Multicenter Study of Secukinumab Uptitration in Axial Spondyloarthritis: Real-World Evidence.

Dalifer Freites Núñez,Adela Gallego,Alicia García Dorta,Andrea García-Valle,Marta Valero Expósito,Isabel De la Morena Barrio,Celia Arconada,Cristina Valero,Manuel Fernández-Prada,Marta López I Gómez,Antonio Álvarez de Cienfuegos,Rubén López-Sánchez,Álvaro García Martos
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Abstract

OBJECTIVE To evaluate the real-world effectiveness, treatment retention, and safety of secukinumab (SEC) uptitration to 300 mg in patients with axial spondyloarthritis (axSpA), including radiographic (r-axSpA) and nonradiographic (nr-axSpA) subtypes, with active disease despite receiving SEC 150 mg every 4 weeks. METHODS This multicenter, retrospective study included patients with axSpA who had received SEC 150 mg for ≥ 3 months and had active disease (Axial Spondyloarthritis Disease Activity Score [ASDAS] ≥ 2.1) at the time of dose escalation. Patients were followed for up to 24 months after escalation. Effectiveness was assessed through changes in ASDAS over time. Treatment retention was analyzed using Kaplan-Meier curves, with factors associated with discontinuation explored by Cox regression. Safety outcomes were reported as incidence of adverse events (AEs). RESULTS Among 106 patients (77 r-axSpA, 29 nr-axSpA), ASDAS significantly declined within 6 months and was sustained through 24 months. Median ASDAS decreased from 4.1 to 2.0 in patients with r-axSpA and from 4.1 to 2.0 in those with nr-axSpA. Overall, 85.9% of patients achieved ASDAS ≤ 2.1 at least once after escalation. Retention of SEC 300 mg was 87.8% at 6 months and 59.1% at 24 months, with no significant difference between subtypes (log-rank P = 0.48). HLA-B27 positivity showed a nonsignificant trend toward higher discontinuation risk. AE incidence was 15.79 per 100 patient-years, and AEs were mostly mild infections and cutaneous reactions. No new safety signals were identified. CONCLUSION SEC uptitration to 300 mg was associated with sustained improvements in disease activity and favorable retention and safety in axSpA patients with active disease after receiving SEC 150 mg, supporting dose escalation as a clinically effective and safe strategy.
轴型脊柱炎中Secukinumab提升的多中心研究:真实世界证据
目的:评估将secukinumab (SEC)提升至300 mg治疗轴性脊柱炎(axSpA)患者的实际疗效、治疗保持性和安全性,包括放射学(r-axSpA)和非放射学(nr-axSpA)亚型,尽管每4周接受150 mg SEC治疗,但仍有活动性疾病。方法:这项多中心、回顾性研究纳入了接受SEC 150 mg≥3个月且在剂量增加时存在活动性疾病(轴性脊柱炎疾病活动性评分[ASDAS]≥2.1)的axSpA患者。患者在病情升级后随访长达24个月。通过ASDAS随时间的变化来评估有效性。使用Kaplan-Meier曲线分析治疗保留情况,并使用Cox回归分析与停药相关的因素。安全性结果以不良事件(ae)发生率报告。结果106例患者(r-axSpA 77例,nr-axSpA 29例),ASDAS在6个月内显著下降,并持续24个月。r-axSpA患者的中位ASDAS从4.1降至2.0,nr-axSpA患者的中位ASDAS从4.1降至2.0。总体而言,85.9%的患者在升级后至少一次达到ASDAS≤2.1。SEC 300 mg的保留率在6个月时为87.8%,在24个月时为59.1%,亚型间无显著差异(log-rank P = 0.48)。HLA-B27阳性患者停药风险升高的趋势不显著。AE的发生率为15.79 / 100患者年,AE多为轻度感染和皮肤反应。没有发现新的安全信号。结论:在接受SEC 150 mg的axSpA活动性疾病患者中,SEC增加至300 mg与疾病活动性的持续改善、良好的保留和安全性相关,支持剂量增加作为临床有效和安全的策略。
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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