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Objective The 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. Methods We 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 + PGAResults We 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, pConclusions In 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.
Ceccarelli et al. (Fri,) studied this question.