Retention, Effectiveness, and Safety of Secukinumab in Plaque Psoriasis: 5-Year Results from SERENA.

INTRODUCTION

Secukinumab has demonstrated sustained efficacy and a favorable safety profile in clinical trials, providing relief from psoriatic symptoms.

OBJECTIVE

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 psoriasis (PsO).

METHODS

SERENA (CAIN457A3403) is a longitudinal, observational study conducted at 438 sites and 19 countries for up to 5 years in adult patients with moderate to severe PsO, psoriatic arthritis, and ankylosing spondylitis. Patients received secukinumab treatment for ≥ 16 weeks before enrollment. This manuscript presents the 5-year data from the SERENA study in patients with moderate to severe PsO.

RESULTS

Overall, 1740 patients (67.5% male), with a mean age of 48.3 years and mean body mass index of 28.8 kg/m2, were included in the analysis. The estimated secukinumab retention rates were 88.5%, 76.3%, 68.6%, 63.1%, and 58.5% at years 1, 2, 3, 4, and 5, respectively. For the 913 patients who discontinued the study, the most common reasons included lack of efficacy (25.4%), patient decision (7.6%), physician decision (5.5%), and loss to follow-up (4.8%). The mean ± standard deviation (SD) absolute Psoriasis Area and Severity Index (PASI) score was 21.1 ± 13.0 at treatment initiation (n = 1545). At enrollment, the mean ± SD PASI score reduced to 2.6 ± 4.2 and remained low at year 1 (2.3 ± 4.3) through year 5 (1.4 ± 2.8). A higher proportion of patients who were biologic naïve and those with a shorter disease duration achieved PASI90 and PASI100 responses and demonstrated higher retention rates than those in patients previously treated with biologics and those with a longer disease duration. The safety profile was consistent with known data, with no new safety signals identified.

CONCLUSIONS

Secukinumab showed high treatment retention, sustained effectiveness, and a consistent safety profile up to 5 years of follow-up in the real-world population of patients with PsO observed in SERENA. Graphical abstract available for this article.