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Methods of evaluating immunotoxicity.

Jacques Descotes1

  • 1Centre Antipoison - Centre de Pharmacovigilance, 162 Avenue Lacassagne, 69424 Lyon cedex 03, France. jacques-georges.descotes@chu-lyon.fr

Expert Opinion on Drug Metabolism & Toxicology
|July 27, 2006
PubMed
Summary

Assessing drug and chemical safety requires evaluating immunotoxicity, focusing on predicting immunosuppression using animal models. Current methods lack consensus and struggle to predict other immune-mediated adverse effects, highlighting a need for standardized human data.

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Area of Science:

  • * Pharmacology and Toxicology
  • * Immunology and Drug Safety

Background:

  • * Immunotoxicology is crucial for evaluating drug and chemical safety, encompassing immunosuppression, immunostimulation, hypersensitivity, and autoimmunity.
  • * Current nonclinical assessments primarily focus on predicting immunosuppression using animal models, with limited consensus on comprehensive testing strategies.

Purpose of the Study:

  • * To review current nonclinical methods for assessing immunotoxicity and identify limitations.
  • * To discuss the reliability of histological examination versus functional immune assays for predicting immunosuppression.
  • * To highlight the challenges in predicting immunostimulation, hypersensitivity, and autoimmunity.

Main Methods:

  • * Review of existing animal models and assays for immunotoxicity assessment.

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  • * Discussion of recommended first-line assays, such as T-dependent antibody response assays (plaque-forming cell assay, ELISA).
  • * Consideration of various supplementary assays including lymphocyte subset analysis, NK cell activity, and host resistance assays.

    • Main Results:

    • * A T-dependent antibody response assay is recommended as a primary screening tool for immunosuppression.
    • * Limited reliable animal models exist for predicting immunostimulation, hypersensitivity, or autoimmunity, except for contact sensitization.
    • * A significant limitation is the lack of human data for validating nonclinical immunotoxicity assessments.

    Conclusions:

    • * Standardized and validated immunological endpoints and clinical criteria are essential for human clinical trials and epidemiological studies.
    • * Further research is needed to develop reliable methods for predicting all types of immune-mediated adverse effects.
    • * Integrating human data is critical for improving the accuracy of immunotoxicity risk assessment.