LONG-TERM EFFICACY AND SAFETY OF RISANKIZUMAB: A RETROSPECTIVE, MULTICENTER, REAL-WORLD STUDY

초록

Introduction: Risankizumab is a humanized monoclonal antibody that selectively blocks the p19 subunit of interleukin-23. While long-term data from clinical trials are available, long-term real-world evidence is still limited. Additionally, most data comes from North America or Europe, with relatively scarce information available from Asia.Objectives: To investigate long-term efficacy and safety of risan-kizumab for moderate-to-severe psoriasisMethods: We conducted a retrospective analysis of all patients undergoing risankizumab treatment for a minimum of 52 weeks within a major university healthcare system. Patients’ demographic data, duration of psoriasis, prior treatment, presence of psoriatic arthritis, severity of psoriasis measured by psoriasis area and severity index (PASI) and body surface area (BSA) at defined timepoints (0, 16, 52, 104, 156 weeks), and recorded adverse events were collected.Results: A total of 155 patients were included in the analysis. The mean PASI score significantly decreased from 10.3 ± 4.4 at baseline to 0.9 ± 0.9 at 52 weeks. Similar reduction was observed for BSA. By week 52, 91.0%, 55.6%, and 37.9% of patients achieved PASI≤2, PASI 90, and PASI 100, respectively. Prior biologic treatment failure correlated with a diminished response to risankizumab. Psoriasis improvement persisted over time, with PASI≤2, PASI 90, and PASI 100 responses increasing to 93.3%, 77.0% and 54.8%, respectively, at week 104. Among those completing 156 weeks of treatment, the treatment response was sustained. The majority of treatment-emergent adverse events were mild, primarily pruritus, injection site reactions, and COVID-19 infection, while all recorded serious adverse events were unrelated to risankizumab.Conclusions: Risankizumab showed sustained long-term efficacy and favorable safety profile in real-life clinical setting.