RÉSUMÉ
Introducción. La inmunoglobulina G endovenosa (IGEV) es un medicamento hemoderivado de inmunoglobulina G polivalente y policlonal. Posee un amplio espectro de indicaciones como inmunomodulador o como terapia de reemplazo. Asimismo, si bien se considera un tratamiento seguro, la incidencia de reacciones adversas reportadas en la literatura varía del 1 % al 81 %. Este trabajo tuvo como objetivo evaluar la utilización de IGEV y describir los acontecimientos adversos por la medicación en un hospital pediátrico de alta complejidad.Población y métodos. Se realizó un estudio de farmacoepidemiología, observacional y prospectivo. Se evaluaron pacientes que recibieron IGEV durante 7 meses, en 6 áreas de un hospital pediátrico de alta complejidad de la Ciudad Autónoma de Buenos Aires. La unidad de análisis fue cada infusión de IGEV, y la principal variable de estudio fue la presencia de reacciones adversas.Resultados. Se analizaron 305 infusiones en 111 pacientes. El 81,6 % de las indicaciones fueron de tipo supletorio. La dosis máxima utilizada fue 1 g/kg. En el 99,6 % de las infusiones, se indicó algún tipo de premedicación; la difenhidramina fue la droga más utilizada, aunque con diferentes posologías. Se registraron 12 reacciones adversas (el 3,9 % de las infusiones), tres de las cuales se consideraron graves: dos meningitis asépticas y una crisis comicial. Todas se resolvieron ad integrum.Conclusiones. La tasa de reacciones adversas de la IGEV en nuestro medio fue baja, con mayoría de reacciones leves e inmediatas y evolución favorable en todos los pacientes.
Introduction. Intravenous immunoglobulin G (IVIG) is a blood product from polyvalent and polyclonal immunoglobulin G. It covers a broad range of indications as immunomodulator or replacement therapy. In addition, although it is considered a safe therapy, the incidence of adverse reactions reported in the bibliography ranges from 1 % to 81 %. The objective of this study was to assess IVIG use and describe related adverse events in a tertiary care children's hospital.Population and methods. This was a pharmacoepidemiological, observational, and prospective study. Patients receiving IVIG for 7 months in 6 areas of a tertiary care children's hospital in the Autonomous City of Buenos Aires were assessed. The analysis unit was each IVIG infusion, and the main variable was the presence of adverse reactions.Results. A total of 305 infusions in 111 patients were analyzed. In 81.6 % of cases, the indication was for replacement. The maximum dose was 1 g/kg. In 99.6 % of infusions, some type of premedication was indicated; diphenhydramine was the most common drug, with varying dosages. A total of 12 adverse reactions (3.9 % of infusions) were recorded; 3 were severe: aseptic meningitis (2 cases) and seizures (1 case). All resolved to normal.Conclusions. The rate of IVIG adverse reactions in our setting was low; most reactions were mild and immediate and resolved favorably in all patients
Sujet(s)
Humains , Mâle , Femelle , Nourrisson , Enfant d'âge préscolaire , Enfant , Adolescent , Immunoglobuline G/effets indésirables , Pharmacovigilance , Immunoglobuline G/administration et posologie , Immunoglobuline G/usage thérapeutique , Études prospectives , Immunoglobulines par voie veineuse , Pharmacoépidémiologie , Effets secondaires indésirables des médicamentsRÉSUMÉ
La hipofisitis linfoplasmocitaria con expresión de inmunoglobulina G4 (IgG4) es una entidad de reciente conocimiento. Pertenece al grupo de enfermedades relacionadas a IgG4 (IgG4-RD, del inglés: IgG4-related disease), donde uno o varios órganos pueden estar comprometidos, con síntomas compresivos u obstructivos, o disfuncionalidad por infiltración celular. La hipófisis puede estar afectada en forma aislada. Clínicamente, se presentan con diabetes insípida, hipopituitarismo y/o síntomas de masa ocupante selar, siendo los principales diagnósticos diferenciales los adenomas selares no secretantes, y otros tipos de hipofisitis. Para arribar al diagnóstico de este tipo patología es necesaria la presencia de una imagen de agrandamiento selar o engrosamiento del tallo pituitario en la resonancia magnética nuclear, una histopatología característica con inmunomarcación positiva para IgG4 en más de 10 células plasmáticas por campo de gran aumento y la presencia de IgG4 sérica elevada. Tienen una excelente respuesta a glucocorticoides, por lo que una sospecha diagnóstica oportuna evitaría una cirugía innecesaria en la mayoría de los pacientes con esta entidad.
