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Determination of the Relative Potency of an Anti-TNF Monoclonal Antibody mAb by Neutralizing TNF Using an In Vitro Bioanalytical Method
Published on: September 16, 2017
The potency of cell-based assays to predict response to TNF inhibitor therapy
Noa Rose1,2, Ari Polachek2,3, Daniel Levinson1,3
1Department of Rheumatology, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel.
Introduction:
Tumor necrosis factor inhibitors (TNFi) have revolutionized rheumatic and inflammatory diseases therapy. Despite their efficacy, at least 30% of patients do not respond to TNFi therapy. There are five FDA-approved TNFis and several TNFi biosimilars, which are equivalent to their reference drugs. Although all TNFi drugs neutralize the TNF cytokine, they differ in many structural and pharmacokinetic properties. These differences may lead to varying patient responses, making one TNFi, but not another, effective for a given patient. An accurate prediction of a priori responsiveness to therapy, rather than trial and error, would therefore be of great value. Biomarkers that may guide the optimal TNFi choice are an unmet need.
Areas Covered:
The authors discuss the diagnostic and predictive utilities of Cell-Based Assays (CBAs) for individualized TNFi therapy. Selection of TNFi can be based upon a given patient's immune cell response to the various TNFi drugs to predict their clinical outcomes to those drugs.
Expert Opinion:
CBAs allow to assess the response of multiple TNFi drugs simultaneously by measuring biomarkers that could distinguish between TNFi responders and non-responders, effectively prioritizing the TNFi of choice. This literature search focuses on biomarkers and techniques that could be used as predictive CBAs for clinical response to TNFi.
