Test Code MIRI Mirikizumab, Serum
Ordering Guidance
Therapeutic drug monitoring of mirikizumab may be useful when assessing response to therapy is difficult or when patients need to be above a certain therapeutic concentration to improve the odds of a clinical response for therapy optimization, dose increases, or de-escalation or discontinuation of therapy.
Specimen Required
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 0.5 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.
Secondary ID
623669Useful For
Assessing the response to mirikizumab therapy
Assessing the need for dose escalation
Evaluating the potential for dose de-escalation or discontinuation of therapy
Monitoring patients who need to be above a certain mirikizumab 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
Serum: 0.25 mL
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| 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 = 0.5 mcg/mL
Interpretation
The optimal therapeutic concentration of mirikizumab associated with favorable outcomes in inflammatory bowel disease (IBD) is not known at this time. The recommendation is to use the lowest concentration that maintains response. Model-based analyses suggest steady-state trough concentrations of 1.5 to 3.0 mcg/mL, with peak concentrations of approximately 10 to 11 mcg/mL during subcutaneous maintenance dosing every-4 weeks in patients with IBD.
Therapeutic thresholds vary according to the disease, treatment regimen, and response or lack of response to therapy.
Method Description
Mirikizumab is extracted from serum and measured by liquid chromatography mass spectrometry.(Unpublished Mayo method)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 |
|---|---|---|
| MIRI | Mirikizumab, S | In Process |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 623669 | Mirikizumab, S | In Process |
Testing Algorithm
For information see Ulcerative Colitis and Crohn Disease Therapeutic Drug Monitoring Algorithm.