Enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of free Golimumab (Simponi®) in serum and plasma. The Assay Genie Golimumab ELISA has been especially developed for the quantitative analysis of free Golimumab in serum and plasma samples.

Solid phase enzyme-linked immunosorbent assay (ELISA) based on the sandwich principle. Standards and diluted samples (serum or plasma) are incubated in the micro-titre plate coated with the reactant for golimumab (Simponi®). After incubation, the wells are washed. A horse radish peroxidase (HRP) conjugated probe is added and binds to golimumab (Simponi®) captured by the reactant on the surface of the wells. Following incubation, wells are washed, and the bound enzymatic activity is detected by addition of chromogen-substrate. The colour developed is proportional to the amount of golimumab in the sample or standard. Results of samples can be determined directly using the standard curve.

Golimumab (Simponi, CNTO-148) is a human immunoglobulin G1 kappa monoclonal antibody which is specific for proinflammatory cytokine, tumor necrosis factor- alpha (TNF alpha). TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Golimumab binds to both the soluble and transmembrane bioactive forms of human TNF and prevent TNF from binding to its receptors and finally inhibits biological activity of TNF.

In 2009, it was approved by FDA for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis in adult patients. Elevated levels of TNF are found in the synovial fluid of rheumatoid arthritis, including juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis patients and play an important role in both the pathologic inflammation and the joint destruction that are hallmarks of these diseases. Increased levels of TNF are also found in psoriasis (Ps) plaques. Its affinity for TNF in surface plasmon resonance assay was 17 pmol/L.

Golimumab was approved to be used in the underlined diseases alone or combination with methotrexate (MTX). According to American College of Rheumatology (ACR) criteria, golimumab 50 or 100 mg every 4 weeks in combination with MTX in methotrexate-naïve (GO-BEFORE) or -experienced (GO-FORWARD) rheumatoid arthritis patients was more effective than MTX alone to overcome the symptoms at week 14 and/or 24.

In rheumatoid arthritis treated with other anti-TNF agents (GO-AFTER) before, golimumab 50 or 100 mg every 4 weeks was more effective than placebo at week 14 and/or 24. These affirmative influences were also shown for psoriatic arthritis GO-REVEAL and ankylosing spondylitis GO-RAISE studies.

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