RESUMEN
AIM: The aim of this study was to identify factors predictive of serious infections over time in patients with systemic lupus erythematosus (SLE). METHODS: A multi-ethnic, multi-national Latin American SLE cohort was studied. Serious infection was defined as one that required hospitalization, occurred during a hospitalization or led to death. Potential predictors included were sociodemographic factors, clinical manifestations (per organ involved, lymphopenia and leukopenia, independently) and previous infections at baseline. Disease activity (SLEDAI), damage (SLICC/ACR Damage Index), non-serious infections, glucocorticoids, antimalarials (users and non-users), and immunosuppressive drugs use; the last six variables were examined as time-dependent covariates. Cox regression models were used to evaluate the predictors of serious infections using a backward elimination procedure. Univariable and multivariable analyses were performed. RESULTS: Of the 1243 patients included, 1116 (89.8%) were female. The median (interquartile range) age at diagnosis and follow-up time were 27 (20-37) years and 47.8 (17.9-68.6) months, respectively. The incidence rate of serious infections was 3.8 cases per 100 person-years. Antimalarial use (hazard ratio: 0.69; 95% confidence interval (CI): 0.48-0.99; p = 0.0440) was protective, while doses of prednisone >15 and ≤60 mg/day (hazard ratio: 4.18; 95 %CI: 1.69-10.31; p = 0.0019) and >60 mg/day (hazard ratio: 4.71; 95% CI: 1.35-16.49; p = 0.0153), use of methylprednisolone pulses (hazard ratio: 1.53; 95% CI: 1.10-2.13; p = 0.0124), increase in disease activity (hazard ratio: 1.03; 95% CI: 1.01-1.04; p = 0.0016) and damage accrual (hazard ratio: 1.22; 95% CI: 1.11-1.34; p < 0.0001) were predictive factors of serious infections. CONCLUSIONS: Over time, prednisone doses higher than 15 mg/day, use of methylprednisolone pulses, increase in disease activity and damage accrual were predictive of infections, whereas antimalarial use was protective against them in SLE patients.
Asunto(s)
Hospitalización/estadística & datos numéricos , Infecciones/epidemiología , Lupus Eritematoso Sistémico/tratamiento farmacológico , Adulto , Antimaláricos/administración & dosificación , Estudios de Cohortes , Relación Dosis-Respuesta a Droga , Femenino , Estudios de Seguimiento , Glucocorticoides/administración & dosificación , Humanos , Inmunosupresores/administración & dosificación , Infecciones/etiología , América Latina , Lupus Eritematoso Sistémico/fisiopatología , Masculino , Metilprednisolona/administración & dosificación , Prednisona/administración & dosificación , Factores Protectores , Factores de Riesgo , Índice de Severidad de la Enfermedad , Adulto JovenRESUMEN
The two co-authors of the mentioned above article were incorrect. The correct are authors should have been "P. A. Beltrán" instead of "P. A. B. Roa" and "J. F. Diaz-Coto" instead of "L. Diaz Soto".
RESUMEN
INTRODUCTION: Biologics have improved the treatment of rheumatic diseases, resulting in better outcomes. However, their high cost limits access for many patients in both North America and Latin America. Following patent expiration for biologicals, the availability of biosimilars, which typically are less expensive due to lower development costs, provides additional treatment options for patients with rheumatic diseases. The availability of biosimilars in North American and Latin American countries is evolving, with differing regulations and clinical indications. OBJECTIVE: The objective of the study was to present the consensus statement on biosimilars in rheumatology developed by Pan American League of Associations for Rheumatology (PANLAR). METHODS: Using a modified Delphi process approach, the following topics were addressed: regulation, efficacy and safety, extrapolation of indications, interchangeability, automatic substitution, pharmacovigilance, risk management, naming, traceability, registries, economic aspects, and biomimics. Consensus was achieved when there was agreement among 80% or more of the panel members. Three Delphi rounds were conducted to reach consensus. Questionnaires were sent electronically to panel members and comments about each question were solicited. RESULTS: Eight recommendations were formulated regarding regulation, pharmacovigilance, risk management, naming, traceability, registries, economic aspects, and biomimics. CONCLUSION: The recommendations highlighted that, after receiving regulatory approval, pharmacovigilance is a fundamental strategy to ensure safety of all medications. Registries should be employed to monitor use of biosimilars and to identify potential adverse effects. The price of biosimilars should be significantly lower than that of reference products to enhance patient access. Biomimics are not biosimilars and, if they are to be marketed, they must first be evaluated and approved according to established regulatory pathways for novel biopharmaceuticals. KEY POINTS: ⢠Biologics have improved the treatment of rheumatic diseases. ⢠Their high cost limits access for many patients in both North America and Latin America. ⢠Biosimilars typically are less expensive, providing additional treatment options for patients with rheumatic diseases. ⢠PANLAR presents its consensus on biosimilars in rheumatology.
