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Test Code QNADL Adalimumab Quantitative, Serum


Specimen Required


Only orderable as part of profile. For more information see ADALP / Adalimumab Quantitative with Antibody, Serum.

 

Patient Preparation: For 12 hours before specimen collection, it is recommended that the patient not take multivitamins or dietary supplements containing biotin (vitamin B7), which is commonly found in hair, skin, and nail supplements and multivitamins.

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial


Useful For

Therapeutic drug monitoring of adalimumab concentration

Testing Algorithm

When this test is ordered, adalimumab quantitation and testing for antibodies to adalimumab will always be performed. 

Method Name

Only orderable as part of a profile. For more information see ADALP / Adalimumab Quantitative with Antibody, Serum.

 

Enzyme-Linked Immunosorbent Assay (ELISA)

Reporting Name

Adalimumab QN, S

Specimen Type

Serum

Specimen Minimum Volume

0.35 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 28 days
  Frozen  28 days

Reference Values

Only orderable as part of profile. For more information see ADALP / Adalimumab Quantitative with Antibody, Serum.

 

ADALIMUMAB QUANTITATIVE:

Limit of quantitation is 0.8 mcg/mL. Optimal therapeutic ranges are disease specific.

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-alpha4-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.

 

Clinical Reference

1. Willrich MAV, Murray DL, Snyder MR. Tumor necrosis factor inhibitors: clinical utility in autoimmune diseases. Transl Res. 2015;165(2):270-282

2. Ordas I, Mould DR, Feagan BG, Sandborn WJ. Anti-TNF monoclonal antibodies in inflammatory bowel disease: pharmacokinetics-based dosing paradigms. Clin Pharmacol Ther. 2012;91(4):635-646

3. Ordas I, Feagan BG, Sandborn WJ. Therapeutic drug monitoring of tumor necrosis factor antagonists in inflammatory bowel disease. Clin Gastroenterol Hepatol. 2012;10(10):1079-1087 e86

4. Restellini S, Chao CY, Lakatos PL, et al. Therapeutic drug monitoring guides the management of Crohn's patients with secondary loss of response to adalimumab. Inflamm Bowel Dis. 2018;24(7):1531-1538

5. American Gastroenterological Association. Therapeutic drug monitoring in inflammatory bowel disease: Clinical decision support tool. Gastroenterology. 2017;153(3):858-859. doi:10.1053/j.gastro.2017.07.039

6. D'Haens GR, Sandborn WJ, Loftus EV Jr, et al. Higher vs standard adalimumab induction dosing regimens and two maintenance strategies: Randomized SERENE CD trial results. Gastroenterology. 2022;162(7):1876-1890. doi:10.1053/j.gastro.2022.01.044

7. Yao J, Jiang X, You JHS. Proactive therapeutic drug monitoring of adalimumab for pediatric Crohn's disease patients: a cost-effectiveness analysis. J Gastroenterol Hepatol. 2021;36(9):2397-2407. doi:10.1111/jgh.15373

8. Kato M, Sugimoto K, Ikeya K, et al. Therapeutic monitoring of adalimumab at non-trough levels in patients with inflammatory bowel disease. PLoS One. 2021;16(7):e0254548

9. Vande Casteele N, Herfarth H, Katz J, Falck-Ytter Y, Singh S. American Gastroenterological Association Institute technical review on the role of therapeutic drug monitoring in the management of inflammatory bowel diseases. Gastroenterology. 2017;153(3):835-857.e6. doi:10.1053/j.gastro.2017.07.031

10. Feuerstein JD, Nguyen GC, Kupfer SS, Falck-Ytter Y, Singh S. American Gastroenterological Association Institute Guideline on Therapeutic Drug Monitoring in Inflammatory Bowel Disease. Gastroenterology. 2017;153(3):827-834. doi:10.1053/j.gastro.2017.07.032

11. Sejournet L, Kerever S, Mathis T, Kodjikian L, Jamilloux Y, Seve P. Therapeutic drug monitoring guides the management of patients with chronic non-infectious uveitis treated with adalimumab: a retrospective study. Br J Ophthalmol. 2022;106(10):1380-1386. doi:10.1136/bjophthalmol-2021-319072

12. Gomez-Arango C, Gorostiza I, Ucar E, et al. Cost-effectiveness of therapeutic drug monitoring-guided adalimumab therapy in rheumatic diseases: A Prospective, Pragmatic Trial. Rheumatol Ther. 2021;8(3):1323-1339. doi:10.1007/s40744-021-00345-5

13. Abdalla T, Mansour M, Bouazzi D, Lowes MA, Jemec GBE, Alavi A. Therapeutic drug monitoring in patients with suboptimal response to adalimumab for hidradenitis suppurativa: A retrospective case series. Am J Clin Dermatol. 2021;22(2):275-283. doi:10.1007/s40257-020-00575-3

Day(s) Performed

Monday, Wednesday, Friday

Report Available

2 to 4 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

80145

LOINC Code Information

Test ID Test Order Name Order LOINC Value
QNADL Adalimumab QN, S 86894-3

 

Result ID Test Result Name Result LOINC Value
QNADL Adalimumab QN, S 86894-3