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Desarrollar guías actualizadas para el manejo farmacológico de la artritis reumatoide (AR). Se conformó un grupo de expertos que fueran representativos de las distintas regiones geográficas y los diferentes servicios médicos que atienden a la población mexicana con AR. Se desarrollaron preguntas basadas en Población, Intervención, Comparación y Desenlace [Outcome] (PICO) que fueron consideradas relevantes desde el punto de vista clínico; las preguntas encontraron su respuesta en los resultados de una revisión sistemática de la literatura (RSL) reciente y la validez de la evidencia fue evaluada mediante el sistema GRADE, considerado un estándar para estos fines. Posteriormente, el grupo de expertos desarrollaró un acuerdo en la dirección y fuerza de las recomendaciones mediante un proceso de votación en distintas etapas. Las guías actualizadas para el tratamiento de la AR categorizan en forma estratificada a las distintas opciones terapéuticas incluyendo las distintas familias de fármacos modificadores de la enfermedad (FARME): convencionales, biológicos e inhibidores de JAK), además de AINE, glucocorticoides y analgésicos. Establece por consenso el uso de todos ellos en distintas subpoblaciones de interés de pacientes con AR, y aborda, además, aspectos relacionados con la vacunación, la COVID-19, la cirugía, el embarazo y la lactancia entre otros. La presente actualización de las guías mexicanas para el tratamiento farmacológico de la AR brinda elementos de referencia en la toma de decisiones basados en la evidencia científica más reciente, y recomienda la participación del paciente para la toma de decisiones conjuntas en la búsqueda del mayor beneficio de nuestros pacientes; establece además, recomendaciones para el manejo de una diversidad de condiciones relevantes que afectan a nuestros pacientes.
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Humanos , Artritis Reumatoide/tratamiento farmacológico , Terapia Biológica , Antirreumáticos/uso terapéutico , MéxicoRESUMEN
OBJECTIVE: To develop updated guidelines for the pharmacological management of rheumatoid arthritis (RA). METHODS: A group of experts representative of different geographical regions and various medical services catering to the Mexican population with RA was formed. Questions based on Population, Intervention, Comparison, and Outcome (PICO) were developed, deemed clinically relevant. These questions were answered based on the results of a recent systematic literature review (SLR), and the evidence's validity was assessed using the GRADE system, considered a standard for these purposes. Subsequently, the expert group reached consensus on the direction and strength of recommendations through a multi-stage voting process. RESULTS: The updated guidelines for RA treatment stratify various therapeutic options, including different classes of DMARDs (conventional, biologicals, and JAK inhibitors), as well as NSAIDs, glucocorticoids, and analgesics. By consensus, it establishes the use of these in different subpopulations of interest among RA patients and addresses aspects related to vaccination, COVID-19, surgery, pregnancy and lactation, and others. CONCLUSIONS: This update of the Mexican guidelines for the pharmacological treatment of RA provides reference points for evidence-based decision-making, recommending patient participation in joint decision-making to achieve the greatest benefit for our patients. It also establishes recommendations for managing a variety of relevant conditions affecting our patients.
