Publications by authors named "Ellen Ginzler"

Article Synopsis
  • The Manhattan Lupus Surveillance Program (MLSP) investigated cardiovascular disease events in systemic lupus erythematosus (SLE) patients and compared their rates to population controls based on sex, age, and race/ethnicity.
  • In a study of 1,285 SLE patients, 13.9% experienced cardiovascular events, with higher risks associated with being male and over the age of 60.
  • The study found that Hispanic/Latino and non-Hispanic Black patients had significantly elevated risks for cardiovascular events compared to other racial groups, highlighting a higher overall prevalence of these events among SLE patients compared to the general population.
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Objectives: This study aims to determine the independent impact of definitions of remission/low disease activity (LDA) on direct/indirect costs (DCs, ICs) in a multicentre inception cohort.

Methods: Patients from 31 centres in 10 countries were enrolled within 15 months of diagnosis and assessed annually. Five mutually exclusive disease activity states (DAS) were defined as (1) remission off-treatment: clinical (c) SLEDAI-2K=0, without prednisone/immunosuppressants; (2) remission on-treatment: cSLEDAI-2K=0, prednisone ≤5 mg/day and/or maintenance immunosuppressants; (3) LDA-Toronto Cohort (TC): cSLEDAI-2K≤2, without prednisone/immunosuppressants; (4) modified lupus LDA state (mLLDAS): SLEDAI-2K≤4, no activity in major organs/systems, no new activity, prednisone ≤7.

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Article Synopsis
  • Cranial neuropathies (CN) are a rare manifestation of neuropsychiatric lupus, and the study investigates the association of anti-KIF20B antibodies as a possible biomarker for this condition within a large cohort of SLE patients.
  • The research involved 795 patients from a larger cohort, revealing that 29.8% were positive for anti-KIF20B, with a significantly higher positivity rate (70%) in those with CN compared to those without (29.3%).
  • Findings suggest that anti-KIF20B positivity is linked to CN in SLE patients, indicating its potential as a biomarker, though further research is required to confirm these results.
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Article Synopsis
  • The study utilized the Manhattan Lupus Surveillance Program (MLSP) to analyze the prevalence of systemic lupus erythematosus (SLE) along with related rheumatic diseases like Sjögren's disease, antiphospholipid syndrome, and fibromyalgia among different demographics.
  • A total of 1,342 SLE patients were examined, with findings indicating that Sjögren's disease (11.0%) and antiphospholipid syndrome (8.9%) were notably common among Latino and Asian patients, while fibromyalgia also affected 8.9% of patients, particularly among non-Latino White and Latino populations.
  • The research revealed significant differences in autoantibody profiles associated with S
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Objectives: Understand the patient experience of a pilot medical student-based patient navigator (PN) program. (2) Assess areas of improvement for further development as a model for expansion.

Methods: This was a cross-sectional study assessing patients' subjective experience of medical student navigators for rheumatological conditions.

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Objective: AURORA 2 evaluated the long-term safety, tolerability, and efficacy of voclosporin compared to placebo in patients with lupus nephritis (LN) receiving an additional two years of treatment following completion of the one-year AURORA 1 study.

Methods: Enrolled patients continued their double-blinded treatment of voclosporin or placebo randomly assigned in AURORA 1, in combination with mycophenolate mofetil and low-dose glucocorticoids. The primary objective was safety assessed with adverse events (AEs) and biochemical and hematological assessments.

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Objective: The goals of this study were to assess the associations of severe nonadherence to hydroxychloroquine (HCQ), objectively assessed by HCQ serum levels, and risks of systemic lupus erythematosus (SLE) flares, damage, and mortality rates over five years of follow-up.

Methods: The Systemic Lupus International Collaborating Clinics (SLICC) Inception Cohort is an international multicenter initiative (33 centers throughout 11 countries). The serum of patients prescribed HCQ for at least three months at enrollment were analyzed.

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Objectives: A novel longitudinal clustering technique was applied to comprehensive autoantibody data from a large, well-characterised, multinational inception systemic lupus erythematosus (SLE) cohort to determine profiles predictive of clinical outcomes.

