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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.


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)

Reporting Name

Mirikizumab, S

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

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.

Clinical Reference

1. Omvoh (mirikizumab). Package insert. Eli Lilly and Company; 2023. Updated November 2025. Accessed March 9, 2026. Available at https://uspl.lilly.com/omvoh/omvoh.html?s=pi

2. Ladwig PM, Barnidge DR, Willrich MA. Quantification of the IgG2/4 kappa monoclonal therapeutic eculizumab from serum using isotype specific affinity purification and microflow LC-ESI-Q-TOF mass spectrometry. J Am Soc Mass Spectrom. 2017;28(5):811-817

3. Ladwig PM, Barnidge DR, Willrich MAV. Mass spectrometry approaches for identification and quantitation of therapeutic monoclonal antibodies in the clinical laboratory. Clin Vaccine Immunol. 2017;24(5):e00545-16

4. Chua L, Friedrich S, Zhang XC. Mirikizumab pharmacokinetics in patients with moderately to severely active ulcerative colitis: Results from phase III LUCENT studies. Clin Pharmacokinet. 2023;62(10):1479-1491. doi:10.1007/s40262-023-01281-z

5.  Kobayashi T, Matsuoka K, Watanabe M, et al. Efficacy and safety of mirikizumab as induction and maintenance therapy for Japanese patients with moderately to severely active ulcerative colitis: a subgroup analysis of the global phase 3 LUCENT-1 and LUCENT-2 studies. Intest Res. 2024;22(2):172-185. doi:10.5217/ir.2023.00043

6. Aslam M, Ali MH, Irfan H. Mirikizumab: A promising breakthrough in Crohn's disease treatment. Health Sci Rep. 2024;7(8):e2294. doi:10.1002/hsr2.2294

Day(s) Performed

Wednesday

Report Available

2 to 9 days

Performing 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

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