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Antirreumáticos , Artritis Reumatoide , Artritis Reumatoide/tratamiento farmacológico , Humanos , México , Antirreumáticos/uso terapéutico , Glucocorticoides/uso terapéutico , Femenino , Antiinflamatorios no Esteroideos/uso terapéutico , Embarazo , Analgésicos/uso terapéuticoRESUMEN
BACKGROUND: Systemic lupus erythematosus (SLE) often mimics symptoms of other diseases, and the interval between symptom onset and diagnosis may be long in some of these patients. Aims: To describe the characteristics associated with the time to SLE diagnosis and its impact on damage accrual and mortality in patients with SLE from a Latin American inception cohort. METHODS: Patients were from a multi-ethnic, multi-national Latin-American SLE inception cohort. All participating centers had specialized lupus clinics. Socio-demographic, clinical/laboratory, disease activity, damage, and mortality between those with a longer and a shorter time to diagnosis were compared using descriptive statistical tests. Multivariable Cox regression models with damage accrual and mortality as the end points were performed, adjusting for age at SLE diagnosis, gender, ethnicity, level of education, and highest dose of prednisone for damage accrual, plus highest dose of prednisone, baseline SLEDAI, and baseline SDI for mortality. RESULTS: Of the 1437 included in these analyses, the median time to diagnosis was 6.0 months (Q1-Q3 2.4-16.2); in 721 (50.2%) the time to diagnosis was longer than 6 months. Patients whose diagnosis took longer than 6 months were more frequently female, older at diagnosis, of Mestizo ethnicity, not having medical insurance, and having "non-classic" SLE symptoms. Longer time to diagnosis had no impact on either damage accrual (HR 1.09, 95% CI 0.93-1.28, p = 0.300) or mortality (HR 1.37, 95% CI 0.88-2.12, p = 0.200). CONCLUSIONS: In this inception cohort, a maximum time of 24 months with a median of 6 months to SLE diagnosis had no apparent negative impact on disease outcomes (damage accrual and mortality).
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Lupus Eritematoso Sistémico , Femenino , Humanos , Progresión de la Enfermedad , Hispánicos o Latinos , América Latina/epidemiología , Lupus Eritematoso Sistémico/diagnóstico , Lupus Eritematoso Sistémico/tratamiento farmacológico , Lupus Eritematoso Sistémico/complicaciones , Prednisona/uso terapéutico , Índice de Severidad de la Enfermedad , MasculinoRESUMEN
OBJECTIVE: To determine the predictors of the occurrence of severe autoimmune hemolytic anemia (AIHA) and its impact on damage accrual and mortality in SLE patients. METHODS: Factors associated with time to severe AIHA (hemoglobin level ≤7 g/dL) occurring from the onset of SLE symptoms were examined by Cox proportional hazards regressions. The association of severe AIHA with mortality was examined by logistic regression analyses while its impact on damage was by negative binomial regression. RESULTS: Of 1,349 patients, 49 (3.6%) developed severe AIHA over a mean (SD) follow-up time of 5.4 (3.8) years. The median time from the first clinical manifestation to severe AIHA was 111 days (IQR 43-450). By multivariable analysis, male sex (HR 2.26, 95% CI 1.02-4.75, p = 0.044), and higher disease activity at diagnosis (HR 1.04, 95% CI 1.01-1.08, p = 0.025) were associated with a shorter time to severe AIHA occurrence. Of the SLEDAI descriptors, only hematologic (leukopenia and/or thrombocytopenia) showed a certain trend toward significance in the multivariable analysis (HR 2.36, 95% CI 0.91-6.13, p = 0.0772). Severe AIHA contributed neither to damage nor to mortality. CONCLUSIONS: Severe AIHA occurs during the early course of SLE. Male sex and higher disease activity at diagnosis emerged as independent predictors of a shorter time to severe AIHA occurrence. Although not statistically significant, hematological abnormalities at SLE diagnosis could predict the occurrence of severe AIHA in a shorter time. Damage and mortality did not seem to be impacted by the occurrence of severe AIHA.
