Anti-Infliximab ELISA (REF. 710101)
The apDia Anti-Infliximab ELISA is an enzyme linked immunosorbent assay intended for the quantitative determination of antibodies to infliximab (ATI) in human serum and plasma.
Infliximab
Infliximab (IFX) is a chimeric antibody that targets the pro-inflammatory cytokine TNF-alpha. The introduction of infliximab has revolutionized the treatment of chronic inflammatory diseases like inflammatory bowel disease (IBD), rheumatoid arthritis (RA) and spondyloarthritis. It has been shown that infliximab can induce deep remission and improve the patient’s quality of life. Some patients do not respond to infliximab therapy upon induction (primary non-responders), while others lose response over time (secondary non-responders).
Immunogenicity
Secondary loss of response is often due to the development of anti-infliximab antibodies (ATI), because of the immunogenic character of the drug3. ATI can develop in any patient undergoing infliximab therapy and are primarily neutralizing the activity of infliximab through immunocomplex formation. In addition, these immunocomplexes are rapidly cleared from the system. Analytically, they are responsible for subtherapeutic infliximab concentrations. Therefore, in the case of very low trough concentrations of infliximab (< 1 μg/mL), subsequent measurement of ATI may be helpful to determine the optimal treatment strategy.
Diagnostic Value
The diagnostic value of the Anti-Infliximab ELISA lies in its ability to stratify patients with subtherapeutic infliximab concentrations (< 1 μg/mL) in patients who need dose intensification or a drug (class) switch. Patients with low infliximab concentrations (< 1 μg/mL) and low ATI titers can benefit from infliximab dose intensification, as shown in several studies4, 5. However, the ATI titer of patients with low ATI titers undergoing a dose intensified treatment regimen must be adequally monitored. Patients that have high ATI titers are preferably switched to another drug, both within class or out of class. The course of ATI 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-Infliximab ELISA is not capable of measuring ATI in the presence of high concentrations of infliximab. It should only be used when < 1 μg/mL infliximab is quantified in the sample using the apDia Infliximab ELISA.
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ANTI-INFLIXIMAB KIT 96 TESTS, REF. 710101
The ELISA kits offered by apDia are validated on open ELISA automates such as the Dynex Instruments.
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