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‣ Ocular toxicity of intravitreous adalimumab (Humira) in the rabbit

MANZANO, Roberta P. A.; PEYMAN, Gholam A.; CARVOUNIS, Petros E.; KIVILCIM, Muhamet; KHAN, Palwasha; CHEVEZ-BARRIOS, Patricia; TAKAHASHI, Walter
Fonte: SPRINGER Publicador: SPRINGER
Tipo: Artigo de Revista Científica
Português
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Purpose To evaluate the ocular toxicity of escalating doses of intravitreous adalimumab (Humira) in the rabbit eye. Methods Twelve New Zealand albino rabbits received unilateral intravitreous injections of 0.1 ml of adalimumab 0.25 mg (three eyes), 0.50 mg (three eyes), 1.0 mg (three eyes) or 0.1 ml balanced salt solution (BSS, threeeyes). Slit-lamp biomicroscopy and fundoscopy were carried out at baseline, day 1, 7 and 14 following intravitreous injection, while electroretinography (ERG) was carried out at baseline and day 14. Animals were euthanized on day 14, and histopathological examination of the eyes was performed. Results Slit-lamp biomicroscopy and fundoscopy were normal in eyes having received BSS, 0.25 mg or 0.50 mg adalimumab; however, inflammation was present in two of three eyes having received 1.0 mg adalimumab. Similarly, comparison of scotopic and photopic ERG light at baseline and day 14 demonstrated no changes in eyes receiving BSS, 0.25 mg or 0.50 mg adalimumab, but two of three eyes having received 1.0 mg adalimumab showed a greater than 30% reduction in a and b wave. Finally, histopathology demonstrated no differences between eyes receiving BSS, 0.25 mg or 0.50 mg of adalimumab, but two of three eyes injected with 1.0 mg demonstrated inflammatory cell infiltration of the vitreous and anterior chamber...

‣ Adalimumab induced-inflammatory myopathy in rheumatoid arthritis

Carlos de Souza, Fernando Henrique; Morais Barros, Thiago Bitar; Levy-Neto, Mauricio; Shinjo, Samuel Katsuyuki
Fonte: MEDFARMA-EDICOES MEDICAS, LDA; ALGES Publicador: MEDFARMA-EDICOES MEDICAS, LDA; ALGES
Tipo: Artigo de Revista Científica
Português
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The application of immunobiologics for the rheumatoid arthritis treatment may present as a rare complication the development of inflammatory myopathy. Until this moment, there have been described in literature only seven cases of inhibitors of tumor necrosis factor induced-myositis. In this paper, we report the case of the patient with 39 years-old with eight years of arthritis rheumatoid and that due to refractory to various immunosuppressive drugs, the adalimumab was introduced, and evolved to dermatomyositis status.

‣ Estudo da toxicidade do adalimumabe (Humira®) intravítreo para a retina de coelhos; Testing intravitreal toxicity of adalimumab (Humira®) in the rabbit

Manzano, Roberta Pereira de Almeida
Fonte: Biblioteca Digitais de Teses e Dissertações da USP Publicador: Biblioteca Digitais de Teses e Dissertações da USP
Tipo: Tese de Doutorado Formato: application/pdf
Publicado em 16/12/2010 Português
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O adalimumabe (Humira®, Abbott) é um antagonista do Fator de Necrose Tumoral- alpha (TNF-alfa ). É aprovado para o tratamento de artrite reumatoide, espondilite anquilosante, doença de Crohn, psoríase crônica e artrite reumatoide juvenil. É um anticorpo monoclonal que contém apenas sequências humanas de peptídeos contra a molécula do Fator de Necrose Tumoral-alfa. Na literatura, relatos e série de casos sugerem que os antagonistas do Fator de Necrose Tumoral-alfa são úteis no tratamento da inflamação ocular, edema macular cistoide e secundário à uveíte e degeneração macular relacionada à idade. Entretanto, a administração sistêmica do adalimumabe pode gerar efeitos adversos graves. A fim de diminuir esses efeitos adversos e aumentar a concentração da medicação no segmento posterior do olho, uma possível opção é a injeção intravítrea. O objetivo do presente estudo foi avaliar a toxicidade do adalimumabe intravítreo nas diferentes doses para a retina de coelhos por meio de avaliação clínica (biomicroscopia e oftalmoscopia indireta), funcional (eletrorretinograma) e histopatológica (microscopia óptica e eletrônica). Foram utilizados 30 coelhos albinos da raça Nova Zelândia divididos em cinco grupos de seis coelhos. Injeções intravítreas foram realizadas nas seguintes concentrações de adalimumabe: 0...

