TNF Inhibitor Antibody; Anti-TNF Inhibitor Antibody; Anti-Humira ® Antibody; Humira ® Anti-drug Antibody
Adalimumab Level and Anti-Drug Antibody for IBD, Serum
Test
Aliases/Synonyms
Method
Enzyme Linked Immunosorbent Assay (ELISA)
Specimens
Important Note: TEST ID ADAIBD S
Non-interfaced clients should specify the Test ID ADAIBD S when ordering this test. Not doing so will cause processing delays while ICL ascertains which test you are requesting - please refer to the notes below.
A similar test is offered by this lab:
Adalimumab Level and Anti-Drug Antibody for Rheumatic Diseases, Serum
Clinical Utility
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.
Test Location
Quest Diagnostics, California USA
Test Version
24-Jan-2023
Specimen
Specimens
Important Note: TEST ID ADAIBD S
Non-interfaced clients should specify the Test ID ADAIBD S when ordering this test. Not doing so will cause processing delays while ICL ascertains which test you are requesting - please refer to the notes below.
A similar test is offered by this lab:
Adalimumab Level and Anti-Drug Antibody for Rheumatic Diseases, Serum
Collection Containers
Red top (no additive)
Sample Volume
2 mL
Minimum Volume
1 mL
Specimen Comment
Avoid gel separator tubes.
Patient Preparation
Refrain from taking biotin supplements or biotin containing vitamins 24 – 48 hours before blood draw .
Collection & Handling
Collection Instructions
Blood should be drawn just before the next infusion of adalimumab to measure the trough drug level.
Handling Information
Store and send frozen.
Stability
Ambient | 48 hours |
---|---|
Refrigerated | 7 days |
Frozen | 42 days |
Rejection Criteria
Hemolysis | Gross |
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Specimen | Gel-separator tubes |
Test Version
24-Jan-2023
Performance / Interpretation
Method
Enzyme Linked Immunosorbent Assay (ELISA)
Turnaround Time
10 days
Results
Name | Units | Reference Range | Conversion Factor | |
---|---|---|---|---|
Adalimumab Level, IBD | µg/mL |
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Adalimumab AB, IBD | AU |
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Interpretation | 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. Subtherapeutic 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).
This information is provided for informational purposes only and is not intended as medical advice. A physician's test selection and interpretation, diagnosis, and patient management decisions should be based on his/her education, clinical expertise, and assessment of the patient. The treating healthcare professional should refer to the manufacturer's approved labeling for prescribing, warnings, side effects and other important information. |
Test Location
Quest Diagnostics, California USA
Test Version
24-Jan-2023
Interface / Setup
HL7 Interface Codes
Order Code | Result Codes | Units |
---|---|---|
ADAIBD S | 63378ADALIMUMAB LEVEL, IBD | ug/mL |
63376ADALIMUMAB AB, IBD | AU | |
63377INTERPRETATION | ||
63379COMMENT |
Test Version
24-Jan-2023