Golimumab (Simponi®) ELISA

ImmunoGuide® Enzyme immunoassay (ELISA) test kit for the determination of free Golimumab (Simponi®) in serum and plasma.<br><br>

The drug Golimumab (trade name Simponi®) is a human monoclonal antibody that binds to both the soluble and transmembrane bioactive forms of human TNFα. This interaction prevents the binding of TNFα to its receptors, thereby inhibiting the biological activity of TNF. Golimumab has been proven effective in the treatment of Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA) or Ulcerative Colitis (UC). Antibodies to Golimumab were detected in 57 (4%) of Golimumab -treated patients across the Phase 3 RA, PsA, and AS trials through Week 24. Similar rates were observed in each of the three indications. Patients who received Golimumab with concomitant Methotrexate (MTX) had a lower proportion of antibodies to Golimumab than patients who received Golimumab without MTX (approximately 2% versus 7%, respectively). Of the patients with a positive antibody response to Golimumab in the Phase 2 and 3 trials, most were determined to have neutralizing antibodies to Golimumab as measured by a cell-based functional assay. The data from the literature demonstrated that Anti-Drug Antibody positivity was significantly associated with low Golimumab levels and poor therapeutic response. The positive correlation between serum drug trough levels and therapeutic response indicates that drug monitoring could be useful for optimizing the dosing of biologics in a personalized therapy strategy.<br><br>

Identification of biomarkers for (non-)response and risk factors for adverse drug reactions that might be related to serum concentrations and maintaining the effective concentration of Golimumab in order to potentially avoid some side effects with a reliable method might be beneficial. For research use only, not for use in diagnostic procedures.