c-peptide and Vomiting

Anti-CD3 mAbs may prolong beta cell function up to 2 years in patients with new onset Type 1 diabetes (T1DM). A randomized open label trial of anti-CD3 mAb, Teplizumab, in T1DM was stopped after 10 subjects because of increased adverse events than in a previous trial related with higher dosing of drug. Teplizumab caused transient reduction in circulating T cells, but the recovered cells were not new thymic emigrants because T cell receptor excision circles were not increased. There was a trend for reduced loss of C-peptide over 2 years with drug treatment (p=0.1), and insulin use was lower (p<0.001). In 4 drug-treated subjects followed up to 60 months, C-peptide responses were maintained. We conclude that increased doses of Teplizumab are associated with greater adverse events without improved efficacy. The drug may marginate rather than deplete T cells. C-peptide levels may remain detectable up to 5 years after treatment.

Topics: Adolescent; Antibodies, Monoclonal, Humanized; C-Peptide; CD3 Complex; Child; Diabetes Mellitus, Type 1; Exanthema; Female; Fever; Follow-Up Studies; Gastrointestinal Diseases; Humans; Hypoglycemic Agents; Insulin; Male; Muromonab-CD3; Nausea; Treatment Outcome; Vomiting