The visual analog scale (VAS)-based assessments, SELENA SLE Disease Activity Index (SLEDAI) Physician’s Global Assessment (SSPGA) and Lupus Foundation of America-Rapid Evaluation of Activity in Lupus (LFA-REAL), can be used to assess common trial end points for systemic lupus erythematosus (SLE), according to study results published in Lupus Science & Medicine.
The study aimed to determine the level of agreement between prospectively collected measures of lupus disease activity and response in a clinical trial. Disease activity measures included (SLEDAI, British Isles Lupus Assessment Group Index 2004 (BILAG 2004), Cutaneous Lupus Area and Severity Index (CLASI), SSPGA, and LFA-REAL; response measures included SLE Responder Index (SRI)-4 and BILAG-Based Combined Lupus Assessment (BICLA).
The trial included 50 patients (47 women; mean age, 45±11.6 years) whose data were assessed at 528 consecutive visits for an average of 10.6±4.1 visits per patient. Researchers examined changes in disease activity compared with baseline in 478 visit pairs.
After analysis, the researchers found that SSPGA and LFA-REAL correlated with each other (r=0.936) and with SLEDAI (r=0.742 and r=0.776, respectively) and BILAG (r=0.778 and r=0.813, respectively; P <.0001).
Compared with screening, changes (Δ) in SSPGA and LFA-REAL correlated with each other (r=0.857), and with changes in SLEDAI and BILAG (ΔSSPGA, r=0.678 [ΔSLEDAI], r=0.624 [ΔBILAG]; ΔLFA-REAL, r=0.686 [ΔSLEDAI] and r=0.700 [ΔBILAG]; P <.0001).
Receiver operating characteristic analysis revealed that changes in SSPGA and LFA-REAL had strong correlations with SRI-4 and BICLA (P <.0001). Results also indicated that LFA-REAL correlated with individual BILAG organ scores, including musculoskeletal (r=0.842) and mucocutaneous (r=0.826).
“Defining the psychometric properties of LFA-REAL and SSPGA will help determine their role in clinical trials, population studies and patient care,” the researchers wrote.
Disclosure: This clinical trial was supported by Bristol-Myers Squibb. Please see the original reference for a full list of authors’ disclosures.
Thanou A, James JA, Arriens C, et al. Scoring systemic lupus erythematosus (SLE) disease activity with simple, rapid outcome measures [published online December 30, 2019]. Lupus Sci Med. doi:10.1136/lupus-2019-000365