Asunto(s)
Biosimilares Farmacéuticos/uso terapéutico , Enfermedades Reumáticas/tratamiento farmacológico , Biosimilares Farmacéuticos/efectos adversos , Consenso , Medicina Basada en la Evidencia , Humanos , América Latina/epidemiología , América del Norte , Guías de Práctica Clínica como Asunto , Reumatología , Sociedades MédicasRESUMEN
OBJECTIVE: To examine the characteristics of patients who developed late onset systemic lupus erythematosus (SLE) in the GLADEL (Grupo Latino Americano de Estudio del Lupus) cohort of patients with SLE. METHODS: Patients with SLE of less than two years of disease duration, seen at 34 centers of nine Latin American countries, were included. Late-onset was defined as >50 years of age at time of first SLE-related symptom. Clinical and laboratory manifestations, activity index (SLEDAI), and damage index (SLICC/ACR- DI) were ascertained at time of entry and during the course (cumulative incidence). Features were compared between the two patient groups (<50 and ≥50) using descriptive statistics and hypothesis tests. Logistic regression was performed to examine the association of late-onset lupus, adjusting for other variables. RESULTS: Of the 1480 patients included, 102 patients (6.9 %) had late-onset SLE, 87% of which were female. Patients with late-onset SLE had a shorter follow-up (3.6 vs. 4.4 years, p < 0.002) and a longer time to diagnosis (10.1 vs. 5.8 months, p < 0.001) compared to the younger onset group. Malar rash, photosensitivity, and renal involvement were less prevalent while interstitial lung disease, pleural effusions, and sicca symptoms were more frequent in the older age group (p > 0.05). In multivariable analysis, late onset was independently associated with higher odds of ocular (OR = 3.66, 95% CI = 2.15-6.23), pulmonary (OR = 2.04, 95% CI = 1.01-4.11), and cardiovascular (OR = 1.76, 95% CI = 1.04-2.98) involvement and lower odds of cutaneous involvement (OR = 0.41, 95% CI = 0.21-0.80), number of cumulative SLE criteria (OR = 0.79, 95% CI = 0.64-0.97), use of cyclophosphamide (OR = 0.47, 95% CI = 0.24-0.95), and anti-RNP antibodies (OR = 0.43, 95% CI = 0.20-0.91). A Cox regression model revealed a higher risk of dying in older onset than the younger-onset SLE (OR = 2.61, 95% CI = 1.2-5.6). CONCLUSION: Late-onset SLE in Latin Americans had a distinct disease expression compared to the younger-onset group. The disease seems to be mild with lower cumulative SLE criteria, reduced renal/mucocutaneous involvements, and less use of cyclophosphamide. Nevertheless, these patients have a higher risk of death and of ocular, pulmonary, and cardiovascular involvements.
Asunto(s)
Ciclofosfamida/uso terapéutico , Inmunosupresores/uso terapéutico , Lupus Eritematoso Sistémico/complicaciones , Lupus Eritematoso Sistémico/tratamiento farmacológico , Lupus Eritematoso Sistémico/etnología , Adolescente , Adulto , Edad de Inicio , Anciano , Femenino , Hispánicos o Latinos , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Índice de Severidad de la Enfermedad , Adulto JovenRESUMEN
OBJECTIVES: The objective of this paper is to assess the predictors of time-to-lupus renal disease in Latin American patients. METHODS: Systemic lupus erythematosus (SLE) patients (n = 1480) from Grupo Latino Americano De Estudio de Lupus (GLADEL's) longitudinal inception cohort were studied. Endpoint was ACR renal criterion development after SLE diagnosis (prevalent cases excluded). Renal disease predictors were examined by univariable and multivariable Cox proportional hazards regression analyses. Antimalarials were considered time dependent in alternative analyses. RESULTS: Of the entire cohort, 265 patients (17.9%) developed renal disease after entering the cohort. Of them, 88 (33.2%) developed persistent proteinuria, 44 (16.6%) cellular casts and 133 (50.2%) both; 233 patients (87.9%) were women; mean (± SD) age at diagnosis was 28.0 (11.9) years; 12.2% were African-Latin Americans, 42.5% Mestizos, and 45.3% Caucasians (p = 0.0016). Mestizo ethnicity (HR 1.61, 95% CI 1.19-2.17), hypertension (HR 3.99, 95% CI 3.02-5.26) and SLEDAI at diagnosis (HR 1.04, 95% CI 1.01-1.06) were associated with a shorter time-to-renal disease occurrence; antimalarial use (HR 0.57, 95% CI 0.43-0.77), older age at onset (HR 0.90, 95% CI 0.85-0.95, for every five years) and photosensitivity (HR 0.74, 95% CI 0.56-0.98) were associated with a longer time. Alternative model results were consistent with the antimalarial protective effect (HR 0.70, 95% CI 0.50-0.99). CONCLUSIONS: Our data strongly support the fact that Mestizo patients are at increased risk of developing renal disease early while antimalarials seem to delay the appearance of this SLE manifestation. These data have important implications for the treatment of these patients regardless of their geographic location.
