Background Radiographic axial spondyloarthritis (r-axSpA), formerly known as ankylosing spondylitis (AS), is a chronic, inflammatory rheumatic disease associated with symptoms such as inflammatory back pain, morning stiffness, and arthritis. First-line recommendations for patients with AS include treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for reducing pain and stiffness. Objectives The objective of our study is to evaluate the efficacy and short-term NSAID-sparing effect of secukinumab in patients with AS currently treated with NSAIDs. Design We assessed the clinical Assessment of SpondyloArthritis International Society (ASAS20) response to secukinumab and evaluated the extent to which the use of concomitant NSAID can be reduced between weeks 4 and 12 in r-axSpA patients treated with secukinumab 150 mg compared with placebo. Methods ASTRUM was a prospective 24-week randomized controlled trial of adult patients with active r-axSpA [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ⩾4] who had a documented inadequate response to ⩾2 NSAIDs. Patients were randomized (1:1:1) to initiate treatment with subcutaneous secukinumab 150 mg from either week 0 (group 1), week 4 (group 2), or week 16 (group 3). From week 4 onward, tapering of NSAIDs was allowed in all groups. Results This study included 211 patients (n = 71, 70, and 70 in groups 1, 2, and 3, respectively). ASAS20 response at week 12 for pooled groups 1 and 2 versus group 3 was 51.1% versus 44.3% (p = 0.35). A higher proportion of patients in groups 1 and 2 achieved ASAS40 and BASDAI50 and showed improvements in other secondary clinical outcomes as compared to group 3 at week 16. More patients in groups 1 and 2 versus group 3 stopped their NSAID intake from baseline through week 16. Conclusion Treatment with secukinumab improved clinical outcomes and showed a short-term NSAID-sparing effect in patients with r-axSpA, even though the primary endpoint was not met. Trial registration ClinicalTrials.gov; NCT02763046, EudraCT 2015-004575-74.

中文翻译：

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苏金单抗 150 mg 在强直性脊柱炎中的功效和 NSAID 节约作用：IV 期 ASTRUM 研究的结果。


背景放射学中轴​​型脊柱关节炎 (r-axSpA)，以前称为强直性脊柱炎 (AS)，是一种慢性炎症性风湿性疾病，与炎症性背痛、晨僵和关节炎等症状相关。对 AS 患者的一线建议包括使用非甾体抗炎药 (NSAID) 治疗以减轻疼痛和僵硬。目的 我们研究的目的是评估苏金单抗对目前接受 NSAID 治疗的 AS 患者的疗效和短期 NSAID 节约效果。设计 我们评估了国际脊椎关节炎协会 (ASAS20) 对苏金单抗反应的临床评估，并评估了与安慰剂相比，接受苏金单抗 150 mg 治疗的 r-axSpA 患者在第 4 周至第 12 周期间可减少联合使用 NSAID 的程度。方法 ASTRUM 是一项为期 24 周的前瞻性随机对照试验，受试者为活动性 r-axSpA [巴斯强直性脊柱炎疾病活动指数 (BASDAI) ⩾4] 成年患者，这些患者已被证明对 ⩾2 NSAID 反应不足。患者被随机分配 (1:1:1)，从第 0 周（第 1 组）、第 4 周（第 2 组）或第 16 周（第 3 组）开始皮下注射苏金单抗 150 mg 治疗。从第 4 周开始，所有组都允许逐渐减少 NSAID 的用量。结果 本研究包括 211 名患者（第 1 组、第 2 组和第 3 组分别有 71 名、70 名和 70 名患者）。第 12 周时，第 1 组和第 2 组与第 3 组的 ASAS20 反应分别为 51.1% 和 44.3% (p = 0.35)。第 16 周时，与第 3 组相比，第 1 组和第 2 组中达到 ASAS40 和 BASDAI50 的患者比例较高，并且在其他次要临床结局方面表现出改善。与第 3 组相比，第 1 组和第 2 组中有更多患者从基线到第 16 周停止了 NSAID 摄入。 结论 尽管未达到主要终点，但苏金单抗治疗可改善 r-axSpA 患者的临床结局，并显示出短期 NSAID 节约效果。试验注册 ClinicalTrials.gov； NCT02763046，EudraCT 2015-004575-74。