RT Journal Article
SR Electronic
T1 Conceptual framework for defining disease modification in systemic lupus erythematosus: a call for formal criteria
JF Lupus Science & Medicine
JO Lupus Sci Med
FD Lupus Foundation of America
SP e000634
DO 10.1136/lupus-2021-000634
VO 9
IS 1
A1 van Vollenhoven, Ronald
A1 Askanase, Anca D
A1 Bomback, Andrew S
A1 Bruce, Ian N
A1 Carroll, Angela
A1 Dall'Era, Maria
A1 Daniels, Mark
A1 Levy, Roger A
A1 Schwarting, Andreas
A1 Quasny, Holly A
A1 Urowitz, Murray B
A1 Zhao, Ming-Hui
A1 Furie, Richard
YR 2022
UL http://lupus.bmj.com/content/9/1/e000634.abstract
AB 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.