ImmunoGuide® Enzyme immunoassay (ELISA) for the specific determination of free Vedolizumab in serum and plasma.<br><br>
The drug Vedolizumab (trade name Entyvio®) is a humanized immunoglobulin G1 monoclonal antibody that binds exclusively to the lymphocyte integrin α4β7, is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis [UC] or Crohn’s disease [CD]. According to the prescribing information, the mean ± SD of Vedolizumab steady-state trough serum concentrations in patients with UC and CD are reported to be 11.2±7.2 µg/mL (n=77) and 13.0±9.1 µg/mL (n=72) respectively. It was also reported in an other study that higher Vedolizumab trough concentrations were associated with greater efficacy in patients with both UC and CD. Higher Vedolizumab trough concentrations also were associated with numerically higher rates of clinical response and mucosal healing at week 6 in patients with UC. As with all therapeutic proteins, there is a potential for immunogenicity. According to the prescribing information, in patients who received Vedolizumab, the frequency of antibodies detected in patients was 13% at 24 weeks after the last dose of study drug. During treatment, 56 of 1434 (4%) of patients treated with Vedolizumab had detectable anti-Vedolizumab antibodies at any time during the 52 weeks of continuous treatment. Nine of 56 patients were persistently positive for anti-Vedolizumab antibodies and 33 of 56 patients developed neutralizing antibodies to Vedolizumab. The presence of persistent anti-Vedolizumab antibodies was observed to substantially reduce serum concentrations of Vedolizumab, either to undetectable or negligible levels at weeks 6 and 52.<br><br>
Identification of biomarkers might be beneficial for (non-) response and risk factors for adverse drug reactions that might be related to serum drug levels and maintaining the effective concentration in order to potentially avoid some side effects with a reliable method. For research use only, not for use in diagnostic procedures.
- Assay Description:
- 1 hour incubation (RT) + 30 min. (RT) + 20 min. (RT) = 1 hour, 50 min. total incubation time
- Catalog number:
- TM09031
- configuration:
- 96 Determinations, 12x8 removable strips
- controls:
- None provided
- design:
- Enzyme immunoassay (ELISA) technique
- FDA Status:
- For research use only, not for use in diagnostic procedures
- MSDS:
- Available upon request
- notes:
- The protocol for this product (see above) is intended to serve as an example only. Please refer to the Instructions For Use provided with the assay kit for precise details.
- Other names:
- Entyvio®
- Protocol:
- Sample types:
- Serum and plasma
- Sample volume:
- 10 µL
- standards:
- 5 standards, ready to use
- Standard range:
- 0 / 5 - 150 ng/mL
- storage:
- 2 - 8 °C
- sensitivity:
- 4 ng/mL
- Species:
- Human
- Products related:
- Anti-Vedolizumab (Entyvio®) ELISA
- Additional info:
