Effect of Anti-IgE therapy in patients with peanut allergy
Effect of Anti-IgE therapy in patients with peanut allergy
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DOI：
10.1056/nejmoa022613
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发表时间：
2003-03-13
影响因子：
158.5
通讯作者：
Shanahan, WR
中科院分区：
文献类型：
--
作者：
Leung, DYM;Sampson, HA;Shanahan, WR
背景：花生引起的过敏反应是一种IgE介导的疾病，估计在美国每年影响150万人，造成50至100人死亡。TNX-901是一种人源化的IgG 1单克隆抗体，对IgE的识别和掩蔽的表位在负责结合到高亲和力的Fc（CD 4）受体上的肥大细胞和嗜碱性粒细胞CH 3区的IgE。方法：我们进行了一项双盲，随机，剂量范围试验，在84例患者的历史，立即过敏花生。超敏反应得到证实，并在筛选时通过双盲、安慰剂对照的口服食物激发建立了胶囊化花生粉的阈值剂量。患者以3：1的比例随机分配接受TNX-901（150、300或450 mg）或安慰剂皮下注射，每四周一次，共4次。结果：从178 ~ 436 mg花生粉的敏感性基线值，安慰剂组的敏感性基线值平均增加710 mg，TNX-901 150 mg组增加913 mg，TNX-901 300 mg组增加1650 mg，TNX-901 450 mg组增加2627 mg（P < 0.01）。
Background:Peanut-induced anaphylaxis is an IgE-mediated condition that is estimated to affect 1.5 million people and cause 50 to 100 deaths per year in the United States. TNX-901 is a humanized IgG1 monoclonal antibody against IgE that recognizes and masks an epitope in the CH3 region of IgE responsible for binding to the high-affinity Fc(epsilon) receptor on mast cells and basophils.Methods:We conducted a double-blind, randomized, dose-ranging trial in 84 patients with a history of immediate hypersensitivity to peanut. Hypersensitivity was confirmed and the threshold dose of encapsulated peanut flour established by a double-blind, placebo-controlled oral food challenge at screening. Patients were randomly assigned in a 3:1 ratio to receive either TNX-901 (150, 300, or 450 mg) or placebo subcutaneously every four weeks for four doses. The patients underwent a final oral food challenge within two to four weeks after the fourth dose.Results:From a mean base-line threshold of sensitivity of 178 to 436 mg of peanut flour in the various groups, the mean increases in the oral-food-challenge threshold were 710 mg in the placebo group, 913 mg in the group given 150 mg of TNX-901, 1650 mg in the group given 300 mg of TNX-901, and 2627 mg in the group given 450 mg of TNX-901 (P