Clinical and economic burden of organ damage among patients with systemic lupus erythematosus in a real-world setting in Germany.

BACKGROUND: Systemic lupus erythematosus (SLE), a chronic multisystem autoimmune disease, carries high risk of organ damage and burden to healthcare systems. SLE disease modification aims to reduce disease activity with minimal treatment toxicity and preventing or minimizing organ damage development. This real-world study utilizing healthcare administrative claims data assessed organ damage development, associated costs and healthcare resource utilization (HCRU) in patients with SLE in Germany. METHODS: Claims data from January 1, 2007, to December 31, 2017, were obtained from the Betriebskrankenkassen German Sickness Fund Database. Adults (> 18 years) with a confirmed SLE diagnosis between January 1, 2009, and December 31, 2014, (inclusion period) were included. The index date was calculated based on the first recorded SLE diagnosis during this period. Patients were propensity score-matched (1:3) to a comparator cohort without SLE by age, sex, and comorbidities (Charlson comorbidity index). Organ damage was identified using an algorithm developed based on conditions described in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI), using ICD-10-GM diagnostic codes, healthcare procedures, and/or treatments. RESULTS: 2121 patients with SLE and 6308 comparator patients were included (mean follow-up time: 6.4 years). Organ damage prevalence increased from 60.5% at baseline to 83.0% during 6 years of follow-up in all patients with SLE, while 17.0% of patients with SLE did not develop organ damage. Patients with newly confirmed SLE diagnosis without organ damage at baseline were nearly twice as likely to develop organ damage within 5 years versus the comparator cohort (52.0% vs. 27.0%). Total annual costs per patient-year for patients with SLE with organ damage were more than double those of patients with SLE without organ damage; both the number of inpatient admissions and length of stay were higher. CONCLUSIONS: The application of a recently developed algorithm allowed us to use claims data to elucidate SLE organ damage, and its associated high clinical and economic burden, in a large, representative sample in Germany. To our knowledge, this is the first European analysis of its kind involving a broad cohort of patients with SLE treated in the routine care setting.

Development of a Conceptual Model to Understand Disease Burden in Patients With Systemic Lupus Erythematosus and Organ Damage.

Background: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that can lead to irreversible organ damage (OD). Data describing the patient burden of OD, as compared with SLE without OD, are limited. Objective: To develop a comprehensive conceptual model describing the burden experienced by patients living with SLE-associated OD. Methods: There were three phases to this qualitative study. First, a targeted literature review was conducted to inform a draft conceptual model. Second, key opinion leaders (KOLs) were interviewed to assess the draft conceptual model and help shape patient interview materials. Third, patients of different demographic backgrounds from across the United States were interviewed individually to gather their perspectives on living with SLE-associated OD. Data from concept elicitation interviews with KOLs and patients were coded and analyzed using NVivo software to identify the key concepts of the overall patient burden of SLE-associated OD. Findings from the KOL and patient interviews were used to finalize the conceptual model. Results: KOLs highlighted that SLE-associated OD carried a higher rate of mortality than SLE alone. Participants with SLE-associated OD (n = 40) experienced detrimental impacts across 4 areas of their lives: physical, cognitive, psychosocial functioning, and economic and work-related well-being. Physical impacts were described by all participants, often affecting their ability to perform everyday tasks. Many also described deterioration of cognitive functioning. Almost all participants experienced emotional impacts and challenges to their relationships and social lives resulting from living with SLE-associated OD. Additionally, SLE-associated OD imposed an economic burden including increased healthcare costs. SLE-associated OD had a more severe and debilitating impact on all aspects of the patient's quality of life than SLE prior to OD development, including further limitations in activities of daily living after the development of OD. Discussion: Study findings guided the development of a comprehensive conceptual model that fully represents the patient experience of living with SLE-associated OD, highlighting the additional burden of OD when compared with SLE alone. Conclusions: The conceptual model will inform improvements in disease management, which may result in better patient outcomes and aid development of clinical outcome assessments of disease burden.

Report on the First PANLAR Rheumatology Review Course Rheumatoid Arthritis: Challenges and Solutions in Latin America.

The First PANLAR Rheumatology Review Course was held in Barranquilla, Colombia, in April 2015. Researchers, rheumatologists, epidemiologists, and a variety of allied professionals and patients attended the meeting. The scientific program included plenary sessions and symposia delivered by renowned experts in the field, followed by an interactive forum of discussion during 2 days.A broad spectrum of topics was discussed, reflecting the current challenges and opportunities for diagnosis and treatment of rheumatoid arthritis (RA) in Latin America. The scientific program included not only traditional disease aspects, but also social implications, research projects, and educational characteristics, patient perspectives, and novel care models, emphasizing the need for training human resources and proposing unique approaches to RA health care in Latin America, therefore helping us to increase and improve the knowledge and understanding of the characteristics of this health condition in the region, thus promoting and encouraging equity, quality, and efficiency of RA health care.

