Test Id : MIRI
Mirikizumab, Serum
Useful For
Suggests clinical disorders or settings where the test may be helpful
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
A short description of the method used to perform the test
Liquid Chromatography Mass Spectrometry (LC-MS)
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
Mirikizumab
Omvoh
Crohn's Disease
Ulcerative Colitis
Crohn Disease
Specimen Type
Describes the specimen type validated for testing
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
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
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.
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
Serum: 0.25 mL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Gross hemolysis | OK |
| Lipemia | Reject |
| Gross icterus | OK |
Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Refrigerated (preferred) | 28 days | |
| Ambient | 28 days | ||
| Frozen | 28 days |
Useful For
Suggests clinical disorders or settings where the test may be helpful
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
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Drug and target:
Mirikizumab (Omvoh, Lilly) is a humanized IgG4 monoclonal antibody that selectively binds the p19 subunit of interleukin 23 (IL23), inhibiting IL23 signaling.
Indications:
Mirikizumab is US Food and Drug Administration-approved for inflammatory bowel disease (IBD). It is used in moderately to severely active ulcerative colitis (UC) and Crohn disease (CD).
Pharmacokinetic highlights:
Mirikizumab has linear pharmacokinetics with dose-proportional exposure. Higher body weight is associated with lower mean concentrations of the drug. Dosing for UC is 300 mg IV at weeks 0, 4 and 8, followed by 200 mg subcutaneous injections at week 12 and every 4 weeks thereafter. Dosing for CD is 900 mg IV at weeks 0, 4 and 8, and 300 mg subcutaneous injections at week 12 and every 4 weeks thereafter. Steady state is achieved after approximately 16 weeks in therapy, and laboratory testing is recommended at trough, after steady state.(1)
Immunogenicity:
During clinical trials, 23% of UC and 13% of CD patients developed anti-drug-antibodies (ADA), with no clinically significant effect of ADA on safety of mirikizumab. In UC subjects only, some of the ADA identified had an association with reduced trough concentrations.
Evidence for therapeutic drug monitoring:
The prescribing information for mirikizumab notes an exposure-response relationship in UC, and in CD, this is not yet fully characterized. Validated therapeutic ranges and trough targets have not been established. Model-based steady state mirikizumab exposures during subcutaneous maintenance doses every 4 weeks in patients with IBD suggest trough concentrations ranging from 1.5 to 3.0 mcg/mL and Cmax (peak) around 10 to 11 mcg/mL.
Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Lower limit of quantitation = 0.5 mcg/mL
Interpretation
Provides information to assist in interpretation of the test results
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.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Lipemic samples will be rejected.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
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
Method Description
Describes how the test is performed and provides a method-specific reference
Mirikizumab is extracted from serum and measured by liquid chromatography mass spectrometry.(Unpublished Mayo method)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
Wednesday
Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
- Authorized users can sign in to Test Prices for detailed fee information.
- Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
- Prospective clients should contact their account representative. For assistance, contact Customer Service.
Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
CPT codes are provided by the performing laboratory.
80299
LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| MIRI | Mirikizumab, S | In Process |
| Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
|---|---|---|
| 623669 | Mirikizumab, S | In Process |