Risk Assessment in Drug Development: Autoimmunity

Abstract

Autoimmunity is a physiological condition in which the immune system responds to normal tissues as if they were foreign pathogens. If this reaction produces pathology, it is referred to as autoimmune disease. Many human diseases (most often chronic in nature) appear to have an autoimmune basis. No model exists that has proven to be sufficiently predictive to screen drugs for potential to induce autoimmunity (hazard identification); thus, it seems somewhat illogical to consider this as an example of risk assessment. However, given the knowledge currently available, it is at least conceivable that drugs could be identified as having the potential to produce autoimmune reactions, and especially to predict the conditions under which autoimmune disease may be induced. This has proven to be an especially important topic with protein drugs designed to replace endogenous molecules. Immunogenicity, thought to be an important component of protein drug-induced autoimmunity, can be modeled in animals. However, interpretation of results with respect to prediction of ability to induce autoimmune disease remains a serious challenge.

The opinions are those of the author and do not reflect FDA policy or positions.

Notes

The opinions are those of the author and do not reflect FDA policy or positions.