METHODS: Data from two Phase 3 trials in adults with nr-axSpA (BE MOBILE 1; N = 254) and r-axSpA (BE MOBILE 2; N = 332) were analyzed pooled and separately to assess the psychometric properties of the FACIT-Fatigue. MWPC and meaningful between-group difference estimates were derived using anchor-based and distribution-based methods. Cross-sectional fatigue severity bands were estimated using logistic regression analysis.
RESULTS: The FACIT-Fatigue presented good internal consistency, adequate convergent and known-groups validity, and was sensitive to change over time across the full axSpA spectrum. A 5-11-point increase in FACIT-Fatigue score was estimated to represent a MWPC, with an 8-point increase selected as the responder definition. A 2.14-5.34-point difference in FACIT-Fatigue score change over a 16-week period was estimated to represent a small-to-medium meaningful between-group difference. FACIT-Fatigue score severity bands were defined as: none or minimal (>40), mild (>30 to ≤40), moderate (>21 to ≤30), and severe (≤21).
CONCLUSIONS: These findings support the use of the FACIT-Fatigue as a fit-for-purpose measure to assess fatigue-related treatment benefit in axSpA clinical trials. The proposed score estimates and thresholds can guide FACIT-Fatigue score interpretation across the full axSpA spectrum.
BACKGROUND: ClinicalTrials.Gov, NCT03928704. Registered 26 April 2019-Retrospectively registered, https://classic.
RESULTS: gov/ct2/show/NCT03928704 .
RESULTS: Gov, NCT03928743. Registered 26 April 2019-Retrospectively registered, https://classic.
RESULTS: gov/ct2/show/NCT03928743 .
方法:对两项针对nr-axSpA(BEMOBILE1;N=254)和r-axSpA(BEMOBILE2;N=332)成人的3期试验数据进行汇总分析,并分别评估FACIT-疲劳的心理测量特性。MWPC和有意义的组间差异估计是使用基于锚和基于分布的方法得出的。使用逻辑回归分析估计横截面疲劳严重程度带。
结果:FACIT-疲劳表现出良好的内部一致性,足够的收敛和已知组有效性,并且对整个axSpA光谱随时间的变化很敏感。FACIT-疲劳评分增加5-11点估计代表MWPC,选择增加8点作为响应者定义。在16周的时间内,FACIT-Furness评分变化的2.14-5.34点差异估计代表了两组之间有意义的差异。FACIT-疲劳评分严重程度带定义为:无或最小(>40),轻度(>30至≤40),中等(>21至≤30),严重(≤21)。
结论:这些发现支持在axSpA临床试验中使用FACIT-Furness作为评估疲劳相关治疗获益的符合目的的措施。所提出的分数估计值和阈值可以指导整个axSpA频谱上的FACIT-疲劳分数解释。
背景:临床试验。政府,NCT03928704。2019年4月26日注册-追溯注册,https://经典。
结果:gov/ct2/show/NCT03928704。
结果:政府,NCT03928743。2019年4月26日注册-追溯注册,https://经典。
结果:gov/ct2/show/NCT03928743。