Navarro-Compán Victoria, Reveille John D, Rahman Proton, Maldonado-Cocco José A, Magrey Marina, Bolce Rebecca, Panni Tommaso, Kronbergs Andris, Rudwaleit Martin
Department of Rheumatology, La Paz University Hospital, IdiPaz, Paseo de La Castellana, 261, 28046, Madrid, Spain.
Division of Rheumatology and Clinical Immunogenetics, University of Texas-McGovern Medical School, Houston, TX, USA.
Adv Ther. 2025 Jul 22. doi: 10.1007/s12325-025-03305-5.
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.
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.
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.
Ixekizumab was shown to be efficacious in both patients with shorter or longer symptom duration and in r-axSpA or nr-axSpA.
ClinicalTrials.gov Identifiers, NCT02696785; NCT02696798; NCT02757352.
本研究的目的是评估在长达52周的时间里，对于有影像学轴向脊柱关节炎（r-axSpA）和非影像学轴向脊柱关节炎（nr-axSpA）患者，症状持续时间较短（<5年）与较长（≥5年）的情况下，使用白细胞介素-17A拮抗剂司库奇尤单抗的治疗反应。
这项事后分析使用了来自三项随机、安慰剂对照试验的数据，包括来自COAST-V（初治生物改善病情抗风湿药[bDMARD]）和COAST-W（有肿瘤坏死因子抑制剂治疗史）的r-axSpA患者，以及来自COAST-X（初治bDMARD）的nr-axSpA患者。患者在第16周前接受司库奇尤单抗（每2或4周80mg）或安慰剂治疗，之后接受司库奇尤单抗治疗至第52周。评估包括脊柱关节炎国际协会40%改善（ASAS40）、轴向脊柱关节炎疾病活动评分（ASDAS）低疾病活动度[LDA（<2.1）]和巴斯强直性脊柱炎疾病活动指数50%改善（BASDAI50）在第52周时的反应率，以及第16周时36项简明健康调查（SF-36）身体成分总结（PCS）相对于基线的变化。
接受司库奇尤单抗（合并给药）治疗的症状持续时间较短的患者比症状持续时间较长的患者更少[r-axSpA组：n = 33 vs. n = 306；nr-axSpA组：n = 73 vs. n = 111]。症状持续时间较短与较长的接受司库奇尤单抗治疗的患者在第16周/第52周时，ASAS40的反应率在数值上更高[r-axSpA组：51.5/60.6 vs. 36.9/40.5；nr-axSpA组：42.5/54.8 vs. 36.0/41.4]，ASDAS LDA的反应率[r-axSpA组：39.4/48.5 vs. 27.5/35.6；nr-axSpA组：32.9/49.3 vs. 27.9/36.9]，以及BASDAI50的反应率[r-axSpA组：42.4/54.5 vs. 31.4/36.6；nr-axSpA组：38.4/49.3 vs. 27.9/34.2]。然而，第16周时的相对风险比并不显著有利于症状持续时间较短的亚组。第16周时SF-36 PCS的结果类似。本研究结果应在一些症状持续时间较短的亚组患者数量较少的背景下进行解读。
司库奇尤单抗在症状持续时间较短或较长的患者以及r-axSpA或nr-axSpA患者中均显示出疗效。
ClinicalTrials.gov标识符，NCT02696785；NCT02696798；NCT02757352。
