Test Catalog

Test Id : RISA

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Risankizumab, Serum

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

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
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.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Risankizumab, S

Aliases
Lists additional common names for a test, as an aid in searching

Risankizumab

Skyrizi

AbbVie

Crohn's disease

Specimen Type
Describes the specimen type validated for testing

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
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Sarstedt Aliquot Tube 5 mL (T914)

Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions:

1. Draw blood immediately before the next scheduled dose (trough specimen).

2. Centrifuge and aliquot serum into plastic vial within 2 hours of collection.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

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 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

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Risankizumab (Skyrizi, AbbVie) is a humanized IgG1 kappa therapeutic monoclonal antibody used to treat moderate to severe plaque psoriasis and Crohn disease. Risankizumab targets interleukin 23A (IL-23p19) binding with high affinity to the p19 subunit and inhibiting further action.

 

Therapeutic drug monitoring (TDM) has become standard of care in the gastroenterology practice for biologic therapies used in inflammatory bowel disease (IBD), Crohn disease, and ulcerative colitis. TDM is routinely used to assess loss of response to therapy and proactively manage patients taking tissue necrosis factor (TNF) inhibitors (eg, infliximab and adalimumab), alpha-4-beta7 integrins (vedolizumab), or IL12/23 blockers (ustekinumab). With the approval of risankizumab for IBD, TDM is expected to play an important role in managing loss of response to therapy and guide decision making for use of monotherapy or combination therapy.

 

Risankizumab is currently US Food and Drug Administration-approved for plaque psoriasis, psoriatic arthritis, and Crohn disease.

 

Patients with plaque psoriasis or psoriatic arthritis are treated with 150 mg subcutaneously at weeks 0, 4, and every 12 weeks thereafter. The steady state maximum concentration (Cmax) and trough concentration (Ctrough) are estimated to be 12 and 2 mcg/mL, respectively.

 

Patients with Crohn disease are treated with 600 mg intravenously at weeks 0, 4, and 8, followed by 180 mg or 360 mg subcutaneously at week 12 and every 8 weeks thereafter. During induction weeks 8 through 12, the median Cmax is estimated to be 156 mcg/mL and the Ctrough is estimated to be 38.8 mcg/mL, according to the drug package insert. Steady state is achieved at 28 weeks after starting treatment in the dosing regimen for Crohn disease. Median Cmax and Ctrough concentrations measured during weeks 40 through 48 of maintenance phase (or weeks 52-60 from start of treatment) are estimated to be 14.0 mcg/mL and 4.1 mcg/mL, respectively, for 180 mg dose or 28.0 mcg/mL and 8.1 mcg/mL, respectively, for 360 mg dose.

 

Risankizumab is immunogenic, like other therapeutic monoclonal antibodies. Clinical trials have shown antibodies-to-risankizumab occur at rates of about 24% for plaque psoriasis, 12% for psoriatic arthritis, and 3.4% for Crohn disease.

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=1.0 mcg/mL

Interpretation
Provides information to assist in interpretation of the test results

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.

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. 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

2. Willrich MA, Murray DL, Barnidge DR, et al. Quantitation of infliximab using clonotypic peptides and selective reaction monitoring by LC-MS/MS. Int Immunopharmacol. 2015;28(1):513-520

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

4. Feagan, B. G., J. Panes, M. Ferrante, et al. Risankizumab in patients with moderate to severe Crohn's disease: an open-label extension study. Lancet Gastroenterol Hepatol. 2018;3(10):671-680

5. Ferrante, M., R. Panaccione, F. Baert, et al. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022;399(10340):2031-2046

6. Skyrizi package insert https://www.rxabbvie.com/pdf/skyrizi_pi.pdf, accessed on October 14, 2023

Method Description
Describes how the test is performed and provides a method-specific reference

Risankizumab 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

No

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.

2 to 9 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

2 weeks

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

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.

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
RISA Risankizumab, 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.
621304 Risankizumab, S In Process

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | PHP Pdf | CMS Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports