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Teplizumab preserved C-peptide in type 1 diabetes
A monoclonal antibody may preserve C-peptide in patients with type 1 diabetes, phase 2 data suggest, and researchers said these findings are promising for the treatment of the disease.
Kevan Herold, MD, of the department of immunobiology and internal medicine at Yale University, and colleagues assigned patients with new-onset type 1 diabetes (aged 8 to 30 years) to teplizumab (n=52; MacroGenics Inc.) or a control in a randomized, open-label trial.
Patients who were randomly assigned to the treatment arm received teplizumab for 2 weeks at diagnosis and after 1 year. The treatment and control groups received diabetes counseling from a certified diabetes educator and were followed for 2 years.
Kevan Herold
According to data, patients randomly assigned to teplizumab demonstrated a 75% improvement to the reduction of C-peptide decline at 2 years (–0.28; 95% CI, –0.36 to –0.20) vs. controls (–0.46; 95% CI, –0.57 to –0.35). Moreover, post-hoc analyses indicate that patients maintained metabolic control.
Eleven serious adverse events were observed in 10 patients treated with teplizumab, according to researchers. The most common adverse events were rash, transient upper respiratory infections, headache and nausea.
“This overall approach to identifying characteristics of individuals most likely to respond to therapies shows great promise because the responders in this study experienced a robust and prolonged drug effect,” Herold said in a press release.
Disclosure: One of the researchers reports a patent on the teplizumab molecule. Herold reports grant support from MacroGenics Inc.