Anti-Adalimumab ELISA (REF. 710301)
The apDia Anti-Adalimumab ELISA is an enzyme linked immunosorbent assay intended for the quantitative determination of antibodies to adalimumab in human serum and plasma.
Adalimumab
Adalimumab (ADM) is a fully human antibody that targets the pro-inflammatory cytokine TNF-alpha. The introduction of therapeutic antibodies has revolutionized the treatment of chronic inflammatory diseases like inflammatory bowel disease (IBD), rheumatoid arthritis (RA), spondyloarthritis and plaque psoriasis. It has been shown that adalimumab can induce deep remission and improve the patient’s quality of life. Some patients do not respond to adalimumab therapy upon induction (primary non-responders), while others lose response over time (secondary nonresponders).
Immunogenicity
Secondary loss of response is often due to the development of anti-adalimumab antibodies (ATA), because of the immunogenic character of the drug. ATA can develop in any patient undergoing adalimumab therapy and are primarily neutralizing the activity of adalimumab through immunocomplex formation.
In addition, these immunocomplexes are rapidly cleared from the system.
Analytically, they are responsible for subtherapeutic adalimumab concentrations. Therefore, in the case of very low trough concentrations of adalimumab (< 1 μg/mL), subsequent measurement of ATA may be helpful to determine the optimal treatment strategy.
Diagnostic Value
The diagnostic value of the Anti-Adalimumab ELISA lies in its ability to stratify patients with subtherapeutic adalimumab concentrations (< 1 μg/mL) in patients who need dose intensification or a drug (class) switch. Patients with low adalimumab concentrations (< 1 μg/mL) and low ATA titers can benefit from adalimumab dose intensification, as shown in several studies. However, the ATA titers of patients with low ATA titers undergoing a dose intensified treatment regimen must be adequately monitored. Patients that have high ATA titers are preferably switched to another drug, both within class or out of class. The course of ATA titers, based on the measurement of antibodies in at least two consecutive samples, is an important basis for the evaluation of the anti-drug antibody titer of the patient, rather than the absolute value of the titer.
Note: The Anti-Adalimumab ELISA is not capable of measuring ATA in the presence of high concentrations of adalimumab. It should only be used when < 1 μg/mL adalimumab is quantified in the sample using the apDia Adalimumab ELISA.
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ANTI-ADALIMUMAB KIT 96 TESTS, REF. 710301
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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