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HelpEpic Test Code LAB5025 Vedolizumab Quantitation with Reflex to Antibodies, Serum
Additional Codes
MML: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, SSpecimen Type
SerumSpecimen 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 | 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.
Day(s) Performed
Monday, Wednesday, Thursday
Report Available
5 to 7 daysSpecimen Retention Time
14 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
CPT Code Information
80280
82397 (if appropriate)
NY State Approved
YesForms
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)