Trial reportRheumatology (Oxford, England)2024
Determinants of neuropsychiatric flares in patients with systemic lupus erythematosus: results from five phase III trials of belimumab.
Trial report in Rheumatology (Oxford, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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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.
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Who cites it
8 citing papers in PubMed, 15 citations in OpenAlex.
- Sex and gender differences in rheumatology: clinical impact and future directions.Nature reviews. Rheumatology · 2026Review
- Lessons Learnt from the Belimumab Trials in Systemic Lupus Erythematosus.International journal of molecular sciences · 2025Review
- 2025 Chinese guidelines for the diagnosis and treatment of systemic lupus erythematosus.Rheumatology and immunology research · 2025Article
- Sex- and gender-related differences in systemic lupus erythematosus: a scoping review.Rheumatology international · 2025Article
- Neuropsychiatric manifestations in systemic lupus erythematosus and Sjogren's disease.Autoimmunity reviews · 2025Review
- The immunological mechanisms linking systemic lupus erythematosus and neuropsychiatric disorders.Frontiers in immunology · 2025Article
- The Challenge of Neuropsychiatric Systemic Lupus Erythematosus: From Symptoms to Therapeutic Strategies.Diagnostics (Basel, Switzerland) · 2024Review
- Effect of anti-P ribosomal and anti-NR2 antibodies on depression and cognitive processes in SLE: an integrated clinical and functional MRI study.Lupus science & medicine · 2023Article
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
Abstract
objectiveTo identify determinants of neuropsychiatric (NP) flares in patients with SLE treated for active SLE yet no ongoing severe NPSLE with non-biologic standard therapy plus belimumab or placebo.
methodsWe analysed data from five phase III trials (BLISS-52, BLISS-76, BLISS-NEA, BLISS-SC, EMBRACE; n = 3638) after exclusion of patients with baseline NP BILAG A. Factors associated with NPSLE flare, defined as a new NP BILAG A or B, were investigated using Cox regression. In a subgroup analysis, we studied patients with baseline NP BILAG E for determinants of de novo NPSLE flare. Organ damage was assessed using the SLICC/ACR Damage Index (SDI).
resultsWe documented 105 (2.9%) NPSLE flares. In multivariable analysis, male sex (HR = 2.37; 95% CI: 1.31, 4.28; P = 0.004), baseline NP BILAG B-D (HR = 5.91; 95% CI: 3.86, 9.06; P < 0.001), and increasing SDI scores (HR = 1.35; 95% CI: 1.21, 1.50; P < 0.001) were strongly associated with NPSLE flare. Belimumab use yielded no association at any dose or administration form. In analysis of SDI domains, NP damage was the strongest determinant of NPSLE flare (HR = 3.25; 95% CI: 2.72, 3.88; P < 0.001), holding true for cognitive impairment (HR = 14.29; 95% CI: 9.22, 22.14; P < 0.001), transverse myelitis (HR = 21.89; 95% CI: 5.40, 88.72; P < 0.001), and neuropathy (HR = 8.87; 95% CI: 5.59, 14.09; P < 0.001). Male sex was the strongest determinant of de novo NPSLE flare (HR = 3.26; 95% CI: 1.51, 7.04; P = 0.003).
conclusionMale sex, NPSLE history, and NP damage were strong determinants of impending NPSLE flare. No clear protection or predisposition was conferred from add-on belimumab.
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