IDKmonitor® Ustekinumab drug level ELISA

Quantitative determination of free ustekinumab concentration in EDTA-plasma und serum

Ustekinumab is a monoclonal (IgG1) human therapeutic antibody targeting p40, the common subunit of interleukin 12 and 23 (IL-12/23). Both cytokines play a fundamental role in immune-mediated inflammatory disorders such as psoriasis, psoriatic arthritis or Crohn’s disease.
Ustekinumab blocks IL-12/23 signalling, thus inhibiting the T-cell mediated immune response and having an immunosuppressive and anti-inflammatory effect.

As a drug ustekinumab is approved for the treatment of moderate to severe plaque psoriasis (in adults and adolescents over 12 years of age) when other therapies have not been responsive, contraindicated or intolerable. Furthermore, it has been shown to be effective in psoriatic arthritis, which affects about one fifth of psoriasis patients.
As well ustekinumab is approved for the treatment of psoriatic arthritis, if the disease has not responded adequately to other medicines known as disease-modifying anti-rheumatism drugs.
Furthermore, ustekinumab is approved for use in adult patients with moderate to severe Crohn's disease who have not responded well or can not respond to other treatments.
The therapy is generally well tolerated, side effects with ustekinumab are sometimes infections (especially the upper respiratory tract), dizziness, headache and muscle pain and fatigue.

The clinical efficacy of anti-IL-12/23 therapy usually correlates with the trough level of the therapeutic antibody, meaning the drug level just before the next application of the drug. Several factors influence the trough level, among them dosage and frequency of anti-IL-12/23 treatment, disease activity, individual pharmacokinetics and immune reaction (formation of anti-drug antibodies, ADA).
The IDKmonitor® ELISA for the determination of the drug level of ustekinumab (e.g. STELARA®) measures quantitatively free ustekinumab in EDTA serum and plasma, giving the treating physician an possibility to monitor and optimise the therapy early on.

IDKmonitor®    Ustekinumab drug level ELISA        K9660

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