Immunoglobulin G4 (IgG4)-related lymphoplasmacytic hypophysitis is a recently known entity. It belongs to the IgG4-related diseases (IgG4-RD), in which one or more organs may be involved, with compressive or obstructive symptoms, or dysfunctionality due to cellular infiltration. The pituitary gland can be isolatedly affected. Clinically, lymphoplasmacytic hypophysitis presents with diabetes insipidus, hypopituitarism and/or symptoms of an occupying sellar mass, being the non-secreting sellar adenomas and other types of hypophysitis the main differential diagnosis. In order to reach the diagnosis, the presence of pituitary enlargement or pituitary stalk thickening on an MRI scan, a distinctive histopathology with positive for IgG4 immunostaining in more than 10 plasma cells per high-powerfield, and elevated serum IgG4 levels, confirms this type of hypophysitis. As this entity has an excellent response to glucocorticoids, the diagnosis suspicion may avoid an unnecessary surgery in most patients.
Sujet(s)
Humains , Mâle , Femelle , Immunoglobuline G/effets indésirables , Immunoglobuline G/immunologie , Hypophysite/diagnostic , Immunoglobuline G/analyse , Diagnostic différentiel , Hypophysite/classification , Hypophysite/épidémiologieRÉSUMÉ
INTRODUCCIÓN: Antecedentes: El presente dictamen expone la evaluación de tecnología de la eficacia y seguridad del uso de vemurafenib como tratamiento de pacientes con diagnóstico de melanoma maligno, metastásico, irresecable, mutación BRAF V600 y que han progresado al tratamiento de primera línea con nivolumab. Aspectos Generales: El Melanoma es un tumor maligno que se origina en los melanocitos y afecta principalmente a la piel. Los melanomas pueden aparecer también en el ojo (úvea, conjuntiva y el cuerpo ciliar), las meninges o en varias superficies de mucosa. Mientras que los melanomas son causantes de cerca del 90% de las muertes asociadas a tumores cutáneos, incluso los tumores pequeños pueden tener tendencia a la metástasis y por lo tanto tener un pronóstico desfavorable. Tecnología Sanitaria de Interés: Vemurafenib (Zelboraf, Roche) es un inhibidor de la proteína quinasa oncogénica BRAF V600. Este medicamento está autorizado para el tratamiento de pacientes adultos con melanoma irresecable o metastásico con la mutación BRAF V600. METODOLOGÍA: Estrategia de Búsqueda: Se realizó una búsqueda de la literatura con respecto a la eficacia y seguridad de vemurafenib para el tratamiento de los pacientes con melanoma maligno, metastásico, irresecable, con mutación BRAF V600 que han progresado a primera línea con nivolumab. Esta búsqueda se realizó utilizando los meta-buscadores: Translating Research into Practice (TRIPDATABASE), National Library (Pubmed-Medline) y Health Systems Evidence. Adicionalmente, se a amplió la búsqueda revisando la evidencia generada por grupos internacionales que realizan revisiones sistemáticas (RS), evaluación de tecnologías sanitarias (ETS) y guías de práctica clínica (GPC), tales como la Cochrane Group, The National Institute for Health and Care Excellence (NICE), the Agency for Health care Research and Quality (AHRQ), The Canadian Agency for Drugs and Technologies in Health (CADTH) y The Scottish Medicine Consortium (SMC). ESta búsqueda se completó ingresando a la página web www,clinicaltrials.gov, para así pode identificar ensayos clínicos en elaboración o que no hayan sido publicados aún, y así disminuir el riesgo de sesgo de publicación. RESULTADOS: Sinopsis de la Evidencia: Se realizó la búsqueda bibliográfica y de eviencia científica para el sustento del uso de vemurafenib para el tratamiento de los pacientes con melanoma maligno, metastásico, irresecable, con mutación BRAF V600 y que han progresado a la primera línea con nivolumab. Se presenta la evidencia disponible según el tipo de publicación priorizada en los criterios de inclusión. Se incluyeron dos GPC, la guía realizada por la Sociedad Europea de Oncología Médica (ESMO) publicada en el 2015, y la guía del Instituto Nacional para Excelencia en el Cuidado de la Salud (NICE) también pulbicada en el 2015.Se incluyó el estudio BRIM3 que comparó vemurafenib con dacar bazina y en el que se basaron las GPC y la ETS. Aunque la población incluida en este estudio eran pacientes sin tratamiento sistémico previo, se trata del único ensayo clínico aleatorizado de fase III. No se encontraton estudios en progreso o sin publicar que respondan a la pregunta de interés de esta evaluación. Estudios excluidos: el estudio de Sosman et al., 2012 no ha sido incluido porque se trata de un ensayo de fase II sin grupo de comparación y la población no incluye a pacientes que han progresado con nivolumab. CONCLUSIONES: Es posible redefinir los tipos de melanomas en función a la presencia de ciertas mutaciones, las cuales