Victoria Navarro-Compán, John D Reveille, Proton Rahman, José A Maldonado-Cocco, Marina Magrey, Rebecca Bolce, Tommaso Panni, Andris Kronbergs, Martin Rudwaleit
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引用次数: 0
Abstract
Introduction: The objective of this study was to assess treatment response to ixekizumab, an interleukin-17A antagonist, by shorter versus longer symptom duration (< 5 years vs. ≥ 5 years) in patients with radiographic axial spondyloarthritis (r-axSpA) and non-radiographic axial spondyloarthritis (nr-axSpA) up to 52 weeks.
Methods: This post hoc analysis used data from three randomized, placebo-controlled trials including patients with r-axSpA from COAST-V [biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve] and COAST-W (tumor necrosis factor inhibitor-experienced) and patients with nr-axSpA from COAST-X (bDMARD-naïve). Patients received ixekizumab (80 mg every 2 or 4 weeks) or placebo through Week 16 and ixekizumab to Week 52. Assessments included the Assessment in SpondyloArthritis international Society 40% improvement (ASAS40) and Axial Spondyloarthritis Disease Activity Score (ASDAS) low disease activity [LDA (< 2.1)] and Bath Ankylosing Spondylitis Disease Activity Index 50% improvement (BASDAI50) response rates through Week 52 and change from baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Week 16.
Results: Fewer patients treated with ixekizumab (pooled dosing) had shorter versus longer symptom duration [n = 33 vs. n = 306 (r-axSpA); n = 73 vs. n = 111 (nr-axSpA)]. Ixekizumab-treated patients with shorter versus longer symptom duration had numerically higher response rates at Week 16/Week 52 for ASAS40 [51.5/60.6 vs. 36.9/40.5 (r-axSpA); 42.5/54.8 vs. 36.0/41.4 (nr-axSpA)], ASDAS LDA [39.4/48.5 vs. 27.5/35.6 (r-axSpA); 32.9/49.3 vs. 27.9/36.9 (nr-axSpA)], and BASDAI50 [42.4/54.5 vs. 31.4/36.6 (r-axSpA); 38.4/49.3 vs. 27.9/34.2 (nr-axSpA)]. However, relative risk ratios at Week 16 did not significantly favor the shorter duration subgroup. Findings were comparable for SF-36 PCS at Week 16. The present findings should be interpreted in the context of small numbers of patients in some shorter duration subgroups.
Conclusion: Ixekizumab was shown to be efficacious in both patients with shorter or longer symptom duration and in r-axSpA or nr-axSpA.
本研究的目的是通过缩短和延长症状持续时间来评估对ixekizumab（一种白细胞介素- 17a拮抗剂）的治疗反应(方法：该事后分析使用了来自三个随机、安慰剂对照试验的数据，包括来自COAST-V[生物疾病改善抗风湿药物(bDMARD)-naïve]和COAST-W（肿瘤坏死因子抑制剂-经验）的r-axSpA患者和来自COAST-X （bDMARD-naïve）的nr-axSpA患者。患者接受ixekizumab（每2或4周80mg）或安慰剂治疗至第16周，ixekizumab至第52周。评估包括国际脊椎关节炎协会评估40%改善（ASAS40）和轴向脊椎关节炎疾病活动评分（ASDAS）低疾病活动[LDA](结果：较少的患者接受ixekizumab（合并剂量）治疗，症状持续时间较短与较长[n = 33 vs. n = 306 (r-axSpA)；n = 73 vs. n = 111 (nr-axSpA)]。ixekizumab治疗的ASAS40患者症状持续时间较短和较长，在第16周/第52周的数值上应答率更高[51.5/60.6比36.9/40.5 (r-axSpA)]；42.5/54.8 vs. 36.0/41.4 (nr-axSpA)], ASDAS LDA [39.4/48.5 vs. 27.5/35.6 (r-axSpA)]；32.9/49.3 vs. 27.9/36.9 (r-axSpA)], BASDAI50 [42.4/54.5 vs. 31.4/36.6 (r-axSpA)]；38.4/49.3 vs. 27.9/34.2 [r- axspa]。然而，第16周的相对风险比并没有显著地偏向于治疗时间较短的亚组。在第16周，sf - 36pcs的研究结果与之相当。目前的研究结果应该在一些持续时间较短的亚组中少数患者的背景下解释。结论：Ixekizumab对症状持续时间较短或较长的患者以及r-axSpA或nr-axSpA均有效。试验注册：ClinicalTrials.gov Identifiers, NCT02696785；NCT02696798;NCT02757352。
期刊介绍：
Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.
The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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