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. 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. 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. 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.
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