Anti-Ustekinumab ELISA Assay Kit
The Anti-Ustekinumab ELISA Assay Kit is For Research Use Only
Size: 12×8 wells
Sensitivity: <5 ng/mL
Standard Range: 5-320 ng/ml
Incubation Time: 2.5 hours
Sample Type: Serum, Plasma, Cell Culture Supernatants
Sample Size: 100 µL
<Alternative Name: Stelara
Assay Background
Ustekinumab is a human monoclonal antibody. It is directed against interleukin 12 and interleukin 23, naturally occurring proteins that regulate the immune system and immune-mediated inflammatory disorders. In two Phase III trials for moderate to severe psoriasis, the longest >76 weeks, ustekinumab was safe and effective. A third Phase III trial, ACCEPT, compared the efficacy and safety of ustekinumab with etanercept in the treatment of moderate to severe plaque psoriasis. This trial found a significantly higher clinical response with ustekinumab over the 12-week study period compared to high-dose etanercept. It also demonstrated the clinical benefit of ustekinumab among patients who failed to respond to etanercept. Ustekinumab is approved in Canada, Europe and the United States to treat moderate to severe plaque psoriasis. Anti-Drug Antibodies (ADA) may induce unwanted side effects in biopharmaceuticals. Hence, ADA has been subjected to increase in scrutiny by the regulatory authorities using immunogenicity safety studies. ADA has been observed in pre-clinical and clinical studies, resulting in significant changes in toxicology, pharmacokinetics and efficacy. These effects result from the generation of drug-induced (neutralizing) autoantibodies against Etanercept and can be responsible for allergic reaction, or even anaphylactic shock. This ELISA kit detects antibodies for Anti-Etanercept and may be used for monitoring immunogenicity.
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