Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Department of Dermatology, Municipal Hospital Hietzing, Vienna, Austria.
J Eur Acad Dermatol Venereol. 2022 Oct;36(10):1796-1804. doi: 10.1111/jdv.18329. Epub 2022 Jul 4.
Randomized controlled trials of secukinumab have shown sustained efficacy and a favourable safety profile in multiple manifestations of psoriatic disease.
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).
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.
In total, 1756 patients (67.3% male) with a mean age of 48.4 years and body mass index of 28.8 kg/m 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.
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.
司库奇尤单抗的随机对照试验表明，其在多种银屑病表现中具有持续的疗效和良好的安全性。
评估司库奇尤单抗在常规临床实践中治疗中重度斑块型银屑病（PsO）的长期、真实世界的保留率、有效性和安全性。
SERENA（CAIN457A3403）是一项正在进行的、长期的、纵向观察性研究，在 19 个国家的 438 个地点进行，预计对中重度斑块型银屑病、银屑病关节炎和强直性脊柱炎患者的观察时间最长可达 5 年。患者在入组前接受了至少 16 周的司库奇尤单抗治疗。这项中期分析提供了来自 PsO 患者的数据，这些患者于 2016 年 10 月至 2018 年 10 月期间入组该研究，并观察了至少 2 年。
共纳入 1756 例（67.3%为男性）患者，平均年龄为 48.4 岁，体重指数为 28.8kg/m。研究中司库奇尤单抗治疗的保留率在第 1、2 和 3 年分别为 88.0%、76.4%和 60.5%。在 648 例退出研究的患者中，最常见的原因包括疗效不佳（42.6%）、不良事件（17.4%）、医生决定（12.2%）和患者决定（11.6%）。在开始治疗时（n=1564），患者的平均（±标准差）绝对 PASI 为 21.0（±13.0）。基线时，平均（±标准差）PASI 评分降低至 2.6（±4.8），第 1 年（2.3（±4.3））、第 2 年（1.9（±3.6））和第 3 年（1.9（±3.5））时仍保持较低水平。在 SERENA 研究期间，司库奇尤单抗的安全性与已知的安全性一致，未报告新的安全性信号。特别观察到炎症性肠病（0.3%；发生率[IR]：0.15）、念珠菌感染（3.1%；IR：1.43）和 MACE（0.9%；IR：0.37）的发生率较低。
在 SERENA 观察到的中重度斑块型银屑病患者真实世界人群中，司库奇尤单抗在长达 3 年的随访中表现出高治疗持久性、持续疗效和良好的安全性。
