SAT0204 LUPUS LOW-DISEASE ACTIVITY STATE VS SLE RESPONDER INDEX IN A “REAL-LIFE” SETTING
Authors: Giuseppe Alvise Ramirez, Valentina Canti, Lucia Moiola, Marco Magnoni, Patrizia Rovere-Querini, Lavinia A. Coletto, Lorenzo Dagna, Angelo Manfredi, Enrica Bozzolo
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background:</h3> Systemic lupus erythematosus (SLE) is a chronic multi-organ autoimmune disease characterised by a heterogeneous pathogenic background and by protean clinical manifestations. Recent efforts in identifying novel agents for therapeutic interventions have led to disappointing results and designing a reliable way to assess drug efficacy and verify the achievement of remission, has become itself a major challenge. The SLE responder index (SRI) is a composite tool developed and validated in clinical trials to define in patients with active disease an acceptable response to investigational agents. The role of SRI outside clinical trials has not been defined. The lupus low disease activity state (LLDAS) has been originally validated in a cohort-based setting and it focuses on the achievement of fixed conditions rather than variations from baseline. A formal comparison of these tools outside clinical trials has not been performed. <h3>Objectives:</h3> To prospectively assess the performance of SRI and LLDAS in a "real world" observational setting. <h3>Methods:</h3> One hundred-thirty-one consecutive patients SLE were subdivided into two groups based on the need or not to escalate their immune suppressive treatment. Clinimetrics including Physician Global Assessment scale (PGA), SLE Disease Activity Index 2000 (SLEDAI-2K) and British Isles Lupus Assessment Group index (BILAG) 2004 version were measured at baseline and at six and 12 months, together with laboratory data and treatment changes. LLDAS and SRI were calculated at each time point. <h3>Results:</h3> LLDAS achievement correlated with treatment de-escalation over 12 months (χ2=5.2, p=0.034, OR=4.1 with 95%CI=1.2-14.4), whereas SRI-4 achievement did not. LLDAS responses were more frequent in patients with lower basal SLEDAI-2K (i.e SLEDAI-2K&lt;6; χ2=21.5, p&lt;0.001, RR=8.4 with 95%CI=3.2-25.0), while SRI-4 responses were more prevalent among patients with higher basal SLEDAI-2K and/or severe renal activity at baseline (χ2=5.9, p=0.025, RR=10.8 with 95%CI=1.1-103.1). Positive anti-DNA antibodies associated with non-achievement of LLDAS at any time point. Serositis was associated with lack of LLDAS at baseline, but did not affect LLDAS achievement at 12 months. Normalising complement levels anticipated the achievement of LLDAS and SRI-4. <h3>Conclusion:</h3> LLDAS is a valuable tool for assessing response to treatment in the daily rheumatology practice. SRI might be less informative, at least in patients with low basal SLEDAI. <h3>References</h3> [1] Franklyn K, et al. Ann Rheum Dis. 2016 [2] Luijten KM, et al. Autoimmunity reviews. 2012 [3] Piga M, et al. Arthritis Res Ther. 2017 <h3>Disclosure of Interests:</h3> Giuseppe Alvise Ramirez: None declared, Valentina Canti: None declared, Lucia Moiola: None declared, Marco Magnoni: None declared, Patrizia Rovere-Querini Grant/research support from: Adienne Pharma &amp; Biotech, Lavinia A. Coletto: None declared, Lorenzo Dagna: None declared, Angelo Manfredi: None declared, Enrica Bozzolo: None declared