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- Nikolopoulos, Dionysis, et al.
(author)
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Patients with neuropsychiatric involvement systemic lupus erythematosus experience poorer health-related quality of life and more fatigue than systemic lupus erythematosus patients with no neuropsychiatric involvement, irrespective of neuropsychiatric activity
- 2024
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In: Rheumatology. - : Oxford University Press. - 1462-0324 .- 1462-0332.
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Journal article (peer-reviewed)abstract
- OBJECTIVES: Substantial proportions of patients with systemic lupus erythematosus (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). The neuropsychiatric SLE (NPSLE) group comprised individuals with NP-British Isles Lupus Assessment group (BILAG) A/B/C/D or score in any descriptor of the NP-SLEDAI-2K at baseline (N = 350), while the non-NPSLE group consisted of patients with NP-BILAG E (N = 2618). HRQoL was assessed with the SF-36, EQ-5D-3L, and FACIT-F. Full health state (FHS) was defined as "no problems" in all EQ-5D dimensions.RESULTS: NPSLE patients reported lower scores in the SF-36 physical and mental component summary compared with the non-NPSLE population (mean±s.d.: 35.7±9.1 versus 39.6±9.6; p<0.001 and 37.3±12.1 versus 41.4±11.0; p<0.001, respectively). NPSLE patients also exhibited impaired HRQoL in all EQ-5D dimensions compared with non-NPSLE patients (p<0.05 for all). A substantially lower proportion among NPSLE patients experienced FHS in comparison with the non-NPSLE group (3.3% versus 14.5%; p<0.001). NPSLE was associated with severe fatigue (23.8±12.2 versus 31.5±11.6; p<0.001). Notably, our findings revealed no discernible distinctions between active and inactive NPSLE patients with regard to SF-36, EQ-5D, FHS, and FACIT-F scores.CONCLUSION: Neuropsychiatric involvement in patients with SLE has a detrimental effect on HRQoL experience and is associated with severe fatigue, regardless of the degree of neuropsychiatric disease activity. Early intervention is warranted in NPSLE patients to enhance long-term HRQoL experience.
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- Palazzo, Leonardo, et al.
(author)
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Determinants of neuropsychiatric flares in patients with systemic lupus erythematosus : results from five phase III trials of belimumab
- 2024
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In: Rheumatology. - : Oxford University Press. - 1462-0324 .- 1462-0332. ; 63:3, s. 798-808
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Journal article (peer-reviewed)abstract
- OBJECTIVE: To identify determinants of neuropsychiatric (NP) flares in patients with systemic lupus erythematosus (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.
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- Parodis, Ioannis, 1981-, et al.
(author)
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Effect of Belimumab on Preventing de novo Renal Lupus Flares
- 2023
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In: Kidney international reports. - : Elsevier. - 2468-0249. ; 8:9, s. 1822-1830
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Journal article (peer-reviewed)abstract
- INTRODUCTION: Belimumab was recently approved for treating lupus nephritis (LN), yet de novo LN cases during belimumab treatment given for nonrenal causes have been reported. Identification of reliable signals of impending flare is imperative.METHODS: We evaluated belimumab efficacy in preventing de novo renal flares and factors associated with renal flare occurrence in nephritis-naïve patients with systemic lupus erythematosus (SLE) who are receiving add-on belimumab or placebo in 5 phase 3 clinical trials using Cox regression analysis.RESULTS: Of 1844 eligible patients, 136 (7.4%) developed a de novo renal flare during a 52-week long follow-up. Asian origin (Adjusted Hazard Ratio [HRadj]: 1.97; 95% confidence interval [CI]: 1.32-2.94; P = 0.001), positive baseline anti-double stranded DNA (anti-dsDNA) levels (HRadj: 1.32; 95% CI: 1.07-1.63; P = 0.008), and increasing mean prednisone dose during follow-up (HRadj: 1.03; 95% CI: 1.02-1.04; P < 0.001) were associated with de novo renal flares. Low-dose intravenous (IV) belimumab (1 mg/kg monthly) yielded a nearly 3-fold lower hazard of de novo renal flare (HRadj: 0.38; 95% CI: 0.20-0.73; P = 0.004). Subcutaneous (SC) belimumab (200 mg weekly) also yielded a lower hazard (HRadj.: 0.69; 95% CI: 0.54-0.88; P = 0.003). The labeled IV dose (10 mg/kg monthly) conferred no clear protection (HRadj.: 0.74; 95% CI: 0.50-1.09; P = 0.127).CONCLUSION: We corroborated the substantial vulnerability of the Asian SLE population to renal affliction. Add-on low-dose IV belimumab (1 mg/kg) and SC belimumab appeared protective against renal flares in nephritis-naïve patients with SLE. The approved IV dose (10 mg/kg) yielded no clear protection.
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