Anti-risankizumab antibodies (ARAs) are immunogenic biomarkers that develop in response to therapeutic exposure to risankizumab, a humanized IgG1 monoclonal antibody targeting interleukin-23 (IL-23). Risankizumab selectively binds the p19 subunit of IL-23, inhibiting downstream inflammatory signaling pathways central to the pathophysiology of autoimmune conditions such as moderate-to-severe plaque psoriasis, active psoriatic arthritis, and Crohn’s disease. ARAs can neutralize the therapeutic activity of risankizumab or alter its pharmacokinetics, impacting treatment efficacy and duration.
In clinical settings, the presence of ARAs may indicate reduced drug responsiveness, necessitating the evaluation of patient-specific immune profiles. Therapeutic drug monitoring (TDM) can be employed to assess circulating drug levels alongside anti-drug antibody titers to tailor dosing regimens for optimal therapeutic outcomes. The development of ARAs is influenced by factors such as treatment duration, administration route, and underlying immune status.
In research, the study of ARAs provides insights into immunogenicity risks associated with biologics and aids in the refinement of biosimilar design. Monitoring ARAs is critical in clinical trials to evaluate long-term safety, consistency in therapeutic response, and immunologic tolerability of risankizumab-based therapies across diverse patient populations.
This product is manufactured in Turkey by Matriks Biotek.