conducen a la activación de proteínas señaladores mutantes que inducen la formación de tumores. Las mutaciones en el gen BRAF están presentes en el 40-70% de los melanomas, condiciendo a una activación de la proliferación celular incontrolada. En EsSalud está disponible el medicamento nivolumab para el tratamiento de primera línea de los pacientes con melanoma metastásico tengan o no la mutación BRAF V600. Frente a esta aprobación los clínicos plantearon la condición clínica de pacientes con melanoma metástasico positivos a la mutación BRAF V600, que progresan a pesar del tratamiento con nivolumab. Esta evaluación se centró en la búsqueda de toda la evidencia respecto a la eficacia de vemurafenib en pacientes que progresaron con nivolumab. Sin embargo, no se ha identificado evidencia respecto a la eficacia de vemurafenib en pacientes con melanoma maligno metastásico irresecable con la mutaciónBRAF V600 y que progresaron al uso de nivolumab. Después de considerar los riesgos de efectos adversos severos con el uso de vemurafenib, los probables costos asociados con el manejo de los mismos y la ausencia de evidencia directa, el balance riesgo beneficio resulta ser claramente de mayor riesgo, mayores inconvenientes para el paciente y probablemente mayores costos frente a un modesto benefício no observado directamente en los pacientes de interés de esta evaluación. En EsSalud está disponible del uso de nivolumad. La dacarbazina se viene usando por más de cuatro décadas y con un perfil de toxicidad conocido y manejable. El Instituto de Evaluación de Tecnologías en Salud e Investigación-IETSI, no aprueba el uso de vemurafenib para el tratamiento de pacientes con MA (irresecable o metastásico) con mutación BRAF V600 después de progresar con nivolumab.
Sujet(s)
Humains , Adulte , Immunoglobuline G/effets indésirables , Mélanome/complications , Mélanome/traitement médicamenteux , Mutation , Protéines proto-oncogènes B-raf/antagonistes et inhibiteurs , Anticorps monoclonaux , Protéines proto-oncogènes B-raf , Évaluation de la technologie biomédicale , Résultat thérapeutiqueRÉSUMÉ
Immunobiologic therapy is indicated for severe forms of psoriasis, resistant to conventional therapy. There is growing concern about their safety profile and possible association with cancer development. This article documents two cases of renal cell cancer during treatment with biologic therapy, reviewing what is described in the literature . The risk of solid tumors as a complication of using TNF-alpha inhibitors is controversial. No conclusion can be drawn from the data in the literature, however, we believe that special attention should be given to those with known risk factors for a specific neoplasm.
Sujet(s)
Adulte , Sujet âgé , Humains , Mâle , Adulte d'âge moyen , Néphrocarcinome/induit chimiquement , Facteurs immunologiques/effets indésirables , Tumeurs du rein/induit chimiquement , Psoriasis/traitement médicamenteux , Facteur de nécrose tumorale alpha/antagonistes et inhibiteurs , Anticorps monoclonaux/effets indésirables , Produits dermatologiques/effets indésirables , Immunoglobuline G/effets indésirables , Récepteurs aux facteurs de nécrose tumorale , Facteurs de risque , Résultat thérapeutiqueSujet(s)
Anticorps monoclonaux humanisés/effets indésirables , Antirhumatismaux/effets indésirables , Arthrite psoriasique/traitement médicamenteux , Éosinophilie/induit chimiquement , Humains , Immunoglobuline G/effets indésirables , Mâle , Adulte d'âge moyen , Récepteurs aux facteurs de nécrose tumorale , Indice de gravité de la maladie , Facteur de nécrose tumorale alpha/antagonistes et inhibiteursRÉSUMÉ
BACKGROUND/AIMS: The treatment for steroid-refractory acute graft versus host disease (GVHD) after allogeneic stem cell transplantation (allo-SCT) needs to be standardized. We report our clinical experience with etanercept for steroid-refractory acute GVHD. METHODS: Eighteen patients who underwent allo-SCT and presented with steroid-refractory acute GVHD at Ajou University Hospital were studied retrospectively. They were given 25 mg of etanercept subcutaneously twice weekly for 4 weeks. The clinical responses were evaluated with regard to the severity of acute GVHD. RESULTS: The median patient age was 43.5 years. Using nonparametric tests, etanercept had a down-grading effect on acute GVHD (p = 0.005), although no patient experienced complete remission. Partial responses were seen in 80%, 17%, and 57% of grade II to IV patients, respectively. Skin and gut GVHD were well controlled with etanercept, whereas hepatic GVHD was not. Four patients died of fatal infections. No factors affecting the clinical outcome of etanercept were identified. CONCLUSIONS: Etanercept has a modest effect on steroid-refractory acute GVHD after allo-SCT, with tolerable side effects.
