Real-world effectiveness of risankizumab in psoriasis: first Sardinian multicenter 2-year experience

BACKGROUND: Psoriasis is an immune-mediated chronic skin disease associated with multiple extracutaneous comorbidities, causing a severe quality of life impairment, whose treatment with risankizumab, a humanized anti-IL-23 monoclonal antibody, is very effective, with good safety profile and long-term outcomes. However, prescription in a real-world setting is conditioned by local health care system constraints, as the proven ineffectiveness or appearance of adverse events to first-line drugs. Such delay and selection of multi-failure patients might affect efficacy and outcomes. METHODS: A prospective multicenter study, approved by the Ethical Independent Committee of AOU Cagliari, acronym ESSOS-BIO-PSO, Prot N° 2023/2532, was conducted to evaluate risankizumab's effectiveness and safety in Sardinian psoriasis centers over 6, 12, and 24 months. RESULTS: 73 patients with moderate-to-severe psoriasis treated with risankizumab over at least 6 months were recruited, predominantly male (70%) with a median age of 50 years and a median disease duration of 22 years. Most patients had extensive, difficult-to-treat areas involved, psoriasis arthritis and other comorbidities. Prior treatments included traditional systemic therapies and biologics (60%). At week 52, 74% achieved PASI-90, increasing to 76.7% at week 104, with all initial PASI-90 responders maintaining the response. Faster and sustained responses were observed in biologic-naïve patients and those with shorter disease duration. The difference between groups was statistically significant at week 16 (Mann-Whitney P=0.042), identifying naïve patients as "super-responders." No severe adverse events occurred; risankizumab was well tolerated and adherence was 100%. CONCLUSIONS: This real-world study investigates effectiveness and safety of Risankizumab in a population with a distinctive historical and genetic background, as well as environmental factors which may influence disease patterns and response to treatments. This first Sardinian study confirms durable results with excellent adherence in moderate-to-severe psoriasis patients, regardless of prior treatments and comorbidities burden, although in biologic-naïve patients the response is quicker.