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Anemia Hemolítica Autoinmune , Leucopenia , Lupus Eritematoso Sistémico , Trombocitopenia , Humanos , Masculino , Lupus Eritematoso Sistémico/complicaciones , América Latina , Hispánicos o Latinos , Anemia Hemolítica Autoinmune/complicaciones , Trombocitopenia/complicacionesRESUMEN
INTRODUCTION: Factors related to presentation of neuropsychiatric (NP) SLE manifestations, early in the course of the disease, and during follow up have not been clearly established. PURPOSE: To identify disease and non-disease related factors associated with NP manifestations in early SLE. METHODS: We included 1193 patients from the GLADEL inception cohort free of NP involvement at cohort entry. We evaluated the association of demographic, clinical and laboratory data with NP involvement during follow-up. STATISTICAL METHODS: Independent factors associated with NP involvement were identified using a multivariable Cox regression model. RESULTS: Factors independently associated with NP manifestations were: mestizo ethnicity (HR 1.701, 95% CI 1.282-2.258, p = 0.0002), myalgias/myositis (HR 1.832, 95% CI 1.335-2.515, p = 0.0002), pneumonitis (HR 2.476, 95% CI 1.085-5.648, p = 0.0312), shrinking lung (HR 2.428, 95% CI 1.074-5.493, p = 0.0331) and hemolytic anemia (HR 1.629, 95% CI 1.130-2.347, p = 0.0089). Longer disease duration at cohort entry (13 to 24 months) was associated with a lower risk of developing NP manifestations (HR 0.642, 95% CI 0.441-0.934, p = 0.0206). CONCLUSIONS: Patients with myalgias/myositis, pneumonitis, shrinking lung and hemolytic anemia are at higher risk of NP involvement, whereas longer disease duration at cohort entry is associated with a lower risk of developing NP involvement.
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Vasculitis por Lupus del Sistema Nervioso Central/epidemiología , Anemia Hemolítica/epidemiología , Anemia Hemolítica/etiología , Femenino , Humanos , América Latina/epidemiología , Enfermedades Pulmonares/epidemiología , Enfermedades Pulmonares/etiología , Lupus Eritematoso Sistémico/complicaciones , Lupus Eritematoso Sistémico/epidemiología , Vasculitis por Lupus del Sistema Nervioso Central/etiología , Masculino , Enfermedades Musculares/epidemiología , Enfermedades Musculares/etiología , Prevalencia , Factores de TiempoRESUMEN
AIM: A decrease in proteinuria has been considered protective from renal damage in lupus nephritis (LN), but a cut-off point has yet to be established. The aim of this study was to identify the predictors of renal damage in patients with LN and to determine the best cut-off point for a decrease in proteinuria. METHODS: We included patients with LN defined clinically or histologically. Possible predictors of renal damage at the time of LN diagnosis were examined: proteinuria, low complement, anti-double-stranded DNA antibodies, red cell casts, creatinine level, hypertension, renal activity (assessed by the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)), prednisone dose, immunosuppressive drugs and antimalarial use. Sociodemographic variables were included at baseline. Proteinuria was assessed at baseline and at 12 months, to determine if early response (proteinuria <0.8 g/day within 12 months since LN diagnosis) is protective of renal damage occurrence. Renal damage was defined as an increase of one or more points in the renal domain of The Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index (SDI). Cox regression models using a backward selection method were performed. RESULTS: Five hundred and two patients with systemic lupus erythematosus patients were included; 120 patients (23.9%) accrued renal damage during their follow-up. Early response to treatment (HR=0.58), antimalarial use (HR=0.54) and a high SES (HR=0.25) were protective of renal damage occurrence, whereas male gender (HR=1.83), hypertension (HR=1.86) and the renal component of the SLEDAI (HR=2.02) were risk factors for its occurrence. CONCLUSIONS: Early response, antimalarial use and high SES were protective of renal damage, while male gender, hypertension and higher renal activity were risk factors for its occurrence in patients with LN.
