To Örebro University

OBJECTIVE: To evaluate Definition Of Remission In SLE (DORIS) and Lupus Low Disease Activity State (LLDAS) attainment with belimumab versus placebo in a dataset of pooled phase III clinical trials in systemic lupus erythematosus (SLE) using modified definitions that excluded the glucocorticoid (GC) component ('non-GC-DORIS' and 'non-GC-LLDAS') as the trials lacked mandated GC tapering protocols.

METHODS: In this post hoc analysis, data of adults with SLE receiving belimumab (10 mg/kg/month intravenously or 200 mg/week subcutaneously) or placebo plus standard therapy were pooled from five clinical trials (BLISS-76 (NCT00410384), BLISS-52 (NCT00424476), North East Asia (NCT01345253), BLISS-SC (NCT01484496) and EMBRACE (NCT01632241)). Non-GC-DORIS and non-GC-LLDAS attainment rates (calculated based on SLE Disease Activity Index 2000 and Physician's Global Assessment only) with belimumab versus placebo were compared up to week 52 in the overall population and in patient subgroups of interest.

RESULTS: Non-GC-DORIS and non-GC-LLDAS attainment at week 52 were significantly higher with belimumab (n=1869) versus placebo (n=1217; non-GC-DORIS: 18% vs 13%, risk ratio, RR (95% CI): 1.44 (1.20 to 1.71); p<0.001; non-GC-LLDAS: 32% vs 21%, RR (95% CI): 1.50 (1.32 to 1.71); p<0.001). Similar results were observed across most analysed patient subgroups; at week 52, differences were generally greater in the high versus low disease activity subgroups and Asian and White subgroups exhibited significantly higher attainment with belimumab versus placebo.

CONCLUSION: Belimumab was associated with higher attainment of DORIS remission and LLDAS excluding the GC component versus placebo; attainment rates were approximately twofold higher than those previously reported using the full definitions.