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Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: ClinicalTrials.gov; NCT02763046, EudraCT 2015-004575-74.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: ClinicalTrials.gov; NCT02763046, EudraCT 2015-004575-74.
摘要：
■影像学轴性脊柱关节炎（r-axSpA），以前称为强直性脊柱炎（AS），是慢性的，与炎症性背痛等症状相关的炎症性风湿性疾病，早晨僵硬，和关节炎。AS患者的一线建议包括使用非甾体抗炎药（NSAIDs）治疗，以减轻疼痛和僵硬。
■我们研究的目的是评估苏金单抗在目前接受NSAIDs治疗的AS患者中的疗效和短期NSAID保护作用。
■我们评估了国际脊柱炎协会（ASAS20）对苏金单抗的临床评估，并评估了与安慰剂相比，150mg苏金单抗治疗的r-axSpA患者在第4周和第12周之间合并使用NSAID的减少程度。
■ASTRUM是一项为期24周的前瞻性随机对照试验，对患有活跃的r-axSpA[巴斯强直性脊柱炎疾病活动指数（BASDAI）4]的成年患者进行了研究，这些患者对2NSAIDs的反应不足。患者从第0周开始随机（1：1：1）开始使用皮下苏金单抗150mg进行治疗（第1组），第4周（第2组），或第16周（第3组）。从第4周开始,所有组均允许NSAIDs逐渐减少。
■这项研究包括211名患者（第1、2和3组分别为n=71、70和70）。合并组1和2对比组3在第12周时的ASAS20应答为51.1%对比44.3%(p=0.35)。与第3组相比，第1组和第2组的患者在第16周时达到ASAS40和BASDAI50并显示其他次要临床结局的改善。与第3组相比，第1组和第2组中更多的患者从基线到第16周停止NSAID摄入。
■苏金单抗治疗可改善r-axSpA患者的临床结局，并显示出短期的NSAID保护作用，即使没有达到主要终点.
■ClinicalTrials.gov；NCT02763046，EudraCT2015-004575-74。
■我们研究的目的是评估苏金单抗在目前接受NSAIDs治疗的AS患者中的疗效和短期NSAID保护作用。
■我们评估了国际脊柱炎协会（ASAS20）对苏金单抗的临床评估，并评估了与安慰剂相比，150mg苏金单抗治疗的r-axSpA患者在第4周和第12周之间合并使用NSAID的减少程度。
■ASTRUM是一项为期24周的前瞻性随机对照试验，对患有活跃的r-axSpA[巴斯强直性脊柱炎疾病活动指数（BASDAI）4]的成年患者进行了研究，这些患者对2NSAIDs的反应不足。患者从第0周开始随机（1：1：1）开始使用皮下苏金单抗150mg进行治疗（第1组），第4周（第2组），或第16周（第3组）。从第4周开始,所有组均允许NSAIDs逐渐减少。
■这项研究包括211名患者（第1、2和3组分别为n=71、70和70）。合并组1和2对比组3在第12周时的ASAS20应答为51.1%对比44.3%(p=0.35)。与第3组相比，第1组和第2组的患者在第16周时达到ASAS40和BASDAI50并显示其他次要临床结局的改善。与第3组相比，第1组和第2组中更多的患者从基线到第16周停止NSAID摄入。
■苏金单抗治疗可改善r-axSpA患者的临床结局，并显示出短期的NSAID保护作用，即使没有达到主要终点.
■ClinicalTrials.gov；NCT02763046，EudraCT2015-004575-74。
