Patient Preparation: Collect specimens before adalimumab treatment.

Preferred Minimum: 1 mL serum
Absolute Minimum: 0.3 mL serum

Contaminated, hemolyzed, icteric, or lipemic specimens.

2-3 days upon receipt at reference laboratory

Adalimumab Quantitation: <0.4 µg/mL
Antibodies to Adalimumab Quantitation: <20 ng/mL

This test measures the capacity of adalimumab to neutralize TNF- activity. Additionally, adalimumab neutralizing antibodies (NAb) are titered (reporting the highest dilution of patient sera in which NAb activity is 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.

The U.S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

-----------------------------------------------------------------------

IF Adalimumab   AND Adalimumab Neutralizing   THEN

Activity is     Ab. Titer is                  

-----------------------------------------------------------------------

Not Detected    Not Detected                  A higher dosage of

                                              adalimumab or shortening

                                              the dosing interval may be

                                              appropriate.

-----------------------------------------------------------------------

Not Detected    1:20 or greater               A change to another anti-

                                              drug may be appropriate.

-----------------------------------------------------------------------

0.65 ug/mL      Not Detected                  A change to another type

or greater                                    of therapy (not targeting

                                              TNF-may be appropriate.

-----------------------------------------------------------------------

0.65 ug/mL      1:20 or greater               Repeat testing is 

or greater                                    suggested to rule out

                                              decreasing adalimumab

                                              activity and/or

                                              increasing adalimumab

                                              neutralizing antibodies.

-----------------------------------------------------------------------

This tests is used to evaluate response failure to adalimumab therapy. Determine and adjust dosage or identify the need for change to another anti-TNF-α inhibitor.

ll Culture/Quantitative Chemiluminescent Immunoassay/ Semi-Quantitative Chemiluminescent Immunoassay