TY - JOUR T1 - Conceptual framework for defining disease modification in systemic lupus erythematosus: a call for formal criteria JF - Lupus Science & Medicine JO - Lupus Sci Med DO - 10.1136/lupus-2021-000634 VL - 9 IS - 1 SP - e000634 AU - Ronald van Vollenhoven AU - Anca D Askanase AU - Andrew S Bomback AU - Ian N Bruce AU - Angela Carroll AU - Maria Dall'Era AU - Mark Daniels AU - Roger A Levy AU - Andreas Schwarting AU - Holly A Quasny AU - Murray B Urowitz AU - Ming-Hui Zhao AU - Richard Furie Y1 - 2022/03/01 UR - http://lupus.bmj.com/content/9/1/e000634.abstract N2 - Disease modification has become a well-established concept in several therapeutic areas; however, no widely accepted definition of disease modification exists for SLE.We reviewed established definitions of disease modification in other conditions and identified a meaningful effect on ‘disease manifestations’ (ie, signs, symptoms and patient-reported outcomes) and on ‘disease outcomes’ (eg, long-term remission or progression of damage) as the key principles of disease modification, indicating a positive effect on the natural course of the disease. Based on these findings and the treatment goals and outcome measures for SLE, including lupus nephritis, we suggest a definition of disease modification based on disease activity indices and organ damage outcomes, with the latter as a key anchor. A set of evaluation criteria is also suggested.Establishing a definition of disease modification in SLE will clarify which treatments can be considered disease modifying, provide an opportunity to harmonise future clinical trial outcomes and enable comparison between therapies, all of which could ultimately help to improve patient outcomes. This publication seeks to catalyse further discussion and provide a framework to develop an accepted definition of disease modification in SLE. ER -