Effectiveness, Safety, and Drug Survival of Bimekizumab in Chronic Plaque Psoriasis over 2 Years: Real-World Experience from Northern Italy

INTRODUCTION: Bimekizumab, a dual interleukin (IL)-17A and IL-17F inhibitor, has demonstrated high efficacy in clinical trials for moderate-to-severe plaque psoriasis. However, real-world evidence regarding its long-term effectiveness, safety, and treatment persistence up to 2 years remains limited. This study evaluates these outcomes in a routine clinical setting. METHODS: We conducted a retrospective, multicenter, real-world study across three Italian referral centers, including 126 adult patients with moderate-to-severe plaque psoriasis treated with bimekizumab. Efficacy was assessed by the proportion of patients achieving Psoriasis Area and Severity Index (PASI)75, PASI90, and PASI100 up to 104 weeks. Firth's penalized multivariable logistic regression was utilized to identify independent predictors of PASI100 at weeks 16 and 52. Drug survival was estimated using Kaplan-Meier analysis. Safety was evaluated through the incidence of treatment-emergent adverse events (TEAEs) expressed per 100 patient-years. RESULTS: Bimekizumab demonstrated rapid and sustained effectiveness with complete skin clearance (PASI100) being achieved by 61.5%, 80.0%, and 76.5% of patients at week 16, 52, and 104, respectively. At week 16, penalized multivariable analysis identified palmo-plantar involvement, nail psoriasis, and concomitant proton pump inhibitor (PPI) use as independent negative predictors of PASI100. By week 52, only palmo-plantar involvement remained a significant negative predictor. The overall cumulative probability of drug survival at 2 years was 72.2%. Stratified analyses revealed that biologic-naïve patients exhibited a significantly higher 2-year retention rate compared to bio-experienced individuals (91.5% versus 64.0%, p = 0.0083), whereas age and body mass index (BMI) did not significantly affect treatment persistence. Clinically significant TEAEs occurred at an incidence rate of 16.8 per 100 patient-years, predominantly driven by candidiasis (8.1 per 100 patient-years) and eczema (5.8 per 100 patient-years). The overall discontinuation rate was 22.2%. CONCLUSIONS: Bimekizumab represents a highly effective and durable therapeutic option for moderate-to-severe plaque psoriasis, maintaining robust clinical responses over a 2-year period. While a history of prior biologic failures negatively influences long-term drug survival, high levels of absolute skin clearance are consistently attainable regardless of challenging baseline characteristics such as advanced age or obesity. Infographic available for this article. INFOGRAPHIC.