Asunto(s)
Antimaláricos/uso terapéutico , Lupus Eritematoso Sistémico/tratamiento farmacológico , Nefritis Lúpica/prevención & control , Adolescente , Adulto , Edad de Inicio , Antimaláricos/administración & dosificación , Estudios de Cohortes , Femenino , Estudios de Seguimiento , Humanos , Hipertensión/epidemiología , América Latina/epidemiología , Estudios Longitudinales , Lupus Eritematoso Sistémico/etnología , Lupus Eritematoso Sistémico/fisiopatología , Nefritis Lúpica/etnología , Masculino , Análisis Multivariante , Trastornos por Fotosensibilidad/epidemiología , Modelos de Riesgos Proporcionales , Análisis de Regresión , Factores de Riesgo , Índice de Severidad de la Enfermedad , Factores de Tiempo , Adulto JovenRESUMEN
OBJECTIVE: The objective of this paper is to examine the role of place of residency in the expression and outcomes of systemic lupus erythematosus (SLE) in a multi-ethnic Latin American cohort. PATIENTS AND METHODS: SLE patients (< two years of diagnosis) from 34 centers constitute this cohort. Residency was dichotomized into rural and urban, cut-off: 10,000 inhabitants. Socio-demographic, clinical/laboratory and mortality rates were compared between them using descriptive tests. The influence of place of residency on disease activity at diagnosis and renal disease was examined by multivariable regression analyses. RESULTS: Of 1426 patients, 122 (8.6%) were rural residents. Their median ages (onset, diagnosis) were 23.5 and 25.5 years; 85 (69.7%) patients were Mestizos, 28 (22.9%) Caucasians and 9 (7.4%) were African-Latin Americans. Rural residents were more frequently younger at diagnosis, Mestizo and uninsured; they also had fewer years of education and lower socioeconomic status, exhibited hypertension and renal disease more frequently, and had higher levels of disease activity at diagnosis; they used methotrexate, cyclophosphamide pulses and hemodialysis more frequently than urban patients. Disease activity over time, renal damage, overall damage and the proportion of deceased patients were comparable in rural and urban patients. In multivariable analyses, rural residency was associated with high levels of disease activity at diagnosis (OR 1.65, 95% CI 1.06-2.57) and renal disease occurrence (OR 1.77, 95% CI 1.00-3.11). CONCLUSIONS: Rural residency associates with Mestizo ethnicity, lower socioeconomic status and renal disease occurrence. It also plays a role in disease activity at diagnosis and kidney involvement but not on the other end-points examined.
Asunto(s)
Lupus Eritematoso Sistémico/etnología , Grupos Raciales/estadística & datos numéricos , Características de la Residencia/estadística & datos numéricos , Salud Rural/estadística & datos numéricos , Salud Urbana/estadística & datos numéricos , Adulto , Factores de Edad , Indio Americano o Nativo de Alaska/estadística & datos numéricos , Población Negra/estadística & datos numéricos , Distribución de Chi-Cuadrado , Comorbilidad , Ciclofosfamida/uso terapéutico , Progresión de la Enfermedad , Escolaridad , Femenino , Accesibilidad a los Servicios de Salud/estadística & datos numéricos , Disparidades en Atención de Salud/etnología , Humanos , Hipertensión/etnología , Inmunosupresores/uso terapéutico , América Latina/epidemiología , Modelos Logísticos , Estudios Longitudinales , Lupus Eritematoso Sistémico/diagnóstico , Lupus Eritematoso Sistémico/terapia , Nefritis Lúpica/etnología , Masculino , Pacientes no Asegurados/etnología , Metotrexato/uso terapéutico , Análisis Multivariante , Oportunidad Relativa , Pronóstico , Diálisis Renal , Factores de Riesgo , Factores Socioeconómicos , Factores de Tiempo , Población Blanca , Adulto JovenAsunto(s)
Anticuerpos Monoclonales/uso terapéutico , Antirreumáticos/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Algoritmos , Anticuerpos Monoclonales/administración & dosificación , Anticuerpos Monoclonales de Origen Murino , Antirreumáticos/administración & dosificación , Contraindicaciones , Esquema de Medicación , Humanos , América Latina , Selección de Paciente , Rituximab , Resultado del TratamientoRESUMEN
