Certolizumab pegol Level and Anti-Certolizumab Antibodies
Label Mnemonic: CERTO
Epic Lab Code: LAB8522
Downtime Form: A-1a Miscellaneous Request
Commercial Mail-out Laboratory
5231 RCP
356-8593
Specimen(s):
Serum
Specimen Instructions:
Note: Dose and interval are required.
Collection Medium:
and
BD Gold SST 5 mL Vacutainer BD Gold SST 5 mL Vacutainer
Minimum:
Preferred Minimum: 7 mL serum in TWO Gold top SST tubes
Absolute Minimum: 5 mL serum in ONE Gold top SST tube
Rejection Criteria:
Grossly hemolyzed samples. Samples sent in red top tubes.
Turn Around Time:
5-7 days upon arrival at reference laboratory
Reference Range:
Certolizumab 3-84 ug/mL
Anti-Certolizumab antibody 5-160 AU/mL
Interpretive Data:
Certolizumab (CTZ)
Endoscopic response and remission are associated with higher plasma concentrations of certolizumab (CTZ).

A significant inverse relationship has been found between plasma concentration of CTZ and C-reactive protein.

In a study of CTZ dose optimization in patients with CD, remission rates were higher in patients whose CTZ levels were greater than 27.5 ug/mL.

Antibodies to Certolizumab

Clinical trials exploring CTZ immunogenicity have not found a relationship between development of antibodies to certolizumab (ATC) and clinical response.

Some patients on anti-TNF therapy may develop antibodies that resolve over time.

The presence of antibodies to certolizumab has been associated with decreased serum CTZ levels and decreased clinical efficacy in rheumatoid arthritis trials.

In patients with CD that fail to respond to anti TNF therapy but have a therapeutic drug concentration and low or undetectable antibody levels, clinical guidelines suggest a switch to another drug class.

In patients with Irritable Bowel Disease (IBD) with good response to other biologic therapies, supra therapeutic doses have been reduced without disease flares, resulting in significant cost savings.
Methodology:
Automated ELISA Quantitative Entyvio Comprehensive TDM InformTX
CPT Code:
83520 x2