Objective 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).
Methods 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, χ2 test and logistic regression.
Results 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.
Conclusions 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.
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Handling editor Josef S Smolen
Contributors All authors have contributed to study design, data collection and analysis, and manuscript creation.
Funding MN is supported by a National Health and Medical Research Council (NHMRC) Career Development Fellowship (APP1126370). SO was supported by a postdoctoral fellowship from Arthritis Australia/Arthritis Victoria. Project funding was received from the St Vincent’s Hospital Research Endowment Fund.
Competing interests EFM has received consulting honoraria from GSK, unconnected to this study. No other authors have any competing interests to declare.
Patient consent Not required.
Ethics approval The studies were approved by a central or local institutional review board or ethics committee, and all patients provided written informed consent.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Data from the original BLISS trials are available through a data sharing agreement with GSK.