Evaluate response failure to adalimumab therapy. Determine and adjust dosage or identify the need for change to another anti-TNF-α inhibitor.
Cell Culture/Quantitative Chemiluminescent Immunoassay/ Semi-Quantitative Chemiluminescent Immunoassay
Collect specimens before adalimumab treatment.
Serum separator tube.
Separate serum from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to an ARUP Standard Transport Tube. (Min: 0.3 mL)
Contaminated, hemolyzed, icteric, or lipemic specimens.
After separation from cells: Ambient: 48 hours; Refrigerated: 4 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles)
|Available Separately||Components||Reference Interval|
|No||Adalimumab Activity||Not Detected|
|No||Adalimumab Neutralizing Antibody||Not Detected|
This test measures the capacity of adalimumab to neutralize TNF activity. Additionally, adalimumab neutralizing antibodies (NAb) are titered, reporting the minimal serum dilution at which blocking of adalimumab activity is no longer observed.
This test is used to evaluate secondary response failures to adalimumab therapy. Secondary response failure is defined as loss of clinical response after initial improvement of clinical signs and symptoms. Therapeutic decision should rest on both the clinical response and the knowledge of the fate of the drug including the emergence of immunogenicity in individual patients.
Circulating adalimumab levels have been shown to vary considerably between patients. These differences relate to route and frequency of administration and patient-related features such as age, gender, weight, drug metabolism, and concomitant medications such as methotrexate and other immunosuppressants.
* AGA recommended target trough concentration for reactive monitoring of patients with active IBD on maintenance therapy is 7.5 ug/mL or greater for adalimumab (Feuerstein JD et al, Gastroenterology 2017; 153:827-834). The AGA makes no recommendation regarding the use of routine, proactive therapeutic drug monitoring in adults with quiescent IBD treated with anti-TNF agents.
|Clinical Interpretation of Adalimumab and Antibody Testing Results in the Context of Treatment Failure|
|Adalimumab Activity||Adalimumab Neutralizing Antibody Titer||Interpretation|
|Not Detected||Not Detected||Sub-therapeutic dose. A higher dosage of adalimumab or shortening the dosing interval may be appropriate.|
|Not Detected||Detected||Likely immune-mediated treatment failure. A change to another anti-TNF drug may be appropriate.|
|Detected - Below Target*||N/A||Sub-therapeutic dose. A higher dosage of adalimumab or shortening the dosing interval may be appropriate.|
|Detected - Above Target*||N/A||A change to another type of therapy (not targeting TNF) may be appropriate if patient is not responding.|
Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
This test is performed pursuant to an agreement with Svar Life Sciences.
|Component Test Code*||Component Chart Name||LOINC|
|2011250||Adalimumab Neutralizing Antibody||92765-7|