Translation, cross-cultural adaptation and validation of the Brazilian version of the Nonarthritic Hip Score.

CONTEXT AND OBJECTIVE The Nonarthritic Hip Score (NAHS) is a clinical evaluation questionnaire that was developed in the English language to evaluate hip function in young and physically active patients. The aims of this study were to translate this questionnaire into the Brazilian Portuguese language, to adapt it to Brazilian culture and to validate it. DESIGN AND SETTING Cohort study conducted between 2008 and 2010, at Universidade do Estado do Rio de Janeiro (UERJ). METHODS Questions about physical activities and household chores were modified to better fit Brazilian culture. Reproducibility, internal consistency and validity (correlations with the Algofunctional Lequesne Index and the Western Ontario and McMaster Universities Arthritis Index [WOMAC]) were tested. The NAHS-Brazil, Lequesne and WOMAC questionnaires were applied to 64 young and physically active patients (mean age, 40.9 years; 31 women). RESULTS The intraclass correlation coefficient (which measures reproducibility) was 0.837 (P < 0.001). Bland-Altman plots revealed a mean error in the difference between the two measurements of 0.42. The internal consistency was confirmed through a Cronbach alpha of 0.944. The validity between NAHS-Brazil and Lequesne and between NAHS-Brazil and WOMAC showed high correlations, r = 0.7340 and r = 0.9073, respectively. NAHS-Brazil showed good validity with no floor or ceiling effects. CONCLUSION The NAHS was translated into the Brazilian Portuguese language and was cross-culturally adapted to Brazilian culture. It was shown to be a useful tool in clinical practice for assessing the quality of life of young and physically active patients with hip pain.

Translation, cross-cultural adaptation and validation of the Brazilian version of the Nonarthritic Hip Score / Traducao, adaptacao cultural e validacao da versao brasileira do questionario Nonarthritic Hip Score

CONTEXT AND OBJECTIVE The Nonarthritic Hip Score (NAHS) is a clinical evaluation questionnaire that was developed in the English language to evaluate hip function in young and physically active patients. The aims of this study were to translate this questionnaire into the Brazilian Portuguese language, to adapt it to Brazilian culture and to validate it. DESIGN AND SETTING Cohort study conducted between 2008 and 2010, at Universidade do Estado do Rio de Janeiro (UERJ). METHODS Questions about physical activities and household chores were modified to better fit Brazilian culture. Reproducibility, internal consistency and validity (correlations with the Algofunctional Lequesne Index and the Western Ontario and McMaster Universities Arthritis Index [WOMAC]) were tested. The NAHS-Brazil, Lequesne and WOMAC questionnaires were applied to 64 young and physically active patients (mean age, 40.9 years; 31 women). RESULTS The intraclass correlation coefficient (which measures reproducibility) was 0.837 (P < 0.001). Bland-Altman plots revealed a mean error in the difference between the two measurements of 0.42. The internal consistency was confirmed through a Cronbach alpha of 0.944. The validity between NAHS-Brazil and Lequesne and between NAHS-Brazil and WOMAC showed high correlations, r = 0.7340 and r = 0.9073, respectively. NAHS-Brazil showed good validity with no floor or ceiling effects. CONCLUSION The NAHS was translated into the Brazilian Portuguese language and was cross-culturally adapted to Brazilian culture. It was shown to be a useful tool in clinical practice for assessing the quality of life of young and physically active patients with hip pain. .

CONTEXTO E OBJETIVO O Nonarthritic Hip Score (NAHS) é um questionário de avaliação clínica que foi desenvolvido na língua inglesa para avaliar a função do quadril em pacientes jovens e fisicamente ativos. O objetivo desse estudo foi traduzir o questionário NAHS para a língua portuguesa do Brasil, adaptá-lo à cultura brasileira e validá-lo. TIPO DE ESTUDO E LOCAL Estudo de coorte, realizado entre 2008 e 2010, na Universidade do Estado do Rio de Janeiro (UERJ). MÉTODOS Questões sobre atividades físicas e tarefas domésticas foram modificadas para melhor adaptação à cultura brasileira. Reprodutibilidade, consistência interna e validade (correlação entre o Algofunctional Lequesne Index e o Western Ontario McMaster Universities Arthritis Index [WOMAC]) foram testadas. Os questionários NAHS-Brasil, Lequesne e WOMAC foram aplicados em 64 pacientes jovens e fisicamente ativos (média de idade, 40,9 anos; 31 mulheres). RESULTADOS O coeficiente de correlação intraclasse que avalia reprodutibilidade mostrou valores de 0,837 (P < 0,001). O gráfico de Bland-Altman revelou um erro médio da diferença das duas medidas de 0,42. A consistência interna foi avaliada pelo alfa de Cronbach com valores de 0,944. A validade entre os questionários NAHS-Brasil/Lequesne e NAHS-Brasil/WOMAC mostraram alta correlação, r = 0,7340 e r = 0,9073; respectivamente. O NAHS-Brasil mostrou boa validade sem efeitos de chão ou de teto. CONCLUSÃO O NAHS foi traduzido para a língua portuguesa do Brasil e adaptado para a cultura brasileira, mostrando ser uma ferramenta útil na prática clínica para avaliar a qualidade de vida de pacientes jovens e fisicamente ativos com dor no quadril. .

