Publications by authors named "Navarra S"
Objective: To estimate the prevalence of organ damage (damage) and flare and to examine longitudinal associations between flares and subsequent damage accrual, in patients with systemic lupus erythematosus (SLE).
Methods: Patients enrolled in the Asia Pacific Lupus Collaboration cohort with ≥3 years of prospectively captured data were studied. Flares were assessed at routine visits, while damage ((Systemic Lupus International Collaborating Clinics/American College of Rheumatology) Damage Index) was assessed annually.
The APLAR has published a set of recommendations on the management of systemic lupus erythematosus (SLE) in 2021. The current consensus paper supplements and updates specifically the treatment of lupus nephritis (LN) according to two rounds of Delphi exercise from members of the APLAR SLE special interest group, invited nephrologists, histopathologists, and lupus nephritis patients. For initial treatment of LN, we recommend a combination of glucocorticoids (GCs) with cyclophosphamide (CYC), mycophenolate mofetil (MMF), or the calcineurin inhibitors (CNIs) as first-line options.
View Article and Find Full Text PDFObjective: High disease activity status (HDAS) in patients with systemic lupus erythematosus (SLE) is associated with adverse long-term outcomes. We examined the frequency of lupus low disease activity state (LLDAS) and remission (REM) attainment in HDAS patients and whether their attainment was associated with improved patient outcomes.
Methods: Demographic, clinical and outcomes data, collected prospectively from a multinational cohort between 2013 and 2020, were analysed.
Background: Sphingosine-1-phosphate (S1P) is a signalling molecule that has an inhibitory role in atherosclerosis, inflammation, cell proliferation, and immunity. Cenerimod is a selective S1P receptor modulator under investigation for the treatment of systemic lupus erythematosus (SLE). We aimed to determine the efficacy, safety, and tolerability of four doses of cenerimod in adults with moderate-to-severe SLE receiving standard of care background therapy.
View Article and Find Full Text PDFObjectives: To develop evidenced recommendations to allow the global systemic lupus erythematosus (SLE) advocacy community to effectively advocate for change and improve care for patients with SLE.
Methods: A Global Working Group consisting of representatives from patient advocacy groups, professional organisations, and the SLE healthcare community defined key areas of unmet need in patients with SLE. Targeted principles for each area of unmet need guided a literature review to investigate the current global situation, pre-existing advocacy efforts, and best practices from other therapy areas.
Article Synopsis
- The lupus low disease activity state (LLDAS) allows some activity in systemic lupus erythematosus (SLE) as long as it stays within certain limits; this study examined the outcomes of patients achieving LLDAS with different levels of activity.
- A total of 2,099 SLE patients were analyzed over a median follow-up of 3.5 years, revealing that 20.8% had clinical activity, 50.4% had serological activity only, and 28.8% had neither while in LLDAS.
- Results indicated that all LLDAS subsets reduced the risk of disease flares and damage, with LLDAS showing no activity being the most protective against severe flares.
Article Synopsis
- - The study aimed to update the 1998 Systemic Lupus Erythematosus (SLE) Core Outcome Set by evaluating existing domains and generating new ones, involving both patients and collaborators in the process.
- - A survey collected responses from 100 patients and 145 collaborators, revealing that patients focused on life-impact domains while collaborators emphasized clinical aspects, highlighting a need for balanced input from both groups.
- - Findings showed agreement on some domains for inclusion in the updated SLE Core Outcome Set, while also identifying areas that need more explanation and suggesting new domains for consideration.
Background: Validation of protective associations of the lupus low disease activity state (LLDAS) against flare, irreversible damage, health-related quality of life, and mortality has enabled the adoption of treat-to-target strategies in patients with systemic lupus erythematosus (SLE). Previous validation studies were of short duration, limiting the ability to detect longer term signals in flare rate and irreversible damage. In addition, previous studies have focused on percent time at target, rather than actual periods of time that are more useful in clinical practice and trials.
View Article and Find Full Text PDFArticle Synopsis
- This study looked at how standard medications for systemic lupus erythematosus (SLE) affect important health outcomes like disease activity, flare-ups, and damage over time, using a substantial patient data set from the Asia Pacific Lupus Collaboration (APLC).
- Findings showed that a significant percentage of patients reached low disease activity levels, but many also had flares, with variations in medication use across different countries; specifically, some medications appeared to have a steroid-sparing effect.
- Key results revealed that patients on specific medications like tacrolimus had better odds of achieving low disease activity, while those taking azathioprine and methotrexate were less likely to reach that outcome; however
Article Synopsis
- The study aimed to determine if achieving Lupus Low Disease Activity State (LLDAS) leads to better outcomes for patients with newly diagnosed systemic lupus erythematosus (SLE).
- Data was collected from a longitudinal SLE cohort in 13 countries, focusing on patients diagnosed within the last year, revealing that these patients had higher disease activity and use of glucocorticoids, but less organ damage initially compared to older patients in the study.
- Results showed that while fewer patients in the recent onset group were in LLDAS at the start, they were more likely to achieve it during follow-up and LLDAS attainment was linked to a lower risk of disease flare-ups.
Article Synopsis
- * Data from a large international cohort of 1,850 mSACQ patients revealed that reducing GCs by 1 mg/day did not increase the risk of overall or severe flares; in fact, the use of antimalarials was linked to a lower risk of flares.
