Real World Evidence, Epidemiology, GlaxoSmithKline, Collegeville, Pennsylvania, USA.
Duke University School of Medicine, Durham, North Carolina, USA.
Lupus Sci Med. 2021 Apr;8(1). doi: 10.1136/lupus-2020-000446.
To assess the impact of mild-moderate systemic lupus erythematosus (SLE) disease activity during a 12-month period on the risk of death or subsequent organ system damage.
1168 patients with ≥24 months of follow-up from the Hopkins Lupus Cohort were included. Disease activity in a 12-month observation period was calculated using adjusted mean Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) version of the SLE Disease Activity Index (SLEDAI), defined as the area under the curve divided by the time interval. Damage accrual in the follow-up period was defined as change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) score ≥1 among patients without prior damage. Patients visited the clinic quarterly and had SELENA-SLEDAI and SDI assessed at every visit.
During follow-up (median 7 years), 39% of patients accrued new damage in any organ system (7% cardiovascular and 3% renal) and 8% died. In adjusted models, an increased SELENA-SLEDAI score increased the risk of death (HR=1.22, 95% CI 1.13 to 1.32, p<0.001), renal damage (HR=1.24, 95% CI 1.08 to 1.42, p=0.003) and cardiovascular damage (HR=1.17, 95% CI 1.07 to 1.29, p<0.001). Hydroxychloroquine use reduced the risk of death (HR=0.46, 95% CI 0.29 to 0.72, p<0.05) and renal damage (HR=0.30, 95% CI 0.13 to 0.68, p<0.05). Non-steroidal anti-inflammatory drug use increased the risk of cardiovascular damage (HR=1.66, 95% CI 1.04 to 2.63, p<0.05). Without prior damage, an increased adjusted mean SELENA-SLEDAI score increased the risk of overall damage accrual (HR=1.09, 95% CI 1.04 to 1.15, p<0.001).
Each one-unit increase in adjusted mean SELENA-SLEDAI during a 12-month observation period was associated with an increased risk of death and developing cardiovascular and renal damage.
评估 12 个月期间轻度至中度系统性红斑狼疮(SLE)疾病活动对死亡或随后发生的器官系统损害风险的影响。
纳入了来自霍普金斯狼疮队列的 1168 名随访时间≥24 个月的患者。在 12 个月的观察期内,使用调整后的平均安全性雌激素在红斑狼疮国家评估(SELENA)版本的系统性红斑狼疮疾病活动指数(SLEDAI)计算疾病活动,定义为曲线下面积除以时间间隔。在随访期间,系统红斑狼疮国际合作临床/美国风湿病学会损害指数(SDI)评分增加≥1 定义为无先前损害的患者的累积损害。患者每季度就诊一次,每次就诊时均评估 SELENA-SLEDAI 和 SDI。
在随访期间(中位数 7 年),39%的患者在任何器官系统中发生新的损害(7%为心血管损害,3%为肾脏损害),8%的患者死亡。在调整后的模型中,SELENA-SLEDAI 评分的升高增加了死亡的风险(HR=1.22,95%CI 1.13 至 1.32,p<0.001)、肾脏损害(HR=1.24,95%CI 1.08 至 1.42,p=0.003)和心血管损害(HR=1.17,95%CI 1.07 至 1.29,p<0.001)。羟氯喹的使用降低了死亡风险(HR=0.46,95%CI 0.29 至 0.72,p<0.05)和肾脏损害风险(HR=0.30,95%CI 0.13 至 0.68,p<0.05)。非甾体抗炎药的使用增加了心血管损害的风险(HR=1.66,95%CI 1.04 至 2.63,p<0.05)。在没有先前损害的情况下,调整后的平均 SELENA-SLEDAI 评分的升高增加了总损害累积的风险(HR=1.09,95%CI 1.04 至 1.15,p<0.001)。
在 12 个月的观察期内,调整后的平均 SELENA-SLEDAI 每增加一个单位,死亡风险以及发生心血管和肾脏损害的风险就会增加。