Trial reportRMD open2026
Belimumab outperforms placebo for attainment of modified DORIS remission and LLDAS without the glucocorticoid component: a post hoc analysis of five phase III SLE trials.
Trial report in RMD open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)
GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)
A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus (SLE)
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Authors and funding
11 authors.
Funding
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Abstract
objectiveTo 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.
methodsIn 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.
resultsNon-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.
conclusionBelimumab 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.
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