Sujet(s)
Adulte , Sujet âgé , Femelle , Humains , Mâle , Adulte d'âge moyen , Jeune adulte , Maladie aigüe , Allogreffes , Maladie du greffon contre l'hôte/étiologie , Transplantation de cellules souches hématopoïétiques/effets indésirables , Immunoglobuline G/effets indésirables , Immunosuppresseurs/effets indésirables , Récepteurs aux facteurs de nécrose tumorale/usage thérapeutique , Études rétrospectives , Stéroïdes/usage thérapeutiqueRÉSUMÉ
There is no consensus on whether it is safe to re-administer tumor necrosis factor-alpha (TNFalpha) inhibitors in patients with rheumatoid arthritis (RA) or ankylosing spondylitis (AS) flared after withdrawal of TNFalpha inhibitors due to active tuberculosis (TB). We evaluated the safety of restarting anti-TNFalpha therapy in patients with TNFalpha-associated TB. We used data of 1,012 patients with RA or AS treated with TNFalpha inhibitors at Seoul St. Mary's Hospital between January 2003 and July 2013 to identify patients who developed active TB. Demographic and clinical data including the results of tuberculin skin tests (TST) and interferon-gamma releasing assays (IGRA) were collected. Fifteen patients developed active TB. Five cases were occurred in RA and 10 cases in AS. Nine of 15 patients had a negative TST or IGRA and 6 TST-positive patients had received prophylaxis prior to initiating anti-TNFalpha therapy. All patients discontinued TNFalpha inhibitors with starting the treatment of TB. Eight patients were re-administered TNFalpha inhibitors due to disease flares and promptly improved without recurrence of TB. TNFalpha inhibitors could be safely resumed after starting anti-TB regimen in patients with RA or AS.
Sujet(s)
Adulte , Sujet âgé , Femelle , Humains , Mâle , Adulte d'âge moyen , Anti-inflammatoires non stéroïdiens/effets indésirables , Anticorps monoclonaux/effets indésirables , Anticorps monoclonaux humanisés/effets indésirables , Antirhumatismaux/effets indésirables , Polyarthrite rhumatoïde/traitement médicamenteux , Antienzymes/effets indésirables , Hydroxychloroquine/effets indésirables , Immunoglobuline G/effets indésirables , Immunosuppresseurs/effets indésirables , Tests de libération d'interféron-gamma , Méthotrexate/effets indésirables , Mycobacterium tuberculosis/isolement et purification , Récepteurs aux facteurs de nécrose tumorale/usage thérapeutique , Études rétrospectives , Pelvispondylite rhumatismale/traitement médicamenteux , Test tuberculinique , Tuberculose/induit chimiquement , Facteur de nécrose tumorale alpha/antagonistes et inhibiteursRÉSUMÉ
The antagonists of tumor necrosis factor alpha (TNF-α) are increasingly being used in the treatment of inflammatory and autoimmune diseases. Several adverse effects of these drugs have been reported, including the paradoxical development of sarcoidosis, especially with the use of etanercept. We present the first Brazilian case report of systemic sarcoidosis induced by etanercept and a literature review.
Os medicamentos antagonistas do fator de necrose tumoral alfa (TNF-α) estão sendo cada vez mais utilizados no tratamento de doenças inflamatórias e autoimunes. Efeitos adversos desses medicamentos vem sendo relatados, incluindo o desenvolvimento paradoxal de sarcoidose, principalmente com o uso do etanercepte. Apresentamos o primeiro relato de caso brasileiro de sarcoidose sistêmica induzida por etanercepte e uma revisão da literatura.
