r-axSpA

  • 文章类型: Journal Article
    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。
    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.
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  • 文章类型: Journal Article
    近几十年来,轴性脊柱关节炎(AxSpA)的诊断和治疗取得了重大进展。对该疾病的免疫发病机制的更深入了解为靶向治疗的发展铺平了道路。其疗效已在随机对照试验中得到证实,荟萃分析和一项生物DMARDs的头对头研究。AxSpA的治疗决策目前受患者选择的影响,合并症,临床医生熟悉度和成本。
    我们回顾了支持AxSpA治疗证据基础的临床试验。我们还涵盖旨在支持临床医生个性化治疗决策的荟萃分析和头对头数据。Further,我们讨论了最近的国际指南,这些指南为临床医生提供了治疗途径和指导.
    我们得出的结论是,管理放射学和非放射学AxSpA的治疗决策应基于与患者的共同决策,药物类的临床有效性,合并症和成本。目前,我们有有限的头对头的数据,以优先考虑一个药物类别比另一个一线治疗,但可以推荐肿瘤坏死因子(TNF),白细胞介素17(IL17)和JAK抑制在临床上具有可比性,结构和患者报告的结果测量。进一步的真实世界数据可以指导个体患者的治疗决策。
    UNASSIGNED: Significant progress has been made in the diagnosis and management of axial spondyloarthritis (AxSpA) over recent decades. A greater understanding of the immunopathogenesis of the disease has paved the way for the development of targeted treatments. Their efficacy has been demonstrated in randomized controlled trials, meta-analyses and one head-to-head study of biologic DMARDs. Treatment decisions in AxSpA are currently influenced by patient choice, co-morbidity, clinician familiarity and cost.
    UNASSIGNED: We review the clinical trials that underpin the evidence base for treatments in AxSpA. We also cover the meta-analyses and head-to-head data that seek to support clinicians in personalizing treatment decisions. Further, we discuss the recent international guidelines that provide clinicians with treatment pathways and guidance.
    UNASSIGNED: We conclude that treatment decisions in managing both radiographic and non-radiographic AxSpA should be based on shared decision-making with patients, the clinical effectiveness of drug class, co-morbidity and cost. At present, we have limited head-to-head data to prioritize one drug class over another for first-line treatment but can recommend tumor necrosis factor (TNF), interleukin 17 (IL17) and JAK inhibition as being comparable in terms of clinical, structural and patient-reported outcome measures. Further real-world data may guide treatment decision-making in individual patients.
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  • 文章类型: Journal Article
    目的:为了比较每4周160mg比马单抗的疗效和安全性,白细胞介素-17F和17A的选择性抑制剂,使用生物/靶向合成的改善疾病的抗风湿药(b/tsDMARDs)治疗非影像学轴性脊柱关节炎(nr-axSpA)和强直性脊柱炎(AS)。
    方法:系统文献综述确定了截至2023年1月的随机对照试验纳入贝叶斯网络荟萃分析(NMA),包括三个b/tsDMARD暴露网络:主要是天真的,天真,并且经验丰富。结果包括12-16周时的脊柱关节炎国际学会(ASAS)20,ASAS40和ASAS部分缓解(PR)反应率评估。安全性NMA调查了在12-16周时因任何原因和严重不良事件而停药。
    结果:NMA包括36项试验。主要是天真的网络提供了最全面的结果。在主要是天真的nr-axSpA分析中,bimekizumab的ASAS20反应率明显高于苏金单抗150mg(有负荷剂量[LD]/无LD),和可比的反应率与其他主动比较。在主要是天真的AS分析中,bimekizumab的ASAS40反应率明显高于苏金单抗150mg(不含LD),与苏金单抗150mg(使用LD)相比,ASAS-PR反应率显着提高,和可比的反应率与其他主动比较。Bimekizumab表现出与其他b/tsDMARD相似的安全性。
    结论:所有ASAS结果,bimekizumab与大多数b/tsDMARD相当,包括ixekizumab,TNF抑制剂和upadacitinib,在主要为b/tsDMARD-nr-axSpA和AS患者中,在12-16周时,某些ASAS结局与苏金单抗相比获得了更高的缓解率。在合并的axSpA网络中,bimekizumab与其他b/tsDMARD的安全性相当。
    OBJECTIVE: To compare the efficacy and safety of bimekizumab 160 mg every 4 weeks, a selective inhibitor of IL-17F and IL-17A, with those of biologic/targeted synthetic DMARDs (b/tsDMARDs) in non-radiographic axial SpA (nr-axSpA) and AS.
