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Geisinger Medical Laboratories Test Catalog
ADALIMUMAB LEVEL AND ANTI-DRUG ANTIBODY |
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Geisinger Epic Procedure Code: LAB1518
Geisinger Epic ID: 49408
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SPECIMEN COLLECTION |
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Specimen type: |
Serum | |
Preferred collection container: |
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Specimen required: |
2 mL aliquot serum; minimum 1 mL. | |
Special notes: |
The blood should be drawn just before the next infusion of adalimumab to measure the trough drug level. | |
Patient preparation: |
No biotin supplements 48 hours prior to blood draw. | |
| SPECIMEN PROCESSING |
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Transport temperature: |
Refrigerated. | |
Specimen stability: |
Room temperature: 48 hours. Refrigerated: 7 days. Frozen -20°: 14 days. Frozen -70°C: 60 days. | |
Rejection criteria: |
Specimen collected in serum-separator tube (SST). Gross hemolysis. | |
TEST DETAILS |
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CPT code(s): |
83520, 80145 | |
| Note: The billing party has sole responsibility for CPT coding. Any questions regarding coding should be directed to the payer being billed. The CPT codes provided by GML are based on AMA guidelines and are for informational purposes only. | ||
Test includes: |
Adalimumab Level, Adalimumab Ab | |
Methodology: |
Enzyme-Linked Immunosorbent Assay (ELISA) |
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Synonyms: |
TNF inhibitor antibody,Anti-TNF inhibitor antibody,Anti-Humira® antibody,Humira® anti-drug antibody, Quest GMC Limited Access code 38314, ADALIMUMAB LEVEL AND ANTI-DRUG ANTIBODY FOR IBD ADALIM
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Clinical significance: |
The American Gastroenterological Association recommends optimal adalimumab trough concentration of 7.5 mcg/mL or greater in patients with active IBD. Data from separate clinical studies suggest an optimal adalimumab trough concentration greater than 4.5 mcg/mL or 8-12 mcg/mL. Sub-therapeutic adalimumab levels may be due to a patient not yet achieving a steady state trough level early in therapy, inadequate dosing, a dosing interval that is too long, or accelerated adalimumab clearance. Accelerated adalimumab clearance may be explained by the presence of adalimumab anti-drug antibody or rheumatoid factor in the patient's serum, or may be caused by other diseases that indirectly lead to immunoglobulin loss (i.e. kidney disease, protein-losing gastroenteropathy). If adalimumab level is sub-therapeutic but total adalimumab anti-drug antibody is not detected: Patients with a sub-therapeutic adalimumab trough level, but no anti-drug antibody, may benefit from an increased adalimumab dose. If adalimumab level is sub-therapeutic and total adalimumab anti-drug antibody is detected: Detectable serum adalimumab anti-drug antibody may cause accelerated adalimumab clearance leading to reduced trough levels and a compromised clinical response. Such patients are more likely to benefit from a switch in biologic therapy than from an increase in adalimumab dose. If adalimumab level is therapeutic and total adalimumab anti-drug antibody is not detected: In patients who do not respond or who lose their clinical response, mucosal inflammation is likely to be driven by a process that is not TNF alpha dependent. A switch to a different class of therapy should be considered. If adalimumab level is therapeutic and total adalimumab anti-drug antibody is detected: If the patient is responding clinically, the detected anti-drug antibody may not be clinically significant because the detected anti-drug antibody may not be functional or the level is inadequate to accelerate adalimumab clearance. Anti-drug antibody may disappear over time or increase, and, if increased, may cause sub-therapeutic adalimumab levels and a loss of response in the future. Patients with a loss of adalimumab response despite therapeutic trough levels may benefit from a switch to a different class of therapy. | |