Real-World Effectiveness and Safety of Risankizumab in Psoriasis: A Comprehensive Analysis from the Saudi Arabia Psoriasis Registry (PSORSA).

Introduction: Psoriasis is a chronic immune-mediated skin condition that has a substantial impact on patients' quality of life. The Saudi Arabia Psoriasis Registry (PSORSA) was established to address long-term real-world data (RWD) on systemic and biologic therapies in the region. This observational cohort study provides a comprehensive analysis of baseline disease characteristics, comorbidities, and treatment efficacy among patients enrolled in PSORSA, with an emphasis on risankizumab.

Methods: Data were sourced from a governmental online database covering multiple healthcare centers. Patients eligible for biologics were followed at baseline and at weeks 16, 28, 40, and 52 to evaluate disease severity, quality of life, and adherence. Statistical analyses were conducted using Jamovi and R. Descriptive statistics were performed for categorical and continuous variables. p-Values < 0.05 were considered significant.

Results: The study cohort included 313 patients. Plaque psoriasis was the most prevalent clinical type (93.9%). An analysis of treatment history revealed that 39.6% of patients had prior therapy exposure, and all patients received risankizumab as a biologic therapy. At baseline, the mean Psoriasis Area and Severity Index (PASI) score was 25.49. By week 52, it had decreased to 0.358, indicating complete clearance. PASI scores showed a steady and substantial reduction over time, with an 88% reduction at week 16, 96% at week 28, 97.5% at week 40, and 98.5% by week 52, demonstrating a strong and sustained treatment effect (p < 0.001). Additionally, risankizumab exhibited a favorable drug survival profile, with many patients maintaining treatment beyond 122 weeks.

Conclusion: This study represents the first real-world assessment of risankizumab for moderate-to-severe psoriasis in Saudi Arabia. The findings demonstrate that risankizumab is an effective and well-tolerated treatment for moderate-to-severe psoriasis in this Saudi Arabian cohort. However, future studies should explore long-term safety outcomes and the comparative effectiveness of risankizumab and emerging biologics in diverse patient populations.