE-mediated FA.
METHODS: IT and/or biologics.
METHODS: Placebo or standard-of-care (allergen avoidance).
RESULTS: Efficacy (desensitization, sustained unresponsiveness (SU), remission), quality of life, and safety (systemic and local adverse reactions (AR)). The Cochrane RoB tool was used to assess the risk of bias. It was reported according to PRISMA and registered in PROSPERO CRD4202229828. After screening, 121 studies were included (111 for IT and 10 for biologics). Most studies had a high risk of bias and showed high heterogeneity in design and results. Metanalysis showed a positive effect of biologics and IT in terms of relative risk (RR) for achieving tolerance to the culprit food compared to avoidance or placebo. Omalizumab for any FA showed a RR of 2.17 [95% confidence interval: 1.22, 3.85]. For peanut allergy, oral IT (OIT) had a RR of 11.94 [1.76, 80.84] versus avoidance or placebo, sublingual IT (SLIT) had a RR of 3.00 [1.04, 8.66], and epicutaneous IT (EPIT) of 2.16 [1.56, 3.00]. OIT had a RR of 5.88 [2.27, 15.18] for cow\'s milk allergy, and of 3.43 [2.24, 5.27] for egg allergy. There was insufficient data on SLIT or EPIT for the treatment of egg and milk allergies. Most ARs reported were mild. For OIT the most common AR involved the gastrointestinal system and for EPIT, AR\'s most commonly affected the skin. There was limited data on severe or life-threatening ARs. There was limited evidence for long term efficacy and quality of life. In conclusion, biologics and IT, alone or in combination, are effective in achieving desensitization while on active treatment but more evidence is needed on long-term tolerance as current evidence is not of high quality. Adverse events while on therapy are generally mild to moderate but a long-term comprehensive safety profile is missing. There is a critical need to optimize and standardize desensitization protocols and outcome measures to facilitate our understanding of the efficacy and safety as well as to allow for comparison between interventions.
摘要：
食物过敏（FA）是一种潜在的威胁生命的慢性疾病，正在成为全球范围内日益严重的公共卫生问题。进行此系统评价（SR）是为了提供有关使用生物制剂和/或IT治疗IgE介导的FA的临床建议的发展，以更新EAACI指南。进行了随机对照试验或准对照试验的SR。研究是通过Medline的综合搜索策略确定的，Embase,和Cochrane图书馆,到2022年4月。
方法：成年人，孩子们,和青少年IgE介导的FA。
方法：IT和/或生物制剂。
方法：安慰剂或标准护理（避免过敏原）。
结果：功效（脱敏，持续无反应(SU)，缓解)，生活质量,和安全性（全身和局部不良反应（AR））。CochraneRoB工具用于评估偏倚风险。据PRISMA报道，并在PROSPEROCRD4202229828中注册。筛选后,纳入了121项研究(111项用于IT，10项用于生物制剂)。大多数研究有很高的偏倚风险，并且在设计和结果方面表现出高度异质性。Metanalysis显示，与避免或安慰剂相比，生物制剂和IT在相对风险（RR）方面对实现对罪魁祸首食物的耐受性方面具有积极作用。奥马珠单抗用于任何FA的RR为2.17[95%置信区间：1.22,3.85]。对于花生过敏，口服IT（OIT）与回避或安慰剂相比，RR为11.94[1.76，80.84]，舌下IT（SLIT）的RR为3.00[1.04，8.66]，和表皮IT（EPIT）为2.16[1.56，3.00]。OIT对牛奶过敏的RR为5.88[2.27,15.18]，和3.43[2.24,5.27]的鸡蛋过敏。关于SLIT或EPIT的数据不足以治疗鸡蛋和牛奶过敏。大多数ARs报告为轻度。对于OIT，最常见的AR涉及胃肠系统，对于EPIT，AR最常影响皮肤。关于严重或危及生命的AR的数据有限。长期疗效和生活质量的证据有限。总之,生物制品和IT，单独或组合，在积极治疗时可有效实现脱敏，但需要更多的证据来证明长期耐受性，因为目前的证据不是高质量的。治疗期间的不良事件通常为轻度至中度，但缺乏长期的综合安全性。迫切需要优化和标准化脱敏方案和结果措施，以促进我们对疗效和安全性的理解，并进行干预措施之间的比较。
方法：成年人，孩子们,和青少年IgE介导的FA。
方法：IT和/或生物制剂。
方法：安慰剂或标准护理（避免过敏原）。
结果：功效（脱敏，持续无反应(SU)，缓解)，生活质量,和安全性（全身和局部不良反应（AR））。CochraneRoB工具用于评估偏倚风险。据PRISMA报道，并在PROSPEROCRD4202229828中注册。筛选后,纳入了121项研究(111项用于IT，10项用于生物制剂)。大多数研究有很高的偏倚风险，并且在设计和结果方面表现出高度异质性。Metanalysis显示，与避免或安慰剂相比，生物制剂和IT在相对风险（RR）方面对实现对罪魁祸首食物的耐受性方面具有积极作用。奥马珠单抗用于任何FA的RR为2.17[95%置信区间：1.22,3.85]。对于花生过敏，口服IT（OIT）与回避或安慰剂相比，RR为11.94[1.76，80.84]，舌下IT（SLIT）的RR为3.00[1.04，8.66]，和表皮IT（EPIT）为2.16[1.56，3.00]。OIT对牛奶过敏的RR为5.88[2.27,15.18]，和3.43[2.24,5.27]的鸡蛋过敏。关于SLIT或EPIT的数据不足以治疗鸡蛋和牛奶过敏。大多数ARs报告为轻度。对于OIT，最常见的AR涉及胃肠系统，对于EPIT，AR最常影响皮肤。关于严重或危及生命的AR的数据有限。长期疗效和生活质量的证据有限。总之,生物制品和IT，单独或组合，在积极治疗时可有效实现脱敏，但需要更多的证据来证明长期耐受性，因为目前的证据不是高质量的。治疗期间的不良事件通常为轻度至中度，但缺乏长期的综合安全性。迫切需要优化和标准化脱敏方案和结果措施，以促进我们对疗效和安全性的理解，并进行干预措施之间的比较。
