Identifying a Response for the Systemic Lupus Erythematosus Disease Activity 2000 Glucocorticoid Index

Abstract

Objective To compare the performance of Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI‐2K) and SLEDAI‐2K glucocorticoids (SLEDAI‐2KG) indices in identifying responders to standard of care (SoC) therapy. Methods Data from adult patients seen between 1995‐2018 at the University of Toronto Lupus Clinic was analyzed. Patients with active disease (SLEDAI‐2K ≥6) and on prednisone ≥ 5 mg/day, and with a follow up visit at 9 months were studied. Response to SoC therapy, at first follow up visit, was assessed by SLEDAI‐2K and SLEDAI‐2KG. The performances of SLEDAI‐2K and SLEDAI‐2KG were compared using a cut‐off point of 4. Results In a cohort of 188, the majority were female (86.0%) and Caucasian (47.9%). Of 188 patients, 145 (77.1%) were responders and had a decrease in SLEDAI‐2K score of ≥4. SLEDAI‐2KG identified 142 (97.9%) responders of SLEDAI‐2K responders. More importantly, SLEDAI‐2KG identified 11 (25.6%) additional responders among SLEDAI‐2K non‐responders (n=43). This resulted from the ability of SLEDAI‐2KG to account for the decrease in glucocorticoids dose. Conclusions SLEDAI‐2KG provides a novel concept for the assessment of lupus disease activity while accounting for glucocorticoids dose to reflect on disease activity overall at a particular visit. SLEDAI‐2KG accounts for the disease activity for each descriptor while also accounting for the current glucocorticoids dose. SLEDAI‐2KG adds one additional variable (corticosteroid dose) to SLEDAI‐2K which could alter response rates in drug trials and observational studies.