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Review
. 2016 Jun;16(6):841-6.
doi: 10.1080/14712598.2016.1180363.

Efficacy and safety of otelixizumab use in new-onset type 1 diabetes mellitus

Chiara Guglielmi  1 , Stefan Rhys Williams  2 , Rossella Del Toro  1 , Paolo Pozzilli  1   2
Affiliations
Review

Efficacy and safety of otelixizumab use in new-onset type 1 diabetes mellitus

Chiara Guglielmi et al. Expert Opin Biol Ther. 2016 Jun.

Abstract

Introduction: Type 1 diabetes (T1DM) is an immune-mediated disease induced by antigen-specific T cells infiltrating pancreatic beta cells leading to the progressive loss of endogenous insulin secretion.

Areas covered: The identification of specific components of the autoimmune response favoured the implementation of several immunomodulatory therapies including antiCD3 monoclonal antibody (mAb) called otelixizumab. Otelixizumab is a chimeric monoclonal antibody that targets the ε-chain of the CD3T-lymphocyte surface receptor that has been developed with the aim of short therapeutic courses capable of inducing a remission of T1DM. Clinical trials have been carried out with otelixizumab to evaluate its safety and efficacy, but despite positive results of Phase I and II studies, the results of Phase III studies have been contradictory.

Expert opinion: High doses of otelixizumab have shown beneficial effects on beta cell function whereas a lower dose, which was tested to avoid the adverse effects associated with higher doses, was not effective on beta cells preservation. We believe that otelixizumab is a drug of potential interest for treating new onset T1DM patients and its use in combination with other immunomodulatory agents should be considered as a solution to circumvent adverse effects while maintaining efficacy.

Keywords: AntiCD3 monoclonal antibody; beta cell function; combination therapy; immunotherapy; monoclonal antibody; type 1 diabetes mellitus.

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