Background: The accurate measurement of patient reported outcomes is a priority for patient-centered care in SLE, a chronic systemic disease with significant impact on quality of life. PROMIS CATs are precise measures of physical, mental, and social health with construct validity in SLE. The longitudinal responsiveness (sensitivity to change) of PROMIS CATs in SLE patients is unknown.

Objectives: To evaluate the responsiveness of PROMIS CATs in SLE outpatients using patient and physician-derived anchors.

Methods: Adult SLE patients were recruited from an SLE Center of Excellence. Subjects completed 14 selected PROMIS CATs at two visits a minimum of one month apart. SLE disease activity was measured with a patient global assessment of change, a physician global assessment and the physician-derived SELENA-SLEDAI. Responsiveness of PROMIS scores was evaluated using known-groups validity. Effect sizes were compared across groups of patients who differed in their patient global assessment of change, physician global assessment, and SELENA-SLEDAI using Wilcoxon rank-sum tests.

Results: A diverse cohort of 228 SLE patients, including 45 (19.8%) patients flaring by SELENA-SLEDAI, completed baseline surveys. Follow up surveys were completed by 190 (83%). There was poor agreement between patient and physician global assessments (weighted kappa statistic [95% CI]=0.16 [0.04–0.28]. Using the patient-based anchor, Anger, Pain Interference, and Physical Function CATs showed low to moderate responsiveness (table 1). Using the physician global assessment, only Anxiety CAT showed low to moderate responsiveness (effect size -0.27, -0.17, and 0.06 [p=0.03] with ≥0.5 point decrease, <0.5 point change, and ≥0.5 point increase respectively), while with the SELENA-SLEDAI as anchor, only Applied Cognition-Abilities CAT showed responsiveness (0.34, -0.01, 0.0 [p<0.01] with ≥3 point decrease, <3 point change, and ≥3 point increase respectively).

Conclusions: PROMIS CATs showed modest responsiveness to patient-reported, but generally not physician-derived changes in lupus health status in domains of anger, pain interference, and physical function. These data suggest that certain PROMIS CATs are precise and sensitive tools which may be used to measure and monitor important aspects of the patient experience of lupus not captured by physician-derived metrics. Further studies are needed to evaluate the responsiveness of PROMIS CATs in populations with greater SLE disease activity and more regular follow up.

Acknowledgements: Funding was provided by the Rheumatology Research Foundation Scientist Development Award.

Disclosure of Interest: None declared