Ustekinumab (Stelara®) is a fully human IgG1κ monoclonal antibody to interleukin (IL)-12/23 that dampens inflammation.

Ustekinumabis a fully human IgG1κ monoclonal antibody to interleukin (IL)-12/23 produced in a murine myeloma cell line using recombinant DNA technology, used to reduce symptoms in inflammatory conditions. 

Mechanism of action

Ustekinumab binds with specificity to the shared p40 protein subunit of human cytokines interleukin (IL)-12 and IL-23. By preventing p40 from binding to the IL-12R1 receptor on the surface of immune cells, ustekinumab inhibit the bioactivity of human IL-12 and IL-23 protein.

IL-12 and IL-23 are heterodimeric cytokines secreted by activated antigen presenting cells, such as macrophages and dendritic cells. IL-12 normally stimulates natural killer (NK) cells and drives the differentiation of CD4+ T cells toward the T helper 1 (Th1) phenotype, IL- 23 induces the T helper 17 (Th17) pathway. Abnormal regulation of IL 12 and IL 23 has been associated with immune mediated diseases, such as psoriasis, psoriatic arthritis and Crohn’s disease. 

Clinical use

In Europe, ustekinumab is indicated for the treatment of:

  • moderate to severe plaque psoriasis, in adults and children above the age of 12 years whose condition has not responded to or who cannot use other systemic (whole-body) psoriasis treatments
  • active psoriatic arthritis in adults who have not responded well enough to other disease-modifying anti-rheumatic drugs
  • moderately to severely active Crohn’s disease in adults whose condition has not responded well enough to other treatments for Crohn’s disease or who cannot receive such treatments

Consult CHMP for details.

What can Sanquin do for you?

We have tests that:

  • can measure the levels of free drug in the serum; levels of therapeutic antibodies are assessed using validated ELISAs.
  • can measure the immunogenicity of ustekinumab; human anti-human antibodies are quantified using validated antigen-binding tests (radioimmunoassay or RIA).

As we have hands-on experience in these assays, we can provide you with accurate and reproducible test results. 

Send in samples

If you want to use our drug level or ADA testing services, fill out this form and send it to us along with 1 ml frozen serum sample per patient.