Methods: Demographic, clinical and serological data from 805 patients with SLE obtained within 15 months of diagnosis and at 3-year and 5-year follow-up were included. For each visit, sera were assessed for 29 antinuclear antibodies (ANA) immunofluorescence patterns and 20 autoantibodies.

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Objectives: Mycophenolate mofetil (MMF) has been long used in the treatment of systemic lupus erythematosus (SLE). Further studies are warranted to investigate its long-term use in maintenance treatment of lupus nephritis (LN). The purpose of this study was to describe our practice experience using MMF with regard to its indications, safety, tolerability, and treatment efficacy.

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Objective: To estimate direct and indirect costs associated with neuropsychiatric (NP) events in the Systemic Lupus International Collaborating Clinics inception cohort.

Methods: NP events were documented annually using American College of Rheumatology definitions for NP events and attributed to systemic lupus erythematosus (SLE) or non-SLE causes. Patients were stratified into 1 of 3 NP states (no, resolved, or new/ongoing NP event).

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Article Synopsis
  • The study aims to provide statistics on the prevalence and incidence of Mixed Connective Tissue Disease (MCTD) by using data from the Manhattan Lupus Surveillance Program (MLSP), which includes diverse populations with systemic lupus erythematosus (SLE) and related diseases.
  • MCTD cases were identified through rheumatology, hospitals, and databases, with specific criteria established for diagnosis, including positive RNP antibodies and certain clinical symptoms.
  • Results showed that the prevalence of MCTD varied significantly depending on the diagnostic criteria used, with the highest age-adjusted prevalence being 16.22 per 100,000 people, highlighting the complexities of defining MCTD in epidemiological research.
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Article Synopsis
  • The study looked at how hydroxychloroquine (HCQ), a medicine for lupus, affects the eyes over a long time.
  • Researchers followed 1,460 lupus patients from 1999 to 2019 and found that only 11 patients had eye problems related to HCQ.
  • The study suggests that people who've been on HCQ for more than 10 years, those who take higher doses, and older patients should have regular eye checks to catch any potential issues.
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Background: The coexistence of Neuromyelitis Optica spectrum disorder (NMOSD) with other autoimmune diseases (AD-NMOSD) presents worse clinical outcomes and healthcare costs than NMOSD alone (NMOSD-only). NMOSD and other autoimmune diseases also have a higher prevalence and morbidity in Black. We aim to compare clinical features and treatment responses in NMOSD patients with and without overlapping autoimmunity in a predominantly Black cohort.

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Lupus autoimmunity frequently presents with neuropsychiatric manifestations, but underlying etiology remains poorly understood. Human brain cytoplasmic 200 RNA (BC200 RNA) is a translational regulator in neuronal synapto-dendritic domains. Here, we show that a BC200 guanosine-adenosine dendritic transport motif is recognized by autoantibodies from a subset of neuropsychiatric lupus patients.

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Objective: This integrated analysis evaluates the efficacy and safety of voclosporin, a novel calcineurin inhibitor, at 23.7 mg twice daily in combination with mycophenolate mofetil (MMF) and oral glucocorticoids in lupus nephritis (LN) using pooled data from two large phase II and phase III clinical trials. The purpose was to expand the pool of patients for safety analyses and to increase power for efficacy analyses in patient subpopulations.

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Objective: To determine the independent impact of different definitions of remission and low disease activity (LDA) on damage accrual.

Methods: Patients with ≥2 annual assessments from a longitudinal multinational inception lupus cohort were studied. Five mutually exclusive disease activity states were defined: remission off-treatment: clinical Systemic Lupus Erythematosus Disease Activity Index (cSLEDAI)-2K=0, without prednisone or immunosuppressants; remission on-treatment: cSLEDAI-2K score=0, prednisone ≤5 mg/day and/or maintenance immunosuppressants; low disease activity Toronto cohort (LDA-TC): cSLEDAI-2K score of ≤2, without prednisone or immunosuppressants; modified lupus low disease activity (mLLDAS): Systemic Lupus Erythematosus Disease Activity Index-2K score of 4 with no activity in major organ/systems, no new disease activity, prednisone ≤7.

