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Test Code LABVEDOL Vedolizumab Quantitation with Reflex to Antibodies, Serum

Additional Codes

Test Name in EPIC EPIC Test Code Mnemonic Mayo Test ID
VEDLIZUMAB QUANTITATION WITH REFLEX TO ANTIBODIES LABVEDOL VEDOL VEDOL

 


Ordering Guidance


If both quantitation and antibody testing are needed, regardless of the quantitation results, order VEDOZ / Vedolizumab Quantitation with Antibodies, Serum.



Specimen Required


Patient Preparation:

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

2. Nivolumab (Opdivo) must be discontinued at least 4 weeks prior to testing for vedolizumab quantitation in serum.

Collection Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 1.5 mL

Collection Instructions:

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

2. Centrifuge and aliquot serum into a plastic vial within 2 hours of collection.


Useful For

Assessing the response to therapy with vedolizumab

 

An aid to achieving desired trough serum concentration of vedolizumab

Reflex Tests

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

Testing Algorithm

Vedolizumab quantitation will be performed by liquid chromatography-mass spectrometry on all samples. When this test is ordered and vedolizumab results are 15.0 mcg/mL or less, then testing for antibodies to vedolizumab will be performed at an additional charge.

 

This test includes vedolizumab drug quantitation and, if appropriate, antibody testing for antibodies-to-vedolizumab will be performed. 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 12 mcg/mL to 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, S

Specimen Type

Serum

Specimen Minimum Volume

0.3 mL

Specimen Stability Information

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

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Clinical Information

Vedolizumab (Entyvio) is a humanized IgG1 kappa monoclonal antibody directed against integrin alpha-4 beta-7. Blocking the alpha-4 beta-7 integrin results in a gut-selective anti-inflammatory response.(1) The drug is US Food and Drug Administration approved for the treatment of adult patients with moderately to severely active ulcerative colitis or Crohn disease. The main indication for therapeutic drug monitoring of vedolizumab is in the setting of primary nonresponse or loss-of-response to therapy, also called reactive monitoring.(2-10) Vedolizumab trough concentrations greater than 12 mcg/mL to 15 mcg/mL have been associated with clinical or endoscopic remission.(3,5,11) Proactive monitoring of vedolizumab concentrations has been proposed, but there is not sufficient data to support routine proactive testing at this time.

 

Therapeutic drug monitoring of biologics is usually carried out by measuring the monoclonal antibody therapy concentration and assessing its immunogenicity or the appearance of anti-drug antibodies. Some patients on vedolizumab may develop antibodies to vedolizumab (ATV) over time. In clinical trials, approximately 4% of patients treated with vedolizumab were positive for ATV at any time and 1% or less were persistently positive. Clinically significant ATV impact drug clearance and a positive ATV is associated with lower trough concentrations of vedolizumab.

Reference Values

VEDOLIZUMAB QUANTITATION:

Vedolizumab lower limit of quantitation: 2.0 mcg/mL

 

VEDOLIZUMAB ANTIBODIES:

Antibodies to vedolizumab: <9.8 ng/mL

Interpretation

The limit of quantitation of the test is 2.0 mcg/mL. 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.(11) Trough (immediately before next infusion) therapeutic concentrations of vedolizumab are expected to be above 15 mcg/mL.

 

Vedolizumab concentration greater than 15 mcg/mL at trough is associated with clinical remission, endoscopic remission, or mucosal healing in inflammatory bowel disease.

 

Clinically significant antibodies-to-vedolizumab impact drug clearance and are associated with low (≤15 mcg/mL at trough) or undetectable vedolizumab concentration.

Cautions

Patients actively undergoing therapy with both vedolizumab and nivolumab (rare scenario) should not have their therapeutic vedolizumab concentration assessed using this test. If the patient has taken nivolumab in the past, they should wait for 4 weeks after therapy with nivolumab has ended before being tested for vedolizumab quantitation using this method.

 

The presence of high concentrations of vedolizumab might inhibit the antibodies to vedolizumab (ATV) assay yielding false-negative results. In patients with concentrations of vedolizumab greater than 15.0 mcg/mL, the presence of an ATV is of little clinical significance.

 

Samples containing more than 100 ng/mL biotin (vitamin B7) may interfere (in the form of depressed signal) with VEMAB / Vedolizumab Antibodies, Serum.

 

Clinical management decisions for patients receiving vedolizumab treatment should not be based solely on quantitation of vedolizumab and assessment of ATV if appropriate. Test results must be interpreted within the clinical context of the patient.

Method Description

Vedolizumab Quantitation:

Vedolizumab is extracted from serum and measured by liquid chromatography (high-resolution accurate-mass, HRAM) mass spectrometry.(Cradic KW, Ladwig PM, Rivard AL, Katrangi W, Wintgens KF, Willrich MAV. Vedolizumab quantitation using high-resolution accurate mass-mass spectrometry middle-up protein subunit: Method validation. Clin Chem Lab Med. 2020;58[6]:864-872)

 

Vedolizumab Antibodies:

Testing for antibodies to vedolizumab is carried out  using a laboratory-developed immunoassay on an electrochemiluminescence (Mesoscale Discovery) platform.(Unpublished Mayo method)

Day(s) Performed

Monday, Wednesday, Thursday

Report Available

5 to 7 days

Specimen Retention Time

14 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

80280

82397 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
VEDOL Vedolizumab QN, S 90805-3

 

Result ID Test Result Name Result LOINC Value
602807 Vedolizumab QN, S 90805-3

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)