Clinical relevance

Biologics have had a profound impact on various medical fields, primarily rheumatology and oncology, but also cardiology, dermatology, gastroenterology, neurology, and other areas. In most of these disciplines, biologics have added major opportunities for the treatment of disease, making this type of medication the fastest growing class of therapeutics today.

Monoclonal antibodies targeting tumor necrosis factor (TNF) were among the first biologicals to appear on the market. They have proved to be powerful drugs applied for such inflammatory diseases as rheumatoid arthritis, ankylosing spondylitis, psoriasis and Crohn’s disease. However, biologics belong to the most expensive drugs available. It is therefore vital that they are applied in a sensible, cost-effective manner.

A growing number of therapeutic biological products is now used in clinical practice. Cumulative clinical experience with approved biological products has led to the appreciation of the importance of evaluating drug levels and immunogenicity given its effect on clinical outcomes. Immunogenicity of a therapeutic biologic refers to production of anti-drug-antibodies (ADA).

A personalized approach can improve therapy efficacy and quality of life

With level testing of biologics, efficacy of therapy can be improved if biologic levels are tested, as treatment decisions may need to be adapted depending on the test results in conjuction with clinical responses to treatment.