van der Heijde Désirée, Østergaard Mikkel, Reveille John D, Baraliakos Xenofon, Kronbergs Andris, Sandoval David M, Li Xiaoqi, Carlier Hilde, Adams David H, Maksymowych Walter P
D. van der Heijde, MD, Department of Rheumatology, Leiden University Medical Centre, Leiden, the Netherlands;
M. Østergaard, MD, Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, and Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
J Rheumatol. 2022 Mar;49(3):265-273. doi: 10.3899/jrheum.210471. Epub 2021 Dec 1.
To evaluate the long-term effect of ixekizumab (IXE) on radiographic changes in the spine in patients with radiographic axial spondyloarthritis (r-axSpA) by measuring change from baseline through 2 years in modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS), and to identify potential predictors of progression.
This study evaluates patients from COAST-V (ClinicalTrials.gov: NCT02696785, biologic disease-modifying antirheumatic drug-naïve) and COAST-W (NCT02696798, tumor necrosis factor inhibitor-experienced) who had mSASSS data at baseline in the originating studies and 108 weeks after baseline in the extension study COAST-Y (NCT03129100). We examined the proportion of patients who did not have spinal radiographic progression through 2 years (108 weeks) of treatment with IXE (80 mg every 2 or 4 weeks) and the change from baseline to year 2 in mSASSS. Potential predictors of spinal radiographic progression were also evaluated.
Among patients with evaluable radiographs who were originally assigned to IXE (n = 230), mean (SD) change in mSASSS from baseline at year 2 was 0.3 (1.8). The proportion of nonprogressors over 2 years was 89.6% if defined as mSASSS change from baseline < 2 and 75.7% if defined as mSASSS change from baseline ≤ 0. Predictors of structural progression at year 2 (mSASSS change > 0) were age ≥ 40, baseline syndesmophytes, HLA-B27 positivity, and male sex. Week 52 inflammation in Spondyloarthritis Research Consortium of Canada spine was also a predictor of radiographic progression at year 2 in patients with magnetic resonance imaging data in COAST-V (n = 109).
The majority of patients with r-axSpA receiving IXE had no radiographic progression in the spine through 2 years of treatment. Predictors were generally consistent with previous studies.
通过测量改良斯托克强直性脊柱炎脊柱评分（mSASSS）从基线至2年的变化，评估司库奇尤单抗（IXE）对放射学轴性脊柱关节炎（r-axSpA）患者脊柱放射学改变的长期影响，并确定疾病进展的潜在预测因素。
本研究评估了来自COAST-V（ClinicalTrials.gov：NCT02696785，未使用过生物改善病情抗风湿药物）和COAST-W（NCT02696798，有肿瘤坏死因子抑制剂使用经验）的患者，这些患者在初始研究中有基线mSASSS数据，并在扩展研究COAST-Y（NCT03129100）中基线后108周有相关数据。我们检查了接受IXE（每2或4周80mg）治疗2年（108周）后无脊柱放射学进展的患者比例，以及mSASSS从基线至第2年的变化。还评估了脊柱放射学进展的潜在预测因素。
在最初分配接受IXE治疗的可评估X线片的患者中（n = 230），第2年mSASSS相对于基线的平均（标准差）变化为0.3（1.8）。如果将无进展定义为mSASSS相对于基线变化<2，则2年无进展者的比例为89.6%；如果定义为mSASSS相对于基线变化≤0，则为75.7%。第2年结构进展（mSASSS变化>0）的预测因素为年龄≥40岁、基线骨桥、HLA-B27阳性和男性。在COAST-V中有磁共振成像数据的患者（n = 109）中，加拿大脊柱关节炎研究联盟脊柱第52周的炎症也是第2年放射学进展的预测因素。
大多数接受IXE治疗的r-axSpA患者在2年治疗期间脊柱无放射学进展。预测因素与先前研究基本一致。
