Rheumatology, St Vincent's Hospital, Melbourne, Victoria, Australia.
University of Melbourne, Melbourne, Victoria, Australia.
Ann Rheum Dis. 2019 May;78(5):629-633. doi: 10.1136/annrheumdis-2018-214427. Epub 2019 Jan 24.
We evaluated the discriminant capacity of the Lupus Low Disease Activity State (LLDAS) in post-hoc analysis of data from the BLISS-52 and BLISS-76 trials of belimumab in systemic lupus erythematosus (SLE).
LLDAS attainment, discrimination between belimumab and placebo arms, and the effects in subgroups with high disease activity at recruitment were evaluated at week 52 using appropriate descriptive statistics, χ test and logistic regression.
At week 52, for belimumab 10 mg/kg, 17.0% and 19.3% of patients who achieved a Systemic Lupus Erythematosus Responder Index-4 also attained LLDAS in BLISS-52 and BLISS-76, respectively. Significantly more patients attained LLDAS on belimumab 10 mg/kg compared with placebo (12.5% vs 5.8%, OR 2.32, p=0.02 for BLISS-52; 14.4% vs 7.8%, OR 1.98, p=0.04 for BLISS-76). In a subgroup analysis, the difference in week 52 LLDAS attainment between belimumab 10 mg/kg and placebo was greater in patients who had higher disease activity at baseline, compared with the overall group.
LLDAS was able to discriminate belimumab 10 mg/kg from placebo in the BLISS-52 and BLISS-76 trials. Our findings support the validity of LLDAS as an outcome measure in SLE clinical trials.
我们在后设分析中评估狼疮低疾病活动状态（LLDAS）在贝利尤单抗治疗系统性红斑狼疮（SLE）的 BLISS-52 和 BLISS-76 试验中的判别能力。
在 BLISS-52 和 BLISS-76 试验中，于第 52 周使用适当的描述性统计、χ 检验和逻辑回归评估 LLDAS 的获得情况、与安慰剂组的区分度以及招募时疾病活动度高的亚组的疗效。
在第 52 周，对于贝利尤单抗 10mg/kg，分别有 17.0%和 19.3%达到系统性红斑狼疮反应指数-4 缓解的患者也达到了 LLDAS，分别在 BLISS-52 和 BLISS-76 试验中。与安慰剂相比，更多的患者达到了 LLDAS（12.5%比 5.8%，OR 2.32，p=0.02，BLISS-52；14.4%比 7.8%，OR 1.98，p=0.04，BLISS-76）。在亚组分析中，与整体组相比，基线疾病活动度较高的患者中，第 52 周 LLDAS 的获得情况，在贝利尤单抗 10mg/kg 和安慰剂之间的差异更大。
在 BLISS-52 和 BLISS-76 试验中，LLDAS 能够区分贝利尤单抗 10mg/kg 和安慰剂。我们的发现支持 LLDAS 作为 SLE 临床试验中的一种结局指标的有效性。
