Test Id : VEDOZ
Vedolizumab Quantitation with Antibodies, Serum
Useful For
Suggests clinical disorders or settings where the test may be helpful
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
A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.
| Test Id | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| VEDOL | Vedolizumab QN, S | Yes | Yes |
| VEMAB | Vedolizumab Ab, S | No | Yes |
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
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
A short description of the method used to perform the test
VEDOL: Liquid Chromatography Mass Spectrometry (LC-MS/MS)
VEMAB: Electrochemiluminescent Bridging Immunoassay
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
VEDOZ
VEMAB
Vedolizumab
VEDO
Entyvio, Takeda Pharmaceuticals
Vedolizumab antibodies
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
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.
Specimen Type
Describes the specimen type validated for testing
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
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
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.
Special Instructions
Library of PDFs including pertinent information and forms related to the test
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)
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
Serum: 0.3 mL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Gross hemolysis | OK |
| Gross lipemia | OK |
| Gross icterus | OK |
Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Refrigerated (preferred) | 28 days | |
| Frozen | 28 days |
Useful For
Suggests clinical disorders or settings where the test may be helpful
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
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
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.
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Drug and target:
Vedolizumab (VDZ, Entyvio) is a humanized IgG1 kappa monoclonal antibody directed against integrin alpha-4 beta-7 integrin expressed on lymphocytes. VDZ blocks the interaction between the alpha-4 beta-7 integrin and MAdCAM-1, preventing lymphocytes from migrating across the endothelium into inflamed gastrointestinal tissue, thereby reducing inflammation.
Indications:
Vedolizumab is US Food and Drug Administration-approved for the treatment of adult patients with moderately to severely active ulcerative colitis or Crohn disease.(1,2) The standard dosing is 300 mg intravenously (IV) at weeks 0, 2, and 6 (induction), and then every 8 weeks for maintenance. It may be given every 4 weeks in certain cases of partial response.
Pharmacokinetic highlights:
Steady-state trough concentrations are typically achieved after the first few maintenance doses (around 14-22 weeks into therapy). Another option is subcutaneous injection with 108 mg every 2 weeks for maintenance after initial IV induction at weeks 0 and 2. The reported median steady state trough serum concentrations range from 19 to 48 mcg/mL, with multiple studies demonstrating an increase of at least 10 mcg/mL after transition from IV to subcutaneous administration.(3-9)
Immunogenicity:
Patients on VDZ may develop antibodies to VDZ (ATV) over time. In clinical trials, approximately 4% of patients treated with VDZ were positive for ATV at any time and 1% or less had samples that were persistently positive. ATV formation may increase drug clearance in treated patients and/or neutralize the drug effect, thereby potentially contributing to the loss of response. ATV could also cause adverse events such as serum sickness and hypersensitivity reactions. VDZ drug level quantitation is commonly performed in conjunction with immunogenicity assessment for ATV.
Evidence for therapeutic drug monitoring:
Optimal therapeutic concentrations of VDZ associated with clinical remission and mucosal healing range between 12 and 28 mcg/mL, depending on the stage of therapy (induction or maintenance).(10-13) Most often, testing is ordered for patients on therapy who are experiencing loss of response (reactive monitoring). In the setting of loss of response to therapy, testing for ATV may be performed as a reflex after the drug quantitation shows subtherapeutic levels of VDZ (VEDOL / Vedolizumab Quantitation with Reflex to Antibodies, Serum) or as a panel where drug quantitation and ATV are performed simultaneously (this test). Results from drug quantitation combined with ATV testing play an important role in patient management.(10,12,13)
Proactive monitoring of ATV in a patient who is responding to therapy with VDZ is not recommended by the American Gastroenterology Association.
Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
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 > or =9.8 ng/mL
Interpretation
Provides information to assist in interpretation of the test results
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 | Antibodies to vedolizumab | 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. |
| > or =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 | > or =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. |
| > or =15 | > or =9.8 | Presence of ATV detected. In the presence of symptoms, this finding would suggest mechanistic failure and immunogenicity. |
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
The presence of high concentrations of vedolizumab might inhibit the antibodies to vedolizumab (ATV) assay yielding false-negative results.
Specimens containing more than 100 ng/mL biotin (vitamin B7) may interfere with ATV (in the form of depressed signal) for VEMAB / Vedolizumab Antibodies, Serum. It is recommended patients stop taking biotin-containing vitamins or supplements 12 hours before specimen collection.
