Test Catalog

Test Id : RISAP

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Risankizumab Quantitation with Antibodies, Serum

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Overview

Test Catalog

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

Evaluation of patients with limited primary (initial) response to or secondary loss of response to risankizumab

Profile Information
A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.

Test Id Reporting Name Available Separately Always Performed
RISA Risankizumab, S Yes Yes
RISAB Risankizumab Ab, S No Yes

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Method Name
A short description of the method used to perform the test

RISA: Liquid Chromatography Mass Spectrometry (LC-MS)

RISAB: Electrochemiluminescent-Bridging Immunoassay (ECLIA)

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 QN with Antibodies, S

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

AbbVie

Anti-IL23 blocker

Antibodies-to-Risankizumab

Crohn's disease

Plaque psoriasis

Psoriatic arthritis

RISA

RISAB

Risankizumab

Risankizumab antibodies

RISAP

Skyrizi

Skyrizi antibodies

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Specimen Type
Describes the specimen type validated for testing

Serum

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

Patient Preparation: For 12 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7).

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1.5 mL

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.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

If not ordering electronically, complete, print, and send Gastroenterology and Hepatology Test Request (T728) with the specimen.

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.

0.75 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis OK
Gross lipemia Reject
Gross icterus OK
Heat-treated specimens Reject

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
Frozen 28 days

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

Evaluation of patients with limited primary (initial) response to or secondary loss of response to risankizumab

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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 approved for the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn disease.(1,2) Risankizumab targets interleukin 23A (IL-23p19), binding with high affinity to the p19 subunit and inhibiting further action.(3)

 

Therapeutic drug monitoring (TDM) has become standard-of-care for biologic therapies used in inflammatory bowel disease (IBD). In this context, TDM requires both quantitation of the therapeutic monoclonal antibody and assessment for the presence of anti-drug antibodies. Accurate interpretation of drug quantitation requires knowledge regarding patient diagnosis, drug dosage, and treatment schedule. 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 mcg/mL 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.(4)

 

The other important aspect of TDM for therapeutic monoclonal antibodies is detection of anti-drug antibodies. Similar to other therapeutic antibodies, risankizumab is immunogenic. Development of antibodies to risankizumab (ATRs) may increase drug clearance in treated patients and/or neutralize the drug effect, thereby potentially contributing to loss-of-response. Clinical trials have shown ATRs occur at rates of about 24% for plaque psoriasis, 12% for psoriatic arthritis, and 3.4% for Crohn disease.

 

In the context of limited initial response or loss-of-response over time to risankizumab, measurement of circulating drug concentrations and assessment for ATRs can help to guide patient management. For example, patients with low risankizumab trough concentrations in the absence of ATRs might benefit from dose escalation in an attempt to increase the circulating amount of the drug. In contrast, for patients with low drug concentrations and a detectable ATR, transition to a new drug therapy may be indicated.

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.

RISANKIZUMAB QUANTITATION:

Risankizumab lower limit of quantitation =1.0 mcg/mL

 

RISANKIZUMAB ANTIBODIES:

Antibodies to risankizumab: <20.0 ng/mL

Interpretation
Provides information to assist in interpretation of the test results

The optimal therapeutic serum concentration of risankizumab associated with favorable outcomes in Crohn disease is not known at this time. The current recommendation is to use the lowest dosing regimen 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.

 

The presence of detectable anti-risankizumab antibodies may be associated with increased risankizumab clearance and lower circulating concentrations of risankizumab in serum. Low trough concentrations of risankizumab may be correlated with loss of response to the drug.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Clinical management decisions for patients receiving risankizumab treatment should not be based solely on quantitation of risankizumab or assessment of antibodies to risankizumab (ATRs). Test results must be interpreted within the clinical context of the patient.

 

Therapeutic ranges have not been established for risankizumab quantitation. Therapeutic concentrations of risankizumab may vary according to the disease (eg, Crohn disease vs psoriatic arthritis vs plaque psoriasis). The limit of quantitation of the liquid chromatography time-of-flight (TOF) mass spectrometry method is 1.0 mcg/mL and reported in place of a reference interval with every test report.

 

Interference with the ATR assay, in the form of depressed signal, was observed in samples containing more than 400 ng/mL biotin.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Feagan BG, Panes J, Ferrante M, 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

2. Ferrante M, Panaccione R, Baert F, 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

3. Pang Y, D'Cunha R, Winzenborg I, Veldman G, Pivorunas V, Wallace K. Risankizumab: Mechanism of action, clinical and translational science. Clin Transl Sci. 2024;17(1):e13706

4. Skyrizi. Package insert. AbbVie, Inc.; Revised March 2024. Accessed June 3, 2024. Available at www.rxabbvie.com/pdf/skyrizi_pi.pdf

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

Risankizumab Quantitation:

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

 

Risankizumab Antibodies:

Testing for antibodies to risankizumab is accomplished using a laboratory-developed immunoassay.(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.

Weekly

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

14 days

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

82397

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
RISAP Risankizumab QN with Antibodies, S 105194-5
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 105041-8
621769 Risankizumab Ab, S 105195-2
621812 RISAB Interpretation 59462-2

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 | 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

Test Update Resources

Change Type Effective Date
New Test 2024-07-30