A randomised, single-blind, placebo-controlled, dose-finding safety and tolerability study of the anti-CD3 monoclonal antibody otelixizumab in new-onset type 1 diabetes

Conclusions/interpretationA metabolic response was observed with otelixizumab 9  mg, while doses higher than 18 mg increased the risk of unwanted clinical EBV reactivation. Although otelixizumab can temporarily compromise immunocompetence, allowing EBV to reactivate, the effect is dose dependent and transient, as evidenced by a rapid emergence of EBV-specific T cells precedin g long-term control over EBV reactivation.Trial registrationClinicalTrials.gov NCT02000817.FundingThe study was funded by GlaxoSmithKline.Graphical abstract
Source: Diabetologia - Category: Endocrinology Source Type: research