Avaliação do uso da hidroxicloroquina no tratamento da osteoartrite sintomática de joelhos / Assessment of the use of hydroxychloroquine on knees' osteoarthritis treatment

OBJETIVO: Avaliar o efeito da hidroxicloroquina (HCQ) no tratamento da osteoartrite (OA) sintomática de joelhos. MÉTODOS: Dois grupos de pacientes com diagnóstico de OA sintomática de joelhos foram avaliados em estudo randomizado, controlado por placebo e duplo-cego, o primeiro constituído de 16 pacientes submetidos à terapêutica com HCQ, na dosagem de 400 mg/dia, durante quatro meses e o outro grupo constituído de 13 pacientes recebeu placebo por igual período. Ambos os grupos foram avaliados utilizando o Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), o índice algofuncional de Lequesne e a escala visual analógica (EVA). RESULTADOS: Não houve diferença entre os grupos nas subescalas do WOMAC em relação à dor (Wdor), p = 0,551, rigidez (Wrig), p = 0,512, e função (Wfunção), p = 0,293. Nas escalas EVA e Lequesne também não houve diferença estatisticamente significante com p = 0,461 e p = 0,803, respectivamente. CONCLUSÃO: Embora os dois grupos tenham apresentado melhora, não houve superioridade no tratamento da OA de joelhos no grupo submetido ao uso de HCQ em relação ao grupo placebo neste estudo.

OBJECTIVE: To assess the effectiveness of hydroxychloroquine (HCQ) on knee osteoarthritis (OA). METHODS: Two groups of patients with OA diagnosis have been assessed in a controlled, randomic, double-blind study, the first group consisted of 16 patients who received the therapeutics with HCQ, with the dosage of 400 milligrams per day during four months and the other one consisted of 13 patients who received the placebo during the same period of time. Both groups were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequèsne Algofunctional Index and the Visual Analogue Scale (VAS). RESULTS: There was not any difference between the groups on the WOMAC subscales in relation to the pain (p=0,551), stiffness (p=0.512) and function (p=0.293). On the VAS and Lequèsne scale, there was not any difference statistically significant with p=0.461 and p=0.803 respectively. CONCLUSION: Although both groups have presented improvement, there was not superiority on the knees' OA treatment in the group which underwent HCQ use in relation to the placebo group in this study.

Noninvasive cardiac assessment in children of women with systemic lupus erythematosus.

OBJECTIVE: Noninvasive cardiac assessment of newborns and infants of women with systemic lupus erythematosus. The children had no congenital total atrioventricular block and were compared with the children of healthy women. METHODS: We prospectively assessed 13 newborns and infants aged 1 to 60 days, children of women with systemic lupus erythematosus and without congenital total atrioventricular block. These children were compared with 30 children of women who had no lupus or anti-Ro/SSA antibodies, and no risk factors for congenital heart disease either. Their age groups matched. The following examinations were performed: cardiological physical examination, electrocardiography, echocardiography, and signal-averaged electrocardiography. RESULTS: The statistical analysis showed no significant difference in ventricular function or in the cardiac conduction system between the groups. CONCLUSION: In regard to the conduction system and ventricular function in the absence of total atrioventricular block, no statistically significant difference was observed between the children of women with systemic lupus erythematosus and children of healthy women.

Avaliação cardíaca por métodos não invasivos em filhos de portadoras de lúpus eritematoso sistêmico / Noninvasive cardiac assessment in children of women with systemic lupus erythematosus

OBJECTIVE: Noninvasive cardiac assessment of newborns and infants of women with systemic lupus erythematosus. The children had no congenital total atrioventricular block and were compared with the children of healthy women. METHODS: We prospectively assessed 13 newborns and infants aged 1 to 60 days, children of women with systemic lupus erythematosus and without congenital total atrioventricular block. These children were compared with 30 children of women who had no lupus or anti-Ro/SSA antibodies, and no risk factors for congenital heart disease either. Their age groups matched. The following examinations were performed: cardiological physical examination, electrocardiography, echocardiography, and signal-averaged electrocardiography. RESULTS: The statistical analysis showed no significant difference in ventricular function or in the cardiac conduction system between the groups. CONCLUSION: In regard to the conduction system and ventricular function in the absence of total atrioventricular block, no statistically significant difference was observed between the children of women with systemic lupus erythematosus and children of healthy women