Ustekinumab ELISA (REF. 710601)
The apDia Ustekinumab ELISA is an enzyme linked immunosorbent assay intended for the quantitative determination of ustekinumab (UST, Stelara®) in human serum and plasma.
Therapeutic drug monitoring
Ustekinumab (UST) is a fully human monoclonal antibody that binds to the p40 subunit common to IL-12 and IL-23 thereby preventing the interaction with the cytokine receptors on T cells, natural killer cells and antigen-presenting cells (1). UST has been approved for treatment of moderate to severe Crohn’s disease (CD), plaque psoriasis and psoriatic arthritis (2,3,4).
A drug can only exert its pharmacological effect when adequate concentrations are achieved in the circulation. The serum concentration of biologicals just before the next administration, defined as trough concentration, has been used for therapeutic drug monitoring (TDM). Recent data have shown a positive relationship between UST serum concentration, either measured at trough or at an intermediate time point, and clinical outcomes in patients with Crohn’s disease and plaque psoriasis, respectively. TDM may therefore be very instrumental to optimize treatment.
The apDia Ustekinumab ELISA uses highly specific monoclonal antibodies developed at the University of Leuven, Belgium (KU Leuven). Anti-TNF drugs (like infliximab, adalimumab, golimumab) or anti-integrin α4β7 drugs (like vedolizumab) do not interfere with the measurement.
As an example of TDM, the use of UST concentration measurements in plaque psoriasis and CD is described.
Crohn’s Disease
UST is administered intravenously (IV) at week 0 and thereafter every 8 weeks subcutaneously (SC). The UNITI-1 and -2 induction trials demonstrated that 33.7% and 55.5% of patients had a clinical response at week 6, respectively. During maintenance therapy with SC ustekinumab every 8 weeks, 53.1% of patients were in remission at week 44 in the IM-UNITI trial (2).
Several studies have demonstrated the relationship between ustekinumab trough concentration and clinical, biological and endoscopic response, indicating the usefulness of therapeutic drug monitoring to guide clinical decision-making (5,6,7).
Plaque psoriasis
UST is weight-based administered subcutaneously at week 0, at week 4 and thereafter every 12 weeks. The PHOENIX 1 and 2 trials indicate that treatment with ustekinumab results in rapid, significant improvements in patients with moderate-to-severe psoriasis (3,4).
A recent study demonstrated a concentration-response relationship at week 4 upon injection for ustekinumab-treated psoriasis patients, indicating that monitoring 4-week post injection ustekinumab concentrations could timely identify underexposed patients who might benefit from treatment optimization (8).
Immunogenicity
It has been shown that the immunogenicity of ustekinumab is very low (8,9).
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USTEKINUMAB KIT 96 TESTS, REF. 710601
The ELISA kits offered by apDia are validated on open ELISA automates such as the Dynex Instruments.
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