Test Details
Methodology
Electrochemiluminescence Immunoassay (ECLIA)
Result Turnaround Time
14 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Use
This test is used for quantification of risankizumab drug (μg/mL) and risankizumab anti-drug antibodies (ng/mL) in patients treated with risankizumab for ulcerative colitis, Crohn's disease, plaque psoriasis and psoriatic arthritis.
Limitations
This test may exhibit interference when sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H or coenzyme R). It is recommended to ask all patients who may be indicated for this test about biotin supplementation. Patients should be cautioned to stop biotin consumption at least 72 hours prior to the collection of a sample.
Specimen Requirements
Specimen
Serum
Volume
2.0 mL
Minimum Volume
1.0 mL
Container
Red-top tube, gel-barrier tube or transfer tube
Collection Instructions
Allow a minimum clotting time of 30 to 60 minutes with serum separation within two hours of collection. Send serum in a plastic transport tube. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.
Stability Requirements
- Room temperature: 7 days
- Refrigerated: 14 days
- Frozen: 14 days
- Freeze/thaw cycles: Stable x6
Storage Instructions
Refrigerated or frozen
Causes for Rejection
Gross lipemic or hemolyzed samples
References
Dutt K, Vasudevan A. Therapeutic Drug Monitoring for Biologic and Small-Molecule Therapies for Inflammatory Bowel Disease. Medicina (Kaunas). 2024 Jan 31;60(2):250. PubMed 38399538
Loftus E. A Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease-Phase 3 Trial-Ongoing Trial, Recruitment Closed. Mayo Clinic website: https://www.mayo.edu/research/clinical-trials/cls-20358836. Accessed July 2025.
Pang Y, Khatri A, Suleiman AA, Othman AA. Clinical Pharmacokinetics and Pharmacodynamics of Risankizumab in Psoriasis Patients. Clin Pharmacokinet. 2020 Mar;59(3):311-326. PubMed 31758502
Rani Soenen JL. Therapeutic Drug Monitoring of Risankizumab in Psoriasis Patients (BIOLOPTIM-RS)-Phase 4 Clinical Trial-Currently Recruiting. Accessed at https://clinicaltrials.gov/study/NCT05685940. Accessed July 2025.
Schaeverbeke T, Truchetet ME, Kostine M, Barnetche T, Bannwarth B, Richez C. Immunogenicity of biologic agents in rheumatoid arthritis patients: lessons for clinical practice. Rheumatology. 2016 Feb;55(2):210-220. PubMed 26268816
Skyrizi [package insert]. North Chicago, IL: AbbVie Inc. June 2024.
Suleiman AA, Goebel A, Bhatnagar S, D'Cunha R, Liu W, Pang Y. Population Pharmacokinetic and Exposure-Response Analyses for Efficacy and Safety of Risankizumab in Patients with Active Crohn's Disease. Clin Pharmacol Ther. 2023 Apr;113(4): 839-850. PubMed 36534322
Suleiman AA, Minocha M, Khatri A, Pang Y, Othman AA. Population Pharmacokinetics of Risankizumab in Healthy Volunteers and Subjects with Moderate to Severe Plaque Psoriasis: Integrated Analyses of Phase I-III Clinical Trials. Clin Pharmacokinet. 2019 Oct;58(10):1309-1321. PubMed 31054118