Use to evaluate response failure to adalimumab therapy. Use to determine and adjust dosage or identify the need for change to another anti-TNF-α inhibitor.
If adalimumab drug level is not detected, adalimumab neutralizing antibody will be added. To assess for both adalimumab activity and neutralizing antibody titer regardless of adalimumab drug level, see Adalimumab Activity and Neutralizing Antibody (2011248).
Cell Culture/Quantitative Chemiluminescent Immunoassay/ Semi-Quantitative Chemiluminescent Immunoassay
New York DOH Approval Status
Collect specimens before next adalimumab treatment.
Serum Separator Tube (SST).
Separate 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|
|2013605||Adalimumab Activity w/Rflx to Antibody||Not Detected|
|No||ADA Rflx to Neutralizing Ab Confirmation||Not Detected|
This test measures the capacity of adalimumab to neutralize TNF activity. If adalimumab is not detected, testing for neutralizing antibodies (NAb) will be performed. Adalimumab NAb titer is obtained by identifying 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.
This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.
|Clinical Interpretation of Adalimumab and Antibody Testing Results in the Context of Treatment Failure|
||Adalimumab Neutralizing Antibody Titer
|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 the patient is not responding adequately to adalimumab therapy.|
Laboratory Developed Test (LDT)
This test is performed pursuant to an agreement with Svar Life Sciences. If Adalimumab drug level is not detected, then Adalimumab Neutralizing Ab Titer will be added. Additional charges apply.
80145; if reflexed, add 82397
|Component Test Code*||Component Chart Name||LOINC|
|2013606||Adalimumab Activity w/Rflx to Ab||86894-3|
|2013607||EER Adalimumab Activity w/Rflx to Ab||11526-1|