Lupus & antiphospholipid syndrome

Belimumab outperforms placebo for attainment of modified Definition Of Remission In SLE (DORIS) remission and Lupus Low Disease Activity State (LLDAS) without the glucocorticoid component: a post hoc analysis of five phase III systemic lupus erythematosus (SLE) trials

RMD OpenPublished Post hoc pooled analysis of five phase III randomised trials

Pooled result · Non-GC-DORIS attainmentResult — go to the resultRelative risk 1.44 95% CI 1.20–1.71

Authors' 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.

Study context

Population
Adults with SLE in five phase III trials (BLISS-76, BLISS-52, North East Asia, BLISS-SC, EMBRACE)5 trials
Participants
1,869 vs 1,217
Comparison
Belimumab plus standard therapy vs placebo plus standard therapy
  • Belimumabn = 1,869
  • Placebon = 1,217reference
Outcome
Non-GC-DORIS and non-GC-LLDAS attainment (DORIS and LLDAS excluding the glucocorticoid (GC) component; based on SLEDAI-2K and PGA only)
Follow-up
Up to week 52
Methodological detailspooled data, placebo-controlled
  • Pooled data
  • Placebo-controlled

Pooled result

Non-GC-DORIS attainment

Relative risk

1.44

95% CI 1.20–1.71

P < 0.001

By group

Belimumabvs Placebo
RR 1.44 (95% CI 1.20–1.71); P < 0.001

As reported in the abstract

Further pooled results

OutcomeBelimumabPlaceboRR (95% CI)P value
Non-GC-LLDAS attainment · up to week 5232%21%1.50 (1.32–1.71)P < 0.001

Patient subgroups · up to week 52

Similar results across most analysed subgroups; differences generally greater in high vs low disease activity subgroups; Asian and White subgroups had significantly higher attainment with belimumab vs placebo

Original publication

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. RMD Open. Published 3 July 2026. doi:10.1136/rmdopen-2025-006624

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