Quantitative Determination of free human antibodies against Vedolizumab
The monoclonal antibody vedolizumab, directed against α4β7 integrin, is used in the treatment of inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis). Vedolizumab represents a treatment option when patients respond inadequately to conventional therapy or to therapies with tumor necrosis factor alpha antagonists. Vedolizumab selectively binds to activated lymphocytes, preventing them from migrating into the intestinal mucosa. The efficacy of the vedolizumab therapy usually correlates with the amount of therapeutic antibody detectable in the patient's serum shortly before the next drug administration, the so-called trough level. Several factors influence the trough level, among them dosage and frequency of the treatment, disease activity, individual differences in pharmacokinetics and a patient's immune response to the therapeutic antibody.
During therapy, a sensitization of the patient’s immune system against the therapeutic antibody can occur, which leads to the formation of anti-drug antibodies (ADA).They bind to the corresponding drug and thus may lead to a reduced therapy success due to a lower drug concentration.
The presence of ADA is associated with allergic reactions and a loss of efficacy of the drugs. In addition to drug concentrations, the determination of ADA can provide valuable information in the context of primary and secondary therapy failure to optimize the treatment. Thus, in patients with low drug trough levels, the choice between changing the drug class or increasing the dose of the drug may depend on the presence of ADA.
The IDKmonitor® Vedolizumab free ADA ELISA reliably determines the free ADA against vedolizumab (e.g. Entyvio®). There is no co-determination of rheumatoid factors or irregular antibodies. Together with the determination of the drug level of vedolizumab, the IDKmonitor® Vedolizumab free ADA ELISA offers the attending physician the opportunity to monitor the therapy and to optimize it at an early stage.
10 μl of the EDTA plasma sample or serum sample are diluted 1: 100 in assay buffer for the test, 100 μl of this dilution are used for the ELISA.
IDKmonitor® Vedolizumab free ADA ELISA K9648