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Role of IgE Bearing Cells in Chronic Idiopathic Urticaria

携带 IgE 的细胞在慢性特发性荨麻疹中的作用

基本信息

批准号：
9477428
负责人：
SARBJIT Singh SAINI
金额：
$ 40.5万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-06-27 至 2020-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9477428
关键词：
Allergens Allergic Allergic Disease Allergic Reaction Antibodies Basophilic Cell Basophils Biological Blood Circulation Cell Count Cell physiology Cell surface Cells Chronic Clinical Clinical Trials Clinical assessments Diagnosis Disease Disease remission Down-Regulation Feedback Frequencies Half-Life Heart Diseases Hour IgE IgE Receptors Individual Laboratories Link Measures Mediating Monitor Pathogenesis Pathway interactions Patients Periodicity Play Quality of life Receptor Activation Role Signs and Symptoms Skin Skin Tissue Subcutaneous Injections Symptoms Testing Therapeutic Tissues United States Urticaria Work anti-IgE anti-IgG base clinical remission density effective therapy expectation experience insight mast cell new therapeutic target omalizumab peripheral blood phase 3 study public health relevance rate of change receptor expression response

项目摘要

DESCRIPTION (provided by applicant): Urticaria is a condition that has a lifetime likelihood of 25% in the United States and a significant proportion of these individuals will experience the disease in a cyclical form that lasts 1-10 years and for which no cause can be identified. If this condition occurs, the patient is given the diagnosis of chronic idiopathic urticaria (CIU). Theof condition can be severe and produce a reduction in the quality of life similar to that measured for heart diseases. At present, there is no known mechanism but recent studies have shown that the disease can be treated with non-aggregating, anti-IgE antibody (omalizumab). More remarkably, treatment with omalizumab leads to remission of active disease with a rapidity that is not consistent with expectations for changes in skin mast cells. There are numerous indications that basophils play a role in expression of this disease and the rate of clinical improvement on omalizumab is consistent with the timing of basophils changes seen in studies of allergic subjects during treatment with omalizumab. This proposal will directly test the hypothesis that changes in IgE-dependent functionality of basophils will be concordant with the rate of clinical improvement during treatment with omalizumab. This study will conduct a clinical trial of omalizumab therapy for patients with active CIU. This trial will be characterized by a hig temporal frequency of both clinical assessments and a variety of metrics of basophil and mast cell function.

描述（由申请人提供）：荨麻疹是一种在美国有25%的终生可能性的疾病，这些人中有很大一部分将以持续1-10年的周期性形式经历这种疾病，并且无法确定原因。如果发生这种情况，患者被诊断为慢性特发性荨麻疹（CIU）。这种情况可能很严重，并导致生活质量下降，类似于心脏病。目前，还没有已知的机制，但最近的研究表明，这种疾病可以用非聚集性抗IgE抗体（奥马珠单抗）治疗。更值得注意的是，奥马珠单抗治疗导致活动性疾病缓解的速度与皮肤肥大细胞变化的预期不一致。有许多迹象表明，嗜碱性粒细胞在这种疾病的表达中发挥作用，奥马珠单抗的临床改善率与奥马珠单抗治疗期间过敏受试者研究中观察到的嗜碱性粒细胞变化的时间一致。本提案将直接检验嗜碱性粒细胞IgE依赖性功能的变化与奥马珠单抗治疗期间的临床改善率一致的假设。本研究将对活动性CIU患者进行奥马珠单抗治疗的临床试验。本试验的特点是临床评估和各种嗜碱性粒细胞和肥大细胞功能指标的时间频率较高。