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Lupus Eritematoso Sistémico , Nefritis Lúpica , Estudios de Cohortes , Humanos , América Latina/epidemiología , Lupus Eritematoso Sistémico/complicaciones , Lupus Eritematoso Sistémico/tratamiento farmacológico , Lupus Eritematoso Sistémico/epidemiología , Nefritis Lúpica/diagnóstico , Nefritis Lúpica/tratamiento farmacológico , Nefritis Lúpica/epidemiología , Masculino , Prednisona/uso terapéuticoRESUMEN
No disponible
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Humanos , Lupus Eritematoso Sistémico/terapia , Nefritis Lúpica/terapia , Diálisis Renal/métodos , Diálisis Peritoneal/métodos , Guías de Práctica Clínica como Asunto , México/epidemiologíaRESUMEN
OBJECTIVES: This study aimed to compare the clinical features, damage accrual, and survival of patients with familial and sporadic systemic lupus erythematosus (SLE). METHODS: A multi-ethnic, multinational Latin American SLE cohort was studied. Familial lupus was defined as patients with a first-degree SLE relative; these relatives were interviewed in person or by telephone. Clinical variables, disease activity, damage, and mortality were compared. Odds ratios (OR) and 95% confidence intervals (CI) were estimated. Hazard ratios (HR) were calculated using Cox proportional hazard adjusted for potential confounders for time to damage and mortality. RESULTS: A total of 66 (5.6%) patients had familial lupus, and 1110 (94.4%) had sporadic lupus. Both groups were predominantly female, of comparable age, and of similar ethnic distribution. Discoid lupus (OR = 1.97; 95% CI 1.08-3.60) and neurologic disorder (OR = 1.65; 95% CI 1.00-2.73) were significantly associated with familial SLE; pericarditis was negatively associated (OR = 0.35; 95% CI 0.14-0.87). The SLE Disease Activity Index and Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) were similar in both groups, although the neuropsychiatric (45.4% vs. 33.5%; p = 0.04) and musculoskeletal (6.1% vs. 1.9%; p = 0.02) domains of the SDI were more frequent in familial lupus. They were not retained in the Cox models (by domains). Familial lupus was not significantly associated with damage accrual (HR = 0.69; 95% CI 0.30-1.55) or mortality (HR = 1.23; 95% CI 0.26-4.81). CONCLUSION: Familial SLE is not characterized by a more severe form of disease than sporadic lupus. We also observed that familial SLE has a higher frequency of discoid lupus and neurologic manifestations and a lower frequency of pericarditis.
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Etnicidad , Lupus Eritematoso Sistémico/mortalidad , Adolescente , Adulto , Factores de Edad , Niño , Estudios de Cohortes , Progresión de la Enfermedad , Femenino , Humanos , América Latina/epidemiología , Lupus Eritematoso Discoide/epidemiología , Masculino , Persona de Mediana Edad , Análisis Multivariante , Pericarditis/epidemiología , Modelos de Riesgos Proporcionales , Índice de Severidad de la Enfermedad , Factores Sexuales , Adulto JovenRESUMEN
OBJECTIVE: To compare the clinical, laboratory and outcome features of SLE patients with and without Jaccoud's arthropathy (JA) from the Grupo Latino Americano De Estudio del Lupus (GLADEL) cohort. METHODS: 1480 patients with SLE [(34 centres, 9 Latin American countries with a recent diagnosis (≤2 years)] constitute the GLADEL cohort. JA was defined as reducible deformity of the metacarpophalangeal axis, without radiographic erosions at any time. Within this cohort, a nested case-control study was carried out. Control was matched for age, gender and centre in a 1:3 proportion. The variables included were: sociodemographic, clinical and immunological features, disease activity, damage and mortality. Comparisons were performed with Wilcoxon and χ2 tests for continuous and categorical variables, respectively. ORs and 95% CIs and Kaplan-Meier survival curve were estimated. RESULTS: Of 1480 patients, 17 (1.1%) JA patients were identified; 16 (94.1%) of them were women, mean age: 31.0 years (SD 12.0). Five (29.4%) patients presented JA at SLE diagnosis and 12 (70.6%) after. The median follow-up time and all disease features were comparable in both groups except for a higher frequency of pneumonitis in the patients with JA [4 (23.5) vs 1 (2.0); p=0.012; (OR: 15.4; 95% CI 1.6 to 149.6)]. The SLE disease activity index, Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage Index and the Kaplan-Meier survival curve were similar in both groups. CONCLUSION: JA may tend to appear early in the course of SLE; it seems not to have an impact on disease activity, damage accrual or in survival.
