Adalimulab therapeutic monitoring performed by Sullivan Nicolaides Pathology.

Please ensure Medicare assignment is signed by patient, otherwise patient may receive an invoice.

Note: Patients with a negative ADL level (<= 0.4 ug/ml) will be tested for anti-ADL antibodies. There may be an out-of-pocket charge for this test. 

Adalimumab (ADL) levels of 5 ug/ml have been suggested as a cut-off for likelihood of clinical remission in IBD. If the patient has an ADL level of >5ug/ml with active disease, this suggests ADL drug resistance. If ADL levels are <5ug/ml with positive anti-ADL antibodies, suggest therapy be changed. Adalimumab levels <5 ug/ml are associated with poorer improvement in DAS28 scores in RA.
Patients with a negative ADL level (<= 0.4 ug/ml) will be tested for Anti-ADL antibodies.

ADL Assay Ranges:
Negative: <=0.4 ug/ml
Positive: > 0.4 ug/ml
Measurement Range: 0.4 to 12.0 ug/ml

Anti-ADL Ranges:
Negative: <=10 AU/ml
Positive: >10 AU/ml
Measurement Range: 10 to 400 AU/ml
Note: The CV of the assay is approximately 20%.
Adalimumab and anti-Adalimumab testing performed by EIA.

In the setting of active IBD:

If ADAL level: subtherapeutic and Anti-ADAL: low or neg
Action: Increase dose and/or decrease interval. Consider adding a thiopurine or methotrexate (if patient is not taking either agent).

If ADAL level: subtherapeutic and Anti-ADAL: High
Action: Switch within class (anti-TNF). Consider adding a thiopurine or methotrexate.

If ADAL level: Therapeutic but not responding, (Anti-ADAL not required)
Action: Switch to vedolizumab with or without immunomodulator.
Ref: Am J Gastroenterol Suppl 2016; 3: 8-16