Sujet(s)
Femelle , Humains , Adulte d'âge moyen , Antirhumatismaux/effets indésirables , Immunoglobuline G/effets indésirables , Sarcoïdose/induit chimiquement , Maladies de la peau/induit chimiquement , Polyarthrite rhumatoïde/traitement médicamenteux , Brésil , Récepteurs aux facteurs de nécrose tumorale , Sarcoïdose/anatomopathologie , Maladies de la peau/anatomopathologie , Facteur de nécrose tumorale alpha/antagonistes et inhibiteursRÉSUMÉ
As elevated levels of tumor necrosis factor-alpha (TNF-α) are associated with disease severity in psoriasis and psoriatic arthritis, TNF-α antagonists are being used to treat moderate to severe disease in patients who have contraindications, fail to respond or develop side effects to conventional systemic therapies. It is of utmost importance to be well versed with the possible adverse effects and contraindications of TNF-α antagonists so that they can be used effectively and safely. Many of their adverse effects have been well studied in patients of rheumatoid arthritis (RA) and inflammatory bowel disease (IBD) and may not be completely applicable in psoriasis. This is because patients with RA and IBD are on multiple immunosuppressants while those with psoriasis are mostly receiving single systemic therapy and often have comorbidities that distinguish them from those with RA or IBD. Also, some of the side effects are still controversial and debated. Long-term prospective randomized controlled studies are needed to better understand the associated risk in patients of psoriasis. Baseline screening and periodic monitoring during treatment can reduce and help in early identification and appropriate management of the adverse outcomes. This article reviews the side effects known to be associated with TNF-α antagonists, their pathomechanisms and management guidelines. Some of the common side effects include infusion and injection site reactions, infections particularly reactivation of tuberculosis, autoantibody formation and drug induced lupus erythematosus, liver function abnormalities, hematological, and solid organ malignancies.
Sujet(s)
Malformations dues aux médicaments et aux drogues/étiologie , Anti-inflammatoires non stéroïdiens/effets indésirables , Anticorps monoclonaux/effets indésirables , Anticorps monoclonaux humanisés/effets indésirables , Hypersensibilité médicamenteuse/étiologie , Hypersensibilité médicamenteuse/thérapie , Humains , Immunoglobuline G/effets indésirables , Injections/effets indésirables , Tuberculose latente/induit chimiquement , Tuberculose latente/traitement médicamenteux , Foie/effets des médicaments et des substances chimiques , Foie/physiopathologie , Tumeurs/induit chimiquement , Maladies du système nerveux/induit chimiquement , Psoriasis/induit chimiquement , Récepteurs aux facteurs de nécrose tumorale , Thrombopénie/induit chimiquement , Thromboembolie/induit chimiquement , Facteur de nécrose tumorale alpha/antagonistes et inhibiteursRÉSUMÉ
As elevated levels of tumor necrosis factor-alpha (TNF-α) are associated with disease severity in psoriasis and psoriatic arthritis, TNF-α antagonists are being used to treat moderate to severe disease in patients who have contraindications, fail to respond or develop side effects to conventional systemic therapies. It is of utmost importance to be well versed with the possible adverse effects and contraindications of TNF-α antagonists so that they can be used effectively and safely. Many of their adverse effects have been well studied in patients of rheumatoid arthritis (RA) and inflammatory bowel disease (IBD) and may not be completely applicable in psoriasis. This is because patients with RA and IBD are on multiple immunosuppressants while those with psoriasis are mostly receiving single systemic therapy and often have comorbidities that distinguish them from those with RA or IBD. Also, some of the side effects are still controversial and debated. Long-term prospective randomized controlled studies are needed to better understand the associated risk in patients of psoriasis. Baseline screening and periodic monitoring during treatment can reduce and help in early identification and appropriate management of the adverse outcomes. This article reviews the side effects known to be associated with TNF-α antagonists, their pathomechanisms and management guidelines. Some of the common side effects include infusion and injection site reactions, infections particularly reactivation of tuberculosis, autoantibody formation and drug induced lupus erythematosus, liver function abnormalities, hematological, and solid organ malignancies.
Sujet(s)
Malformations dues aux médicaments et aux drogues/étiologie , Anti-inflammatoires non stéroïdiens/effets indésirables , Anticorps monoclonaux/effets indésirables , Anticorps monoclonaux humanisés/effets indésirables , Hypersensibilité médicamenteuse/étiologie , Hypersensibilité médicamenteuse/thérapie , Humains , Immunoglobuline G/effets indésirables , Injections/effets indésirables , Tuberculose latente/induit chimiquement , Tuberculose latente/traitement médicamenteux , Foie/effets des médicaments et des substances chimiques , Foie/physiopathologie , Tumeurs/induit chimiquement , Maladies du système nerveux/induit chimiquement , Psoriasis/induit chimiquement , Récepteurs aux facteurs de nécrose tumorale , Thrombopénie/induit chimiquement , Thromboembolie/induit chimiquement , Facteur de nécrose tumorale alpha/antagonistes et inhibiteursRÉSUMÉ
Psoriasis is a chronic inflammatory disease that can affect skin and joints. Their treatment varies depending on the severity and includes topical and systemic. Among the latter are the immunobiological that target the T cell We report a case that demonstrates the close relationship between psoriasis, lymphoma and biologic therapies.
