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Abstract：
The unmet need in systemic lupus erythematosus (SLE) with the current standard of care is widely recognised, but few studies have quantified this. The recent definition of treat-to-target endpoints and other thresholds of uncontrolled disease activity provide an opportunity to formally define unmet need in SLE. In this study, we enumerated the prevalence of these states and examined their association with adverse outcomes.
Data were collected prospectively in a 13-country longitudinal SLE cohort between 2013 and 2019. Unmet need was defined as never attaining lupus low disease activity state (LLDAS), a time-adjusted mean SLEDAI-2K (AMS) > 4, or ever experiencing high disease activity status (HDAS; SLEDAI-2K ≥10). Health-related quality of life (HRQoL) was assessed using SF36 (v2) and damage accrual using the SLICC-ACR SLE Damage Index (SDI).
A total of 3384 SLE patients were followed over 30,313 visits (median [IQR] follow-up 2.4 [0.4, 4.3] years). Eight hundred thirteen patients (24%) never achieved LLDAS. Median AMS was 3.0 [1.4, 4.9]; 34% of patients had AMS > 4. Twenty-five per cent of patients had episodes of HDAS. Each of LLDAS-never, AMS>4, and HDAS-ever was strongly associated with damage accrual, higher glucocorticoid use, and worse HRQoL. Mortality was significantly increased in LLDAS-never (adjusted HR [95% CI] = 4.98 [2.07, 12.0], p<0.001) and HDAS-ever (adjusted hazard ratio (HR) [95% CI] = 5.45 [2.75, 10.8], p<0.001) patients.
Failure to achieve LLDAS, high average disease activity, and episodes of HDAS were prevalent in SLE and were significantly associated with poor outcomes including organ damage, glucocorticoid exposure, poor quality of life, and mortality.
Data were collected prospectively in a 13-country longitudinal SLE cohort between 2013 and 2019. Unmet need was defined as never attaining lupus low disease activity state (LLDAS), a time-adjusted mean SLEDAI-2K (AMS) > 4, or ever experiencing high disease activity status (HDAS; SLEDAI-2K ≥10). Health-related quality of life (HRQoL) was assessed using SF36 (v2) and damage accrual using the SLICC-ACR SLE Damage Index (SDI).
A total of 3384 SLE patients were followed over 30,313 visits (median [IQR] follow-up 2.4 [0.4, 4.3] years). Eight hundred thirteen patients (24%) never achieved LLDAS. Median AMS was 3.0 [1.4, 4.9]; 34% of patients had AMS > 4. Twenty-five per cent of patients had episodes of HDAS. Each of LLDAS-never, AMS>4, and HDAS-ever was strongly associated with damage accrual, higher glucocorticoid use, and worse HRQoL. Mortality was significantly increased in LLDAS-never (adjusted HR [95% CI] = 4.98 [2.07, 12.0], p<0.001) and HDAS-ever (adjusted hazard ratio (HR) [95% CI] = 5.45 [2.75, 10.8], p<0.001) patients.
Failure to achieve LLDAS, high average disease activity, and episodes of HDAS were prevalent in SLE and were significantly associated with poor outcomes including organ damage, glucocorticoid exposure, poor quality of life, and mortality.
摘要：
系统性红斑狼疮（SLE）目前的护理标准未满足的需求已得到广泛认可，但是很少有研究对此进行量化。最近对治疗到目标终点的定义和不受控制的疾病活动的其他阈值提供了正式定义SLE中未满足的需求的机会。在这项研究中,我们列举了这些州的患病率,并检查了它们与不良结局的相关性.
2013年至2019年期间，在13个国家的纵向SLE队列中前瞻性地收集了数据。未满足的需求被定义为从未达到狼疮低疾病活动状态(LLDAS)，经时间调整的平均SLEDAI-2K(AMS)>4,或曾经经历过高度疾病活动状态(HDAS;SLEDAI-2K≥10)。使用SF36（v2）评估与健康相关的生活质量（HRQoL），并使用SLICC-ACRSLE损害指数（SDI）评估损害累积。
共3384例SLE患者随访超过30,313次（中位[IQR]随访2.4[0.4,4.3]年）。八百十三位患者（24％）从未获得LLDAS。中位AMS为3.0[1.4,4.9];34%的患者AMS>4。25%的患者有HDAS发作。每个LLDAS-never，AMS>4，HDAS-ever与损害累积密切相关，更高的糖皮质激素使用，更糟糕的HRQoL。LLDAS-never的死亡率显着增加（调整后的HR[95%CI]=4.98[2.07,12.0]，p<0.001)和HDAS-ever(调整后的危险比(HR)[95%CI]=5.45[2.75，10.8]，p<0.001)患者。
未能实现LLDAS，高平均疾病活动，HDAS的发作在SLE中普遍存在，并且与包括器官损伤在内的不良结局显着相关，糖皮质激素暴露，生活质量差，和死亡率。
2013年至2019年期间，在13个国家的纵向SLE队列中前瞻性地收集了数据。未满足的需求被定义为从未达到狼疮低疾病活动状态(LLDAS)，经时间调整的平均SLEDAI-2K(AMS)>4,或曾经经历过高度疾病活动状态(HDAS;SLEDAI-2K≥10)。使用SF36（v2）评估与健康相关的生活质量（HRQoL），并使用SLICC-ACRSLE损害指数（SDI）评估损害累积。
共3384例SLE患者随访超过30,313次（中位[IQR]随访2.4[0.4,4.3]年）。八百十三位患者（24％）从未获得LLDAS。中位AMS为3.0[1.4,4.9];34%的患者AMS>4。25%的患者有HDAS发作。每个LLDAS-never，AMS>4，HDAS-ever与损害累积密切相关，更高的糖皮质激素使用，更糟糕的HRQoL。LLDAS-never的死亡率显着增加（调整后的HR[95%CI]=4.98[2.07,12.0]，p<0.001)和HDAS-ever(调整后的危险比(HR)[95%CI]=5.45[2.75，10.8]，p<0.001)患者。
未能实现LLDAS，高平均疾病活动，HDAS的发作在SLE中普遍存在，并且与包括器官损伤在内的不良结局显着相关，糖皮质激素暴露，生活质量差，和死亡率。