    METHODS: A systematic literature review identified randomized controlled trials until January 2023 for inclusion in Bayesian network meta-analyses (NMAs), including three b/tsDMARDs exposure networks: predominantly-naïve, naïve, and experienced. Outcomes were Assessment of SpondyloArthritis international Society (ASAS)20, ASAS40 and ASAS partial remission (PR) response rates at 12-16 weeks. A safety NMA investigated discontinuations due to any reason and serious adverse events at 12-16 weeks.
    RESULTS: The NMA included 36 trials. The predominantly-naïve network provided the most comprehensive results. In the predominantly-naïve nr-axSpA analysis, bimekizumab had significantly higher ASAS20 response rates vs secukinumab 150 mg [with loading dose (LD)/without LD], and comparable response rates vs other active comparators. In the predominantly-naïve AS analysis, bimekizumab had significantly higher ASAS40 response rates vs secukinumab 150 mg (without LD), significantly higher ASAS-PR response rates vs secukinumab 150 mg (with LD) and comparable response rates vs other active comparators. Bimekizumab demonstrated similar safety to that of other b/tsDMARDs.
    CONCLUSIONS: Across ASAS outcomes, bimekizumab was comparable with most b/tsDMARDs, including ixekizumab, TNF inhibitors and upadacitinib, and achieved higher response rates vs secukinumab for some ASAS outcomes in predominantly b/tsDMARD-naïve nr-axSpA and AS patients at 12-16 weeks. In a pooled axSpA network, bimekizumab demonstrated comparable safety vs other b/tsDMARDs.
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  • 文章类型: Journal Article
    目的探讨中止第一种TNF抑制剂(TNFi)的原因是否影响轴性脊柱关节炎(axSpA)对第二种TNFi的反应。
    来自风湿病葡萄牙注册(ReumaPt)的axSpA患者,包括在2008年6月至2018年5月期间终止其第一个TNFi并开始第二个TNFi的人.通过强直性脊柱炎疾病活动评分(ASDAS)临床重要改善(ASDAS-CII)评估反应,重大重要改进(ASDAS-MI),低疾病活动度(ASDAS-LDA),和非活动性疾病(ASDAS-ID)。定义了终止第一个TNFi的原因,根据ASDAS-CII作为主要故障(无反应≤6个月),二次失败(反应≤6个月,但此后丢失),不良事件,和其他人。在多变量广义方程(GEE)模型中评估了终止第一TNFi的原因与随时间对第二TNFi的反应之间的关联。
    总共,193名患者被包括在内。停止第一个TNFi的原因并不影响对第二个TNFi的反应,根据ASDAS-CII。然而,在更严格的结果中发现了差异,例如,对于因继发性失败而终止第一次TNFi的患者,使用第二次TNFi实现ASDAS-ID的可能性更高(OR7.3[95CI1.9;27.7]),不良事件(OR9.1[2.5;33.3]),或其他原因(OR7.7[1.6;37.9])与主要故障相比。
    axSpA首次TNFi继发衰竭的患者,与那些主要失败的人相比,根据严格的结果,对第二次TNFi有更好的反应。
    To investigate whether the reason to discontinue the first TNF inhibitor (TNFi) affects the response to the second TNFi in axial spondyloarthritis (axSpA).
    Patients with axSpA from the Rheumatic Diseases Portuguese Register (ReumaPt), who discontinued their first TNFi and started the second TNFi between June 2008 and May 2018, were included. Response was assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS) clinically important improvement (ASDAS-CII), major important improvement (ASDAS-MI), low disease activity (ASDAS-LDA), and inactive disease (ASDAS-ID). The reason for discontinuation of the first TNFi was defined, according to ASDAS-CII as primary failure (no response ≤ 6 months), secondary failure (response ≤ 6 months but lost thereafter), adverse events, and others. The association between the reason for discontinuation of the first TNFi and response to the second TNFi over time was assessed in multivariable generalized equation (GEE) models.
    In total, 193 patients were included. The reason for discontinuation of the first TNFi did not influence the response to the second TNFi, according to the ASDAS-CII. However, a difference was found with more stringent outcomes, e.g., there was a higher likelihood to achieve ASDAS-ID with the second TNFi for patients discontinuing the first TNFi due to secondary failure (OR 7.3 [95%CI 1.9; 27.7]), adverse events (OR 9.1 [2.5; 33.3]), or other reasons (OR 7.7 [1.6; 37.9]) compared to primary failure.
    Patients with axSpA with secondary failure to their first TNFi, compared to those with primary failure, have a better response to the second TNFi according to stringent outcomes.
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