Objective: To 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.
Methods: We 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).
Results: We 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).
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.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10907808 | PMC |
| http://dx.doi.org/10.1093/rheumatology/kead249 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Trajectories of disease evolution upon treatment initiation in systemic lupus erythematosus: results from four clinical trials of belimumab.
Rheumatology (Oxford)
October 2024
Referral Center for Systemic Autoimmune Diseases, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano, Milan, Italy.
Article Synopsis
- The study aimed to understand how systemic lupus erythematosus (SLE) progresses after starting therapy, focusing on different patient responses and outcomes.
- Researchers analyzed data from 2868 patients across four clinical trials, identifying four distinct disease evolution characteristics based on both clinical measures and patient-reported outcomes.
- The findings suggest that categorizing patients into these trajectories could help personalize treatments and improve future clinical study designs, as no single factor can predict how SLE will progress.
Neuropsychiatric involvement in systemic lupus erythematosus contributes to organ damage beyond the nervous system: a post-hoc analysis of 5 phase III randomized clinical trials.
Rheumatol Int
September 2024
Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
Objective: To investigate the association between neuropsychiatric systemic lupus erythematosus (NPSLE) and SLICC/ACR damage index (SDI) items, especially non-neuropsychiatric items.
Methods: Baseline data from five phase III trials (BLISS-52, BLISS-76, BLISS-SC, BLISS-NEA, EMBRACE) were analysed. NPSLE involvement was defined as NP BILAG A/B/C/D (n = 272); NP BILAG E denoted non-neuropsychiatric SLE (n = 3273).
Patients with NPSLE experience poorer HRQoL and more fatigue than SLE patients with no neuropsychiatric involvement, irrespective of neuropsychiatric activity.
Rheumatology (Oxford)
September 2024
Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
Objectives: Substantial proportions of patients with SLE report poor health-related quality of life (HRQoL). Our objective was to investigate the impact of neuropsychiatric involvement (NP) in SLE on patient-reported outcomes.
Methods: We analysed data from four phase III trials (BLISS-52, BLISS-76, BLISS-SC, EMBRACE; N = 2968).
Efficacy and safety of intravenous belimumab in a subgroup of South Korean patients with systemic lupus erythematosus enrolled into a Phase 3, randomized, placebo-controlled trial in North East Asia.
Int J Rheum Dis
January 2024
Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Hanyang University Institute for Rheumatology and Hanyang University Institute of Bioscience and Biotechnology, Seoul, Korea.
Article Synopsis
- The study aimed to assess the effectiveness and safety of intravenous belimumab in South Korean patients with systemic lupus erythematosus (SLE) who participated in a larger trial known as the North East Asia (NEA) study.
- The analysis found that significantly more patients receiving belimumab (53.0%) achieved a key treatment response compared to those on placebo (23.5%), with similar rates of adverse events reported in both groups.
- Overall, belimumab showed to be both effective and well tolerated for treating SLE in this specific patient subgroup.
Gastrointestinal manifestations in systemic lupus erythematosus: data from an Indian multi-institutional inception (INSPIRE) cohort.
Rheumatology (Oxford)
January 2025
Department of Clinical Immunology and Rheumatology, SMS Medical College & Hospital, Jaipur, India.
Objectives: To study the prevalence, correlates, and outcomes of GI manifestations in a prospectively enrolled nationwide cohort of SLE in India (INSPIRE).
Methods: It is an observational cohort study with analysis of the baseline database of the INSPIRE cohort with early outcomes assessed till 10 April 2023. Cases with GI manifestations as per the BILAG index were selected, pertinent clinical and laboratory data were retrieved for analysis.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!