P15 Evaluating risankizumab for moderate-to-severe plaque psoriasis: real-world outcomes from an international study

Abstract Risankizumab has shown high efficacy in Phase III randomized controlled trials (RCTs) for treating moderate-to-severe plaque psoriasis, outperforming ustekinumab and adalimumab in terms of skin clearance. However, there is limited data on its long-term effectiveness and safety in real-world settings. This study aims to bridge this gap by evaluating the 1-year real-world outcomes of risankizumab in adult patients with moderate-to-severe plaque psoriasis, focusing on both its efficacy and safety. We conducted an international, multicentre retrospective study involving five tertiary academic dermatology clinics in Canada and Portugal. The study included adult patients aged 18 years or older diagnosed with moderate-to-severe plaque psoriasis, characterized by a Physician’s Global Assessment (PGA) score of 3 or 4. One year after initiating risankizumab treatment, we assessed efficacy based on achieving a psoriasis area and severity index (PASI90) or PGA score of 0 (clear) or 1 (almost clear). Safety evaluations were based on the frequency and nature of adverse events reported by the patients. The study included 291 participants, with a mean age of 50.7 ± 15.0 years, of whom 62.5% were male. Of these, 56.4% (164/291) had not previously been treated with systemic biologic therapy, and the group had previously failed an average of 0.79 systemic biologics. After 1 year of treatment, 264 patients (90.7%) achieved PASI90 or a PGA score of 0/1. Furthermore, 90.7% attained a PASI ≤2, 56.4% achieved a PASI <1, and 72% reported a body surface area <1%. Adverse events were noted in 4.5% of the cohort (13/291), with fatigue being the most frequently reported, affecting 23% (3/13) of those with adverse events. None of the adverse events were considered severe, and all patients experiencing adverse events continued with the treatment. Treatment discontinuation occurred in 7.9% (23/291) of the patients, primarily due to insufficient efficacy (15/23, 65.2%). The findings from this study indicate that risankizumab provides substantial real-world efficacy and maintains a strong safety profile for treating moderate-to-severe plaque psoriasis, supporting the results seen in Phase III clinical trials. The treatment resulted in high levels of skin clearance over 1 year. However, further validation through larger real-world cohort studies with control groups is essential to confirm these results.