Choice of therapy for psoriasis: inhibition of IL-23 p19 – data from clinical studies and real practice

Abstract

The article presents the results of clinical studies and real practice of the effectiveness and safety of the use of a new genetically engineered biological drug Risankizumab. Skyrizi (risankizumab) is an innovative drug, it is a humanized monoclonal antibody – immunoglobulin class G1 (IgG1) – which specifcally inhibits the cytokine IL-23 by binding to its subunit p19. It is believed that cytokine IL-23, involved in inflammatory processes, is associated with a number of chronic immune-mediated diseases, including psoriasis. According to direct comparative randomized clinical trials, risankizumab is superior in effectiveness in the short term and, most importantly, in the long term most genetically engineered biologic drugs, including TNF-α inhibitors, secukinumab, ustekinumab. In the ultIMMa-1 and ultIMMa-2 studies, sPGA 0/1 and PASI 90 (p < 0.001) were achieved after 16 weeks of treatment with Skyrizi. After 16 weeks of treatment in both studies, the majority of patients achieved sPGA 0/1 (88% and 84%, respectively), and PASI 90 in both studies reached 75% of patients receiving Skyrizi. According to the LIMMitless open extended study, after completion of ultIMMa-1 and –2 (based on LOCF analysis), the proportion of patients receiving Skyrizi up to 2.5 years (136 weeks) withholding PASI 90 and PASI 100 was 87% and 63%, respectively. One of the potential advantages of IL-23 inhibitors is also the long-term maintenance of the achieved effect after treatment cessation. During patient management in the course of randomized controlled trials of phase 3, data were obtained on the high safety of the drug and the absence of signifcant risks in relation to serious infections, cardiovascular events, malignant neoplasms. The drug is effective in case of insuffcient response to adalimumab, ustekinumab, secukinumab. The article presents two clinical cases of the use of risankizumab in patients of different ages with severe psoriasis, with ineffciency or intolerance to systemic therapy, as well as in connection with the eluding effect of previously conducted treatment methods. PASI 90/100 was achieved in all patients. No adverse events were observed.