在欧洲真实世界环境中，司库奇尤单抗在中重度斑块状银屑病、银屑病关节炎和强直性脊柱炎患者中的应用：来自 SERENA 研究的基线数据。

Secukinumab Use in Patients with Moderate to Severe Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis in Real-World Setting in Europe: Baseline Data from SERENA Study.

机构信息

Rheumazentrum Ruhrgebiet, Herne, Germany.

Ruhr-University Bochum, Bochum, Germany.

出版信息

Adv Ther. 2020 Jun;37(6):2865-2883. doi: 10.1007/s12325-020-01352-8. Epub 2020 May 6.

INTRODUCTION

Secukinumab, a fully human monoclonal antibody that directly inhibits interleukin-17A, has demonstrated robust efficacy in the treatment of moderate to severe psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS), with a rapid onset of action, sustained long-term clinical responses and a consistently favourable safety profile across phase 3 trials. Here, we report the clinical data at enrolment from SERENA, designed to investigate the real-world use of secukinumab across all three indications.

METHODS

SERENA is an ongoing, longitudinal, observational study conducted at 438 sites across Europe in patients with moderate to severe plaque PsO, active PsA or active AS. Patients should have received at least 16 weeks of secukinumab treatment before enrolment in the study.

RESULTS

Overall 2800 patients were included in the safety set; patients with PsA (N = 541) were older than patients with PsO (N = 1799) and patients with AS (N = 460); patients with PsO had a higher mean body weight than patients with PsA and patients with AS; and patients with PsO and patients with AS were predominantly male. Time since diagnosis was longer in patients with PsO compared with patients with PsA and patients with AS, and about 40% of patients were either current or former smokers. The proportion of obese patients (body mass index ≥ 30 kg/m) was similar across indications. Patients were treated with secukinumab for a mean duration of 1 year prior to enrolment (range 0.89-1.04). The percentages of patients with prior biologics exposure were 31.5% PsO, 59.7% PsA and 55% AS. The percentages of patients prescribed secukinumab monotherapy were 75% (n = 1349) in PsO, 48.2% (n = 261) in PsA and 48.9% (n = 225) in AS groups.

CONCLUSION

Baseline demographics of the study population are consistent with existing literature. This large observational study across all secukinumab indications will provide valuable information on the long-term effectiveness and safety of secukinumab in the real-world setting.

简介

司库奇尤单抗是一种完全人源化的单克隆抗体，可直接抑制白细胞介素-17A，在治疗中重度银屑病（PsO）、银屑病关节炎（PsA）和强直性脊柱炎（AS）方面显示出强大的疗效，起效迅速，长期持续的临床应答，且在 3 期临床试验中始终具有良好的安全性。在此，我们报告了 SERENA 研究中的入组时临床数据，旨在调查司库奇尤单抗在所有三种适应证中的实际应用情况。

方法

SERENA 是一项正在进行的、纵向的、观察性研究，在欧洲 438 个地点开展，入组的患者患有中重度斑块状银屑病、活动性 PsA 或活动性 AS。患者在入组研究前应至少接受了 16 周的司库奇尤单抗治疗。

结果

总体而言，2800 例患者被纳入安全性分析集；PsA 患者（n=541）的年龄大于 PsO 患者（n=1799）和 AS 患者（n=460）；PsO 患者的平均体重高于 PsA 患者和 AS 患者；PsO 患者和 AS 患者主要为男性。与 PsA 患者和 AS 患者相比，PsO 患者的发病时间更长，约 40%的患者为现吸烟或既往吸烟者。各适应证患者中肥胖（体重指数≥30kg/m）的比例相似。患者在入组前接受司库奇尤单抗治疗的平均时间为 1 年（范围 0.89-1.04）。有既往生物制剂治疗史的患者比例分别为 PsO 组 31.5%、PsA 组 59.7%和 AS 组 55%。接受司库奇尤单抗单药治疗的患者比例分别为 PsO 组 75%（n=1349）、PsA 组 48.2%（n=261）和 AS 组 48.9%（n=225）。