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The original version of this article, unfortunately, contained an error. The first and family name of Loreto Massardo was interchanged and is now presented correctly in this article.
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OBJECTIVES: To identify baseline predictors of remission and low disease activity (LDA) in early rheumatoid arthritis (RA) from the GLADAR (Grupo Latino Americano De estudio de la Artritis Reumatoide) cohort. METHODS: Patients with 1- and 2-year follow-up visits were included. Remission and LDA were defined by DAS28-ESR (< 2.6 and ≤ 3.2, respectively). Baseline predictors examined were gender, ethnicity, age at diagnosis, socioeconomic status, symptoms' duration, DMARDs, RF, thrombocytosis, anemia, morning stiffness, DAS28-ESR (and its components), HAQ-DI, DMARDs and corticosteroid use, and Sharp-VDH score. Multivariable binary logistic regression models (excluding DAS28-ESR components to avoid over adjustment) were derived using a backward selection method (α-level set at 0.05). RESULTS: Four hundred ninety-eight patients were included. Remission and LDA/remission were met by 19.3% and 32.5% at the 1-year visit, respectively. For the 280 patients followed for 2 years, these outcomes were met by 24.3% and 38.9%, respectively. Predictors of remission at 1 year were a lower DAS28-ESR (OR 1.17; CI 1.07-1.27; p = 0.001) and HAQ-DI (OR 1.48; CI 1.04-2.10; p = 0.028). At 2 years, only DAS28-ESR (OR 1.40; CI 1.17-1.6; p < 0.001) was a predictor. Predictors of LDA/remission at 1 year were DAS28-ESR (OR 1.42; CI 1.26-1.61; p < 0.001), non-use of corticosteroid (OR 1.74; CI 1.11-2.44; p = 0.008), and male gender (OR 1.77; CI 1.2-2.63; p = 0.036). A lower baseline DAS28-ESR (OR 1.45; CI 1.23-1.70; p < 0.001) was the only predictor of LDA/remission at 2 years. CONCLUSIONS: A lower disease activity consistently predicted remission and LDA/remission at 1 and 2 years of follow-up in early RA patients from the GLADAR cohort. Key Points ⢠In patients with early RA, a lower disease activity at first visit is a strong clinical predictor of achieving remission and LDA subsequently. ⢠Other clinical predictors of remission and LDA to keep in mind in these patients are male gender, non-use of corticosteroids and low disability at baseline. ⢠Not using corticosteroids at first visit is associated with a lower disease activity and predicts LDA/remission at 1 year in these patients.
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Artritis Reumatoide/terapia , Inducción de Remisión , Corticoesteroides/uso terapéutico , Adulto , Antirreumáticos/uso terapéutico , Artritis Reumatoide/etnología , Femenino , Humanos , América Latina , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Análisis de Regresión , Resultado del TratamientoRESUMEN
Existen varias guías de práctica clínica tanto nacionales como internacionales para el tratamiento del lupus eritematoso sistémico. No obstante, la mayoría de las guías disponibles no están diseñadas para población mexicana o solamente son para el manejo de manifestaciones específicas como nefritis lúpica o para algún estado fisiológico como el embarazo. El Colegio Mexicano de Reumatología se propuso elaborar unas guías de práctica clínica que conjuntaran la mayor parte de las manifestaciones de la enfermedad y que incluyeran adicionalmente pautas en situaciones controversiales como lo son la vacunación y el periodo perioperatorio. En el presente documento se presenta la «Guía de práctica clínica para el manejo del lupus eritematoso sistémico» propuesta por el Colegio Mexicano de Reumatología, que puede ser de utilidad principalmente a médicos no reumatólogos que se ven en la necesidad de tratar a pacientes con lupus eritematoso sistémico sin tener la formación de especialistas en reumatología. En esta guía se presentan recomendaciones sobre el manejo de manifestaciones generales, articulares, renales, cardiovasculares, pulmonares, neurológicas, hematológicas, gastrointestinales, respecto a la vacunación y al manejo perioperatorio
