Thanou Aikaterini, James Judith A, Arriens Cristina, Aberle Teresa, Chakravarty Eliza, Rawdon Joseph, Stavrakis Stavros, Merrill Joan T, Askanase Anca
Arthritis and Clinical Immunology Research Program, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, USA.
Department of Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.
Lupus Sci Med. 2019 Dec 30;6(1):e000365. doi: 10.1136/lupus-2019-000365. eCollection 2019.
Existing methods for grading lupus flares or improvement require definition-based thresholds as increments of change. Visual analogue scales (VAS) allow rapid, continuous scaling of disease severity. We analysed the performance of the SELENA SLEDAI Physician's Global Assessment (SSPGA) and the Lupus Foundation of America-Rapid Evaluation of Activity in Lupus (LFA-REAL) as measures of improvement or worsening in SLE.
We evaluated the agreement between prospectively collected measures of lupus disease activity [SLE Disease Activity Index (SLEDAI), British Isles Lupus Assessment Group Index 2004 (BILAG 2004), Cutaneous Lupus Area and Severity Index (CLASI), SSPGA and LFA-REAL] and response [(SLE Responder Index (SRI)-4 and BILAG-Based Combined Lupus Assessment (BICLA)] in a clinical trial.
Fifty patients (47 females, mean age 45 (±11.6) years) were assessed at 528 consecutive visits (average 10.6 (±4.1) visits/patient). Changes in disease activity compared with baseline were examined in 478 visit pairs. SSPGA and LFA-REAL correlated with each other (r=0.936), and with SLEDAI and BILAG (SSPGA: r=0.742 (SLEDAI), r=0.776 (BILAG); LFA-REAL: r=0.778 (SLEDAI), r=0.813 (BILAG); all p<0.0001). Changes (∆) in SSPGA and LFA-REAL compared with screening correlated with each other (r=0.857) and with changes in SLEDAI and BILAG (∆SSPGA: r=0.678 (∆SLEDAI), r=0.624 (∆BILAG); ∆LFA-REAL: r=0.686 (∆SLEDAI) and 0.700 (∆BILAG); all p<0.0001). Changes in SSPGA and LFA-REAL strongly correlated with SRI-4 and BICLA by receiver operating characteristic analysis (p<0.0001 for all). Additionally, LFA-REAL correlated to individual BILAG organ scores (musculoskeletal: r=0.842, mucocutaneous: r=0.826 (p<0.0001 for both)).
SSPGA and LFA-REAL are reliable surrogates of common SLE trial end points and could be used as continuous or dichotomous response measures. Additionally, LFA-REAL can provide individualised scoring at the symptom or organ level.
NCT02270957.
现有的狼疮病情发作或改善分级方法需要基于定义的阈值作为变化增量。视觉模拟量表（VAS）可实现疾病严重程度的快速、连续分级。我们分析了SELENA SLEDAI医生整体评估（SSPGA）和美国狼疮基金会-狼疮活动快速评估（LFA-REAL）作为系统性红斑狼疮（SLE）病情改善或恶化指标的性能。
我们在一项临床试验中评估了前瞻性收集的狼疮疾病活动指标[系统性红斑狼疮疾病活动指数（SLEDAI）、2004年英伦三岛狼疮评估组指数（BILAG 2004）、皮肤狼疮面积和严重程度指数（CLASI）、SSPGA和LFA-REAL]与反应指标[（SLE反应者指数（SRI）-4和基于BILAG的综合狼疮评估（BICLA）]之间的一致性。
对50例患者（47例女性，平均年龄45（±11.6）岁）进行了528次连续访视评估（平均每位患者10.6（±4.1）次访视）。在478对访视中检查了与基线相比的疾病活动变化。SSPGA和LFA-REAL相互相关（r=0.936），且与SLEDAI和BILAG相关（SSPGA：r=0.742（SLEDAI），r=0.776（BILAG）；LFA-REAL：r=0.778（SLEDAI），r=0.813（BILAG）；所有p<0.0001）。与筛查相比，SSPGA和LFA-REAL的变化（∆）相互相关（r=0.857），且与SLEDAI和BILAG的变化相关（∆SSPGA：r=0.678（∆SLEDAI），r=0.624（∆BILAG）；∆LFA-REAL：r=0.686（∆SLEDAI）和0.700（∆BILAG）；所有p<0.0001）。通过受试者工作特征分析，SSPGA和LFA-REAL的变化与SRI-4和BICLA密切相关（所有p<0.0001）。此外，LFA-REAL与各个BILAG器官评分相关（肌肉骨骼：r=0.842，黏膜皮肤：r=0.826（两者p<0.0001））。
SSPGA和LFA-REAL是常见SLE试验终点的可靠替代指标，可作为连续或二分反应指标使用。此外，LFA-REAL可在症状或器官水平提供个体化评分。
NCT02270957。
