Abstract
Objective: To derive childhood-onset SLE (cSLE) specific remission definitions for future treat-to-target (T2T) trials, observational studies, and clinical practice. Methods: The cSLE International T2T Task Force conducted Delphi surveys exploring paediatric perspectives on adult-onset SLE remission targets. A modified nominal group technique was used to discuss, refine, and agree on the cSLE remission target criteria. Results: The Task Force proposed two definitions of remission: ‘cSLE clinical remission on steroids (cCR)’ and ‘cSLE clinical remission off steroids (cCR-0)’. The common criteria are: (1) Clinical-SLEDAI-2 K = 0; (2) PGA score < 0.5 (0–3 scale); (4) stable antimalarials, immunosuppressive, and biologic therapy (changes due to side-effects, adherence, weight, or when building up to target dose allowed). Criterion (3) in cCR is the prednisolone dose ≤0.1 mg/kg/day (maximum 5 mg/day), whereas in cCR-0 it is zero. Conclusions: cSLE definitions of remission have been proposed, maintaining sufficient alignment with the adult-SLE definition to facilitate life-course research.
| Original language | English |
|---|---|
| Article number | 110214 |
| Number of pages | 9 |
| Journal | Clinical Immunology |
| Volume | 263 |
| DOIs | |
| Publication status | Published - Jun 2024 |
Keywords
- Childhood-onset SLE
- cSLE
- Remission
- T2T
- Treat-to-target
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In: Clinical Immunology, Vol. 263, 110214, 06.2024.
Research output: Contribution to journal › Article › Research › peer-review
TY - JOUR
T1 - Defining remission in childhood-onset lupus
T2 - PReS-endorsed consensus definitions by an international task force
AU - Smith, E. M.D.
AU - Aggarwal, A.
AU - Ainsworth, J.
AU - Al-Abadi, E.
AU - Avcin, T.
AU - Bortey, L.
AU - Burnham, J.
AU - Ciurtin, C.
AU - Hedrich, C. M.
AU - Kamphuis, S.
AU - Lambert, L.
AU - Levy, D. M.
AU - Lewandowski, L.
AU - Maxwell, N.
AU - Morand, E.
AU - Özen, S.
AU - Pain, C. E.
AU - Ravelli, A.
AU - Saad Magalhaes, C.
AU - Pilkington, C.
AU - Schonenberg-Meinema, D.
AU - Scott, C.
AU - Tullus, K.
AU - Beresford, M. W.
AU - on behalf of the International cSLE T2T Task Force
N1 - 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 EMDS by the Faculty of Health and Life Sciences, University of Liverpool\u2019 and through a NIHR CRN: Children/Versus Arthritis Paediatric Rheumatology Clinical Studies Group grant, awarded to EMDS The study took place as part of the UK's \u2018Experimental Arthritis Treatment Centre for Children\u2019 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 . During this work, EMDS was 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 cSLE T2T Task Force (co-authors) who took part in the online consensus meetings, and our close collaborators (named Collaborators) 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 \u2018Experimental Arthritis Treatment Centre for Children\u2019 (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 cSLE T2T Task Force initiative, Delphi surveys and consensus meeting and Natasha Goss for also assisting with co-ordination of the Delphi surveys. 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 EMDS by the Faculty of Health and Life Sciences, University of Liverpool\u2019 and through a NIHR CRN: Children/Versus Arthritis Paediatric Rheumatology Clinical Studies Group grant, awarded to EMDS. The study took place as part of the UK's \u2018Experimental Arthritis Treatment Centre for Children\u2019 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. During this work, EMDS was 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.The Steering Committee (EMDS, MWB) would like to thank all members of the cSLE T2T Task Force (co-authors) who took part in the online consensus meetings, and our close collaborators (named Collaborators) 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 \u2018Experimental Arthritis Treatment Centre for Children\u2019 (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 cSLE T2T Task Force initiative, Delphi surveys and consensus meeting and Natasha Goss for also assisting with co-ordination of the Delphi surveys. Publisher Copyright: © 2024 The Authors
PY - 2024/6
Y1 - 2024/6
N2 - Objective: To derive childhood-onset SLE (cSLE) specific remission definitions for future treat-to-target (T2T) trials, observational studies, and clinical practice. Methods: The cSLE International T2T Task Force conducted Delphi surveys exploring paediatric perspectives on adult-onset SLE remission targets. A modified nominal group technique was used to discuss, refine, and agree on the cSLE remission target criteria. Results: The Task Force proposed two definitions of remission: ‘cSLE clinical remission on steroids (cCR)’ and ‘cSLE clinical remission off steroids (cCR-0)’. The common criteria are: (1) Clinical-SLEDAI-2 K = 0; (2) PGA score < 0.5 (0–3 scale); (4) stable antimalarials, immunosuppressive, and biologic therapy (changes due to side-effects, adherence, weight, or when building up to target dose allowed). Criterion (3) in cCR is the prednisolone dose ≤0.1 mg/kg/day (maximum 5 mg/day), whereas in cCR-0 it is zero. Conclusions: cSLE definitions of remission have been proposed, maintaining sufficient alignment with the adult-SLE definition to facilitate life-course research.
AB - Objective: To derive childhood-onset SLE (cSLE) specific remission definitions for future treat-to-target (T2T) trials, observational studies, and clinical practice. Methods: The cSLE International T2T Task Force conducted Delphi surveys exploring paediatric perspectives on adult-onset SLE remission targets. A modified nominal group technique was used to discuss, refine, and agree on the cSLE remission target criteria. Results: The Task Force proposed two definitions of remission: ‘cSLE clinical remission on steroids (cCR)’ and ‘cSLE clinical remission off steroids (cCR-0)’. The common criteria are: (1) Clinical-SLEDAI-2 K = 0; (2) PGA score < 0.5 (0–3 scale); (4) stable antimalarials, immunosuppressive, and biologic therapy (changes due to side-effects, adherence, weight, or when building up to target dose allowed). Criterion (3) in cCR is the prednisolone dose ≤0.1 mg/kg/day (maximum 5 mg/day), whereas in cCR-0 it is zero. Conclusions: cSLE definitions of remission have been proposed, maintaining sufficient alignment with the adult-SLE definition to facilitate life-course research.
KW - Childhood-onset SLE
KW - cSLE
KW - Remission
KW - T2T
KW - Treat-to-target
UR - https://www.scopus.com/pages/publications/85191445420
U2 - 10.1016/j.clim.2024.110214
DO - 10.1016/j.clim.2024.110214
M3 - Article
C2 - 38604255
AN - SCOPUS:85191445420
SN - 1521-6616
VL - 263
JO - Clinical Immunology
JF - Clinical Immunology
M1 - 110214
ER -