There are national and international clinical practice guidelines for systemic lupus erythematosus treatment. Nonetheless, most of them are not designed for the Mexican population or are devoted only to the treatment of certain disease manifestations, like lupus nephritis, or are designed for some physiological state like pregnancy. The Mexican College of Rheumatology aimed to create clinical practice guidelines that included the majority of the manifestations of systemic lupus erythematosus, and also incorporated guidelines in controversial situations like vaccination and the perioperative period. The present document introduces the «Clinical Practice Guidelines for the Treatment of Systemic Lupus Erythematosus» proposed by the Mexican College of Rheumatology, which could be useful mostly for non-rheumatologist physicians who need to treat patients with systemic lupus erythematosus without having the appropriate training in the field of rheumatology. In these guidelines, the reader will find recommendations on the management of general, articular, kidney, cardiovascular, pulmonary, neurological, hematologic and gastrointestinal manifestations, and recommendations on vaccination and treatment management during the perioperative period
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Humanos , Lupus Eritematoso Sistémico/tratamiento farmacológico , Enfermedades Reumáticas/tratamiento farmacológico , Lupus Eritematoso Sistémico/complicaciones , México/epidemiología , Pautas de la Práctica en MedicinaRESUMEN
There are national and international clinical practice guidelines for systemic lupus erythematosus treatment. Nonetheless, most of them are not designed for the Mexican population or are devoted only to the treatment of certain disease manifestations, like lupus nephritis, or are designed for some physiological state like pregnancy. The Mexican College of Rheumatology aimed to create clinical practice guidelines that included the majority of the manifestations of systemic lupus erythematosus, and also incorporated guidelines in controversial situations like vaccination and the perioperative period. The present document introduces the «Clinical Practice Guidelines for the Treatment of Systemic Lupus Erythematosus¼ proposed by the Mexican College of Rheumatology, which could be useful mostly for non-rheumatologist physicians who need to treat patients with systemic lupus erythematosus without having the appropriate training in the field of rheumatology. In these guidelines, the reader will find recommendations on the management of general, articular, kidney, cardiovascular, pulmonary, neurological, hematologic and gastrointestinal manifestations, and recommendations on vaccination and treatment management during the perioperative period.
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Lupus Eritematoso Sistémico/terapia , Antiinflamatorios/uso terapéutico , Terapia Combinada , Humanos , Inmunosupresores/uso terapéutico , Lupus Eritematoso Sistémico/complicaciones , Lupus Eritematoso Sistémico/diagnóstico , MéxicoRESUMEN
Systemic lupus erythematosus (SLE), a complex and heterogeneous autoimmune disease, represents a significant challenge for both diagnosis and treatment. Patients with SLE in Latin America face special problems that should be considered when therapeutic guidelines are developed. The objective of the study is to develop clinical practice guidelines for Latin American patients with lupus. Two independent teams (rheumatologists with experience in lupus management and methodologists) had an initial meeting in Panama City, Panama, in April 2016. They selected a list of questions for the clinical problems most commonly seen in Latin American patients with SLE. These were addressed with the best available evidence and summarised in a standardised format following the Grading of Recommendations Assessment, Development and Evaluation approach. All preliminary findings were discussed in a second face-to-face meeting in Washington, DC, in November 2016. As a result, nine organ/system sections are presented with the main findings; an 'overarching' treatment approach was added. Special emphasis was made on regional implementation issues. Best pharmacologic options were examined for musculoskeletal, mucocutaneous, kidney, cardiac, pulmonary, neuropsychiatric, haematological manifestations and the antiphospholipid syndrome. The roles of main therapeutic options (ie, glucocorticoids, antimalarials, immunosuppressant agents, therapeutic plasma exchange, belimumab, rituximab, abatacept, low-dose aspirin and anticoagulants) were summarised in each section. In all cases, benefits and harms, certainty of the evidence, values and preferences, feasibility, acceptability and equity issues were considered to produce a recommendation with special focus on ethnic and socioeconomic aspects. Guidelines for Latin American patients with lupus have been developed and could be used in similar settings.
