Real‐World Long‐Term Effectiveness and Safety of Secukinumab in Psoriasis: Up to 7 Years of Evidence from the Italian Landscape Psoriasis (IL PSO) Multicenter Retrospective Study

Introduction: Secukinumab, approved in 2015 for the treatment of moderate-to-severe psoriasis, has demonstrated sustained efficacy and safety in pivotal randomized controlled trials. However, real-world data on its long- term effectiveness and safety are limited. We conducted a multicenter retrospective study involving 15 Italian dermatology units to assess the long-term effectiveness and safety of secuki- numab in routine clinical practice over a period of up to 7 years. Methods: A total of 769 adult patients with moderate-to-severe psoriasis who received con- tinuous secukinumab treatment for at least 4 years were included. We assessed effectiveness in terms of the Psoriasis Area and Severity Index (PASI) 90 and 100 (complete skin clearance) and an absolute PASI score of≤2 at various time points from week 16 to 7 years. We performed subgroup analyses to evaluate the impact of different comorbidities. Safety was assessed by recording all adverse events (AEs) reported dur- ing follow-up visits. Results: PASI 90 was achieved by 36.0% of patients at week 16, increasing to 71.0% at year 1, 84.1% at year 4, 87.0% at year 5, and 90.0% at year 6. PASI 100 rates rose from 27.4% at week 16 to 67.1% at year 4 and 80.2% at year 7. Patients with concomitant psoriatic arthritis (PsA) showed significantly higher PASI 100 rates at years 5 and 6 (p≤0.05). The overall incidence of AEs was low, with serious AEs occurring in a small number of patients. Treatment was per- manently discontinued due to adverse drug reactions in five patients (three due to de novo malignancies, one due to eosinophilic pneu- monia, and one due to massive pulmonary embolism). Conclusions: In this selected cohort of long- term responders, secukinumab demonstrated sustained and progressively increasing effective- ness with a favorable safety profile over up to 7 years of treatment.