Otelixizumab in the treatment of type 1 diabetes mellitus.

Anti-CD3 antibodies have been demonstrated in both animal and human studies to be able to reverse autoimmune diseases; for example Type 1 diabetes. Not only does treatment with anti-CD3 antibodies result in the removal of pathogenic T cells but evidence suggests that a state of operational tolerance can be induced through the effects on regulatory T cells. The clinical use of anti-CD3 antibodies has been hampered by their safety profile. However, the introduction of humanized, nonmitogenic, aglycosylated anti-CD3 antibodies, such as otelixizumab, and promising results reported in newly-diagnosed patients with Type 1 diabetes, have renewed the interest for these antibodies in the treatment of autoimmune diseases.