Sign in →

Test Code VEDOZ Vedolizumab Quantitation with Antibodies, Serum


Ordering Guidance


If there is a known justification for performing both quantitation and antibody levels, this is the correct test to order. If there is not a known reason to perform the antibodies component, consider VEDOL / Vedolizumab Quantitation with Reflex to Antibodies, Serum. VEDOL testing begins with vedolizumab quantitation. When the quantitation results are 15.0 mcg/mL or less, testing for antibodies to vedolizumab will be performed.



Specimen Required


Patient Preparation: For 12 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7).

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 1.5 mL Serum

Collection Instructions:

1. Draw blood immediately before next scheduled dose (trough specimen).

2. Within 2 hours of collection, centrifuge and aliquot serum into a plastic vial.


Useful For

Evaluation of patients with loss of response to vedolizumab (VDZ) with recurrence of symptoms and/or low or undetectable serum VDZ measured at trough

 

Monitoring vedolizumab concentrations in patients undergoing therapy with this biologic for ulcerative colitis or Crohn disease

 

Assessing the loss of response to VDZ therapy

 

As an aid to achieving desired serum concentration of VDZ

Profile Information

Test ID Reporting Name Available Separately Always Performed
VEDOL Vedolizumab QN, S Yes Yes
VEMAB Vedolizumab Ab, S No Yes

Testing Algorithm

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

 

This test includes both quantitation and antibody testing on all specimens. The therapeutic thresholds for vedolizumab and optimal concentrations associated with good outcomes are not well established. Currently, the American Gastroenterology Association does not have a formal guideline on optimal thresholds for vedolizumab trough concentrations in the setting of loss of response to therapy, but trough concentrations greater than 15 mcg/mL have been associated with clinical or endoscopic remission and mucosal healing in inflammatory bowel disease.

 

For more information see Ulcerative Colitis and Crohn Disease Therapeutic Drug Monitoring Algorithm.

Method Name

VEDOL: Liquid Chromatography Mass Spectrometry (LC-MS/MS)

VEMAB: Electrochemiluminescent Bridging Immunoassay

Reporting Name

Vedolizumab QN with Antibodies, S

Specimen Type

Serum

Specimen Minimum Volume

Serum: 0.3 mL

Specimen Stability Information

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

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Reference Values

VEDOLIZUMAB QUANTITATION:

Vedolizumab lower limit of quantitation=1.0 mcg/mL

 

VEDOLIZUMAB ANTIBODIES:

Antibodies to vedolizumab: <9.8 ng/mL

Absence of antibodies to vedolizumab is defined as <9.8 ng/mL

Presence of ATV is reported as positive when concentrations are ≥9.8 ng/mL

Interpretation

Unlike anti-tumor necrosis factor agents, the American Gastroenterology Association has not set formal target concentrations for vedolizumab. However, experts acknowledge that vedolizumab trough concentrations greater than 15 mcg/mL are associated with better outcomes in inflammatory bowel disease (IBD), with an association between higher vedolizumab concentration and clinical remission in IBD. European Crohn's and Colitis Organization (ECCO) guidance suggests considering intensification if the trough result is less than 20 mcg/mL in active disease.

 

In summary, current consensus is that vedolizumab therapeutic drug monitoring is useful reactively, and that trough results greater than or equal to 15 mcg/mL are desirable for optimal response, although an official "therapeutic range" is not firmly established. In a retrospective Mayo Clinic study with 171 patients (62% Crohn disease, 31% ulcerative colitis, and 7% indeterminate colitis), the median vedolizumab trough concentration was 15.3 mcg/mL. VDZ concentration greater than 15 mcg/mL at trough was associated with clinical remission, endoscopic remission, or mucosal healing in IBD.

 

Clinically significant antibodies to vedolizumab (ATV) impact drug clearance and are associated with low or undetectable vedolizumab concentration. Presence of ATV is associated with poorer outcomes and increased VDZ clearance.

 

Table. Interpretation

Vedolizumab quantitation
mcg/mL

Antibodies to vedolizumab
ng/mL

Comment

<15

<9.8

Absence of detectable antibodies to vedolizumab (ATV). Low or undetectable concentration of vedolizumab (VDZ) may be attributable to other parameters related to VDZ clearance.

≥15

<9.8

Absence of detectable ATV. VDZ concentration is associated with clinical remission, endoscopic remission, or mucosal healing in inflammatory bowel disease.

 

In the presence of symptoms, this finding would suggest mechanistic failure.

 

At this concentration of VDZ, a low-titer ATV cannot be completely excluded. However, the presence of a high-titer ATV is unlikely.

 

If there is clinical suspicion for a low-titer ATV, suggest submission of a new sample obtained at trough.

<15

≥9.8

Presence of ATV detected, which may correlate with low or undetectable concentration of VDZ. ATVs may be associated with increased clearance and lower circulating concentrations of VDZ.

≥15

≥9.8

Presence of ATV detected. In the presence of symptoms, this finding would suggest mechanistic failure and immunogenicity.

Day(s) Performed

Vedolizumab quantitation: Monday, Wednesday, Thursday

Vedolizumab antibodies: Tuesday, Friday

Report Available

5 to 8 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

80280

82397

LOINC Code Information

Test ID Test Order Name Order LOINC Value
VEDOZ Vedolizumab QN with Antibodies, S 90794-9

 

Result ID Test Result Name Result LOINC Value
602807 Vedolizumab QN, S 90805-3
603298 Vedolizumab Ab, S 86899-2
603299 VEMAB Interpretation 59462-2

Forms

If not ordering electronically, complete, print, and send 1 of the following with the specimen:

-Gastroenterology and Hepatology Test Request (T728)

-Therapeutics Test Request (T831)