Headache is common in systemic lupus erythematosus with reported prevalence as high as 70%. The aims of this study were: to estimate the prevalence and types of headache in a sample of patients with systemic lupus erythematosus comparing it with rheumatoid arthritis, to determine clinical and serological associations. Eighty-one systemic lupus erythematosus and 29 rheumatoid arthritis consecutive patients seen in our outpatient clinic were interviewed. Headache was evaluated using the diagnostic criteria proposed by the International Headache Society. Additional evaluations were carried out in the 81 systemic lupus erythematosus patients including depression, disease activity, lupus damage, function disability, quality of life, and severity degree using a validated scales. We analysed the following autoantibodies: anti-double stranded DNA, anti-nucleosomes, anti-histones, anti-ribosomal P, anti-cardiolipin antibodies, anti-beta2-glycoprotein-I (GPI), and antinuclear antibodies. Forty-one per cent of systemic lupus erythematosus and 17% of rheumatoid arthritis patients suffered from headache (P = 0.02). No significant difference for any primary headache type between the two groups was found. Frequency of headache types in systemic lupus erythematosus patients was: migraine 24%, tensional-type headache 11%, and mixed headache 5%. In systemic lupus erythematosus patients the risk factors associated with headaches were Raynaud's phenomenon (OR 3.6; 95% CI 1.3-9.5; P = 0.009) and beta2GPI antibody positivity (OR 4.5; 95% CI 1.2-16.2; p = 0.016). We conclude that headache is more common in systemic lupus erythematosus than in rheumatoid arthritis patients and was independently associated with Raynaud's phenomenon and beta2GP-I antibodies.
Asunto(s)
Cefalea/epidemiología , Lupus Eritematoso Sistémico/epidemiología , Adulto , Artritis Reumatoide/epidemiología , Autoanticuerpos/sangre , Comorbilidad , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Prevalencia , Enfermedad de Raynaud/epidemiología , Factores de Riesgo , Encuestas y CuestionariosRESUMEN
El comportamiento comunitario en la demanda de ayuda en nuestro medio fue analizado mediante los resultados obtenidos en la encuesta comunitaria COPCORD desarrollada en el municipio Lawton. Los datos sociodemográficos resultaron similares a los de la población general. La prevalencia de afecciones reumáticas pesquisada alcanzó el 43,9 por ciento de la serie, con la osteoarttritis como la más prevalerte afección y los niveles de discapacidad elevados. Los pacientes orientan su demandada de atención hacia el facultativo principalmente médico familiar, acude también al hospital donde Ortopédicos, Fisiatras y Reumatólogos le brindanatención. La medicina tradicional es frecuentemente utilizada con el 18.1 por ciento de la serie y no entraña abandono del tratamiento convencionalmente aprobado. La automedicación como práctica desaconsejada resultó frecuente en la población estudiada(AU)
Asunto(s)
Artritis Reumatoide/epidemiología , Medicina ComunitariaRESUMEN
OBJECTIVE: Rheumatic diseases are prevalent conditions around the world, but precise information is not easily obtainable in developing countries. The aim of this study was to estimate the prevalence of musculoskeletal complaints in the community in Cuba using the ILAR/COPCORD core questionnaire and published methodologies. METHODS: The ILAR/COPCORD core questionnaire was administered in the form of a home survey to 300 adult subjects. Cases, defined as those with present pain and no trauma, underwent a physical examination and selected laboratory or X ray evaluations. RESULTS: The questionnaire was filled out in a mean time of 8 minutes. Ninety-one subjects had present musculoskeletal pain not related to trauma and 83 had had pain in the past. The most frequently affected regions were the lower back (14%); cervical spine (14%); knee (11.5%) and shoulders (10%). Osteoarthritis was the most common diagnosis (19.6%). A total of 166 subjects sought professional help; 56 were treated by a rheumatologist. Most subjects were satisfied with the results of their medical treatment. CONCLUSIONS: Musculoskeletal symptoms were prevalent in this community. A larger study will be necessary to obtain a better estimate of diagnoses with a low prevalence.
Asunto(s)
Personas con Discapacidad/estadística & datos numéricos , Enfermedades Musculoesqueléticas/epidemiología , Enfermedades Musculoesqueléticas/fisiopatología , Adulto , Cuba/epidemiología , Femenino , Humanos , Masculino , Enfermedades Musculoesqueléticas/psicología , Dolor/fisiopatología , Aceptación de la Atención de Salud , Prevalencia , Encuestas y CuestionariosRESUMEN
Los primeros reportes en personas en edades gariatricas aparecieron en el 1983 en hijos de mujeres promiscuas, drogadictas y niños que recibieron transfusiones de sangre de donants infectados con el virus del SIDA...(AU)