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Síndrome Antifosfolípido/tratamiento farmacológico , Enfermedades Hematológicas/tratamiento farmacológico , Enfermedades Renales/tratamiento farmacológico , Lupus Eritematoso Sistémico/tratamiento farmacológico , Síndrome Antifosfolípido/etiología , Cardiopatías/tratamiento farmacológico , Cardiopatías/etiología , Enfermedades Hematológicas/etiología , Humanos , Enfermedades Renales/etiología , América Latina , Enfermedades Pulmonares/tratamiento farmacológico , Enfermedades Pulmonares/etiología , Lupus Eritematoso Sistémico/complicaciones , Nefritis Lúpica/tratamiento farmacológico , Nefritis Lúpica/etiología , Trastornos Mentales/tratamiento farmacológico , Trastornos Mentales/etiología , Enfermedades Musculoesqueléticas/tratamiento farmacológico , Enfermedades Musculoesqueléticas/etiología , Enfermedades de la Piel/tratamiento farmacológico , Enfermedades de la Piel/etiología , Nivel de AtenciónRESUMEN
OBJECTIVES: A systematic review was conducted to explore the immunogenicity of biologic agents across inflammatory diseases and its potential impact on efficacy/safety. METHODS: Literature searches were conducted through November 2016 to identify controlled and observational studies of biologics/biosimilars administered for treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), psoriasis (Ps), Crohn's disease, and ulcerative colitis. RESULTS: Of >21,000 screened publications, 443 were included. Anti-drug antibody (ADAb) rates varied widely among biologics across diseases (and are not directly comparable because of immunoassay heterogeneity); the highest overall rates were reported with infliximab (0-83%), adalimumab (0-54%), and infliximab biosimilar CT-P13 (21-52%), and the lowest with secukinumab (0-1%), ustekinumab (1-11%), etanercept (0-13%), and golimumab (0-19%). Most ADAbs were neutralizing, except those to abatacept and etanercept. ADAb+ versus ADAb- patients had lower rates of clinical response to adalimumab (RA, PsA, JIA, AS, Ps), golimumab (RA), infliximab (RA, PsA, AS, Ps), rituximab (RA), ustekinumab (Ps), and CT-P13 (RA, AS). Higher rates of infusion-related reactions were reported in infliximab- and CT-P13-treated ADAb+ patients. Background immunosuppressives/anti-proliferatives reduced biologic immunogenicity across diseases. CONCLUSIONS: Based on reviewed reports, biologic/biosimilar immunogenicity differs among agents, with the highest rates observed with infliximab and adalimumab. As ADAb formation in biologic-/biosimilar-treated patients may increase the risk of lost response, the immunogenicity of these agents is an important (albeit not the only) consideration in the treatment decision-making process.
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Antiinflamatorios no Esteroideos/uso terapéutico , Anticuerpos Monoclonales/uso terapéutico , Biosimilares Farmacéuticos/uso terapéutico , Abatacept/uso terapéutico , Antiinflamatorios no Esteroideos/inmunología , Anticuerpos Monoclonales/inmunología , Antirreumáticos/uso terapéutico , Artritis Juvenil/tratamiento farmacológico , Artritis Psoriásica/tratamiento farmacológico , Artritis Reumatoide/tratamiento farmacológico , Colitis Ulcerosa/tratamiento farmacológico , Enfermedad de Crohn/tratamiento farmacológico , Etanercept/uso terapéutico , Humanos , Infliximab/uso terapéutico , Espondilitis Anquilosante/tratamiento farmacológico , Ustekinumab/uso terapéuticoRESUMEN
La relación que involucra al médico y la industria abarca un espectro amplio de formas, para lo cual se requiere una exposición clara y transparente de términos y principios. Uno de los objetivos primordiales de la industria es contar con un respaldo académico que le permita dar a conocer las características y las propiedades de sus productos -eficacia, eficiencia y seguridad- con el propósito de ser prescritos y usados. Los fines de la industria son la venta de sus productos, el reconocimiento como empresas de prestigio y la ganancia económica. Implícitamente, para CETREMI el principio de mayor importancia en esta relación es indudablemente el beneficio del enfermo.
