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Adalimumab Level and Anti-Drug Antibody for IBD, Serum

Test ID: ADAIBD S

Test

Aliases/Synonyms

TNF Inhibitor Antibody; Anti-TNF Inhibitor Antibody; Anti-Humira ® Antibody; Humira ® Anti-drug Antibody

Method

Enzyme Linked Immunosorbent Assay (ELISA)

Specimens

Avoid gel-separator tubes; Serum

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

Avoid gel-separator tubes; Serum

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
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
Adalimumab AB, IBD AU
  • < 10
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).
  • If adalimumab level is subtherapeutic but total adalimumab anti-drug antibody is not detected: Patients with a subtherapeutic adalimumab trough level, but no anti-drug antibody, may benefit from an increased adalimumab dose.
  • If adalimumab level is subtherapeutic 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 subtherapeutic 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.

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