A psoríase é uma doença inflamatória crônica que pode afetar a pele e as articulações. Seu tratamento varia conforme a gravidade e inclui medicamentos tópicos e sistêmicos. Dentre os últimos estão os imunobiológicos, que têm como alvo a célula T. Relatamos um caso que demonstra a estreita relação entre a psoríase, o linfoma e os imunobiológicos.
Sujet(s)
Adulte , Femelle , Humains , Immunoglobuline G/effets indésirables , Immunosuppresseurs/effets indésirables , Lymphomes/étiologie , Psoriasis/traitement médicamenteux , Psoriasis/complications , Récepteurs aux facteurs de nécrose tumorale , Tumeurs cutanées/étiologieRÉSUMÉ
O fator de necrose tumoral alfa (TNF-alfa) é uma citocina pró-inflamatória, e seu excesso pode levar a sérias consequências. Esses efeitos são conhecidos por serem antagonizados por inibidores da atividade do TNF-alfa. O etanercepte é uma proteína de fusão que inibe a ação do TNF-alfa. Como a regulação do TNF-alfa está relacionada à diferenciação celular de várias células envolvidas na resposta imunológica por meio da expressão de várias outras citocinas, é possível que o uso de inibidores dessa citocina possa causar citopenia. Relatamos dois casos de bicitopenia induzidos por etanercepte. Em ambos os casos houve melhora clínica do quadro após a retirada da medicação. Discutimos a necessidade da introdução de testes laboratoriais de rotina em pacientes que usam terapia anti-TNF, para identificar possíveis alterações hematológicas.
Tumor necrosis factor-alpha (TNF-alpha) is a proinflammatory cytokine, and its excess can lead to severe consequences. Those effects are known to be antagonized by TNF-alpha inhibitors. Etanercept is a fusion protein that inhibits TNF-alpha action. As TNF-alpha regulation is related to cellular differentiation of various cellular types involved in immune response through expression of several other cytokines, it is possible that the use of its inhibitors may cause cytopenia. We report two cases of bicytopenia induced by etanercept. Both cases recovered after drug withdrawal. We discuss the need of introduction of routine laboratorial tests in patients using anti-TNF therapy, in order to identify possible hematological changes.
Sujet(s)
Adulte , Femelle , Humains , Mâle , Adulte d'âge moyen , Antirhumatismaux/effets indésirables , Immunoglobuline G/effets indésirables , Leucopénie/induit chimiquement , Thrombopénie/induit chimiquement , Récepteurs aux facteurs de nécrose tumoraleRÉSUMÉ
OBJETIVO: Avaliar as complicações imediatas da aplicação de agentes anti-TNFα no Centro de Dispensação de Medicação deAlto Custo do HC-FMUSP. PACIENTES E MÉTODOS: Foram incluídos todos os pacientes que receberam agentes anti-TNFα entre agosto/2007 e março/2009.As complicações imediatas (até 1 hora após o término da aplicação) foram classificadas em leves (cefaleia, rash, tontura, prurido, náuseas), moderadas (febre, urticária, palpitação, dor torácica, dispneia, variação da pressão arterial de 20 a 40 mmHg) ou graves (febre com calafrios, dispneia com sibilância, variação da pressão arterial > 40 mmHg). RESULTADOS: Foram avaliados 242 pacientes: 94 (39 por cento) com artrite reumatoide, 64 (26 por cento) com espondilite anquilosante, 32 (13 por cento) com artrite psoriásica, 26 (11 por cento) com artrite idiopática juvenil e 27 (11 por cento) com outros diagnósticos. O número total de aplicações foi de 3.555, sendo 992 (28 por cento) de adalimumabe, 1.546 (43 por cento) de etanercepte e 1.017 (29 por cento) de infliximabe. Complicações imediatas foram observadas em 39/242 (16 por cento) pacientes. As complicações ocorreram em 45/3.555 (1,2 por cento) aplicações. Estas foram mais frequentes com infliximabe comparado com adalimumabe (3,7 por cento vs. 0,5 por cento, P < 0,0001), e com etanercepte (3,7 por cento vs. 0,25 por cento, P < 0,0001). As complicações foram: leves 14/45 (31 por cento), moderadas 21/45 (47 por cento) e graves 10/45 (22 por cento); ocorreram principalmente nos primeiros seis meses de tratamento (56 por cento) e nas aplicações endovenosas, predominantemente na primeira hora de infusão (76 por cento). CONCLUSÃO: As reações agudas, apesar de raras, são potencialmente graves e ocorrem principalmente nas primeiras aplicações tanto no uso de medicações endovenosas como de subcutâneas...
