Lupus
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Multicenter Study
Incidence and variables associated with short and long-term mortality in patients with systemic lupus erythematosus and sepsis admitted in intensive care units.
Background Infections are common among patients with systemic lupus erythematosus (SLE), and are associated with increased morbidity and mortality. Objectives To determine whether SLE is an independent risk factor for short- and long-term mortality in patients admitted to an intensive care unit (ICU) with sepsis, and to identify the characteristics of SLE patients admitted to an ICU with sepsis. Methods A retrospective age- and sex-matched cohort study, based on data of the SEPSIS-ISR (Sepsis Israel) Registry, an ongoing study that collects data on all patients admitted with sepsis to the ICUs. ⋯ Conclusions SLE is not an independent risk factor for 30-day or 3-year mortality following ICU admission with sepsis. Increased late mortality was associated with congestive heart failure within the SLE patients alone. None of the SLE-related variables were statistically different between the living and deceased SLE patients.
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Randomized Controlled Trial Multicenter Study
A 6-month open-label extension study of the safety and efficacy of subcutaneous belimumab in patients with systemic lupus erythematosus.
Objective To evaluate the safety, tolerability and efficacy of subcutaneous (SC) belimumab in patients with systemic lupus erythematosus (SLE) beyond 1 year. Methods This was a 24-week, open-label extension following a 52-week, double-blind, placebo-controlled trial of belimumab SC. Patients who completed the double-blind phase were eligible to enter the open-label phase. ⋯ Conclusion Belimumab SC was well tolerated and efficacy was maintained during the extension phase of this study. The safety profile of belimumab SC is consistent with that of previous experience with belimumab. Trial registration ClinicalTrials.gov identifier: NCT01484496.
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Randomized Controlled Trial Multicenter Study Comparative Study
Efficacy and safety of rivaroxaban vs warfarin in high-risk patients with antiphospholipid syndrome: Rationale and design of the Trial on Rivaroxaban in AntiPhospholipid Syndrome (TRAPS) trial.
New oral anticoagulants may simplify long-term therapy in conditions requiring anticoagulation. Rivaroxaban is a direct factor Xa inhibitor that has been extensively studied and is now approved for the prevention and therapy of a number of thromboembolic conditions. ⋯ The methods and the study design should be appropriate to achieve study results that are both scientifically valid and relevant to clinical practice.
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Multicenter Study
Early Lupus Project - A multicentre Italian study on systemic lupus erythematosus of recent onset.
Systemic lupus erythematosus (SLE) is an autoimmune disease with a high degree of variability at onset that is problematic for a correct and prompt diagnosis. We undertook this project with the purpose of collecting an inception cohort of Italian patients with recent-onset SLE, in order to obtain information on the main clinical and serological characteristics at the beginning of the disease. In this first report we describe the characteristics of this cohort at study entry. ⋯ In this paper we describe the main clinical and serological characteristics of an Italian inception cohort of patients with recent-onset SLE. At disease onset, mucocutaneous manifestations, arthritis and haematologic manifestations were the most frequent symptoms; ANA, anti-dsDNA and complement reduction were the most frequent laboratory findings. Our data confirm that the diagnosis of SLE is a challenging one, and that SLE is a severe disease even at onset, since the majority of patients require at least a hospitalization before the diagnosis.
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Multicenter Study
Associations of clinical features and prognosis with age at disease onset in patients with systemic lupus erythematosus.
The objective of this study is to evaluate the association of clinical features and prognosis with age at disease onset in patients with systemic lupus erythematosus (SLE) in a large, multicenter Chinese cohort. Medical records of 1898 SLE inpatients from 15 hospitals were reviewed and classified into three groups according to their ages at disease presentation. Categorical data were analyzed by chi-square test and potentially associated factors were tested by multinomial logistic regression. ⋯ Interestingly, our data showed that more patients with late-onset disease had a SLEDAI score change of >7 at discharge. In conclusion, age at onset has an impact on SLE disease status, and infection is the main cause of death in those with late-onset lupus. Considering that the late-onset patients had simultaneously easily controllable diseases and high incidence of comorbidities, a different treatment strategy from younger patients should be considered.