Evaluate response failure to adalimumab therapy. Determine and adjust dosage or identify the need for change to another anti-TNF-α inhibitor.
- Patient Preparation
- Collect specimens before adalimumab treatment.
- Serum Separator Tube (SST).
- Specimen Preparation
- Separate from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to an ARUP Standard Transport Tube. (Min: 0.3 mL)
- Storage/Transport Temperature
- Unacceptable Conditions
- 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 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 the patient is not responding adequately to adalimumab therapy.|
|Component Test Code*||Component Chart Name||LOINC|
|2013606||Adalimumab Activity w/Rflx to Ab|
|2013607||EER Adalimumab Activity w/Rflx to Ab|