What is the Origin of Clinical Immunogenicity?

The concept of immunogenicity is fundamental to immunology, but the term "clinical immunogenicity" gained specific relevance with the development of biological therapeutics, including recombinant hormones like growth hormone or certain insulins. It emerged from the need to systematically evaluate the human immune system's reaction to non-native protein structures introduced for therapeutic benefit.

What is the Mechanism of Clinical Immunogenicity?

The mechanism involves the presentation of the therapeutic agent's molecular structure as a foreign antigen to the patient's immune system, primarily by antigen-presenting cells. T-cells and B-cells subsequently become activated, leading to the production of ADAs that bind to the therapeutic hormone. These antibodies can interfere with the hormone's binding to its physiological receptor, accelerating its clearance, or in rare instances, cross-reacting with the patient's endogenous hormones, leading to an autoimmune endocrine dysfunction.

Clinical Immunogenicity

Meaning

Clinical immunogenicity describes the capacity of a therapeutic agent, such as a peptide hormone or a biological drug, to elicit an unwanted immune response in a human patient. This response involves the generation of anti-drug antibodies (ADAs) which can potentially neutralize the therapeutic effect of the drug or, in some cases, trigger adverse immunological reactions. In the context of hormonal health, immunogenicity is a critical factor in the efficacy and safety profile of administered bioidentical or synthetic hormones.