OP0296 THE 2021 DORIS DEFINITION OF REMISSION IN SLE – FINAL RECOMMENDATIONS FROM AN INTERNATIONAL TASK FORCE

Abstract

Background:Remission is the stated goal for both patient and care-giver (1), but consensus on a definition of remission has been lacking. Previously, an international task force consisting of patient representatives and medical specialists published a frame-work for such a definition (2), but without making a final recommendation.Objectives:To achieve consensus around a definition of remission in SLE (DORIS).Methods:The DORIS task force met annually from 2015 to 2020 and consisted of patient representatives and specialists in rheumatology, nephrology, dermatology, and clinical immunology. Systemic literature reviews of several key topics were done and specific research questions were examined in suitably chosen datasets. The findings were discussed, reformulated as recommendations, and voted upon. Level of evidence (LoE), strength of recommendation (SoR), and agreement were determined in standard fashion. The final recommendation for the DORIS definition of remission was established by electronic vote after finalization of the minutes of the most recent task force meeting.Results:Based on data from the literature and from several SLE-specific data sets, five key recommendations were endorsed (Table 1) that should be seen as additions to those published previously (2). Literature reviews identified strong support for the face-, content-, construct- and criterion validity of the definition based on the clinical SLEDAI (not including anti-DNA and complement) equal to zero plus low physician global assessment and allowing stable medical treatment. Thus, the DORIS Task Force recommended a single definition of remission in SLE, based on clinical SLEDAI = 0, evaluator’s global assessment <0.5 (0-3), prednisone 5 mg/day or less, and stable antimalarials, immunosuppressives and biologics.Table 1.Vote in favorLoESoRAgreement1.Inclusion of serology [anti-DNA, complement] in the DORIS definition of remission-on-treatment does not meaningfully alter the construct validity and therefore it is not recommended to include it90%2aB8.382.While the goal of treatment is sustained remission, a definition of remission should be able to be met at any point in time; therefore, duration should not be included in the definition100%5C9.023.To date, the SLEDAI-based definitions of remission have formally been investigated more extensively than BILAG-or ECLAM-based definitions. The SLEDAI-based definitions can therefore more confidently be recommended91%2aB9.254.Remission off treatment, while the ultimate goal for many patients and providers, is achieved very rarely. In clinical research and as an outcome in clinical trials, the definition for remission-on-treatment is recommended92%2aB9.525.In clinical trials, the LLDAS definition for low disease activity and the DORIS definition of remission are both recommended as outcomes100%5C9.25The 2021 DORIS definition of remission in SLE:Conclusion:The 2021 DORIS definition of remission in SLE was established. It is recommended for use as an aspirational treatment target in clinical care, a clear concept in education, and a key outcome in research including clinical trials and observational studies.References:[1]van Vollenhoven RF, Mosca M, Bertsias G, et al. Treat-to-target in systemic lupus erythematosus: recommendations from an international task force. Ann Rheum Dis 2014;73:958-67.[2]van Vollenhoven R, Voskuyl A, Bertsias G, et al. A framework for remission in SLE: consensus findings from a large international task force on definitions of remission in SLE (DORIS). Ann Rheum Dis 2016.Disclosure of Interests:Ronald van Vollenhoven Speakers bureau: AbbVie, Galapagos, GSK, Janssen, Pfizer, UCB, Consultant of: AbbVie, AstraZeneca, Biogen, Biotest, Celgene, Galapagos, Gilead, Janssen, Pfizer, Sanofi, Servier, UCB, Vielabo, Grant/research support from: BMS, GSK, Lilly, UCB, George Bertsias: None declared, Andrea Doria: None declared, David Isenberg: None declared, Eric F. Morand: None declared, Michelle A Petri: None declared, Bernardo Pons-Estel Consultant of: GSK, Janssen, Anisur Rahman: None declared, Manuel Ugarte-Gil Grant/research support from: Janssen, Pfizer, Alexandre Voskuyl: None declared, Laurent Arnaud Consultant of: Alexion, Amgen, Astra-Zeneca, BMS, GSK, Janssen-Cilag, LFB, Lilly, Menarini France, Medac, Novartis, Pfizer, Roche-Chugaï, UCB., Ian N. Bruce: None declared, Ricard Cervera Consultant of: GSK, Alexion, Eli Lilly, Astra Zeneca, Termo-Fisher, Rubió, Nathalie Costedoat-Chalumeau: None declared, Caroline Gordon Speakers bureau: UCB, Consultant of: Center for Disease Control, Astra-Zeneca, MGP, Sanofi, UCB, Frederic Houssiau: None declared, Marta Mosca: None declared, Matthias Schneider: None declared, Michael Ward: None declared, Cynthia Aranow: None declared.