Key messages
- L’obiettivo del presente studio è stato valutare l’efficacia a lungo termine di secukinumab dai dati aggregati di 28 trial clinici e di una sorveglianza sulla sicurezza post-marketing nel trattamento della psoriasi, dell’artrite psoriasica e della spondilite anchilosante.
- Secukinumab ha mostrato un profilo di sicurezza favorevole fino a 5 anni di trattamento per le 3 indicazioni, senza nuovi segnali relativi alla sicurezza.
Abstract
Secukinumab, a selective interleukin (IL)-17A inhibitor, is approved for use in adult and paediatric psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis. The aim of this study was to report the long-term safety of secukinumab in pooled data from 28 clinical trials and a post-marketing safety surveillance in psoriasis, psoriatic arthritis and ankylosing spondylitis patients. Analyses included 12,637 secukinumab-treated patients, corresponding to 15,063, 5,985 and 3,527 patient-years of exposure in psoriasis, psoriatic arthritis and ankylosing spondylitis patients, respectively. Incidences of serious adverse events were low, with no identifiable patterns across indications. Active tuberculosis or latent tuberculosis infections were rare. The incidence of opportunistic infections was < 0.2/100 patient-years, the incidence of malignancy was ≤ 1/100 patient-years, and the incidence of major adverse cardiovascular events was < 0.7/100 patient-years, with no apparent increases over time. Secukinumab demonstrated a favourable safety profile for up to 5 years of treatment across the 3 indications, and no new safety signals were identified.