OBJECTIVE: To evaluate the immediate complications of anti-TNFα drugs at the "Center for Dispensation of High Cost Medications" of HC-FMUSP. PATIENTS AND METHODS: All patients who received anti-TNFα agents between August 2007 and March 2009 were included in this study. Immediate complications (up to 1 hour after the injection) were classified as mild (headache, rash, dizziness, itching, nausea), moderate (fever, urticaria, palpitation, chest pain, dyspnea, blood pressure variations between 20 and 40 mmHg), or severe (fever with chills, dyspnea with wheezing, variations in blood pressure > 40 mmHg). RESULTS: Two hundred and forty-two patients were evaluated: 94 (39 percent) with rheumatoid arthritis, 64 (26 percent) with ankylosing spondylitis, 32 (13 percent) with psoriatic arthritis, 26 (11 percent) with juvenile idiopathic arthritis; and 27 (11 percent) with other diagnoses. A total of 3,555 injections were administered: 992 (28 percent) adalimumab, 1,546 (43 percent) etanercept, and 1,017 (29 percent) infliximab. Immediate adverse events were observed in 39/242 (16 percent) patients. Injectionrelated complications were observed in 46/3,555 (1.2 percent) injections. They were more common with infliximab than adalimumab (3.7 percent vs. 0.5 percent, P < 0.0001) and etanercept (3.7 percent vs. 0.25 percent, P < 0.0001). Complications were classified as mild 14/45 (31 percent), moderate 21/45 (47 percent), and severe 10/45 (22 percent), and occurred mainly in the first six months of treatment (56 percent) and after intravenous injections, especially (76 percent) in the first hour. CONCLUSION: Although rare, acute reactions can be severe, being observed more commonly after the initial injections, both intravenous and subcutaneous...
Sujet(s)
Adulte , Sujet âgé , Femelle , Humains , Mâle , Adulte d'âge moyen , Anticorps monoclonaux/effets indésirables , Immunoglobuline G/effets indésirables , Facteur de nécrose tumorale alpha/antagonistes et inhibiteurs , Effets secondaires indésirables des médicaments/épidémiologie , Injections veineuses , Injections sous-cutanées , Prévalence , Récepteurs aux facteurs de nécrose tumorale , Indice de gravité de la maladie , Facteurs tempsRÉSUMÉ
Etanercept is a tumor necrosis factor (TNF) inhibitor that has been used for the treatment of chronic inflammatory diseases including rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. Because of its immunosuppressive activity, opportunistic infections have been noted in treated patients, most notably caused by Mycobacterium tuberculosis. Tuberculosis may present in an extrapulmonary or disseminated form. Since TNF-alpha inhibitors have been used in Korea, a few cases of TNF-alpha inhibitor associated tuberculosis have been described. However, tuberculous arthritis has not been previously reported. We describe a case of tuberculous arthritis in a 57-year-old woman with rheumatoid arthritis who was treated with etanercept.
Sujet(s)
Femelle , Humains , Adulte d'âge moyen , Antirhumatismaux/effets indésirables , Polyarthrite rhumatoïde/traitement médicamenteux , Immunoglobuline G/effets indésirables , Récepteurs aux facteurs de nécrose tumorale , Tuberculose ostéoarticulaire/induit chimiquement , Facteur de nécrose tumorale alpha/antagonistes et inhibiteursRÉSUMÉ
Inhibitors of tumor necrosis factor-alpha (TNF-alpha) have been approved for treating rheumatoid arthritis. As one of the biological response modifiers, etanercept has also been used in the treatment of psoriatic arthritis and inflammatory bowel disease. While etanercept is effective, certain infectious complications, such as tuberculosis, fungus, and cytomegalovirus, have been reported. We report the first Korean case of adenoviral pneumonia in a 55-year-old female who developed disseminated adenoviral infection following etanercept treatment, which resolved after anti-TNF-alpha discontinuation.
