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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

623669

Useful 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

Serum

Specimen 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Mirikizumab is extracted from serum and measured by liquid chromatography mass spectrometry.(Unpublished Mayo method)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 days

Specimen Retention Time

2 weeks

Performing 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