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HelpTest Code INTAD Adalimumab Panel, Interpretation
Secondary ID
620312Useful For
Interpretation of therapeutic drug monitoring of adalimumab concentration and antibody levels
Method Name
Only orderable as part of a profile. For more information see ADALP / Adalimumab Quantitative with Antibody, Serum.
Technical Interpretation
Specimen Type
SerumSpecimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Refrigerated (preferred) | 28 days | |
| Frozen | 28 days |
Reference Values
Only orderable as part of a profile. For more information see ADALP / Adalimumab Quantitative with Antibody, Serum.
Interpretation
Adalimumab quantitation is generally performed in conjunction with immunogenicity assessment for antibodies to adalimumab (ATA). Most often, this testing is ordered for patients with inflammatory bowel disease (IBD) who are on adalimumab therapy and who are experiencing loss of response (reactive monitoring),(5) but the testing may be ordered for anyone on adalimumab-even when treatment is going well (proactive monitoring).(6-8)
Results from adalimumab and ATA testing play an important role in patient management. In the setting of loss of response to adalimumab therapy for adults with active IBD, a clinical decision tool from the American Gastroenterology Association(9,10) suggests the following scenarios for a blood draw that occurred at trough, immediately before the next injection dose:
-For patients who have undetectable or low concentrations of adalimumab (<8 mcg/mL) but no detectable ATA, the patient care team may choose to increase the dose of adalimumab in an attempt to increase the amount of the drug in circulation.
-If the patient has subtherapeutic adalimumab concentrations (<8 mcg/mL) in the presence of an ATA, the patient care team may switch the patient to another TNF inhibitor.
-For patients with increased trough concentrations of adalimumab (therapeutic or greater), whether an ATA is present or not, it may be necessary to switch the patient to a therapy with a different mechanism of action such as the anti-alpha 4-beta-7-integrin antibody vedolizumab or the IL12/IL23 antibody ustekinumab.
-Low trough concentrations may be correlated with loss of response to adalimumab.
Adalimumab concentration results above 35 mcg/mL are suggestive of a blood draw at a time-point in treatment other than trough.
Test interpretation relies on clinical presentation and may differ from the statements above, which were designed for adults with IBD experiencing loss of response. For individuals on adalimumab therapy for other conditions such as rheumatoid arthritis, or pediatric patient populations or proactive monitoring, drug concentration therapeutic targets and patient management decision may be individualized. When both the drug quantitation and anti-drug-antibodies are ordered, an interpretive guide is offered below.
|
Adalimumab quantitation, mcg/mL |
ATA, AU/mL |
Comment |
|
<8 |
Negative |
Absence of detectable antibody-to-adalimumab (ATA). Low concentration of adalimumab (ADL) may be attributable to other parameters related to adalimumab clearance. |
|
<8 |
Positive |
Presence of antibody-to-adalimumab (ATA) detected, which correlates with low concentration of adalimumab (ADL). ATAs may be associated with increased clearance and lower circulating concentrations of ADL. |
|
8.1-15 |
Negative |
Absence of detectable antibody-to-adalimumab (ATA).
At this concentration of adalimumab (ADL), a low-titer (50-150 AU/mL) or moderate titer (150-500 AU/mL) ATA cannot be excluded. However, the presence of a high-titer ATA (≥500 U/mL) is unlikely.
If there is clinical suspicion for a low-titer ATA, suggest submission of a new sample obtained at trough.
This test has demonstrated drug tolerance up to 40 mcg/mL for ATAs ≥500 AU/mL, up to 15 mcg/mL for ATAs between 150-500 and up to 8 mcg/mL ADL for ATAs between 50-150 AU/mL. |
|
Low or moderate positive (14-499) |
Presence of antibody-to-adalimumab (ATA) detected. At this concentration of adalimumab (ADL), the detected titer of the ATA may be modestly underestimated.
This test has demonstrated drug tolerance up to 40 mcg/mL for ATAs ≥500 AU/mL, up to 15 mcg/mL for ATAs between 150-500 and up to 8 mcg/mL ADL for ATAs between 50-150 AU/mL. |
|
|
High positive (≥500) |
Presence of antibody-to-adalimumab (ATA) detected.
This test has demonstrated drug tolerance up to 40 mcg/mL for ATAs ≥500 AU/mL, up to 15 mcg/mL for ATAs between 150-500 and up to 8 mcg/mL ADL for ATAs between 50-150 AU/mL. |
|
|
>15 |
Negative |
At this concentration of adalimumab (ADL), a low (50-150 AU/mL) or moderate titer (150-500 AU/mL) ATA cannot be excluded. The presence of a high-titer ATA (≥500 U/mL) is unlikely but also cannot be completely excluded.
If there is clinical suspicion for an ATA, suggest submission of a new sample obtained at trough, preferably during the maintenance phase of therapy.
This test has demonstrated drug tolerance up to 40 mcg/mL for ATAs ≥500 AU/mL, up to 15 mcg/mL for ATAs between 150-500 and up to 8 mcg/mL ADL for ATAs between 50-150 AU/mL. |
|
Low positive (14-149) |
Presence of antibody-to-adalimumab (ATA) detected. At this concentration of adalimumab (ADL), the detected titer of the ATA is likely underestimated.
Suggest submission of a new sample obtained at trough, preferably during the maintenance phase of therapy. This test has demonstrated drug tolerance up to 40 mcg/mL for ATAs ≥500 AU/mL, up to 15 mcg/mL for ATAs between 150-500 and up to 8 mcg/mL ADL for ATAs between 50-150 AU/mL. |
|
|
Moderate positive (150-499 U/mL) |
Presence of antibody-to-adalimumab (ATA) detected. At this concentration of adalimumab (ADL), the detected titer of the ATA may be underestimated. Suggest submission of a new sample obtained at trough, preferably during the maintenance phase of therapy. This test has demonstrated drug tolerance up to 40 mcg/mL for ATAs ≥500 AU/mL, up to 15 mcg/mL for ATAs between 150-500 and up to 8 mcg/mL ADL for ATAs between 50-150 AU/mL. |
|
|
High positive (≥500) |
Presence of antibody-to-adalimumab (ATA) detected.
This test has demonstrated drug tolerance up to 40 mcg/mL for ATAs ≥500 AU/mL, up to 15 mcg/mL for ATAs between 150-500 and up to 8 mcg/mL ADL for ATAs between 50-150 AU/mL. |
Method Description
This interpretation is generated by the laboratory information system based on adalimumab quantitation and antibody to adalimumab test results.
Day(s) Performed
Monday, Wednesday, Friday
Report Available
2 to 4 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
LOINC Code Information
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| INTAD | Adalimumab Interpretation | 77202-0 |