Toxicity as a result of immunostimulation by biologics

The immune system has evolved highly effective mechanisms of surveillance and defense against foreign pathogens, and is also thought to act in surveillance and suppression of cancer. Thus, a predominant. goal of immune system-based therapies is to normalize or enhance the host immune response in the areas of infectious disease and oncology. This review considers general approaches used for therapeutic immunostimulation, alterations in immune response mechanisms that occur with these treatments and the syndromes that commonly arise as a result of these changes. Because nonclinical studies of these therapies are conducted in animal models as the basis for predicting potential human toxicities, this review also considers the value of nonclinical testing to predict human toxicity.