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HelpTest Code RISA Risankizumab, Serum
Ordering Guidance
Risankizumab trough levels may be useful to document therapeutic levels and to assess lack of response. For patients not responding properly to therapy, a risankizumab level could aid in the decisions to escalate, de-escalate, or discontinue risankizumab.
Specimen Required
Supplies: Sarstedt Aliquot Tube 5 mL (T914)
Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 0.5 mL
Collection Instructions:
1. Draw blood immediately before the next scheduled dose (trough specimen).
2. Within 2 hours of collection, centrifuge and aliquot serum into plastic vial.
Secondary ID
621304Useful For
Assessing the response to risankizumab therapy
Assessing the need for dose escalation
Evaluating potential changes or discontinuation of therapy
Monitoring patients who need to be above a certain risankizumab concentration to improve the odds of a clinical response for therapy optimization
Method Name
Liquid Chromatography Mass Spectrometry (LC-MS)
Specimen Type
SerumSpecimen Minimum Volume
0.25 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Refrigerated (preferred) | 28 days | |
| Ambient | 28 days | ||
| Frozen | 28 days |
Reject Due To
| Gross hemolysis | OK |
| Lipemia | Reject |
| Gross icterus | OK |
Reference Values
Lower limit of quantitation=1.0 mcg/mL
Interpretation
The optimal therapeutic concentration of risankizumab associated with favorable outcomes in inflammatory bowel disease is not known at this time. In Crohn disease, the recommendation is to use the lowest concentration that maintains response. According to the package insert, concentrations of risankizumab at steady state ranged from 4.1 mcg/mL (trough) to 14 mcg/mL (peak) at 180 mg dosing and 8.1 mcg/mL (trough) to 28 mcg/mL (peak) at 360 mg dosing. Steady state is achieved 28 weeks after initiation of therapy for the dosing regimen in Crohn disease.
Other therapeutic thresholds vary according to the disease, treatment regimen, and response or lack of response to therapy.
Method Description
Risankizumab is extracted from serum and measured by liquid chromatography mass spectrometry.(Unpublished Mayo method)
Day(s) Performed
Wednesday
Report Available
2 to 9 daysSpecimen Retention Time
2 weeksPerforming Laboratory
Mayo Clinic Laboratories in Rochester
CPT Code Information
80299
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| RISA | Risankizumab, S | 105041-8 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 621304 | Risankizumab, S | 105041-8 |
Testing Algorithm
For more information see Ulcerative Colitis and Crohn Disease Therapeutic Drug Monitoring Algorithm.
Special Instructions
Forms
If not ordering electronically, complete, print, and send Gastroenterology and Hepatology Test Request (T728) with the specimen.