Median time to type 1 diabetes diagnosis 48.4 months with teplizumab and 24.4 months with placebo
THURSDAY, June 13, 2019 (HealthDay News) — A 14-day course of an Fc receptor-nonbinding anti-CD3 monoclonal antibody, teplizumab, can delay progression to type 1 diabetes in individuals at high risk, according to a study published online June 9 in the New England Journal of Medicine to coincide with the annual meeting of the American Diabetes Association, held from June 7 to 11 in San Francisco.
Kevan C. Herold, M.D., from Yale University in New Haven, Connecticut, and colleagues conducted a phase 2 trial involving 76 relatives of patients with type 1 diabetes who did not have diabetes but were at high risk for developing clinical disease. Patients were randomly assigned to a single 14-day course of teplizumab or placebo (44 and 32, respectively).
The researchers found that the median time to type 1 diabetes diagnosis was 48.4 and 24.4 months in the teplizumab and placebo groups, respectively. The disease was diagnosed in 43 and 72 percent of those randomly assigned to teplizumab and placebo, respectively. For diagnosis of type 1 diabetes, the hazard ratio was 0.41. The annualized rate of diabetes diagnosis was 14.9 and 35.9 percent in the teplizumab and placebo groups, respectively.
“Although the trial showed a marked delay in the onset of overt diabetes, the results should not be taken to imply that immune modulation constitutes a potential curative approach,” write the authors of an accompanying editorial. “Rather, these data provide strong albeit indirect evidence about the pathogenesis of beta-cell destruction and the potential to modify the course of type 1 diabetes with newer biologic agents.”
Several authors disclosed financial ties to Provention Bio, the manufacturer of teplizumab.
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