Autor/a:
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Van Vollenhoven, Ronald F.; Voskuyl, Alexandre E.; Bertsias, George; Aranow, Cynthia; Aringer, Martin; Arnaud, Laurent; Askanase, Anca; Balá ová, Petra; Bonfa, Eloisa; Bootsma, Hendrika; Boumpas, Dimitrios; Bruce, Ian N.; Cervera i Segura, Ricard, 1960-; Clarke, Ann E.; Coney, Cindy; Costedoat-Chalumeau, Nathalie; Czirják, László; Derksen, R.H.W.M.; Doria, Andrea; Dörner, Thomas; Fischer-Betz, Rebecca; Fritsch-Stork, Ruth; Gordon, Caroline; Graninger, Winfried; Györi, Noémi; Houssiau, Frédéric A.; Isenberg, David; Jacobsen, Søren; Jayne, David; Kuhn, Annegret; Le Guern, Veronique; Lerstrøm, Kirsten; Levy, Roger A.; Machado-Ribeiro, Francinne; Mariette, Xavier; Missaykeh, Jamil; Morand, Eric; Mosca, Marta; Inanc, Murat; Navarra, Sandra
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Abstract:
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Objectives Treat-to-target recommendations have identified 'remission' as a target in systemic lupus erythematosus (SLE), but recognise that there is no universally accepted definition for this. Therefore, we initiated a process to achieve consensus on potential definitions for remission in SLE. Methods An international task force of 60 specialists and patient representatives participated in preparatory exercises, a face-to-face meeting and follow-up electronic voting. The level for agreement was set at 90%. Results The task force agreed on eight key statements regarding remission in SLE and three principles to guide the further development of remission definitions: 1. Definitions of remission will be worded as follows: remission in SLE is a durable state characterised by . (reference to symptoms, signs, routine labs). 2. For defining remission, a validated index must be used, for example, clinical systemic lupus erythematosus disease activity index (SLEDAI)=0, British Isles lupus assessment group (BILAG) 2004 D/E only, clinical European consensus lupus outcome measure (ECLAM)=0; with routine laboratory assessments included, and supplemented with physician's global assessment. 3. Distinction is made between remission off and on therapy: remission off therapy requires the patient to be on no other treatment for SLE than maintenance antimalarials; and remission on therapy allows patients to be on stable maintenance antimalarials, low-dose corticosteroids (prednisone ≤5 mg/day), maintenance immunosuppressives and/or maintenance biologics. The task force also agreed that the most appropriate outcomes (dependent variables) for testing the prognostic value (construct validity) of potential remission definitions are: death, damage, flares and measures of health-related quality of life. Conclusions The work of this international task force provides a framework for testing different definitions of remission against long-term outcomes. |