Clinical management decisions for patients receiving vedolizumab treatment should not be based solely on quantitation of vedolizumab and assessment of ATV. Test results must be interpreted within the clinical context of the patient.
The test measures vedolizumab drug concentration specifically. When biosimilars for vedolizumab become available, the assay would be expected to detect them as they have the same molecular structure. The report would likely note it cannot distinguish Entyvio from a biosimilar. Currently, this is not applicable.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Feagan BG, Rutgeerts P, Sands BE, et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013;369(8):699-710
2. Chan AC, Carter PJ. Therapeutic antibodies for autoimmunity and inflammation. Nat Rev Immunol. 2010;10(5):301-316. doi:10.1038/nri2761
3. Sandborn WJ, Baert F, Danese S, et al. Efficacy and safety of Vedolizumab subcutaneous formulation in a randomized trial of patients with ulcerative colitis. Gastroenterology. 2020;158(3):562-572
4. Vermeire S, D'Haens G, Baert F, et al. Efficacy and safety of subcutaneous Vedolizumab in patients with moderately to severely active Crohn's disease: Results from the VISIBLE 2 randomised trial. J. Crohns Colitis. 2022;16(1):27-38
5. Volkers A, Straatmijer T, Duijvestein M, et al. Real-world experience of switching from intravenous to subcutaneous Vedolizumab maintenance treatment for inflammatory bowel diseases. Aliment Pharmacol. Ther. 2022;56(6):1044-1054
6. Wiken TH, Hoivik ML, Buer L, et al. Switching from intravenous to subcutaneous vedolizumab maintenance treatment in patients with inflammatory bowel disease followed by therapeutic drug monitoring. Scand J Gastroenterol. 2023;58(8):863-873
7. Bergqvist V, Holmgren J, Klintman D, Marsal J. Real-world data on switching from intravenous to subcutaneous vedolizumab treatment in patients with inflammatory bowel disease. Aliment Pharmacol. Ther. 2022;55(11):1389-1401
8. Ventress E, Young D, Rahmany S, et al. Transitioning from intravenous to subcutaneous vedolizumab in patients with inflammatory bowel disease [TRAVELESS] J. Crohns Colitis. 2022;16(6):911-921
9. Orsic Fric V, Borzan V, Sahinovic I, Borzan A, Kurbel S. Real-world study on Vedolizumab serum concentration, efficacy, and safety after the transition from intravenous to subcutaneous vedolizumab in inflammatory bowel disease patients: single-center experience. Pharmaceuticals (Basel). 2023;16(2):239
10. Al-Bawardy B, Ramos GP, Willrich MAV, et al. Vedolizumab drug level correlation with clinical remission, biomarker normalization, and mucosal healing in inflammatory bowel disease. Inflamm Bowel Dis. 2019;25(3):580-586
11. Dulai PS, Amiot A, Peyrin-Biroulet L, et al. A clinical decision support tool may help to optimise vedolizumab therapy in Crohn's disease. Aliment Pharmacol Ther. 2020;51(5):553-564
12. Dreesen E, Verstockt B, Bian S, et al. Evidence to support monitoring of vedolizumab trough concentrations in patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol. 2018;16(12):1937-1946.e8
13. Papamichael K, Cheifetz AS, Melmed GY, et al. Appropriate therapeutic drug monitoring of biologic agents for patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol. 2019;17(9):1655-1668.e3
14. 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
Method Description
Describes how the test is performed and provides a method-specific reference
Vedolizumab quantitation:
Vedolizumab is extracted from serum and measured by liquid chromatography (high-resolution accurate-mass, HRAM) mass spectrometry.(Unpublished Mayo method)
Vedolizumab antibodies:
Testing for antibodies to-vedolizumab is carried out using a laboratory-developed immunoassay.(Unpublished Mayo method)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
Vedolizumab quantitation: Monday, Wednesday, Thursday
Vedolizumab antibodies: Tuesday, Friday
Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
- Authorized users can sign in to Test Prices for detailed fee information.
- Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
- Prospective clients should contact their account representative. For assistance, contact Customer Service.
Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
CPT codes are provided by the performing laboratory.
80280
82397
LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| VEDOZ | Vedolizumab QN with Antibodies, S | 90794-9 |
| Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
|---|---|---|
| 602807 | Vedolizumab QN, S | 90805-3 |
| 603298 | Vedolizumab Ab, S | 86899-2 |
| 603299 | VEMAB Interpretation | 59462-2 |