Conceptual framework for defining disease modification in systemic lupus erythematosus: a call for formal criteria

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 manif...

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Published inLupus science & medicine Vol. 9; no. 1; p. e000634
Main Authors van Vollenhoven, Ronald, Askanase, Anca D, Bomback, Andrew S, Bruce, Ian N, Carroll, Angela, Dall'Era, Maria, Daniels, Mark, Levy, Roger A, Schwarting, Andreas, Quasny, Holly A, Urowitz, Murray B, Zhao, Ming-Hui, Furie, Richard
Format Journal Article
LanguageEnglish
Published England BMJ Publishing Group LTD 01.03.2022
BMJ Publishing Group
Subjects
Clinical outcomes
Clinical trials
Disease prevention
Humans
Lupus
Lupus Erythematosus, Systemic - drug therapy
Lupus Nephritis - diagnosis
Outcome Assessment, Health Care
Patients
Quality of life
Remission (Medicine)
Review
Rheumatology
Severity of Illness Index
Surveys and Questionnaires
British Isles
lupus erythematosus, systemic
lupus nephritis
therapeutics
outcome assessment, health care
Online AccessGet full text
ISSN2053-8790
2053-8790
DOI10.1136/lupus-2021-000634

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Abstract 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.
AbstractList 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.
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.
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.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.
Author Levy, Roger A
van Vollenhoven, Ronald
Furie, Richard
Dall'Era, Maria
Bruce, Ian N
Zhao, Ming-Hui
Urowitz, Murray B
Quasny, Holly A
Bomback, Andrew S
Carroll, Angela
Daniels, Mark
Askanase, Anca D
Schwarting, Andreas
AuthorAffiliation 2 Columbia University Medical Center , New York , New York , USA
3 Columbia University College of Physicians and Surgeons , New York , New York , USA
5 GlaxoSmithKline , Research Triangle Park , North Carolina , USA
1 Amsterdam Rheumatology and Immunology Center and Amsterdam University Medical Centers , Amsterdam , The Netherlands
11 Toronto Western Hospital , Toronto , Ontario , Canada
13 Northwell Health , Great Neck , New York , USA
4 The University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre , Manchester , UK
8 GlaxoSmithKline , Philadelphia , Pennsylvania , USA
9 Rheumatology Center Rhineland Palatinate , Bad Kreuznach , Germany
6 University of California San Francisco School of Medicine , San Francisco , California , USA
7 GlaxoSmithKline , Stevenage , UK
10 University Medical Centre of the Johannes Gutenberg University Mainz , Mainz , Germany
12 Peking University First Hospital
AuthorAffiliation_xml – name: 11 Toronto Western Hospital , Toronto , Ontario , Canada
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/35346982$$D View this record in MEDLINE/PubMed
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Issue 1
Keywords lupus erythematosus, systemic
lupus nephritis
therapeutics
outcome assessment, health care
Language English
License Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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SecondaryResourceType review_article
Snippet Disease modification has become a well-established concept in several therapeutic areas; however, no widely accepted definition of disease modification exists...
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SubjectTerms Clinical outcomes
Clinical trials
Disease prevention
Humans
Lupus
Lupus Erythematosus, Systemic - drug therapy
Lupus Nephritis - diagnosis
Outcome Assessment, Health Care
Patients
Quality of life
Remission (Medicine)
Review
Rheumatology
Severity of Illness Index
Surveys and Questionnaires
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Title Conceptual framework for defining disease modification in systemic lupus erythematosus: a call for formal criteria
URI https://www.ncbi.nlm.nih.gov/pubmed/35346982
https://www.proquest.com/docview/2832374437
https://www.proquest.com/docview/2644945504
https://pubmed.ncbi.nlm.nih.gov/PMC8961173
https://doaj.org/article/677b9fbf4bef480ea911147614263bae
Volume 9
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