Department of Women's & Children's Health, Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, UK; Department of Paediatric Rheumatology, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.
Department of Clinical Immunology & Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India.
Clin Immunol. 2023 May;250:109296. doi: 10.1016/j.clim.2023.109296. Epub 2023 Mar 17.
To achieve a consensus-based definition of Low Disease Activity (LDA) for use in cSLE trials.
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.
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.
A cSLE-appropriate definition of cLLDAS has been generated, maintaining alignment with the adult-SLE definition to promote life-course research.
达成共识,为 cSLE 临床试验定义低疾病活动度(LDA)。
由儿科风湿病学家/肾病学家和成人风湿病学家组成的国际 cSLE T2T 工作组进行了一系列 Delphi 调查/共识会议,讨论、完善并投票表决 cSLE LDA 标准。
工作组同意 LDA 应基于成人-SLE 狼疮低疾病活动状态定义(LLDAS),并进行修改以使其适用于 cSLE(cLLDAS)。他们同意了五个 cLLDAS 标准:(1)SLE 疾病活动指数(SLEDAI)-2K≤4,无主要器官系统活动;(2)与上次评估相比,无狼疮疾病活动的新特征;(3)医师整体评估评分≤1(0-3 分);(4)泼尼松龙剂量≤0.15mg/kg/天,7.5mg/天/最大剂量;同时(5)稳定的抗疟药、免疫抑制剂和生物制剂。
已经生成了适用于 cSLE 的 cLLDAS 定义,与成人-SLE 定义保持一致,以促进全生命周期研究。