Long-Term Real-World Safety Profile of Secukinumab Assessed Through a 9-Year Experience in Patients Affected by Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis: Results From a Multicentric Retrospective Study

Abstract

Secukinumab is a biologic agent known for its durable efficacy in chronic plaque psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS). Monitoring the safety of secukinumab is a priority to ensure its long-term usage. We aimed to provide an extended safety assessment of secukinumab treatment in a real-world setting. This bicentric observational study enrolled 332 patients with PsO, PsA and AS who received subcutaneous injections of secukinumab for up to 9 years. Adverse events (AEs) were reported annually as exposure-adjusted incidence rates (EAIRs) per 100 patient-years (pt-y). The total secukinumab exposure was 1129 pt-y. The retention rate was 73%, with 16 (4.8%) of patients discontinuing due to AEs. Despite most AEs being reported within the first 2 years, their incidence was low and decreased over time. The EAIR of any AEs was the highest in the initial 6 months (32.72/100 pt-y), followed by year 1 (7.62/100 pt-y), and year 2 of treatment (3.01/100 pt-y). Common AEs included respiratory and urinary tract infections, candidiasis, and diarrhoea. Secukinumab showed sustained safety over an extended 9-year treatment period, supporting its use for the long-term management of these immune-inflammatory disorders.