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Publications
Publications (33)
Introduction
High-dose glucocorticoid (GC)-based dual immunosuppressive treatment regimens are still frequently used in active lupus nephritis (LN) despite their known association with dose-dependent toxicities and incomplete efficacy. We hypothesised that the addition of voclosporin to low-dose GCs and mycophenolate mofetil (MMF) would reduce expo...
Background and Aims
Voclosporin is a second generation calcineurin inhibitor (CNI) approved for the treatment of adults with active lupus nephritis (LN) in combination with immunosuppressive therapy. An integrated analysis of the Phase 2 AURA-LV and Phase 3 AURORA 1 studies concluded that combining voclosporin with lower-dose mycophenolate mofetil...
We present a detailed analysis of myeloid cell populations found in the kidneys of lupus nephritis (LN) patients, based on the single-cell RNA-sequencing (scRNA-seq) data collected as part of the Accelerating Medicines Partnership (AMP) in RA/SLE consortium. Overall, 23,819 cells isolated from 156 LN patients and 30 healthy donors passed QC. Cluste...
Background
Lupus nephritis (LN) is a common and severe complication of systemic lupus erythematosus requiring renal biopsy to guide treatment decisions. Despite standard-of-care therapy, a third of patients with LN class III, IV, or V show a progressive decline in kidney function. Identifying distinct inflammatory processes associated with LN using...
Background
The Lupus Low Disease Activity State (LLDAS) has been prospectively validated as protective from flares, damage accrual, and mortality and is an important treatment goal in patients with SLE. Recent analysis of pooled data from 2 phase 3 trials (TULIP-1 and TULIP-2) found that LLDAS attainment was achieved earlier, more frequently, and f...
Background
The G1 and G2 risk variants (RVs) in Apolipoprotein L1 (APOL1) associate with chronic kidney disease (CKD) and may contribute to poorer outcomes for African American (AA) patients with lupus nephritis (LN). While the pathogenetic mechanism for APOL1 related CKD remains unknown, most studies focus on glomerular injury. This study leverage...
Objective
Lupus nephritis (LN) can occur as an isolated component of disease activity or be accompanied by diverse extrarenal manifestations. Whether isolated renal disease is sufficient to decrease health related quality of life (HRQOL) remains unknown. This study compared Patient-Reported Outcomes Measurement Information System 29-Item (PROMIS-29...
Objective
Early reduction in proteinuria after initial treatment has been associated with improved long-term kidney outcomes in lupus nephritis (LN). The addition of voclosporin, a second generation calcineurin inhibitor, to MMF and low-dose glucocorticoids (GC)s led to greater reductions in proteinuria compared to conventional therapy in the AURA-...
Objective
We investigated DORIS (Definition of Remission in SLE) attainment in patients with SLE in the placebo-controlled phase 3 TULIP long-term extension (LTE) trial of anifrolumab. DORIS attainment includes a requirement for a clinical SLEDAI-2K (cSLEDAI-2K) score of 0. Initial analyses of DORIS in the TULIP-LTE excluded all laboratory paramete...
Background
Leveraging the Accelerating Medicines Partnership (AMP) Lupus Nephritis (LN) dataset, we evaluated longitudinal patterns, rates, and predictors of response to standard-of-care therapy in patients with lupus nephritis.
Methods
Patients from US academic medical centers with class III, IV, and/or V LN and a baseline urine protein/creatinin...
Background
Systemic lupus erythematosus (SLE) patients are prone to frequent emergency department (ED) visits. This study explores the epidemiology and outcomes of ED visits by patients with SLE utilizing the Nationwide Emergency Department Sample (NEDS).
Methods
Using NEDS (2019), SLE ED visits identified using ICD-10 codes (M32. xx) were compare...
Background
The Lupus Low Disease Activity State (LLDAS) has been prospectively validated as protective from flares, damage accrual, and mortality and is an important treatment goal in patients with SLE. [1] Recent analysis of pooled data from 2 phase 3 trials (TULIP-1 and TULIP-2) found that LLDAS attainment was achieved earlier, more frequently, a...
Background
Lupus nephritis (LN) is a common and severe complication of systemic lupus erythematosus (SLE) requiring renal biopsy to guide treatment decisions. Despite standard-of-care therapy, a third of patients with LN class III, IV, or V show a progressive decline in kidney function, including those with improved proteinuria. Defining LN heterog...
