Secukinumab demonstrated sustained retention, effectiveness and safety in a real‐world setting in patients with moderate‐to‐severe plaque psoriasis: long‐term results from an interim analysis of the SERENA study

Abstract Background Randomized controlled trials of secukinumab have shown sustained efficacy and a favourable safety profile in multiple manifestations of psoriatic disease. Objectives To assess the long‐term, real‐world retention, effectiveness and safety of secukinumab in routine clinical practice for the treatment of moderate‐to‐severe plaque‐type psoriasis (PsO). Methods SERENA (CAIN457A3403) is a large, ongoing, longitudinal, observational study conducted at 438 sites and 19 countries for an expected duration of up to 5 years in adult patients with moderate‐to‐severe PsO, psoriatic arthritis and ankylosing spondylitis. Patients received ≥16 weeks of secukinumab treatment before enrolment. This interim analysis presents data from PsO patients, who were enrolled in the study between October‐2016 and October‐2018 and were observed for ≥2 years. Results In total, 1756 patients (67.3% male) with a mean age of 48.4 years and body mass index of 28.8 kg/m 2 were included in the analysis. The secukinumab treatment retention rates after 1, 2 and 3 years in the study were 88.0%, 76.4% and 60.5%, respectively. Of the 648 patients who discontinued the study, the most common reasons included lack of efficacy (42.6%), adverse event (17.4%), physician decision (12.2%) and subject decision (11.6%). Mean ± SD absolute PASI was 21.0 ± 13.0 at the start of treatment ( n = 1,564). At baseline, the mean ± SD PASI score reduced to 2.6 ± 4.8 and remained low at Year 1 (2.3 ± 4.3), Year 2 (1.9 ± 3.6) and Year 3 (1.9 ± 3.5). The safety profile of secukinumab during the SERENA study was consistent with its known safety profile, with no new safety signals reported. Particularly, low rates of inflammatory bowel disease (0.3%; Incidence Rate [IR]:0.15), candida infections (3.1%; IR:1.43) and MACE (0.9%; IR:0.37) were observed. Conclusions Secukinumab showed high treatment persistence, sustained effectiveness and a favourable safety profile up to 3 years of follow‐up in the real‐world population of PsO patients observed in SERENA.