Specimen Collection Manual and Test Catalog

2 mL aliquot serum; minimum 1 mL.

The blood should be drawn just before the next infusion of adalimumab to measure the trough drug level.

No biotin supplements 48 hours prior to blood draw.

Refrigerated.

Room temperature: 48 hours. Refrigerated: 7 days. Frozen -20°: 14 days. Frozen -70°C: 60 days.

Specimen collected in serum-separator tube (SST). Gross hemolysis.

Adalimumab Level, Adalimumab Ab

TNF inhibitor antibody,Anti-TNF inhibitor antibody,Anti-Humira® antibody,Humira® anti-drug antibody, Quest GMC Limited Access code 38314, LAC38314, ADALIMUMAB LEVEL AND ANTI-DRUG ANTIBODY FOR IBD, ADALIM

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.