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Objective: Using the Manhattan Lupus Surveillance Program, a multiracial/ethnic population-based registry, we aimed to compare 3 commonly used classification criteria for systemic lupus erythematosus (SLE) to identify unique cases and determine the incidence and prevalence of SLE using the EULAR/American College of Rheumatology (ACR) criteria.

Methods: SLE cases were defined as fulfilling the 1997 ACR, the Systemic Lupus International Collaborating Clinics (SLICC), or the EULAR/ACR classification criteria. We quantified the number of cases uniquely associated with each and the number fulfilling all 3 criteria.

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Organ damage is a key determinant of poor long-term prognosis and early death in patients with systemic lupus erythematosus (SLE). Prevention of damage is a key treatment goal of the 2019 update of the European Alliance of Associations for Rheumatology (EULAR) recommendations for SLE management. Belimumab is a monoclonal antibody that inhibits B lymphocyte stimulator (BLyS) and is the only therapy approved for both SLE and lupus nephritis.

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Objectives: A perception derived from cross-sectional studies of small systemic lupus erythematosus (SLE) cohorts is that there is a marked discrepancy between antinuclear antibody (ANA) assays, which impacts on clinicians' approach to diagnosis and follow-up. We compared three ANA assays in a longitudinal analysis of a large international incident SLE cohort retested regularly and followed for 5 years.

Methods: Demographic, clinical and serological data was from 805 SLE patients at enrolment, year 3 and 5.

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Objective: The Systemic Lupus International Collaborating Clinics (SLICC), American College of Rheumatology (ACR), and the Lupus Foundation of America are developing a revised systemic lupus erythematosus (SLE) damage index (the SLICC/ACR Damage Index [SDI]). Shifts in the concept of damage in SLE have occurred with new insights into disease manifestations, diagnostics, and therapy. We evaluated contemporary constructs in SLE damage to inform development of the revised SDI.

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Article Synopsis
  • - The study investigates the link between glucocorticoid (GC) exposure and the risk of irreversible organ damage in patients with systemic lupus erythematosus (SLE), emphasizing the importance of managing GC use effectively.
  • - Researchers conducted a literature review and analyzed 49 studies involving over 16,000 SLE patients to assess how different levels of GC exposure correlate with specific organ damage outcomes over an average follow-up of about 105 months.
  • - Findings revealed that higher daily GC doses were connected to increased occurrences of cardiovascular issues, osteoporosis with fractures, and osteonecrosis, suggesting the need for careful management of GC therapy in SLE patients to balance treatment benefits and potential harm.
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Objectives: To evaluate systemic lupus erythematosus (SLE) flares following hydroxychloroquine (HCQ) reduction or discontinuation versus HCQ maintenance.

Methods: We analysed prospective data from the Systemic Lupus International Collaborating Clinics (SLICC) cohort, enrolled from 33 sites within 15 months of SLE diagnosis and followed annually (1999-2019). We evaluated person-time contributed while on the initial HCQ dose ('maintenance'), comparing this with person-time contributed after a first dose reduction, and after a first HCQ discontinuation.

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Hydroxychloroquine (HCQ) and chloroquine (CQ) are well-established medications used in treating systemic lupus erythematosus and rheumatoid arthritis, as well as skin conditions such as cutaneous lupus erythematosus. In rare cases, arrhythmias and conduction system abnormalities, as well as cardiomyopathy, have been reported in association with HCQ/CQ use. Recently, however, the corrected QT interval (QTc)-prolonging potential of these medications, and risk of torsade de pointes (TdP) in particular, have been highlighted in the setting of their experimental use for COVID-19 infection.

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Objective: Enrollment of patients of Black African ancestry with systemic lupus erythematosus (SLE) in phase II and phase III of the belimumab trials was not reflective of the racial distribution observed in the lupus population. This study was undertaken to assess the efficacy and safety of intravenous (IV) belimumab plus standard therapy in patients of self-identified Black race.

Methods: EMBRACE (GSK Study BEL115471; ClinicalTrials.

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