在两项关于肿瘤坏死因子α抑制剂起始治疗和剂量减少的纵向研究中，对轴向型脊柱关节炎患者评估ASAS健康指数的结构效度和反应性。
Construct validity and responsiveness of ASAS Health Index assessed in two longitudinal studies of tumour necrosis factor alpha inhibitor initiation and dose reduction in patients with axial spondyloarthritis.
作者信息
Lorincz Mate, Østergaard Mikkel, Wetterslev Marie, Sørensen Inge Juul, Madsen Ole Rintek, Christiansen Sara Nysom, Hetland Merete Lund, Bakkegaard Mads, Klarlund Mette, Duer Anne, Boesen Mikael, Gosvig Kasper Kjærulf, Pedersen Susanne Juhl
机构信息
Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Copenhagen, Denmark
Department of Clinical Medicine, Faculty of Health and Medical Science, University of Copenhagen, Copenhagen, Denmark.
出版信息
RMD Open. 2024 Dec 20;10(4):e004948. doi: 10.1136/rmdopen-2024-004948.
BACKGROUND
The Assessment of SpondyloArthritis international Society Health Index (ASAS HI) is a novel questionnaire of global functioning for patients with axial spondyloarthritis (SpA).
OBJECTIVE
The objective was to assess the construct validity, discriminatory ability and responsiveness of ASAS HI in relation to patient-reported outcome measures (PROMs), MRI and radiography.
METHODS
Data from two longitudinal studies with tumour necrosis factor inhibitor (TNFi) initiation (novel MRI And biomarkers in Golimumab-treated patients with axial spondyloarthritis (MANGO): n=45) respectively tapering (Dose adjustment of Biological treatment in patients with SpA (DOBIS): n=106) were used. Analyses included a wide panel of PROMs, MRI and radiography scores of the spine and sacroiliac joints (SIJs).
RESULTS
In the MANGO study, 30 (68%) patients were clinical responders at week 16. In the DOBIS study, 105 (99%) patients flared after mean (SD; min-max) 31 (17; 2.7-81) weeks. After initiation of TNF inhibitor in MANGO, ASAS HI significantly decreased from baseline to week 4, 16 and 52. In DOBIS, ASAS significantly increased from baseline to the flare visit and significantly decreased from the flare visit to week 96. In multivariate regression models, ASAS HI was independently associated with Spondyloarthritis Research Consortium of Canada MRI SIJ Inflammation score, Canada-Denmark MRI Spine Inflammation score, EuroQol, Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Disease Activity Index and Patient Global. Patients stratified according to ASAS HI health status groups (good, moderate, poor) at baseline and change categories (absolute and percentage change) from baseline to week 16/flare showed good discriminatory ability for almost all outcome variables (p≤0.001). ASAS HI had a large responsiveness in MANGO (standardised response mean (SRM)=-1.3, effect size (ES)=-1.7) and moderate responsiveness in DOBIS (SRM=0.7, ES=0.6).
CONCLUSION
ASAS HI showed good construct validity, discriminatory ability and responsiveness.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov: NCT02011386.
背景
脊柱关节炎国际协会健康指数（ASAS HI）是一种针对中轴型脊柱关节炎（SpA）患者全球功能的新型问卷。
目的
评估ASAS HI在患者报告结局测量（PROMs）、MRI和X线摄影方面的结构效度、区分能力和反应性。
方法
使用来自两项纵向研究的数据，一项是开始使用肿瘤坏死因子抑制剂（TNFi）（戈利木单抗治疗中轴型脊柱关节炎患者的新型MRI和生物标志物研究（MANGO）：n = 45），另一项是逐渐减量（脊柱关节炎患者生物治疗剂量调整研究（DOBIS）：n = 106）。分析包括一系列广泛的PROMs、脊柱和骶髂关节（SIJ）的MRI和X线摄影评分。
结果
在MANGO研究中，30例（68%）患者在第16周时为临床缓解者。在DOBIS研究中，105例（99%）患者在平均（标准差；最小值 - 最大值）31（17；2.7 - 81）周后病情复发。在MANGO研究中开始使用TNF抑制剂后，ASAS HI从基线到第4周、16周和52周显著下降。在DOBIS研究中，ASAS从基线到病情复发访视时显著增加，从病情复发访视到第96周显著下降。在多变量回归模型中，ASAS HI与加拿大脊柱关节炎研究联盟MRI SIJ炎症评分、加拿大 - 丹麦MRI脊柱炎症评分、欧洲生活质量量表、强直性脊柱炎疾病活动指数、巴斯强直性脊柱炎疾病活动指数和患者整体状况独立相关。根据基线时ASAS HI健康状况分组（良好、中等、差）以及从基线到第16周/病情复发时的变化类别（绝对变化和百分比变化）进行分层的患者，对几乎所有结局变量均显示出良好的区分能力（p≤0.001）。ASAS HI在MANGO研究中有较大反应性（标准化反应均值（SRM）=-1.3，效应大小（ES）=-1.7），在DOBIS研究中有中等反应性（SRM = 0.7，ES = 0.6）。
结论
ASAS HI显示出良好的结构效度区分能力和反应性。
试验注册号
ClinicalTrials.gov：NCT02011386。
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