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司库奇尤单抗在有生物制剂使用经验的银屑病关节炎患者中的真实疗效和安全性

Real Life Efficacy and Safety of Secukinumab in Biologic-Experienced Patients With Psoriatic Arthritis.

作者信息

Klavdianou Kalliopi, Lazarini Argyro, Grivas Alexandros, Tseronis Dimitrios, Tsalapaki Christina, Rapsomaniki Panagiota, Antonatou Katerina, Thomas Konstantinos, Boumpas Dimitrios, Katsimbri Pelagia, Vassilopoulos Dimitrios

机构信息

Clinical Immunology-Rheumatology Unit, 2nd Department of Medicine and Laboratory, Hippokration General Hospital, Athens, Greece.

Clinical Immunology-Rheumatology Unit, 4th Department of Medicine, School of Medicine, Attikon University Hospital, National and Kapodistrian University of Athens, Athens, Greece.

出版信息

Front Med (Lausanne). 2020 Jun 19;7:288. doi: 10.3389/fmed.2020.00288. eCollection 2020.

Abstract

Real world evidence data regarding secukinumab (SEC) use in biologic-experienced patients with psoriatic arthritis (PsA) are scarce. To assess the real life survival, safety and efficacy of SEC in biologic-experienced patients with PsA. All biologic-experienced PsA patients treated with SEC in 2 University Rheumatology Units were included (3/2016-12/2018). Patients' and disease characteristics were recorded at baseline and during SEC therapy. 75 patients were included; 76% were females with a mean age of 53.9 years, median disease duration of 6.7 years and median SEC treatment duration of 11.1 months. At baseline, 97% had peripheral arthritis, 42% axial involvement, 22% enthesitis, and 12% dactylitis. Regarding previous biologic exposure, 48 (64%) had been exposed to anti-tumor necrosis factor (TNF) agents only, 5 (7%) to the interleukin (IL)-12/23 inhibitor (Ustekinumab-UST) only while 22 (29%) both to anti-TNFs and UST. Fifty-three percent received SEC in combination with non-biologics and 35% with glucocorticoids, respectively. During follow-up, statistically significant improvement in different disease activity indices were noted (DAS28-CRP, DAPSA, BASDAI). SEC survival rate at the end of follow-up was 64% (48/75), without difference between patients exposed to anti-TNFs only (67%) vs. anti-TNFs and UST (68%) as well as to 1 vs. ≥2 anti-TNFs. The rate of serious adverse events and serious infections during follow-up was 4.8 and 1.2/100 patient-years, respectively. In real life, in biologic-experienced patients with PsA, SEC displayed a high retention rate, regardless of the type, and number of previous biologics (anti-TNFs ± anti-IL12/23), without significant side effects.

摘要

关于在有生物制剂使用经验的银屑病关节炎(PsA)患者中使用司库奇尤单抗(SEC)的真实世界证据数据稀缺。为了评估SEC在有生物制剂使用经验的PsA患者中的实际生存情况、安全性和疗效。纳入了2个大学风湿病科单位中所有接受SEC治疗的有生物制剂使用经验的PsA患者(2016年3月至2018年12月)。在基线和SEC治疗期间记录患者和疾病特征。共纳入75例患者;76%为女性,平均年龄53.9岁,疾病中位病程6.7年,SEC治疗中位时长11.1个月。基线时,97%有外周关节炎,42%有轴向受累,22%有附着点炎,12%有指(趾)炎。关于既往生物制剂暴露情况,48例(64%)仅暴露于抗肿瘤坏死因子(TNF)药物,5例(7%)仅暴露于白细胞介素(IL)-12/23抑制剂(优特克单抗-UST),而22例(29%)既暴露于抗TNF药物又暴露于UST。分别有53%和35%的患者接受SEC联合非生物制剂和糖皮质激素治疗。在随访期间,不同疾病活动指标有统计学意义的改善(DAS28-CRP、DAPSA、BASDAI)。随访结束时SEC的生存率为64%(48/75),仅暴露于抗TNF药物的患者(67%)与暴露于抗TNF药物和UST的患者(68%)之间以及暴露于1种与≥2种抗TNF药物的患者之间无差异。随访期间严重不良事件和严重感染的发生率分别为4.8和1.2/100患者年。在现实生活中,在有生物制剂使用经验的PsA患者中,无论既往生物制剂的类型和数量(抗TNF药物±抗IL12/23)如何,SEC均显示出高保留率,且无明显副作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f81c/7317305/cd9186acdb9f/fmed-07-00288-g0001.jpg

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