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Test Code RISA Risankizumab, 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


Supplies: Sarstedt Aliquot Tube 5 mL (T914)

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions:

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

2. Within 2 hours of collection, centrifuge and aliquot serum into plastic vial.


Useful For

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

Liquid Chromatography Mass Spectrometry (LC-MS)

Reporting Name

Risankizumab, S

Specimen Type

Serum

Specimen Minimum Volume

0.25 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 28 days
  Ambient  28 days
  Frozen  28 days

Reference Values

Lower limit of quantitation=1.0 mcg/mL

Interpretation

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.

Clinical Reference

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. AbbVie, Inc.; Revised June 2024. Accessed October 4, 2024. Available at www.rxabbvie.com/pdf/skyrizi_pi.pdf

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
RISA Risankizumab, S 105041-8

 

Result ID Test Result Name Result LOINC Value
621304 Risankizumab, S 105041-8

Forms

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