Vedolizumab ELISA (REF. 710501)
The apDia Vedolizumab ELISA is an enzyme linked immunosorbent assay intended for the quantitative determination of vedolizumab (VDZ, Entyvio®, anti-integrin α4β7) in human serum and plasma.
Therapeutic drug monitoring
Vedolizumab (VDZ) is a humanised monoclonal antibody that binds exclusively to the lymphocyte integrin α4β7. VDZ inhibits the interaction of α4β7-expressing cells with mucosal addressin cell adhesion molecule-1 on endothelial cells, thereby hampering the infiltration of the α4β7-expressing cells into the gastrointestinal mucosa and gut-associated lymphoid tissue. VDZ suppresses gut inflammation and has therefore been approved for the treatment of patients with moderate to severe ulcerative colitis (UC) and Crohn’s disease (CD). It has been shown that VDZ can induce clinical remission and improve the patient’s quality of life.
A drug can only exert its pharmacologic effect when adequate concentrations are achieved in the circulation. The serum concentration of biologicals just before their next infusion, defined as trough concentration, has been used for therapeutic drug monitoring (TDM). Recent data on TDM have shown a positive relationship between VDZ trough serum concentrations and clinical outcomes in patients with UC and CD. TDM may therefore be very instrumental to optimize treatment. The apDia Vedolizumab ELISA uses highly specific monoclonal antibodies developed at the KU Leuven. Anti-TNF drugs (like infliximab, adalimumab, golimumab) do not interfere with the measurement. As an example of TDM, the use of VDZ trough concentration measurements in UC and CD is described.
Ulcerative colitis
VDZ is given at week 0, week 2 and week 6 (induction) and upon good clinical response at week 14, treatment is continued by infusions every 8 weeks (maintenance). The exposure-efficacy relationships of VDZ evaluated in GEMINI 1 revealed a positive exposure-response relationship for clinical remission, clinical response, and mucosal healing for VDZ induction therapy in UC. VDZ trough concentration measurements during or shortly after induction may thus be used to identify undertreated patients.
It has been demonstrated that higher VDZ concentrations are associated with deep remission in patients with UC on maintenance therapy. Thus, regularly checking VDZ trough concentrations during maintenance therapy may be useful to evaluate the VDZ treatment schedule.
Crohn’s Disease
VDZ is given at week 0, week 2 and week 6 (induction) and upon good clinical response at week 14, treatment is continued by infusions every 8 weeks (maintenance). The exposure-efficacy relationships of VDZ evaluated in GEMINI 2 and 3 revealed a modest positive exposure-response relationship. Clinical remission rates were higher at week 10 than at week 6 in both studies. The European Medicines Agency allows an additional dose at week 10 before assessment of an induction response at week 14.
Due to the dosing regimen, trough concentrations during induction at week 2, week 6, week 10 (CD) & 14 (CD) are higher compared to trough concentrations during maintenance when VDZ is given every 8 weeks.
Immunogenicity
Secondary loss of response is often due to the development of anti-drug antibodies. The immunogenicity rate during treatment with VDZ is very low (4%).
WHY CHOOSE FOR
VEDOLIZUMAB 96 TESTS, REF. 710501
The ELISA kits offered by apDia are validated on open ELISA automates such as the DYNEX® instruments.
instructions for use (IFU) available upon request
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