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Test Code VEDOL Vedolizumab Quantitation with Reflex to Antibodies, Serum


Advisory Information


This test includes quantitation and, if appropriate, antibody testing will be performed. Therapeutic thresholds for vedolizumab optimal concentrations associated with good outcomes are not well established. The American Gastroenterology Association (AGA) does not have a formal guideline on optimal thresholds for vedolizumab at this time.

 

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



Specimen Required


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

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

Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Specimen Volume: 1.5 mL

Collection Instructions:

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

2. Centrifuge within 2 hours of draw.


Secondary ID

602807

Useful For

Assessing the response to therapy with vedolizumab

 

An aid to achieving desired trough serum levels of vedolizumab

 

Monitoring patient compliance

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 quantitation and, if appropriate, antibody testing will be performed. The therapeutic thresholds for vedolizumab and optimal concentrations associated with good outcomes are not well established. The American Gastroenterology Association (AGA) does not have a formal guideline on optimal thresholds for vedolizumab at this time.

 

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

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

0.75 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 Reject
Gross icterus OK

Clinical Information

Vedolizumab (Entyvio) is a humanized monoclonal antibody directed against integrin alpha-4 beta-7. Blocking the alpha-4 beta-7 integrin results in a gut-selective anti-inflammatory response. The drug is FDA-approved for the treatment of adult patients with moderately to severely active ulcerative colitis or Crohn disease. Although optimal therapeutic concentrations of vedolizumab are not well known, Mayo Clinic Gastroenterologists are working to correlate drug concentrations with patient outcomes. Vedolizumab testing will assess the patients loss of response to therapy, similar to therapy received using tumor necrosis factor (TNF) inhibitors, such as infliximab and adalimumab. 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. Therefore, simultaneous testing for measurement of ATV is recommended. ATV uses a bridging immunoassay on an electrochemiluminescence (Mesoscale Discovery) platform.

Reference Values

VEDOLIZUMAB QUANTITATION :

Vedolizumab lower limit of quantitation: 2.0 mcg/mL

 

VEDOLIZUMAB ANTIBODIES :

Antibodies to vedolizumab: <9.8 ng/mL

Interpretation

Data in the literature with association of vedolizumab trough levels and improved outcomes is still scarce. The limit of quantitation of the test is 2.0 mcg/mL. In a retrospective Mayo Clinic study conducted from 2016-2017 with 171 patients (62% Crohn disease, 31% ulcerative colitis, and 7% indeterminate colitis), the median vedolizumab trough concentration was 15.3 mcg/mL. Minimum trough (immediately before next infusion) therapeutic concentrations of vedolizumab are expected to be above 15 mcg/mL.

Clinical Reference

1. Willrich MA, Murray DL, Barnidge DR, et al: Quantitation of infliximab using clonotypic peptides and selective reaction monitoring by LC-MS/MS. International immunopharmacology 2015 Sep;28(1):513-520

2. Katrangi W, Ladwig PM, Barnidge DR, et al: A-260 Vedolizumab Quantitation in Serum using SRM and micro LC-ESI-Q-TOF Mass Spectrometry. Clin Chem 2015;61

3. Ladwig PM, Barnidge DR, Willrich MA: Mass Spectrometry Approaches for Identification and Quantitation of Therapeutic Monoclonal Antibodies in the Clinical Laboratory. Clin Vaccine Immunol 2017 May 5;24(5)

4. Ladwig PM, Barnidge DR, Willrich MA: Quantification of the IgG2/4 kappa Monoclonal Therapeutic Eculizumab from Serum Using Isotype Specific Affinity Purification and Microflow LC-ESI-Q-TOF Mass Spectrometry. J Am Soc Mass Spectrom 2017 May;28(5):811-817

5. Feagan BG, Rutgeerts P, Sands BE, et al: Vedolizumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med 2013;Aug 22;369(8):699-710

6. Schulze H, Esters P, Hartmann F, et al: A prospective cohort study to assess the relevance of vedolizumab drug level monitoring in IBD patients. Scand J Gastroenterol. 2018:1-7

7. Al-Bawardy B, Piovezani Ramos G, Willrich MAV, et al: P167 Vedolizumab Trough Levels and Antibodies in Inflammatory Bowel Disease: Updated Initial Experience. Gastroenterology154:S89

Day(s) and Time(s) Performed

VEDOL: Monday, Thursday

VEMAB: Tuesday, Friday

Analytic Time

7 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. This test has not been cleared or approved by the U.S. 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 a Gastroenterology and Hepatology Client Test Request (T728) with the specimen.