Background
Anifrolumab is a type I interferon (IFN) receptor antagonist approved for treating adults with moderate to severe SLE [1] . The efficacy and safety of anifrolumab was evaluated in two 1-year phase 3 TULIP studies ( NCT02446912 , NCT02446899 ), and patients completing treatment in TULIP-1/-2 could enter the 3-year, placebo-controlled long...
Background
Cenerimod is an orally active, selective sphingosine 1-phosphate (S1P) 1 receptor modulator under investigation for the treatment of systemic lupus erythematosus (SLE). The Phase 2 CARE study (NCT03742037) did not meet its primary endpoint after adjustment for multiplicity, but patients treated with cenerimod 4 mg showed reduced disease...
Introduction
Care of young adults with SLE (YA-SLE, 18–24 years) is challenging due to major life transitions co-occurring with chronic healthcare needs. Studies have demonstrated poorer outcomes in the post-transition period. Epidemiological studies focused on serious infection-related hospitalisation (SIH) in YA-SLE are lacking.
Methods
We used...
Body
There is a growing interest and use of cellular therapies in almost all fields of medicine. Mesenchymal stromal cells (MSCs) are pluripotent in their ability to differentiate in chondrocytes, adipocytes and osteoblasts. They more recently were reported to have significant immune activity, primarily by producing anti-inflammatory molecules. The...
Background
In a 24-week, phase 2 clinical study ( NCT02708095 ) in patients with systemic lupus erythematosus (SLE), baricitinib (BARI), an oral selective inhibitor of Janus kinase 1 and 2 approved for the treatment of rheumatoid arthritis and atopic dermatitis, inhibited the type l interferon gene signature, multiple other cytokine pathways, and i...
Background
SLE is a heterogeneous disease with diverse clinical presentations, and up to 70–80% of patients develop skin manifestations. 1–3 In SLE, plasmacytoid dendritic cells (pDCs), a major source of Type I interferon (IFN), accumulate in the skin. ⁴ Treatment with BIIB059, a humanized monoclonal antibody targeting blood dendritic cell antigen...
Genetic variants are vital in informing clinical phenotypes, aiding physical diagnosis, guiding genetic counseling, understanding the molecular basis of disease, and potentially stimulating drug development. Here we describe two families with an ultrarare ACVR1 gain-of-function pathogenic variant (codon 375, Arginine > Proline; ACVR1R375P) responsi...
Objective
To determine predictors of change in neuropsychiatric (NP) event status in a large, prospective, international inception cohort of patients with systemic lupus erythematosus (SLE).
Methods
Upon enrollment and annually thereafter, NP events attributed to SLE and non‐SLE causes and physician‐determined resolution were documented. Factors p...
Objective: The Systemic Lupus International Collaborating Clinics (SLICC) 2012 systemic lupus erythematosus (SLE) classification criteria and the revised American College of Rheumatology (ACR) 1997 criteria are list based, counting each SLE manifestation equally. We derived a classification rule based on giving variable weights to the SLICC criteri...
Background
Patients with cutaneous lupus erythematosus (CLE) experience symptoms including photosensitivity, rash, pain, and skin damage that can impact their quality of life. No targeted therapies are approved for CLE. BIIB059 is a humanized monoclonal antibody that targets blood dendritic cell antigen-2 (BDCA2), expressed exclusively on the surfa...
Background
Patients with systemic lupus erythematosus (SLE) who received anifrolumab, a type I interferon receptor antibody, had greater BILAG–based Composite Lupus Assessment (BICLA) response rates vs placebo at Week (W)52 in the phase 2 MUSE ¹ and the phase 3 TULIP-1 ² and TULIP-2 ³ trials. Patients receiving anifrolumab also had fewer flares, an...
Background
Type I interferons and other inflammatory mediators derived from plasmacytoid dendritic cells (pDCs) are implicated in systemic lupus erythematous (SLE) pathology. BIIB059 is a humanized monoclonal antibody that targets blood dendritic cell antigen 2 (BDCA2), a pDC-specific receptor. The binding of BIIB059 to BDCA2 leads to rapid interna...
