Performance of cut-offs of the ASAS Health Index to discriminate between treatment groups in patients with axial spondyloarthritis in the TICOSPA trial

IF 4.6 2区医学 Q1 RHEUMATOLOGY

Seminars in arthritis and rheumatism Pub Date : 2024-08-30 DOI:10.1016/j.semarthrit.2024.152542

U Kiltz , A Molto , C Lopez-Medina , M Dougados , D van der Heijde , A Boonen , F Van den Bosch , J Braun

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引用次数: 0

Abstract

Objective

To test trial and longitudinal known group discrimination of thresholds of meaning for improvement and health states of the ASAS Health Index (ASAS HI) in patients with active axSpA treated in a randomized study.

Methods

Data from baseline and week 48 from the tight-controlled, treat-to-target trial TICOSPA study were used. The performance of different thresholds to assess change or health states of the ASAS HI were evaluated between arms and against changes in patients’ relevant outcomes and various external responder criteria. Analyses were performed by comparing the mean values t-tests or proportion of responders of continuous and dichotomous external criteria respectively. Trial discrimination of the ASAS HI thresholds were assessed by odds ratios and Phi coefficient in a large number of potential ASAS HI thresholds. Differences in health states in relevant external outcomes between ASAS HI responders and non-responders was assessed by comparing the best performing improvement and state thresholds by using t-tests and chi-square, as appropriate. Missing data on outcomes was handled by non-responder imputation (NRI).

Results

All 160 patients had available ASAS HI data. Trial discrimination was larger for absolute ASAS HI change of ≥2.0, ≥2.5, and ≥3.0 points followed by ASAS HI 20 % improvement. Odds ratio ranged between 1.27 and 1.75 for absolute and between 1.0 and 1.64 for relative improvement outcomes. Longitudinal discrimination of ASAS HI improvement ≥30 % or ≥ 3.0 points had a larger reduction in patient global and disease activity and reached more often remission compared to patients with no significant improvement in global functioning. Patients who achieved ASAS HI ≤ 5.0 compared with patients who did not achieve such states were more likely to have ASAS partial remission, ASDAS inactive disease or ASDAS low activity at week 48.

Conclusions

The data-driven thresholds of the ASAS HI identified in a longitudinal observational setting perform well in the context of a randomized trial.

查看原文本刊更多论文

在 TICOSPA 试验中，ASAS 健康指数临界值在区分轴性脊柱关节炎患者治疗组方面的表现。

目的测试随机研究中接受治疗的活动性轴索硬化症患者的ASAS健康指数（ASAS Health Index，ASAS HI）改善意义阈值和健康状态的试验和纵向已知组别判别：方法：采用严格对照、目标治疗试验 TICOSPA 研究的基线和第 48 周数据。根据患者相关结果的变化和各种外部应答者标准，评估了各组间评估 ASAS HI 变化或健康状态的不同阈值的性能。分析方法是分别比较连续和二分外部标准的平均值 t 检验或应答者比例。在大量潜在的 ASAS HI 临界值中，通过几率比和 Phi 系数评估 ASAS HI 临界值的试验区分度。ASAS HI应答者和未应答者在相关外部结果中的健康状态差异通过比较表现最佳的改善和状态阈值进行评估，根据情况使用t检验和秩和检验。结果缺失数据由非应答者估算（NRI）处理：所有 160 名患者都有 ASAS HI 数据。ASAS HI绝对值变化≥2.0、≥2.5和≥3.0分，然后ASAS HI改善20%，试验区分度较大。绝对改善结果的比值比介于 1.27 和 1.75 之间，相对改善结果的比值比介于 1.0 和 1.64 之间。与整体功能无明显改善的患者相比，ASAS HI改善≥30%或≥3.0分的纵向分辨患者的整体功能和疾病活动度下降幅度更大，更常达到缓解。与未达到这种状态的患者相比，达到ASAS HI≤5.0的患者在第48周时更有可能出现ASAS部分缓解、ASDAS非活动性疾病或ASDAS低活动性：在纵向观察中确定的 ASAS HI 数据驱动阈值在随机试验中表现良好。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Seminars in arthritis and rheumatism 医学-风湿病学

CiteScore

9.20

自引率

4.00%

发文量

176

审稿时长

46 days

期刊介绍： Seminars in Arthritis and Rheumatism provides access to the highest-quality clinical, therapeutic and translational research about arthritis, rheumatology and musculoskeletal disorders that affect the joints and connective tissue. Each bimonthly issue includes articles giving you the latest diagnostic criteria, consensus statements, systematic reviews and meta-analyses as well as clinical and translational research studies. Read this journal for the latest groundbreaking research and to gain insights from scientists and clinicians on the management and treatment of musculoskeletal and autoimmune rheumatologic diseases. The journal is of interest to rheumatologists, orthopedic surgeons, internal medicine physicians, immunologists and specialists in bone and mineral metabolism.