An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes
An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes
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DOI：
10.1056/nejmoa1902226
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发表时间：
2019-08-15
影响因子：
158.5
通讯作者：
Greenbaum, Carla J.
中科院分区：
文献类型：
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作者：
Herold, Kevan C.;Bundy, Brian N.;Greenbaum, Carla J.
在这项试验中，1型糖尿病患者的高风险非糖尿病亲属被随机分配接受teplizumab（一种抗CD3单克隆抗体）或安慰剂，并随访1型糖尿病。1型糖尿病是一种慢性自身免疫性疾病，可导致分泌胰岛素的β细胞受损，并依赖外源性胰岛素维持生存。一些干预措施延缓了1型糖尿病患者胰岛素产生的丧失，但需要在诊断前进行可能影响临床进展的干预措施。方法：我们进行了一项2期、随机、安慰剂对照、双盲的teplizumab（一种Fc受体非结合性抗CD3单克隆抗体）试验，试验对象为未患糖尿病但有发生临床疾病高风险的1型糖尿病患者亲属。患者被随机分配到一个单一的14天疗程的teplizumab或安慰剂，并进行后续的进展为临床1型糖尿病与口服葡萄糖耐量试验，在6个月的时间间隔。结果共有76名参与者（其中55人[72%]是
In this trial, high-risk nondiabetic relatives of patients with type 1 diabetes were randomly assigned to receive teplizumab (an anti-CD3 monoclonal antibody) or placebo and were followed for type 1 diabetes. Teplizumab delayed progression to clinical type 1 diabetes in high-risk participants.Background Type 1 diabetes is a chronic autoimmune disease that leads to destruction of insulin-producing beta cells and dependence on exogenous insulin for survival. Some interventions have delayed the loss of insulin production in patients with type 1 diabetes, but interventions that might affect clinical progression before diagnosis are needed. Methods We conducted a phase 2, randomized, placebo-controlled, double-blind trial of teplizumab (an Fc receptor-nonbinding anti-CD3 monoclonal antibody) involving relatives of patients with type 1 diabetes who did not have diabetes but were at high risk for development of clinical disease. Patients were randomly assigned to a single 14-day course of teplizumab or placebo, and follow-up for progression to clinical type 1 diabetes was performed with the use of oral glucose-tolerance tests at 6-month intervals. Results A total of 76 participants (55 [72%] of whom were