Treatment of patients with new onset Type 1 diabetes with a single course of anti-CD3 mAb Teplizumab preserves insulin production for up to 5 years.
Treatment of patients with new onset Type 1 diabetes with a single course of anti-CD3 mAb Teplizumab preserves insulin production for up to 5 years.
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DOI：
10.1016/j.clim.2009.04.007
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发表时间：
2009-08
期刊：
影响因子：
--
通讯作者：
Immune Tolerance Network ITN007AI Study Group
中科院分区：
文献类型：
--
作者：
Herold KC;Gitelman S;Greenbaum C;Puck J;Hagopian W;Gottlieb P;Sayre P;Bianchine P;Wong E;Seyfert-Margolis V;Bourcier K;Bluestone JA;Immune Tolerance Network ITN007AI Study Group
抗CD3单克隆抗体可能使新发1型糖尿病（T1DM）患者的β细胞功能延长至2年。一项关于抗CD3单克隆抗体替普利珠单抗治疗T1DM的随机开放标签试验在纳入10名受试者后停止，原因是与之前一项试验相比，不良事件增加，这与药物剂量较高有关。替普利珠单抗导致循环T细胞短暂减少，但恢复的细胞不是新的胸腺迁出细胞，因为T细胞受体切除环没有增加。药物治疗2年期间，C肽损失有减少的趋势（p = 0.1），胰岛素使用量较低（p < 0.001）。在接受药物治疗并随访至60个月的4名受试者中，C肽反应得以维持。我们得出结论，替普利珠单抗剂量增加会导致更多不良事件，且疗效未提高。该药物可能使T细胞边缘化而不是耗尽T细胞。治疗后长达5年C肽水平可能仍可检测到。
Anti-CD3 mAbs may prolong β cell function up to 2 years in patients with new onset Type 1 diabetes (T1DM). A randomized open label trial of anti-CD3 mAb, Teplizumab, in T1DM was stopped after 10 subjects because of increased adverse events than in a previous trial related with higher dosing of drug. Teplizumab caused transient reduction in circulating T cells, but the recovered cells were not new thymic emigrants because T cell receptor excision circles were not increased. There was a trend for reduced loss of C-peptide over 2 yrs with drug treatment (p=0.1), and insulin use was lower (p<0.001). In 4 drug treated subjects followed up to 60 months, C-peptide responses were maintained. We conclude that increased doses of Teplizumab are associated with greater adverse events without improved efficacy. The drug may marginate rather than deplete T cells. C-peptide levels may remain detectable up to 5 yrs after treatment.
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