An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes

This phase 2, randomized, placebo controlled trial investigated the efficacy of teplizumab, an anti CD3 monoclonal antibody, in delaying the onset of type 1 diabetes in high risk relatives of patients with the disease. Participants (n=76) were nondiabetic but had two or more diabetes related autoantibodies and dysglycemia. They received a 14 day course of teplizumab or placebo and were followed for progression to clinical diabetes. Results showed that teplizumab significantly delayed the diagnosis of type 1 diabetes, with a median time to diagnosis of 48.4 months in the teplizumab group compared to 24.4 months in the placebo group (hazard ratio, 0.41; 95% CI, 0.22–0.78; P=0.006). The annualized diabetes diagnosis rates were 14.9% and 35.9% in the teplizumab and placebo groups, respectively. Adverse events included rash and transient lymphopenia. The study suggests that teplizumab may alter the course of autoimmune type 1 diabetes in high-risk individuals.

This phase 2, randomized, placebo controlled trial investigated the efficacy of teplizumab, an anti CD3 monoclonal antibody, in delaying the onset of type 1 diabetes in high risk relatives of patients with the disease. Participants (n=76) were nondiabetic but had two or more diabetes related autoantibodies and dysglycemia. They received a 14 day course of teplizumab or placebo and were followed for progression to clinical diabetes. Results showed that teplizumab significantly delayed the diagnosis of type 1 diabetes, with a median time to diagnosis of 48.4 months in the teplizumab group compared to 24.4 months in the placebo group (hazard ratio, 0.41; 95% CI, 0.22–0.78; P=0.006). The annualized diabetes diagnosis rates were 14.9% and 35.9% in the teplizumab and placebo groups, respectively. Adverse events included rash and transient lymphopenia. The study suggests that teplizumab may alter the course of autoimmune type 1 diabetes in high-risk individuals.