Abstract
Objective: To achieve a consensus-based definition of Low Disease Activity (LDA) for use in cSLE trials. Methods: The International cSLE T2T Task Force, comprising of paediatric rheumatologists/nephrologists, and adult rheumatologists undertook a series of Delphi surveys/consensus meetings to discuss, refine, and vote upon cSLE LDA criteria. Results: The Task Force agreed that LDA should be based upon the adult-SLE Lupus Low Disease Activity State definition (LLDAS), with modifications to make it applicable to cSLE (cLLDAS). They agreed upon five cLLDAS criteria: (1) SLE Disease Activity Index (SLEDAI)-2 K ≤4, with no activity in major organ systems; (2) no new features of lupus disease activity compared with the last assessment; (3) Physician Global Assessment score of ≤1 (0–3 scale); (4) prednisolone dose of ≤0.15 mg/kg/day, 7.5 mg/day/maximum; while on (5) stable antimalarials, immunosuppressives, and biologics. Conclusions: A cSLE-appropriate definition of cLLDAS has been generated, maintaining alignment with the adult-SLE definition to promote life-course research.
| Original language | English |
|---|---|
| Article number | 109296 |
| Journal | Clinical Immunology |
| Volume | 250 |
| DOIs | |
| Publication status | Published - May 2023 |
Bibliographical note
Funding Information:This work was supported by the Wellcome Trust through a Wellcome Trust Institutional Strategic Support Fund [204822z16z], Equality and Diversity grant, awarded to E.S. by the Faculty of Health and Life Sciences, University of Liverpool ’ and through a NIHR CRN: Children/ Versus Arthritis Paediatric Rheumatology Clinical Studies Group grant, awarded to E.S. The study took place as part of the UK's ‘Experimental Arthritis Treatment Centre for Children’ supported by Versus Arthritis [grant number ARUK-20621], the University of Liverpool , Alder Hey Children's NHS Foundation Trust and the Alder Hey Charity, and based at the University of Liverpool and Alder Hey Children's NHS Foundation Trust. Dr. Smith is a National Institute of Health and Social Care Research (NIHR) Academic Clinical Lecturer. Dr. Lewandowski is supported by the NIAMS Intramural Research Program. The funding bodies detailed above were not involved in the design, collection, analysis, and interpretation of data; in the writing of the manuscript; and in the decision to submit the manuscript for publication.
Funding Information:
The Steering Committee (EMDS, MWB) would like to thank all members of the Task Force (co-authors) who took part in the online consensus meetings, and our close named collaborators (Beatrice Goilav from Albert Einstein College of Medicine, New York, US; Stephen D Marks from Great Ormond Street Hospital for Children NHS Foundation Trust and the NIHR Great Ormond Street Hospital Biomedical Research Centre, London, UK; Louise Oni from the Department of Women's & Children's Health, Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool UK) who completed the online Delphi surveys feeding into the consensus meetings. We would like to thank the PReS Executive Council and PReS Lupus Working Party for their endorsement of the cLLDAS definition. All the authors would like to acknowledge the TARGET LUPUS PPIE group for providing in-put into this study. The study was supported by the UK's ‘Experimental Arthritis Treatment Centre for Children’ (supported by Versus Arthritis, the University of Liverpool and Alder Hey Children's NHS Foundation Trust). Special recognition also goes to Laura Whitty for co-ordination of the Task Force initiative, Delphi surveys and consensus meeting and Natasha Goss for also assisting with co-ordination of the consensus meeting.
Funding Information:
This work was supported by the Wellcome Trust through a Wellcome Trust Institutional Strategic Support Fund [204822z16z], Equality and Diversity grant, awarded to E.S. by the Faculty of Health and Life Sciences, University of Liverpool’ and through a NIHR CRN: Children/Versus Arthritis Paediatric Rheumatology Clinical Studies Group grant, awarded to E.S. The study took place as part of the UK's ‘Experimental Arthritis Treatment Centre for Children’ supported by Versus Arthritis [grant number ARUK-20621], the University of Liverpool, Alder Hey Children's NHS Foundation Trust and the Alder Hey Charity, and based at the University of Liverpool and Alder Hey Children's NHS Foundation Trust. Dr. Smith is a National Institute of Health and Social Care Research (NIHR) Academic Clinical Lecturer. Dr. Lewandowski is supported by the NIAMS Intramural Research Program. The funding bodies detailed above were not involved in the design, collection, analysis, and interpretation of data; in the writing of the manuscript; and in the decision to submit the manuscript for publication.
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© 2023