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SLE generics

Hong-Wei Fan, Zhi-Xiang Ma, Jing Chen, Xing-Ye Yang, Jun-Lin Cheng, Ying-Bin Li
INTRODUCTION: Hydroxychloroquine (HCQ), 4-aminoquinoline, is an antimalarial drug and has become a basic therapy for rheumatic disease treatment. It can stabilize the condition of SLE patients and reduce the chances of patient relapse through its immunosuppressive function and antiinflammatory effects. This drug was absorbed completely and rapidly by oral administration, but has a prolonged half-life for elimination. The objective of this study was to evaluate the pharmacokinetic parameters and relative bioequivalence of a new generic (test) formulation with the branded (reference) formulation of HCQ in healthy Chinese male volunteers...
December 2015: Rheumatol Ther
Mathilde Pugès, Pascal Biscay, Thomas Barnetche, Marie-Élise Truchetet, Christophe Richez, Julien Seneschal, Noémie Gensous, Estibaliz Lazaro, Pierre Duffau
OBJECTIVES: The aim was to assess the immunogenicity and the impact on disease activity of pneumococcal and influenza vaccines in SLE patients. METHODS: We conducted a systematic literature review and meta-analysis of studies comparing the humoral response of either pneumococcal (serotype 23F) or influenza (AH1N1, AH3N2 and B strains) vaccines between SLE patients and healthy controls, assessed by a seroconversion or a seroprotection rate 3-6 weeks after vaccination...
September 2016: Rheumatology
Mary Mahieu, Susan Yount, Rosalind Ramsey-Goldman
Successful management of complex conditions such as systemic lupus erythematosus (SLE) and comorbid conditions benefit from patient-reported outcomes (PRO). Measuring health-related quality of life with PROs provides SLE patients with an opportunity to participate in their treatment and to facilitate better communication with the multidisciplinary team involved in their care. Health outcomes research has produced well-validated instruments that can be used across diseases; others have been specifically developed for SLE...
May 2016: Rheumatic Diseases Clinics of North America
Hui Wang, Xiaoxiao Guo, Jinzhi Lai, Qian Wang, Zhuang Tian, Yongtai Liu, Mengtao Li, Jiuliang Zhao, Xiaofeng Zeng, Quan Fang
OBJECTIVES: Understanding health-related quality of life (HRQoL) is important in the management of patients with systemic lupus erythematosus associated pulmonary arterial hypertension (SLE-APAH), however, little is known about HRQoL and its determinants in these patients. METHODS: A total of 60 female SLE-APAH patients with mean age of 33.5 years were prospectively recruited from May 2013 to November 2014. Right heart catheter, SF-36 generic questionnaire, disease activity and functional status were assessed in all patients...
March 2016: Clinical and Experimental Rheumatology
César Magro-Checa, Elisabeth J Zirkzee, Tom W Huizinga, Gerda M Steup-Beekman
Neuropsychiatric systemic lupus erythematosus (NPSLE) is a generic definition referring to a series of neurological and psychiatric symptoms directly related to systemic lupus erythematosus (SLE). NPSLE includes heterogeneous and rare neuropsychiatric (NP) manifestations involving both the central and peripheral nervous system. Due to the lack of a gold standard, the attribution of NP symptoms to SLE represents a clinical challenge that obligates the strict exclusion of any other potential cause. In the acute setting, management of these patients does not differ from other non-SLE subjects presenting with the same NP manifestation...
March 2016: Drugs
Amirhossein Sahebkar, Jana Rathouska, Giuseppe Derosa, Pamela Maffioli, Petr Nachtigal
BACKGROUND AND PURPOSE: Efficacy and safety of statin therapy in patients with systemic lupus erythematosus (SLE) is controversial. The aim of this meta-analysis was to evaluate whether statin therapy affects SLE disease activity and systemic inflammation (C-reactive protein, CRP) according to the evidence from controlled clinical trials. EXPERIMENTAL APPROACH: A systematic review followed by a bibliographic search in Medline and SCOPUS (up to March 2015) was performed...
April 2016: Autoimmunity Reviews
Su-li Wang, Evelyn Hsieh, Li-an Zhu, Bin Wu, Liang-jing Lu
In a time of increasing economic constraints, it is crucial that health systems optimize their resource use to ensure that they generate the maximum possible health gain. Therefore, it is necessary for health interventions to be evaluated and compared across therapeutic boundaries. Undertaking such an evaluation a generic utility-based measure is required. But it remains uncertain whether the utility values obtained by direct or indirect methods are comparable and which approach is the most appropriate in Systemic Lupus Erythematosus (SLE) population...
