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Certolizumab and Anti-Certolizumab Antibody, DoseASSURE™ CTZ

CPT: 80299; 82397
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Synonyms

  • Anti-TNF
  • Anti-TNF drug
  • Biologic drug level and anti-drug antibody
  • Biologic monitoring
  • Cimzia
  • DoseASSURE
  • Immunogenicity testing
  • therapeutic drug monitoring (TDM)
  • TNF inhibitor

Expected Turnaround Time

8 - 15 days



Specimen Requirements


Specimen

Serum


Volume

2 mL


Minimum Volume

600 µL


Container

Red-top tube, serum from red-top tube, serum from a gel tube, or serum transfer tube


Collection

Allow a minimum clotting time of 30 to 60 minutes with serum separation within 2 hours of collection. Send serumin a plastic transport tube. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.


Storage Instructions

Refrigerate or freeze.


Stability Requirements

Temperature

Period

Room temperature

4 hours

Refrigerated

14 days

Frozen

14 days

Freeze/thaw cycles

Stable x6


Causes for Rejection

Gross hemolysis; gross lipemia; incorrect specimen type


Test Details


Use

Provides certolizumab drug concentration and anti-certolizumab antibodies in order to optimize treatment and facilitate clinical decision-making. This assay may be helpful in any patient on certolizumab therapy for Crohn's disease, psoriasis, or other autoimmune condition.


Limitations

As with other biologics, the optimal certolizumab concentration depends upon patient-specific factors including co-morbidities, disease, and desired therapeutic endpoint.

Trough blood collection (just before the next dose) is suitable because target ranges and therapeutic cut-offs are established by clinical studies that typically evaluate trough concentrations.

Therefore, the timing of specimen collection should be considered when interpreting drug concentrations. Drug half-life should be factored in when evaluating non-trough concentrations.

Adequate drug trough levels do not guarantee clinical efficacy since primary non-response can be due to mechanistic failure.

Lack of clinical response may be due to inadequate drug exposure, immunogenicity or mechanistic mismatch. Positive anti-certolizumab antibodies should be interpreted in the context of the concomitant free certolizumab drug level.


Methodology

Electrochemiluminescence Immunoassay (ECLIA); Surface Plasmon Resonance


References

Cimzia® [package insert]. Smyrna, GA: UCB Inc; 2016.
Jani M, Isaacs JD, Morgan AW, et al. High frequency of antidrug antibodies and association of random drug levels with efficacy in certolizumab pegol-treated patients with rheumatoid arthritis: results from the BRAGGSS cohort. Ann Rheum Dis. 2017 Jan;76(1):208-213.27245864
Ramos GP, Al-Bawardy B, Willrich M, et al. Certolizumab Trough Levels And Antibodies In Inflammatory Bowel Disease: A Single-Center Experience. Gastroenterology. 2018 May;154(6):S826-S827.10.1016/S0016-5085(18)32819-1
Sandborn W, Feagan B, Parker G, Bosny P-L, Lee S. The Relationship Between Plasma Concentrations of Certolizumab Pegol and Clinical Efficacy: Results from the PRECiSE 2 Trial. Inflamm Bowel Dis. 2012 Dec;18:S23.10.1097/00054725-201212001-00057
Vande Casteele N, Herfarth H, Katz J, Falck-Ytter Y, Singh S. American Gastroenterological Association Institute Technical Review on the Role of Therapeutic Drug Monitoring in the Management of Inflammatory Bowel Diseases. Gastroenterology. 2017 Sep;153(3):835-857.e6.28774547
Vermeire S, Gils A, Accossato P, Lula S, Marren A. Immunogenicity of biologics in inflammatory bowel disease. Therap Adv Gastroenterol. 2018 Jan 21;11:1756283X17750355.29383030

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
504627 Certolizumab and Anti-Certo Ab 504628 Certolizumab DRUG Level ug/mL 87404-0
504627 Certolizumab and Anti-Certo Ab 504629 Anti-Certolizumab Ab Level ng/mL 87405-7

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