- * Tapering GCs was found to reduce the risk of damage accrual for patients starting with higher prednisolone doses (over 5 mg/day
Background: The Outcome Measures in Rheumatology (OMERACT) Systemic Lupus Erythematosus (SLE) Working Group held a Special Interest Group (SIG) at the OMERACT 2023 conference in Colorado Springs where SLE collaborators reviewed domain sub-themes generated through qualitative research and literature review.
Objective: The objective of the SIG and the subsequent meetings of the SLE Working Group was to begin the winnowing and binning of candidate domain sub-themes into a preliminary list of candidate domains that will proceed to the consensus Delphi exercise for the SLE COS.
Methods: Four breakout groups at the SLE SIG in Colorado Springs winnowed and binned 132 domain sub-themes into candidate domains, which was continued with a series of virtual meetings by an advisory group of SLE patient research partners (PRPs), members of the OMERACT SLE Working Group Steering Committee, and other collaborators.
Background: Targets of treatment for systemic lupus erythematosus (SLE) include the Lupus Low Disease Activity State (LLDAS), remission, and complete remission. Whether treatment can be tapered after attaining these targets and whether tapering is safer in patients in complete remission compared with LLDAS are unknown. We aimed to assess the odds of disease flares after treatment tapering in stable disease, versus continuing the same therapy.
View Article and Find Full Text PDFObjectives: To update the EULAR recommendations for the management of systemic lupus erythematosus (SLE) based on emerging new evidence.
Methods: An international Task Force formed the questions for the systematic literature reviews (January 2018-December 2022), followed by formulation and finalisation of the statements after a series of meetings. A predefined voting process was applied to each overarching principle and recommendation.
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.
Objective: Disease activity monitoring in SLE includes serial measurement of anti-double stranded-DNA (dsDNA) antibodies, but in patients who are persistently anti-dsDNA positive, the utility of repeated measurement is unclear. We investigated the usefulness of serial anti-dsDNA testing in predicting flare in SLE patients who are persistently anti-dsDNA positive.
Methods: Data were analysed from patients in a multinational longitudinal cohort with known anti-dsDNA results from 2013 to 2021.
Objective: To investigate the impact of sustained low disease activity (LDA)/remission (REM) on physical function, quality of life (QoL) and structural outcomes in secukinumab-treated psoriatic arthritis (PsA) patients from the FUTURE 5 study.
Methods: FUTURE 5 was a randomised, double-blind, placebo-controlled, parallel-group, phase 3 study in patients with active PsA. Patients were categorised according to LDA (Minimal Disease Activity, MDA/Disease Activity index for Psoriatic Arthritis, DAPSA LDA+REM) or REM (very LDA/DAPSA REM): not achieving LDA/REM, achieving it once or sustained LDA/REM ≥3 times up to week 104.
Background: The selection and categorisation of laboratory tests in disease activity measures used within systemic lupus erythematosus (SLE) trial endpoints lack strong evidence. We aimed to determine whether longitudinal improvements in routinely measured laboratory tests are associated with measures of clinical improvement in patients with baseline active SLE.
Methods: We included patients from a multicentre longitudinal cohort (recruited between May 1, 2013, and Dec 31, 2019) with active SLE (SLEDAI-2K ≥6) coinciding with an abnormality in at least one of 13 routine laboratory tests, at a visit designated as baseline.
Background: Treat-to-target goals for patients with systemic lupus erythematosus (SLE) have been validated to protect against organ damage and to improve quality of life. We aimed to investigate the association between lupus low disease activity state (LLDAS) and remission and risk of mortality in patients with SLE. We hypothesised that LLDAS has a protective association with mortality risk.
View Article and Find Full Text PDFObjective: In trials of systemic lupus erythematosus (SLE), the SLE Responder Index (SRI) is the most commonly used primary efficacy end point but has limited validation against long-term outcomes. We aimed to investigate associations of attainment of a modified version of the SRI (mSRI) with key clinical outcomes in SLE patients with up to 5 years of follow-up.
Methods: We used data from a large multicenter, longitudinal SLE cohort in which patients received standard of care.
Background: Antibody-binding of blood dendritic cell antigen 2 (BDCA2), which is expressed exclusively on plasmacytoid dendritic cells, suppresses the production of type I interferon that is involved in the pathogenesis of systemic lupus erythematosus (SLE). The safety and efficacy of subcutaneous litifilimab, a humanized monoclonal antibody that binds to BDCA2, in patients with SLE have not been extensively studied.
Methods: We conducted a phase 2 trial of litifilimab involving participants with SLE.
Background: Blood dendritic cell antigen 2 (BDCA2) is a receptor that is exclusively expressed on plasmacytoid dendritic cells, which are implicated in the pathogenesis of lupus erythematosus. Whether treatment with litifilimab, a humanized monoclonal antibody against BDCA2, would be efficacious in reducing disease activity in patients with cutaneous lupus erythematosus has not been extensively studied.
Methods: In this phase 2 trial, we randomly assigned adults with histologically confirmed cutaneous lupus erythematosus with or without systemic manifestations in a 1:1:1:1 ratio to receive subcutaneous litifilimab (at a dose of 50, 150, or 450 mg) or placebo at weeks 0, 2, 4, 8, and 12.
Objectives: Dactylitis is an important clinical domain of psoriatic arthritis (PsA) associated with significant burden of disease and impaired function. Post-hoc analysis of the FUTURE 5 study was performed to evaluate the efficacy of secukinumab in patients with dactylitis at baseline over 2 years.
Methods: Randomised patients received secukinumab 300mg with loading dose (LD)/150mg LD/150mg without loading dose/placebo.