Efficacy of upadacitinib in subgroups of patients with axial spondyloarthritis with early versus established disease.

IF 5.1 2区医学 Q1 RHEUMATOLOGY

RMD Open Pub Date : 2025-03-04 DOI:10.1136/rmdopen-2024-005110

Victoria Navarro-Compán, Filip Van den Bosch, Percival Degrava Sampaio-Barros, Andrew J K Östör, Bhumik Parikh, Koji Kato, Tianming Gao, Jayne Stigler, Sofia Ramiro

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引用次数: 0

Abstract

Objectives: Early disease activity control with targeted therapies may improve long-term outcomes in axial spondyloarthritis (axSpA). Here, we evaluated the efficacy of upadacitinib in patients with axSpA with shorter versus longer symptom durations.

Methods: SELECT-AXIS 1 and 2 studies enrolled patients with radiographic axSpA (r-axSpA) and non-radiographic axSpA (nr-axSpA) naïve to biologic disease-modifying antirheumatic drugs (bDMARD-naïve) and with an intolerance or inadequate response to bDMARD therapy. Patients were stratified by symptom duration (nr-axSpA: early vs established (≤2 vs >2 years=Assessment of SpondyloArthritis international Society (ASAS) definition) and shorter vs longer (≤5 vs >5 years); r-axSpA: ≤5 vs >5 years). Efficacy endpoints assessed through week 14 included the proportion of patients achieving Axial Spondyloarthritis Disease Activity Score and ASAS40 responses, among others. Across all endpoints, the efficacy of upadacitinib versus placebo was assessed by relative risk (RR), and the placebo-adjusted effect of upadacitinib between shorter versus longer symptom duration was assessed by the RR ratio.

Results: At week 14, better responses were observed in patients treated with upadacitinib in all endpoints assessed compared with placebo, regardless of symptom duration. When comparing patients with early/shorter versus established/longer symptom durations, for all measures assessed, no statistically significant differences were observed except for the change from baseline in high-sensitivity C-reactive protein in the nr-axSpA group, with a better response in early disease (difference -8.2, 95% CI -14.9 to -1.6).

Conclusion: Regarding short-term outcomes, both subgroups of patients (shorter axSpA symptom duration (≤2 years) and longer symptom duration (>2 years)) achieved comparable results when treated with upadacitinib.

Trial registration number: NCT03178487 (SELECT-AXIS 1) and NCT04169373 (SELECT-AXIS 2).

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upadacitinib在早期与已建立疾病的轴性脊柱炎患者亚组中的疗效

目的：早期疾病活动控制与靶向治疗可能改善轴性脊柱炎（axSpA）的长期预后。在这里，我们评估了upadacitinib在症状持续时间较短和较长axSpA患者中的疗效。方法：SELECT-AXIS 1和2研究纳入了对生物缓解疾病抗风湿药物（bDMARD-naïve）有放射学axSpA （r-axSpA）和非放射学axSpA (nr-axSpA) naïve且对bDMARD治疗不耐受或反应不充分的患者。根据症状持续时间对患者进行分层（nr-axSpA：早期vs已建立（≤2 vs >2年=国际脊椎关节炎协会（ASAS）定义评估））和较短vs较长（≤5 vs >5年）；r-axSpA:≤5 vs >5年)。通过第14周评估的疗效终点包括达到轴性脊柱炎疾病活动评分和ASAS40反应的患者比例等。在所有终点，upadacitinib与安慰剂的疗效通过相对风险（RR）进行评估，upadacitinib在较短和较长症状持续时间之间的安慰剂调整效果通过RR比率进行评估。结果：在第14周，与安慰剂相比，upadacitinib治疗的患者在所有终点均观察到更好的反应，无论症状持续时间如何。当比较早期/较短症状持续时间与建立/较长症状持续时间的患者时，对于所有评估的措施，除了nr-axSpA组的高敏c反应蛋白从基线变化外，没有观察到统计学上的显着差异，在早期疾病中有更好的反应（差异-8.2,95% CI -14.9至-1.6）。结论：在短期结局方面，两个亚组患者(axSpA症状持续时间较短（≤2年）和症状持续时间较长（>2年）在upadacitinib治疗后取得了相当的结果。试验注册号：NCT03178487 （SELECT-AXIS 1）和NCT04169373 （SELECT-AXIS 2）。

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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来源期刊

RMD Open RHEUMATOLOGY-

CiteScore

7.30

自引率

6.50%

发文量

205

审稿时长

14 weeks

期刊介绍： RMD Open publishes high quality peer-reviewed original research covering the full spectrum of musculoskeletal disorders, rheumatism and connective tissue diseases, including osteoporosis, spine and rehabilitation. Clinical and epidemiological research, basic and translational medicine, interesting clinical cases, and smaller studies that add to the literature are all considered.