Klavdianou Kalliopi, Lazarini Argyro, Grivas Alexandros, Tseronis Dimitrios, Tsalapaki Christina, Rapsomaniki Panagiota, Antonatou Katerina, Thomas Konstantinos, Boumpas Dimitrios, Katsimbri Pelagia, Vassilopoulos Dimitrios
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.
Front Med (Lausanne). 2020 Jun 19;7:288. doi: 10.3389/fmed.2020.00288. eCollection 2020.
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.
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。