Sujet(s)
Adulte d'âge moyen , Humains , Femelle , Facteurs de risque , Protéines de fusion recombinantes/immunologie , Récepteurs aux facteurs de nécrose tumorale/immunologie , Immunoglobuline G/effets indésirables , Sujet immunodéprimé/effets des médicaments et des substances chimiques , Polyarthrite rhumatoïde/traitement médicamenteux , Antirhumatismaux/effets indésirables , Anticorps monoclonaux/effets indésirables , Infections humaines à adénovirus/étiologieRÉSUMÉ
Avaliou-se a influência do manejo de fornecimento de colostro nas concentrações de imunoglobulina G, glicose, proteína total, triglicerídeos, lactato e cortisol de 18 bezerros da raça Holandesa. Os animais foram distribuídos em três tratamentos: T1 - os bezerros foram separados das vacas 6h após o nascimento, mamando em suas mães, por 30 minutos, duas vezes ao dia, nos três primeiros dias; T2 - os bezerros foram separados 6h após o nascimento e nos três primeiros dias receberam o colostro em mamadeiras, duas vezes ao dia, quando receberam 2l/refeição; T3 - permaneceram o tempo todo com as vacas durante os três primeiros dias de vida. Foram colhidas amostras de sangue nos tempos de 0; 12; 24; 48; 72 e 96h após o nascimento. Os valores de IgG do T3 foram mais altos que os encontrados no T1, às 24h (P<0,10). No T3, os níveis de glicose foram mais elevados que os verificados nos demais tratamentos (P<0,10). Os níveis de proteína total no T2 foram maiores que no T1 (P<0,10). As concentrações de cortisol e lactato foram maiores ao nascimento nos três tratamentos (P<0,10). Conclui-se que o T2 seria o manejo mais indicado por sua praticidade.
The influence of colostrum supply on immunoglobulin G, glucose, total protein, triglycerides, lactate and cortisol concentrations of 18 Holstein calves, was evaluated. Calves were allotted to three treatments, T1 - calves were separated from cows 6h after birth, nursing 30 minutes a day in their mothers, twice a day in the first three days; T2 - calves were separated 6h after birth, and in the first three days they received colostrum through nipple bottles twice a day, 2l/meal; and T3 - calves remained all the time with cows during the first three days. Blood samples were taken at times 0; 12; 24; 48; 72 and 96h after birth. IgG levels were higher in T3 than in T1 at 24h (P<0.10). Glucose levels were higher in T3 than in the other treatments (P<0.10). Total protein levels in T2 were higher than in T1 (P<0.10). Cortisol and lactate concentrations at birth were higher in all treatments (P<0.10). Howewer, T2 would be more indicated for its feasibility.
Sujet(s)
Animaux , Mâle , Femelle , Allaitement naturel/effets indésirables , Bovins , Colostrum/physiologie , Immunoglobuline G/effets indésirables , SevrageRÉSUMÉ
Tumor necrosis factor (TNF) is known to play a critical role in the pathogenesis of rheumatoid arthritis (RA). Etanercept is a recombinant soluble fusion protein of TNF type II receptor and IgG, which acts as a specific TNF- antagonist. Anti-TNF-therapy has been an important advance in the treatment of RA. However, induction of autoantibodies in some proportion of patients treated with TNF inhibitors raised concerns for development of systemic autoimmune diseases such as systemic lupus erythematosus (SLE). Although new autoantibody formation is common with anti-TNF therapy, there are only rare reports of overt SLE, most of which manifested without major organ involvement and resolved shortly after discontinuation of the therapy. We describe a 55-yr-old Korean woman who developed overt life threatening SLE complicated by pneumonia and tuberculosis following etanercept treatment for RA. This case is to our knowledge, the first report of etanercept-induced SLE in Korea.
Sujet(s)
Adulte d'âge moyen , Humains , Femelle , Récepteurs aux facteurs de nécrose tumorale , Lupus érythémateux disséminé/induit chimiquement , Immunoglobuline G/effets indésirables , Polyarthrite rhumatoïde/traitement médicamenteux , Antirhumatismaux/effets indésirablesRÉSUMÉ
Introducción. La enfermedad de Graves-Basedow es una enfermedad autoinmune con producción de anticuerpos antitiroideos que son inmunoglobulinas del tipo IgG; éstas, durante la gestación pueden atravesar la placenta y producir estimulación anormal de la tiroides fetal ocasionando hipertiroidismo. Presentación del caso clínico. Se presenta el caso de un recién nacido femenino, producto de madre con enfermedad de Graves-Basedow que presentó datos clínicos (peso bajo para la edad gestacional, exoftalmos, taquicardia) y de laboratorio de hipertiroidismo en el periodo neonatal, ameritando tratamiento con metamizol, propanolol y prednisona. Conclusiones. Se analizan las características clínicas del hipertiroidismo transitorio neonatal secundario a paso de anticuerpos antitiroideos durante la gestación