A framework for remission in SLE: consensus findings from a large international task force on definitions of remission in SLE (DORIS).
van Vollenhoven R., Voskuyl A., Bertsias G., Aranow C., Aringer M., Arnaud L., Askanase A., Balážová P., Bonfa E., Bootsma H., Boumpas D., Bruce I., Cervera R., Clarke A., Coney C., Costedoat-Chalumeau N., Czirják L., Derksen R., Doria A., Dörner T., Fischer-Betz R., Fritsch-Stork R., Gordon C., Graninger W., Györi N., Houssiau F., Isenberg D., Jacobsen S., Jayne D., Kuhn A., Le Guern V., Lerstrøm K., Levy R., Machado-Ribeiro F., Mariette X., Missaykeh J., Morand E., Mosca M., Inanc M., Navarra S., Neumann I., Olesinska M., Petri M., Rahman A., Rekvig OP., Rovensky J., Shoenfeld Y., Smolen J., Tincani A., Urowitz M., van Leeuw B., Vasconcelos C., Voss A., Werth VP., Zakharova H., Zoma A., Schneider M., Ward M.
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.