Lupus & antiphospholipid syndrome
Fragility of randomised controlled trials for systemic lupus erythematosus and lupus nephritis therapies
Authors' conclusion
The evidence of therapies for patients with SLE and LN is derived mostly from fragile RCTs.
Study context
- Population
- Phase III randomised controlled trials (RCTs) that included patients with active SLE or lupus nephritis (LN)RCTs (16 SLE, four LN)
- Participants
- 20 participants
- Outcome
- FI/RFI score across all RCTs
Methodological detailsfragility analysis, phase III RCTs, fragility index, reverse fragility index, fragility quotient
- Fragility analysis
- Phase III RCTs
- Fragility index
- Reverse fragility index
- Fragility quotient
Pooled result
As reported in the abstract
Mean fragility index (FI)/reverse FI (RFI) score (SD 6.6)
13.6
Further pooled results
FI in RCTs with statistically significant results (9 RCTs: seven SLE, two LN)
- Mean FI score (SD 6.2)
- 10.2
- Lowest FI: ILLUMINATE-2
- 2
- Highest FI: BLISS-52
- 17
RFI in RCTs with non-statistically significant results (12 studies: 10 SLE, two LN)
- Mean RFI score (SD 6.1)
- 15.6
- Lowest RFI: ILLUMINATE-1
- 4
- Highest RFI: TULIP-1
- 27
Fragility quotient (FQ) score
- Lowest FQ scores in the ILLUMINATE trials; highest in the Rituximab trials (EXPLORER and LUNAR), the most robust results after accounting for sample size
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Fragility of randomised controlled trials for systemic lupus erythematosus and lupus nephritis therapies. Lupus Sci Med. Published 10 January 2024. doi:10.
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