Drug survival, effectiveness and safety of risankizumab for moderate-to-severe psoriasis for up to 4 years

Background: Numerous randomized controlled trials and real-life studies have shown risankizumab to be safe and effective for the treatment of psoriasis. However, real-life data on treatment for up to 4 years are lacking. Objectives: We aimed to estimate the drug survival (DS), effectiveness and safety of risankizumab over a period of 208 weeks. Methods: We included all consecutive patients between 1 January 2020 and 31 December 2024 with psoriasis or psoriatic arthritis who received at least one dose of risankizumab. Effectiveness was evaluated according to the achievement of 100% and 90% improvement in Psoriasis Area and Severity Index (PASI 100 and PASI 90, respectively). DS was evaluated using a Kaplan-Meier curve. Results: In total, 545 patients were included in the study. Mean PASI decreased from 14 at baseline to 0.5 at 208 weeks. PASI 100 showed an increasing trend, achieved in 33% and 74% of patients at 16 and 208 weeks, respectively. A similar trend was seen for PASI 90, peaking at 208 weeks with 81% of patients achieving this outcome. The estimated DS at 208 weeks was 87.2% in patients at risk of treatment discontinuation. Biologic treatment-naïve patients showed a significantly more rapid response than biologic treatment-experienced patients. Having obesity and difficult-to-treat site involvement appeared to slow the response, with patients with difficult-to-treat site involvement having a lower risk of drug interruption compared with patients with no difficult-to-treat site involvement (hazard ratio 0.15, 95% confidence interval 0.07-0.31; P < 0.001). Safety was good, with just five patients interrupting their treatment due to an adverse event. Conclusions: Our study indicates that risankizumab exhibited good effectiveness and favourable safety in a real-world setting for up to 4 years.