Teplizumab: Phase II data

Researchers at Yale University and colleagues reported data from an open-label, U.S. Phase II trial in 52 patients with recent-onset Type I diabetes - most of whom were less than 14 years old - showing that teplizumab for 2 weeks at diagnosis and again 1 year later met the primary endpoint of a smaller decline in mean C-peptide levels from baseline to 2 years vs. untreated controls (0.28 vs. 0.46 nmol/L, p=0.002). The researchers said a response was observed in about half of the patients, while some patients lost >=50% of their ability to produce insulin. The researchers said it is unclear why patients responded differently, but said the reason likely involves differences in metabolic condition and severity of disease at baseline. The most common adverse events were rash, transient upper respiratory infections, headache and nausea. Patients received daily insulin injections throughout the trial. Data were published in Diabetes. The study was part of the Immune Tolerance Network, an international clinical research consortium supported by NIH's National Institute of Allergy and Infectious Diseases (NIAID) and the Juvenile Diabetes Research Foundation (JDRF). The trial was also supported by grants from NIH. ...