Lupus & antiphospholipid syndrome

Belimumab induces early and sustained resolution of lupus thrombocytopenia

Lupus Sci MedPublished Post hoc pooled analysis of five phase III randomised controlled trials

Authors' conclusion

This post hoc analysis of data from five large phase III RCTs suggests a benefit from belimumab compared with placebo in the haematological domain. A benefit from belimumab was seen in improving thrombocytopenia, but not leucopenia.

Study context

Population
Patients with SLE with active thrombocytopenia or leucopenia at baseline, from five phase III RCTs of belimumab
Participants
1,769 vs 1,144
Comparison
Belimumab vs placebo, on top of standard therapy, in SLE with active thrombocytopenia or leucopenia at baseline
  • Belimumabn = 1,769
  • Placebon = 1,144reference
Outcome
Sustained resolution of thrombocytopenia or leucopenia from the time of resolution through week 52
Follow-up
Week 52
Methodological detailspooled data from five phase III RCTs, placebo-controlled, log-rank tests
  • Pooled data from five phase III RCTs
  • Placebo-controlled
  • Log-rank tests

Pooled result

As reported in the abstract

Sustained resolution of thrombocytopenia

Belimumab

One-third

13 of 1769

Placebo

8%

2

P = 0.0267

Further pooled results

Resolution of leucopenia · week 52

Improvements slower than in thrombocytopenia, with no apparent difference between belimumab and placebo (baseline leucopenia: 346 belimumab, 203 placebo)

Original publication

Belimumab induces early and sustained resolution of lupus thrombocytopenia. Lupus Sci Med. Published 17 June 2026. doi:10.1136/lupus-2026-002010

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