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

Secukinumab has demonstrated sustained efficacy and a favorable safety profile in clinical trials, providing relief from psoriatic symptoms. 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). 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. 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. 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. Plaque psoriasis is a skin condition that causes red, scaly patches and can greatly affect a person’s quality of life. Secukinumab is a medicine specifically designed to block interleukin-17A, a protein found in high amounts in people with plaque psoriasis. Studies have shown that secukinumab works well and is generally safe, but it is important to understand patients’ experiences with secukinumab in everyday life over time. The SERENA study followed 1740 adults with moderate to severe plaque psoriasis across 19 countries for up to 5 years. All participants had been taking secukinumab for at least 16 weeks before joining the study. This study assessed the number of people who continued using secukinumab over time (retention), its long-term effectiveness in controlling psoriasis symptoms, and its safety. The results showed that almost 60% of people were still using secukinumab after 5 years. Most people experienced improvement in their skin symptoms, with many achieving clear or almost clear skin that lasted throughout the study. People who started secukinumab earlier in their disease, or who had not used similar medicines before, tended to do even better. Only a small number of people developed psoriatic arthritis, a joint condition that can occur in people with psoriasis. Given the descriptive nature of this observational study, these findings should be interpreted carefully. No new safety risks were found. In summary, secukinumab helped people manage plaque psoriasis effectively and safely over time and may also reduce the risk of development of psoriatic arthritis.