Objective In axSpA, validated PROs are well-established in clinical trials, but it remains unclear whether they comprehensively reflect patients’ discomfort and disease status. We aimed to investigate how patients’ self-reported disease status does compare to validated clinical trial measures during routine clinical visits. Methods Data from axSpA patients’ initial and last five visits were retrospectively analyzed. ASDAS, BASDAI, ASAS20, ASAS40 and ASAS partial remission were assessed at each visit and compared with patients’ self-reported disease status, categorized into very good (status satisfaction), mild, severe, and very severe based on patient’s self-reported opinion on the level of severity of symptoms’ burden related to axSpA. The association of these PROs with patients’ self-reported disease status was analyzed using mixed models. Results 3,120 visits over a median follow-up of 4.7 years from 557 axSpA patients were analyzed. Very good or mild self-reported disease status was reported in 98.7% and 90.9% of visits with inactive or low ASDAS, compared with 67.9% and 39.3% with high or very high ASDAS. Severe or very severe self-reported disease status was reported in 15.1% of visits with ASAS20 achievement, in 7.2% with ASAS40 achievement, and in 0.6% with achievement of ASAS partial remission, compared with 26.0% without ASAS20 achievement, 25.1% without ASAS40 achievement, and 30.1% without achievement of ASAS partial remission. Conclusions Patientś self-reported disease status was well captured by ASDAS and BASDAI in most clinical visits. Other investigated measures used in clinical trials failed to capture patientś self-reported disease status in a large proportion of visits.

中文翻译：

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中轴型脊柱关节炎患者报告的结局指标与患者自我报告的疾病状态的关联


目的 在 axSpA 中，经过验证的 PRO 在临床试验中得到充分证实，但尚不清楚它们是否能全面反映患者的不适和疾病状态。我们旨在调查患者自我报告的疾病状态与常规临床访视期间经过验证的临床试验措施的比较。方法 回顾性分析 axSpA 患者初次和最近 5 次就诊的数据。在每次就诊时评估 ASDAS、BASDAI、ASAS20、ASAS40 和 ASAS 部分缓解，并与患者自我报告的疾病状态进行比较，根据患者自我报告的意见分为非常好（状态满意度）、轻度、严重和非常严重与 axSpA 相关的症状负担的严重程度。使用混合模型分析这些 PRO 与患者自我报告的疾病状态的关联。结果 分析了 557 例 axSpA 患者在中位随访 4.7 年内的 3,120 次就诊。98.7% 和 90.9% 的非活动性或低 ASDAS 就诊报告了非常好或轻度的自我报告疾病状态，而高或非常高的 ASDAS 就诊率分别为 67.9% 和 39.3%。15.1% 的 ASAS20 达到、7.2% 的 ASAS40 和0.6% 的 ASAS 部分缓解，而没有 ASAS20 的 26.0%，没有 ASAS40 的 25.1%，30.1% 没有 ASAS 部分缓解。结论 在大多数临床就诊中，ASDAS 和 BASDAI 可以很好地捕捉患者自我报告的疾病状态。临床试验中使用的其他调查措施未能在很大一部分就诊中捕捉患者自我报告的疾病状态。