Journal Article

P60 Performance of SLE-DAS to assess subcutaneous belimumab efficacy in a cohort of systemic lupus erythematosus patients

Natalucci, Francesco, Moretti, Valeria, Alessandri, Cristiano, Conti, Fabrizio, Ceccarelli, Fulvia, Picciariello, Licia, Spinelli, Francesca Romana

2024

Overview

ObjectiveThe assessment of disease activity in patients with Systemic Lupus Erythematosus (SLE) represents an essential need for clinical practice and clinical trials. Nevertheless, the validation of a sensitive and reproducible instrument remains a challenge for the rheumatologist due to SLE heterogeneity. SLE-DAS (SLE Disease Activity Score), a recently proposed index, demonstrated higher sensitivity to change in comparison to SLEDAI-2k. However, few studies have tested its performance in the assessment of treatment efficacy. Thus, we aimed at assessing the efficacy of subcutaneous (sc) belimumab (BLM) by SLE-DAS in a monocentric SLE cohort. In particular, we evaluated the achievement of remission according to SLE-DAS and DORIS definition. Secondly, we investigated the construct validity of SLE-DAS in comparison with SLEDAI-2k. MethodsWe evaluated SLE patients treated with sc BLM from March 2019. Disease activity has been assessed by SLEDAI-2k, SLE-DAS and PGA (Physician Global Assessment) in all the established time-points [baseline (T0), after 1 (T1), 3 (T3), 6 (T6) and 12 (T12) months]. Furthermore, we applied and compared the achievement of remission according to SLE-DAS values (SLE-DAS ≤2.08 + PDN ≤5mg/daily) and DORIS definition (clinical SLEDAI-2k=0 + PGA<0.5 + antimalarials treatment, PDN≤5mg/daily, stable immunosuppressive treatment).ResultsWe enrolled 86 patients [M/F 5/81, median age 48 years (IQR 17.5), median disease duration 166 months (IQR 216)]. At baseline, median values of SLEDA-2k and SLE-DAS were 6 (IQR 4) and 5.77 (IQR 4.33), respectively, and they significantly correlated (r=0.719, CI 95% 0.586–0.815, p<0.0001; figure 1A). Median duration of treatment was 14 months (IQR 20). We found a significant reduction of SLEDAI-2k and SLE-DAS already at T1, maintained in the subsequent time-points (p<0.0001). At T12, a remission state was achieved by 60.4% of patients according to SLE-DAS definition and by 62.3% according to DORIS one (figure 1B). The two definitions of remission have demonstrated an agreement of 84%, with a Cohen’s kappa equal to 0.6.Abstract P60 Figure 1(A) Correlation analysis by Spearman test between SLEDAI-2k and SLE-DAS at baseline (r=0.719, p<0.0001). (B) Stacked column chart for remission states according to SLE-DAS and DORIS definitionsConclusionsIn this study we applied SLE-DAS to assess the efficacy of sc BLM, by analyzing its over-time changes and by comparing its performance with SLEDAI-2k. Indeed, our results suggest the usefulness of this new activity index in a real-life setting.

• Publisher: Lupus Foundation of America,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Lupus / Monoclonal antibodies / Poster Presentations / Remission (Medicine)