Sustained reduction in delaying type 1 diabetes with teplizumab

Iskandar Idris
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引用次数: 1

Abstract

Previous phase II randomised controlled trials have shown that teplizumab (an Fc receptor–nonbinding anti-CD3 monoclonal antibody) was able to delay progression to type 1 diabetes in high-risk patients.

The study enrolled 76 participants (55 children and 21 adults) who were the relatives of people with type 1 diabetes and did not have diabetes themselves, but were at high risk for developing the condition. At the end of the trial, 53% of the teplizumab-treated group did not have type 1 diabetes, compared to 28% in the placebo group.

New follow up data, presented at the American Diabetes Association's virtual meeting in 2020 have showed sustained reduction in the onset of type 1 diabetes - a delay of as much as three years, compared to placebo.

In addition, people who were treated with teplizumab showed a significant reversal in C-peptide decline in the six months following treatment, after which C-peptide levels seemed to stabilize. These findings provide early evidence for the potential of this therapy to prevent type 1 diabetes in high risk patients, and an FDA decision could be expected by mid-2021.

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替普利珠单抗持续降低延缓1型糖尿病的疗效
先前的II期随机对照试验表明,替普利珠单抗(一种Fc受体-非结合性抗CD3单克隆抗体)能够延缓高危患者发展为1型糖尿病。这项研究招募了76名参与者(55名儿童和21名成年人),他们是1型糖尿病患者的亲属,自己没有糖尿病,但有患糖尿病的高风险。试验结束时,替普利珠单抗治疗组53%的患者没有1型糖尿病,而安慰剂组为28%。在2020年美国糖尿病协会的虚拟会议上公布的新的随访数据显示,1型糖尿病的发病率持续下降,与安慰剂相比,延迟了三年之久。此外,接受替普利珠单抗治疗的人在治疗后的六个月内,C肽水平的下降出现了显著逆转,之后C肽水平似乎趋于稳定。这些发现为这种疗法预防高危患者1型糖尿病的潜力提供了早期证据,预计美国食品药品监督管理局将在2021年年中做出决定。
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