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Clin Immunol. 2013 Dec;149(3):345-55. doi: 10.1016/j.clim.2013.02.002. Epub 2013 Feb 15.

Trials in type 1 diabetes: Antigen-specific therapies.

Author information

1
Type 1 Diabetes R&D Center, Novo Nordisk Inc., Seattle, WA, USA.

Abstract

Type 1 diabetes (T1D) results from an aberrant immunological response against the insulin-producing beta cells in the islets of the pancreas. The ideal therapy would restore immune balance in a safe and lasting fashion, stopping the process of beta cell decay. The efficacy of immune suppressive agents such as cyclosporin underscores the notion that T1D can in principle be prevented, albeit at an unacceptable long-term safety risk. Immune modulatory drugs such as monoclonal anti-CD3 antibody, on the other hand, have recently had rather disappointing results in phase 3 trials, possibly due to inadequate dosing or choice of inappropriate endpoints. Therefore, it is argued that striking the right balance between safety and efficacy, together with careful trial design, will be paramount in preventing T1D. Here we outline the concept of antigen-specific tolerization as a strategy to safely induce long-term protection against T1D, focusing on available clinical trial data, key knowledge gaps and potential future directions.

KEYWORDS:

Antigen-specific therapies; Clinical trials; Immune intervention; Type 1 diabetes

PMID:
23490422
PMCID:
PMC5777514
DOI:
10.1016/j.clim.2013.02.002
[Indexed for MEDLINE]
Free PMC Article

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