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Industrias , Relaciones Interprofesionales , Liderazgo , Médicos , Ética Médica , Guías como Asunto , MéxicoRESUMEN
Introducción. La estenosis subglótica (ESG) en la granulomatosis con poliangitis (GPA) puede ser consecuencia de la enfermedad activa o de procesos inflamatorios repetitivos. Nuestro objetivo es describir las características clínicas y el tratamiento de los pacientes con ESG. Métodos. Estudio descriptivo retrospectivo de los casos diagnosticados durante el período comprendido entre el 1 de enero del 2000 y el 1 de junio del 2015. Resultados. Presentamos 4 casos; la ESG se presentó entre los 2 y 144 meses del diagnóstico de la GPA, los síntomas de presentación fueron disnea de esfuerzo y el estridor laríngeo, 3 desarrollaron ESG en ausencia de actividad sistémica. Dos sujetos con ESG grado i fueron tratados con dilatación traqueal, 2 casos presentaron reestenosis y en 3 casos fue necesario la realización de traqueostomía. Conclusión. La ESG presenta una alta morbilidad. La dilatación endoscópica proporciona alivio sintomático; sin embargo, suelen existir recidivas de la estenosis. La obstrucción grave de la vía aérea a menudo requiere de traqueostomía (AU)
Introduction. Subglottic stenosis (SGS) in granulomatosis with polyangiitis (GPA) may result from active disease or from chronic recurrent inflammation. The objective of the study was to describe the clinical features and treatment of patients with subglottic stenosis. Methods. We retrospectively reviewed the medical records of all patients with SGS due to GPA diagnosed at Rheumatology deparment between January 2000 and June 2015. Results. We present 4 cases of SGS at our department during a period of 15 years. The interval between the presentation of the GPA and SGS varied between 2 and 144 months. The leading symptoms of SGS were dyspnoea on exertion and stridor. Three patients presented SGS without evidence of systemic activity. Two patients presented SGS grade i and received tracheal dilatation; two recurred and three needed a tracheostomy due to severe airway-limiting stenosis. Conclusion. SGS presents high morbidity. Even though subglottic dilatation provides symptomatic relief, recurrences may present. Severe airway-limiting stenosis often requires tracheostomy (AU)
Asunto(s)
Humanos , Masculino , Femenino , Adulto Joven , Adulto , Anciano , Estenosis Subaórtica Fija/cirugía , Estenosis Subaórtica Fija/fisiopatología , Estenosis Subaórtica Fija , Granulomatosis con Poliangitis/complicaciones , Granulomatosis con Poliangitis/fisiopatología , Granulomatosis con Poliangitis , Traqueostomía/instrumentación , Traqueostomía/métodos , Granulomatosis con Poliangitis/cirugía , Estudios Retrospectivos , Metilprednisolona/uso terapéutico , Prednisona/uso terapéuticoRESUMEN
Granulomatosis with polyangiitis (GPA), formerly known as Wegener's granulomatosis, is a systemic necrotizing vasculitis, which affects small and medium sized blood vessels and is often associated with cytoplasmic anti-neutrophil cytoplasmic antibodies (ANCA). Inflammatory pseudotumor is a rare condition characterized by the appearance of a mass lesion that mimics a malignant tumor both clinically and on imaging studies, but that is thought to have an inflammatory/reactive pathogenesis. We report a patient with a GPA which was originally diagnosed as malignancy.