Hunnicutt Jacob, Georgiou Mary Elizabeth, Richards Anna, Quasny Holly, Magder Laurence, Goldman Daniel, Petri Michelle A
Epidemiology, GSK, Collegeville, Pennsylvania, USA.
Value Evidence and Outcomes, GSK, Brentford, UK
Lupus Sci Med. 2024 Dec 11;11(2):e001206. doi: 10.1136/lupus-2024-001206.
One key target of treating patients with systemic lupus erythematosus (SLE) is to prevent organ damage. This analysis quantified the association between time spent in four specific SLE low disease activity (LDA) states and organ damage rate.
This retrospective real-world data analysis (GSK Study 207168), undertaken to help contextualise the BLISS-BELIEVE clinical trial, included adults with SLE enrolled for≥1 year in the Hopkins Lupus Cohort and treated with standard therapy in a specialist care centre between 1987 and 2019. LDA states (Lupus Low Disease Activity State (LLDAS), disease control, clinical and complete remissions) were defined using SLE Disease Activity Index (SLEDAI)/Physician Global Assessment scores, prednisone-equivalent dose and medication use criteria combinations. Time spent in each LDA state was expressed as a percentage of total follow-up (0%; >0-<25%; 25-49%; 50-74%; ≥75%). Pooled logistic models were used to estimate adjusted rate ratios (aRR) between time spent in LDA states and organ damage rate (assessed using the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI)).
Overall, 1632 patients experienced 1246 organ damage events. Follow-up time (calculated from days of follow-up) totalled 9841.1 person-years. At baseline, the mean (SD) SLEDAI score was 2.8 (3.3) and the mean (SD) SDI score was 1.7 (1.9). Organ damage rates were lower in patients who achieved an LDA state versus those who did not. Rates decreased with increasing time spent in each LDA state. Even a small percentage of time (>0-<25% vs 0%) spent in an LDA state was associated with reduced damage (aRR (95% CI): LLDAS, 0.75 (0.61, 0.91); disease control, 0.80 (0.68, 0.93); clinical remission, 0.73 (0.60, 0.88); complete remission, 0.80 (0.68, 0.93)).
Regardless of definition, achieving and maintaining a low disease activity state was associated with reduced organ damage in patients with SLE.
治疗系统性红斑狼疮（SLE）患者的一个关键目标是预防器官损伤。本分析量化了处于四种特定SLE低疾病活动（LDA）状态的时间与器官损伤率之间的关联。
这项回顾性真实世界数据分析（GSK研究207168）旨在帮助将BLISS - BELIEVE临床试验置于背景中，纳入了1987年至2019年期间在霍普金斯狼疮队列中登记≥1年并在专科护理中心接受标准治疗的成年SLE患者。LDA状态（狼疮低疾病活动状态（LLDAS）、疾病控制、临床缓解和完全缓解）使用SLE疾病活动指数（SLEDAI）/医生整体评估评分、泼尼松等效剂量和药物使用标准组合来定义。处于每种LDA状态的时间表示为总随访时间的百分比（0%；>0 - <25%；25 - 49%；50 - 74%；≥75%）。使用汇总逻辑模型来估计处于LDA状态的时间与器官损伤率（使用系统性红斑狼疮国际协作临床/美国风湿病学会损伤指数（SDI）评估）之间的调整率比（aRR）。
总体而言，1632名患者发生了1246次器官损伤事件。随访时间（根据随访天数计算）总计9841.1人年。基线时，平均（标准差）SLEDAI评分为2.8（3.3），平均（标准差）SDI评分为1.7（1.9）。达到LDA状态的患者的器官损伤率低于未达到的患者。随着在每种LDA状态下花费的时间增加，损伤率降低。即使在LDA状态下花费的时间占比很小（>0 - <25% 对比 0%）也与损伤减少相关（aRR（95%CI）：LLDAS，0.75（0.61，0.91）；疾病控制，0.80（0.68，0.93）；临床缓解，0.73（0.60，0.88）；完全缓解，0.80（0.68，0.93））。
无论定义如何，达到并维持低疾病活动状态与SLE患者器官损伤减少相关。
