Access, Effectiveness, Safety And Survival Of Secukinumab In Patients With Axial Spondyloarthritis And Axial Psoriatic Arthritis: Real-Life Study In Argentina.

María Victoria Martire,Josefina Marin,Hernán Maldonado Ficco,Mariana Benegas,Pamela Giorgis,Diego Vila,Carolina Ayelen Isnardi,María Julieta Gamba,Javier Federico Flores Trejo,Rodolfo Perez-Alamino,Antonio Jorge Chemez,Leandro Ferreyra Garrott,Micaela A Cosatti,Emilio Andrés Buschiazzo,María de Los Angeles Correa,Rodrigo Aguila Maldonado,Brian Manases Roldan,Camila Lizarraga,Maria Agustina Alfaro,Julieta Morbiducci,Lia Valentina Ingolotti,Gisela Pendón,Romina Estefanía Nieto,María Sofía Velloso,Alejandro Martinez Muñoz,Nicolás Lloves Schenone,Natalia V Zamora,Etel Saturansky,Ana Carolina Costi,Maria Jezabel Haye Salinas,Carla Antonela Airoldi,Amelia Granel
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Abstract

OBJECTIVE To describe the access, effectiveness, survival and adverse events (AE) of secukinumab (SEC) in patients with axial spondyloarthritis (axSpA) and axial psoriatic arthritis (axPsA). METHODS A multicentre, observational, retrospective cohort study. Patients ≥18 years with axSpA) and patients with PsA with axial involvement who had received at least one dose of SEC were included. The number of days elapsed between the request for the drug and the first application was calculated. Effectiveness was defined as BASDAI < 4 at six months. Drug survival was analysed using Kaplan-Meier curves and Cox regression analysis. RESULTS One hundred seventeen patients were included, 72 (61.5%) with axPsA and 45 (38.5%) with axSpA. Those having public health insurance presented a longer delay in receiving SEC 90 days (IQR 60-150) vs those with social security (p=0.01) and those with private health coverage (p=0.009). Effectiveness of SEC after 6 months was achieved in 72 (61.5%) patients, 44 (61.5%) patients with axial PsA and 28 (62.2%) patients with axSpA, (p=0.91). The median SEC survival was 48 months (95% CI 32-63). The only factor associated with reduced survival was SEC being given in the third or higher line of treatment (HR 3.43, 95%CI 1.11-11.10, p=0.04). The incidence of AE was 7.9 events per 100 patients/year (CI 95% 5-12). CONCLUSION The delay in receiving SEC was longer in patients with public health insurance. Patients using SEC as third-line or higher therapy had 3.4 times less survival. AE were mild and no AE of interest were observed.
Secukinumab治疗轴性脊柱炎和轴性银屑病关节炎的可及性、有效性、安全性和生存率:阿根廷的现实研究
目的:描述secukinumab (SEC)在轴性脊柱炎(axSpA)和轴性银屑病关节炎(axPsA)患者中的可及性、有效性、生存期和不良事件(AE)。方法采用多中心、观察性、回顾性队列研究。≥18岁的axSpA患者和至少接受过一剂SEC的轴向受累PsA患者被纳入研究。计算药物申请和首次申请之间经过的天数。疗效定义为6个月时BASDAI < 4。采用Kaplan-Meier曲线和Cox回归分析药物生存期。结果共纳入117例患者,其中axPsA组72例(61.5%),axSpA组45例(38.5%)。有公共医疗保险的人比有社会保险的人(p=0.01)和有私人医疗保险的人(p=0.009)在收到SEC 90天(IQR 60-150)的延迟时间更长。72例(61.5%)患者、44例(61.5%)轴向PsA患者和28例(62.2%)axSpA患者在6个月后获得了SEC的有效性,(p=0.91)。中位生存期为48个月(95% CI 32-63)。与生存率降低相关的唯一因素是在第三线或更高的治疗中给予SEC (HR 3.43, 95%CI 1.11-11.10, p=0.04)。AE的发生率为每100例患者/年7.9次(CI 95% 5-12)。结论公共健康保险患者接受SEC的延迟时间较长。使用SEC作为三线或更高级别治疗的患者生存率降低了3.4倍。AE为轻度,未观察到感兴趣的AE。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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