Association of validated patient reported outcome measures with patients' self-reported disease status in axial...

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 compares with validated clinical trial measures during routine clinical visits.

Data from axSpA patients' initial and last five visits were retrospectively analysed. 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 patients' self-reported opinion on the level of severity of symptom burden related to axSpA. The association of these PROs with patients' self-reported disease status was analysed using mixed models.

A total of 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% of visits with inactive and 90.9% of visits with low ASDAS compared to 67.9% with high and 39.3% with 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.

Patients' 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 patients' self-reported disease status in a large proportion of visits.