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HelpTest 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, SSpecimen Type
SerumSpecimen Minimum Volume
Serum: 0.3 mL
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum | Refrigerated (preferred) | 28 days |
| Frozen | 28 days |
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 |
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. |
|
≥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. |
Clinical Reference
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
Day(s) Performed
Vedolizumab quantitation: Monday, Wednesday, Thursday
Vedolizumab antibodies: Tuesday, Friday
Report Available
5 to 8 daysPerforming 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
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)