Background Patient reported outcomes (PRO) are important to understand, educate, manage and follow patients with systemic lupus erythematosus (SLE). Lupus Impact Tracker (LIT) is a ten-item tool that was developed from LupusPRO, to facilitate patient-physician communication. In clinical trial, LIT was found to have good validity, reliability, and responsiveness against the Systemic Lupus Erythematosus Responder Index (SRI), an outcome used commonly in SLE Clinical Trials. Herein, we test LIT responsiveness to SELENA-SLEDAI.
Objectives To test the responsiveness of LIT to changes in disease activity assessments obtained during routine SLE patient care setting.
Methods Longitudinal data on LupusPRO and disease activity assessments were collected during 185 SLE patients routine clinical care visits for the Rush Lupus Data Repository. We derived the LIT total score from the LupusPRO data. Disease activity assessments used as anchors for testing responsiveness include the physician global assessment (PGA), Total SELENA-SLEDAI and the SELENA-Flare Index (SFI) (Yes/No). Cut offs used to determine change in disease activity were: PGA (of 0.3), SELENA-SLEDAI (of 4) and SFI (Remitting, stable and flaring). Non-parametric analysis of variance were used to compare changes in LIT against disease activity anchors.
Results Mean (SD) age and SELENA-SLEDAI were 43.5 (13.2) yrs and 6.4 (7.3) respectively. PGA changed significantly for 270 visit data (Increased in 125, decreased in 145), while 360 visit data had unchanged PGA. SELENA-SLEDAI changed significantly among 65 visits (30 increased, 35 decreased), and remained stable among 184 visits. Significant changes in SFI were observed in 151 visit data (79 remitting, 72 flaring), while 463 visit data was stable. LIT scores trended towards significant and appropriate directions changes in response to changes in PGA (p=0.09). LIT scores responded significantly and in the appropriate direction for changes in SLEDAI (p 0.01) and SFI (0.002). Mean (Median) change in LIT was an increase of 3.2 (2.5) in response to SFI flared status, while a decrease of 3.0 (-2.5) with SFI remission. The mean (median) LIT change was -1.6 (0.0) in those with unchanged SFI status.
Conclusions LIT is responsive to changes in SELENA Flare Index in routine patient care setting in SLE. It may now be used in clinical trials in SLE, besides use by patients and physicians in facilitating communication and tracking the disease impact in SLE.
Disclosure of Interest None declared