FRI0334 Comparison of different definitions of remission in systemic lupus erythematosus (SLE) – a study based on the bliss-76 clinical trial
Authors: S. Emamikia, C. Gentline, E. Arkema, L. Arnaud, K. Chatzidionysiou, R. van Vollenhoven
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Standardisation of a definition of disease remission in SLE is one of the most important unmet needs in rheumatology and up to today there is no gold standard for the definition of remission.<sup>1</sup> <h3>Objectives</h3> An international task force consisting of 60 rheumatologists, nephrologists, dermatologists, clinical immunologists and patient representatives agreed on various definitions of remission in SLE (DORIS).<sup>2</sup> Our aim was to apply these definitions on a clinical trial. <h3>Methods</h3> This is a post-hoc analysis of a prospective randomised controlled trial (RCT) in SLE, the BLISS-76 clinical trial.<sup>3</sup> We have applied two DORIS definitions (table 1) at three time points, week (wk) 24, 52 and 76. The patient could be in remission <i>on</i> or <i>off</i> treatment. Remission <i>on</i> treatment allowed maintenance anti-malarials, low dose glucocorticoids (GCs) (prednisone ≤5 mg/day or equivalent), maintenance immunosuppressives and maintenance biologics. Remission o<i>ff</i> treatment allowed maintenance anti-malarials only. Additionally, we applied each definition where the remission <i>on</i> treatment allowed a GC dose ≤10 mg/day (not a part of the original DORIS-definitions). <h3>Results</h3> There were 819 patients enrolled in BLISS-76. The proportions of patients that fulfilled remission according to the above definitions are shown in table 2. The highest point prevalence (9.5%) was when definition 1a <i>on</i> treatment was applied at wk 76. As expected, even more patients fulfilled definition 1a when a GC dose ≤10 mg/day was allowed at wk 76 (13.8%). More patients fulfilled the remission criteria when clinical SLEDAI was used compared to when BILAG was used. When serology (anti-DNA antibodies and complement) was taken into consideration (definitions 1b and 3b), less patients fulfilled remission. Very low numbers of patients (≤1%) fulfilled remission off treatment. <h3>Conclusions</h3> Overall, few patients fulfilled remission according to these definitions. More patients fulfilled the definitions when serology was excluded and when a higher dose of GCs was allowed. <h3>References</h3> [1] Winthrop KL, Strand V, van der Heijde D, Mease P, Crow M, Weinblatt M, et al. The unmet need in rheumatology: Reports from the targeted therapies meeting 2017. Clin Immunol. 2017. [2] van Vollenhoven R, et al. A framework for remission in SLE: consensus findings from a large international task force on definitions of remission in SLE (DORIS). Annals of the rheumatic diseases2016. [3] Furie R, et al. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum. 2011;63:3918–30. <h3>Disclosure of Interest</h3> S. Emamikia: None declared, C. Gentline: None declared, E. Arkema: None declared, L. Arnaud Grant/research support from: Amgen, Astra-Zeneca, GSK, Lilly, Pfizer, Roche, K. Chatzidionysiou Consultant for: Lilly, AbbVie, Pfizer, Roche, Sandoz, R. van Vollenhoven Grant/research support from: AbbVie, Amgen, BMS, GSK, Pfizer, Roche, UCB, Consultant for: AbbVie, Biotest, BMS, Crescendo, GSK, Janssen, Lilly, Merck, Pfizer, Roche, UCB, Vertex