Lupus & antiphospholipid syndrome
Determinants of neuropsychiatric flares in patients with systemic lupus erythematosus: results from five phase III trials of belimumab
Authors' conclusion
Male sex, NPSLE history, and NP damage were strong determinants of impending NPSLE flare. No clear protection or predisposition was conferred from add-on belimumab.
Study context
- Population
- Patients with active SLE yet no ongoing severe NPSLE (baseline neuropsychiatric (NP) BILAG A excluded), from BLISS-52, BLISS-76, BLISS-NEA, BLISS-SC and EMBRACE
- Participants
- 3,638 patients5 phase III trials
- Comparison
- Determinants of NPSLE flare in patients receiving non-biologic standard therapy plus belimumab or placebo
- Outcome
- NPSLE flare, defined as a new NP BILAG A or B
Methodological detailsCox regression, multivariable analysis, subgroup analysis (baseline NP BILAG E)
- Cox regression
- Multivariable analysis
- Subgroup analysis (baseline NP BILAG E)
Pooled result
As reported in the abstract
Determinants of NPSLE flare (multivariable Cox)
Hazard ratio (95% CI)P value
Male sex
2.37(1.31–4.28)
P = 0.004Baseline NP BILAG B-D
5.91(3.86–9.06)
P < 0.001Increasing SDI scores
1.35(1.21–1.50)
P < 0.001- NPSLE flares documented
- 105 (2.9%)
Further pooled results
NPSLE flare by SLICC/ACR Damage Index (SDI) domain (NP damage)
| HR (95% CI) | P value | ||
|---|---|---|---|
| NP damage | 3.25 (2.72–3.88) | P < 0.001 | |
| Cognitive impairment | 14.29 (9.22–22.14) | P < 0.001 | |
| Transverse myelitis | 21.89 (5.40–88.72) | P < 0.001 | |
| Neuropathy | 8.87 (5.59–14.09) | P < 0.001 | |
| 0.050.21520Hazard ratio (log scale) |
De novo NPSLE flare (subgroup with baseline NP BILAG E)
| HR (95% CI) | P value | ||
|---|---|---|---|
| Male sex | 3.26 (1.51–7.04) | P = 0.003 | |
| 0.10.31310Hazard ratio (log scale) |
Original publication
Determinants of neuropsychiatric flares in patients with systemic lupus erythematosus: results from five phase III trials of belimumab. Rheumatology (Oxford). Published 25 May 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →