Evaluation of i-Tracker kits shows rapid results and high accuracy in quantifying risankizumab and anti-risankizumab, suggesting improvements in therapeutic drug monitoring.
Background Risankizumab, a human monoclonal antibody directed against IL-23, is a drug widely used for the treatment of inflammatory diseases (e.g., plaque psoriasis, Crohn*s disease, ulcerative colitis). Therapeutic drug monitoring is currently proposed to provide useful information to clinicians to improve the efficacy of the treatment. Biosynex has just developed the innovative i-Tracker kits: fast quantification of Risankizumab and Anti-Risankizumab antibodies fully automated on the random-access IDS-i10 chemiluminescent analyzer. Methods The analytical performance was studied using two types of samples: human serum samples spiked with Risankizumab or anti-Risankizumab antibodies, and human serum samples from patients with inflammatory diseases treated with Risankizumab. For drug assay, Risankizumab was captured using IL-23-coupled magnetic microparticles and detected using an acridinium ester-conjugated anti-Risankizumab polyclonal antibody. For the assay of anti-Risankizumab antibodies, microparticles coupled to Risankizumab were used. The anti-Risankizumab antibodies thus captured were detected by Risankizumab conjugated to the acridinium ester. Light emission from acridinium ester conjugates is directly related to the amount of Risankizumab or anti-Risankizumab antibodies present in the sample. Results The quantification of Risankizumab by the i-Tracker Risankizumab kit shows very good accuracy (the percentages of recovery are between 80% and 100%). The intra-test and inter-test reproducibility is very good (CV <7.3% for the Risankizumab assay and CV <8.0% for the anti-Risankizumab antibody assay). No interference from biological agents (bilirubin, hemoglobin, triglycerides, rheumatoid factors) was detected. The assay measurement ranges are 1 µg/mL to 80 µg/mL for Risankizumab and 10 ng/mL to 2000 ng/mL for anti-Risankizumab antibodies. Conclusion The i-Tracker Risankizumab and anti-Risankizumab kits are rapid tests (results obtained in less than 40 minutes) and highly accurate. Monitoring Risankizumab plasma levels could provide clinicians with relevant information to improve treatment efficacy.
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Sabalza et al. (2025) studied this question.
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