2015: Scientific Reports
Jordan T Jones, Natoshia Cunningham, SusmitA Kashikar-Zuck, Hermine I Brunner
OBJECTIVE: To evaluate pain, fatigue, and psychological functioning of childhood-onset systemic lupus erythematosus (SLE) patients and examine how these factors impact health-related quality of life (HRQOL). METHODS: At a tertiary rheumatology clinic, 60 childhood-onset SLE patients completed the following: a visual analog scale (VAS) of pain intensity (0-10), the Pediatric Quality of Life (PedsQL) multidimensional fatigue scale, Pain Coping Questionnaire, Pain Catastrophizing Scale (PCS), Children's Depression Inventory I (CDI-I), the Screen for Child Anxiety Related Emotional Disorders (SCARED) questionnaire, and the PedsQL generic core (GC) scale and rheumatology module (RM)...
January 2016: Arthritis Care & Research
Randy Q Cron, Sergio Davi, Francesca Minoia, Angelo Ravelli
Macrophage activation syndrome (MAS) is increasingly recognized among febrile hospitalized patients. Clinically, MAS resembles multiorgan dysfunction and shock. Laboratory features include hepatobiliary dysfunction, coagulopathy, pancytopenia, hyperferritinemia and markers of immune activation. Pathologically, hemophagocytosis is commonly seen but is only present in 60% of MAS patients. MAS, or secondary hemophagocytic lymphohistiocytosis (HLH), is triggered by infectious (e.g., herpes family viruses), rheumatologic (e...
2015: Expert Review of Clinical Immunology
I Castrejon, L Carmona, N Agrinier, M Andres, K Briot, M Caron, R Christensen, A Consolaro, R Curbelo, Montserrat Ferrer, Violaine Foltz, C Gonzalez, F Guillemin, P M Machado, Birgit Prodinger, A Ravelli, M Scholte-Voshaar, T Uhlig, L H D van Tuyl, A Zink, L Gossec
OBJECTIVES: Patient reported outcomes (PROs) are relevant in rheumatology. Variable accessibility and validity of commonly used PROs are obstacles to homogeneity in evidence synthesis. The objective of this project was to provide a comprehensive library of "validated PROs". METHODS: A launch meeting with rheumatologists, PROs methodological experts, and patients, was held to define the library's aims and scope, and basic requirements. To feed the library we performed systematic reviews on selected diseases and domains...
November 2015: Clinical and Experimental Rheumatology
E Cozzani, G Gasparini, M Papini, M Burlando, F Drago, A Parodi
Vasculitis in connective tissue disease (CTD) is quite rare, it is reported in approximately 10% of patients with CTD; systemic lupus erythematosus (SLE) shows the highest association rate. Vessels of any size may be involved, but mainly small vessels vasculitis is reported. At present the classification of these vasculitis is unsatisfactory. According to the 2012 revised International Chapel Hill Consensus Conference, vasculitides secondary to CTD are a well identified entity and are classified under the category of "vasculitis associated with systemic disease"...
April 2015: Giornale Italiano di Dermatologia e Venereologia: Organo Ufficiale, Società Italiana di Dermatologia e Sifilografia
O N Pamuk, A M Onat, S Donmez, C Mengüs, B Kisacik
BACKGROUND: Systemic lupus erythematosus (SLE) patients have seriously impaired quality of life (QoL). In addition to activity and damage indices used in the past, tools to evaluate QoL in SLE have been developed in recent years. In this study, we test the validity of the Turkish version of the Lupus-QoL (LupusQoL-TR) score, and investigate its association with clinical findings and activity indices. METHODS: A total of 132 patients diagnosed with SLE according to ACR 1997 criteria were included...
July 2015: Lupus
I Castrejón, C Tani, M Jolly, A Huang, M Mosca
This review summarises most currently used indices to assess and monitor patients with systemic lupus erythematosus (SLE) in clinical trials, long-term observational studies, and clinical care. Six SLE disease activity indices include the British Isles Lupus Assessment Group Index (BILAG), European Consensus Lupus Activity Measurement (ECLAM), Systemic Lupus Activity Measure (SLAM), Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), Lupus Activity Index (LAI), and Systemic Lupus Erythematosus Activity Questionnaire (SLAQ)...
