Secukinumab在银屑病关节炎和强直性脊柱炎中的高长期保留率:来自希腊患者的观察性前瞻性SERENA研究的3年中期分析。

IF 3.2 3区 医学 Q2 RHEUMATOLOGY
Andreas Bounas, Anna Kandyli, Gkikas Katsifi, Dimitrios Boumpa, Maria G Tektonidou, Sousana Gazi, Anastasios Kotrotsios, Lazaros I Sakkas, Athanasios N Georgiadis, Loukas Settas, Xenia Madia, Dimitra Ignatiadi, Petros P Sfikakis
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引用次数: 0

摘要

SERENA是最近完成的一项为期5年的非介入性多国研究,评估secukinumab在现实世界中治疗中重度银屑病、活动性银屑病关节炎(PsA)和活动性强直性脊柱炎(AS)患者中的保留性、有效性、患者报告的结果和安全性。本文介绍了在希腊中心治疗的PsA和AS患者的三年中期数据。PsA和AS成人按照批准的标签接受secukinumab治疗≥16周。总的来说,214例PsA和81例AS患者入组,平均年龄分别为53.0岁和48.2岁,平均疾病持续时间分别为7.5年和9.1年。PsA和AS患者分别有73.4%和56.8%的生物经验。入组后1年、2年和3年的Secukinumab保留率在PsA中分别为87.1%、76.9%和74.0%,在AS患者中分别为89.9%、80.5%和77.3%。停药的主要原因是缺乏疗效(37.1%)和不良事件(AE;27.1%)。安全组(签署知情同意书后至少接受1次secukinumab剂量的患者)包括218例PsA和81例AS患者,其中13.3%和13.6%分别经历了与secukinumab相关的ae。恶性肿瘤报告1例。无念珠菌感染、主要不良心血管事件、炎症性肠病或葡萄膜炎报道。总之,经过3年的观察,PsA和AS对secukinumab具有类似的高持久性,具有良好的安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
High long-term retention rates of Secukinumab in psoriatic arthritis and ankylosing spondylitis: a 3-year interim analysis from the observational, prospective SERENA study, in Greek patients.

SERENA is a recently completed, non-interventional, multinational, 5-year study evaluating retention, effectiveness, patient-reported outcomes and safety of secukinumab in patients with moderate-to-severe psoriasis, active psoriatic arthritis (PsA), and active ankylosing spondylitis (AS) treated in real-world settings. Three-year interim data from PsA and AS patients treated in Greek centres are presented herein. PsA and AS adults receiving secukinumab per the approved label for ≥ 16 weeks were included. Overall, 214 PsA and 81 AS eligible patients were enrolled, with mean age of 53.0 and 48.2 years and mean disease duration of 7.5 and 9.1 years, respectively. Of PsA and AS patients, 73.4% and 56.8% were bio-experienced, respectively. Secukinumab retention rates at 1, 2, and 3 years post-enrolment were 87.1%, 76.9%, and 74.0% in PsA and 89.9%, 80.5%, and 77.3% in AS patients, respectively. Main reasons for drug discontinuation were lack of effectiveness (37.1%) and adverse event (AE; 27.1%). The safety set (patients with at least 1 secukinumab dose after signing the informed consent) included 218 PsA and 81 AS patients, of whom 13.3% and 13.6% experienced secukinumab-related AEs, respectively. One malignancy was reported. No candida infections, major adverse cardiovascular events, inflammatory bowel disease or uveitis were reported. In conclusion, similarly high persistence to secukinumab was observed for both PsA and AS after 3 years of observation, with a favourable safety profile.

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来源期刊
Rheumatology International
Rheumatology International 医学-风湿病学
CiteScore
7.30
自引率
5.00%
发文量
191
审稿时长
16. months
期刊介绍: RHEUMATOLOGY INTERNATIONAL is an independent journal reflecting world-wide progress in the research, diagnosis and treatment of the various rheumatic diseases. It is designed to serve researchers and clinicians in the field of rheumatology. RHEUMATOLOGY INTERNATIONAL will cover all modern trends in clinical research as well as in the management of rheumatic diseases. Special emphasis will be given to public health issues related to rheumatic diseases, applying rheumatology research to clinical practice, epidemiology of rheumatic diseases, diagnostic tests for rheumatic diseases, patient reported outcomes (PROs) in rheumatology and evidence on education of rheumatology. Contributions to these topics will appear in the form of original publications, short communications, editorials, and reviews. "Letters to the editor" will be welcome as an enhancement to discussion. Basic science research, including in vitro or animal studies, is discouraged to submit, as we will only review studies on humans with an epidemological or clinical perspective. Case reports without a proper review of the literatura (Case-based Reviews) will not be published. Every effort will be made to ensure speed of publication while maintaining a high standard of contents and production. Manuscripts submitted for publication must contain a statement to the effect that all human studies have been reviewed by the appropriate ethics committee and have therefore been performed in accordance with the ethical standards laid down in an appropriate version of the 1964 Declaration of Helsinki. It should also be stated clearly in the text that all persons gave their informed consent prior to their inclusion in the study. Details that might disclose the identity of the subjects under study should be omitted.
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