September 2014: Clinical and Experimental Rheumatology
Hervé Devilliers, Zahir Amoura, Jean-François Besancenot, Bernard Bonnotte, Jean-Louis Pasquali, Denis Wahl, Francois Maurier, Pierre Kaminsky, Jean-Loup Pennaforte, Nadine Magy-Bertrand, Laurent Arnaud, Christine Binquet, Francis Guillemin, Claire Bonithon-Kopp
OBJECTIVES: This study aimed to estimate the responsiveness to change of a generic [the 36-item Short Form Health Survey (SF-36)] and a specific health-related quality of life questionnaire [the Lupus Quality if Life questionnaire (LupusQoL)] according to SLE patients' self-reported changes in health status. METHODS: In a cohort of 185 SLE patients, quality of life (QoL) was measured three times at 3 month intervals by the LupusQoL and SF-36 questionnaires. Anchors for responsiveness were defined by patients' global assessment of disease impact according to changes in a visual analogue scale (VAS), a 7-point Likert scale and a 0-3 scale of five patient-reported symptoms...
May 2015: Rheumatology
G Chehab, J Richter, M Schneider
BACKGROUND: Over the last three decades patient reported outcomes (PRO) have become increasingly more important for the assessment of the course of diseases and therapy response. It represents the generic term for instruments which elicit information on various disease dimensions by direct questioning of patients and thereby collate subjective estimations and perceptions. AIM OF THE STUDY: This article presents the current situation with respect to the utilization of PRO...
October 2014: Zeitschrift Für Rheumatologie
Chi Chiu Mok, Mark Kosinski, Ling Yin Ho, Kar Li Chan, Meenakshi Jolly
OBJECTIVE: LupusPRO is a disease-targeted, patient-reported outcome (PRO) measure that was developed and validated for assessment of quality of life in US patients with systemic lupus erythematosus (SLE). We present results of adapting the LupusPRO into Chinese and testing its psychometric properties in Chinese patients with SLE. METHODS: LupusPRO was translated into "traditional" Chinese, followed by pretesting among native Cantonese Chinese speakers. The translation version was revised based on the feedback obtained...
February 2015: Arthritis Care & Research
Laura Holloway, Louise Humphrey, Louise Heron, Claire Pilling, Helen Kitchen, Lise Højbjerre, Martin Strandberg-Larsen, Brian Bekker Hansen
BACKGROUND: Despite overall progress in treatment of autoimmune diseases, patients with systemic lupus erythematosus (SLE) experience many inflammatory symptoms representing an unmet medical need. This study aimed to create a conceptual model of the humanistic and economic burden of SLE, and review the patient-reported outcomes (PROs) used to measure such concepts in SLE clinical trials. METHODS: A conceptual model for SLE was developed from structured review of published articles from 2007 to August 2013 identified from literature databases (MEDLINE, EMBASE, PsycINFO, EconLit) plus other sources (PROLabels, FDA/EMA websites, Clinicaltrials...
2014: Health and Quality of Life Outcomes
Zoubida Tazi Mezalek, Wafaa Bono
In emerging countries, systemic lupus erythematosus (SLE) has been associated with several unfavorable outcomes including disease activity, damage accrual, work disability and mortality. Poor socioeconomic status (SES) and lack of access to healthcare, especially in medically underserved communities, may be responsible for many of the observed disparities. Diagnostic delay of SLE or for severe organ damages (renal involvement) have a negative impact on those adverse outcomes in lupus patients who either belong to minority groups or live in emerging countries...
June 2014: La Presse Médicale
Anisha B Dua, Zahi Touma, Sergio Toloza, Meenakshi Jolly
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that has major implications for health-related quality of life (HRQoL). Improvements in the monitoring and management of SLE improves survival; however, improvement of HRQoL remains of paramount importance among these patients. Measurement of HRQoL has been recommended in clinical practice and research including drug development and testing in clinical trials. Both generic and disease specific instruments have been developed to ascertain HRQoL...
December 2013: Current Rheumatology Reports
Su-Li Wang, Bin Wu, Lin Leng, Richard Bucala, Liang-Jing Lu
OBJECTIVES: To adapt and assess the validity and reliability of LupusQoL for use in Chinese patients with systemic lupus erythematosus (SLE). METHODS: Debriefing interviews of subjects with SLE guided the language modifications of the tool. The process of adaptation proceeded according to the guideline and pre-testing results of LupusQoL-China. 220 SLE patients completed LupusQoL-China and a generic preference-based measurement of health EuroQoL scale (EQ-5D), and 20 patients repeated them after 2 weeks...
2013: PloS One
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