‣ HEPATITIS AND PNEUMONITIS DURIN ADALIMUMAB THERAPY IN CROHN’ DISEASE: mind the histoplasmosis!

PINHEIRO,Bruno do Valle; DELGADO,Áureo de Almeida; CHEBLI,Julio Maria Fonseca
Fonte: Instituto Brasileiro de Estudos e Pesquisas de Gastroenterologia - IBEPEGE ; Colégio Brasileiro de Cirurgia Digestiva - CBCD ; Sociedade Brasileira de Motilidade Digestiva - SBMD ; Federação Brasileira de Gastroenterologia - FBG; Sociedade Brasileira de Hepatologia - SBH; Sociedade Brasileira de Endoscopia Digestiva - SOBED Publicador: Instituto Brasileiro de Estudos e Pesquisas de Gastroenterologia - IBEPEGE ; Colégio Brasileiro de Cirurgia Digestiva - CBCD ; Sociedade Brasileira de Motilidade Digestiva - SBMD ; Federação Brasileira de Gastroenterologia - FBG; Sociedade Brasileira de Hepatologia - SBH; Sociedade Brasileira de Endoscopia Digestiva - SOBED
Tipo: Artigo de Revista Científica Formato: text/html
Publicado em 01/03/2014 Português
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Context Tumor necrosis factor-alpha (TNF-α) inhibitor therapy plays a pivotal role in the management of moderate to severe inflammatory bowel disease. Because of the role of TNF-α in the host defenses, anti-TNF therapy has been associated with an increase the risks of granulomatous infections. Objective To report the first case of adalimumab-associated invasive histoplasmosis presenting as an acute hepatitis-like syndrome and febrile pneumonitis in a patient with Crohn’s disease. Method Case report of a patient with progressive histoplasmosis confirmed by percutaneous fine needle aspiration biopsy lung and urine Histoplasma antigen. Results We present the case of a young man with CD who developed pneumonia and acute hepatitis-like features caused by Histoplasma capsulatum infection during adalimumab therapy. To the best of our knowledge, this acute hepatitis-like manifestation has never been reported as a presentation of the histoplasmosis in patients with Crohn’s disease. Conclusions This case underscores the potential risk for serious infection that may arise in this setting and should alert clinicians to the need to consider the histoplasmosis diagnosis in patients presenting with acute hepatitis-like syndrome associated with prolonged febrile illness or pneumonitis during therapy with anti-TNF-α antibodies.

‣ Update on the management of inflammatory bowel disease: specific role of adalimumab

Guidi, Luisa; Pugliese, Daniela; Armuzzi, Alessandro
Fonte: Dove Medical Press Publicador: Dove Medical Press
Tipo: Artigo de Revista Científica
Publicado em 15/07/2011 Português
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Anti-tumor necrosis factor alpha (TNF-α) medications are a class of biologics employed in the treatment of patients with inflammatory bowel disease (IBD). Adalimumab is the first fully human monoclonal immunoglobulin directed against TNF-α, which binds with high affinity and specificity to membrane and soluble TNF. Adalimumab administered subcutaneously has demonstrated efficacy in the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and severe chronic psoriasis. Studies have shown that adalimumab is effective for inducing and maintaining remission of moderate-to-severe active Crohn’s disease (CD) patients at an induction dose of 160/80 mg (week 0 and 2) and at a maintenance dose of 40 mg every other week. The efficacy of adalimumab as a second-line therapy has also been documented for patients with loss of response or intolerance to infliximab. Adalimumab is also superior to placebo for inducing and maintaining complete perianal fistula closure. It also seems effective for reducing extraintestinal manifestations. The safety profile is similar to that of other anti-TNF therapy in CD patients, with lower immunogenicity and rate of adverse injection reactions than infliximab. Adalimumab is not approved for the treatment of ulcerative colitis (UC). Recently...

‣ The presence of anti-citrullinated protein antibodies (ACPA) does not affect the clinical response to adalimumab in a group of RA patients with the tumor necrosis factor (TNF) α-308 G/G promoter polymorphism

Aravena, Octavio; Aguillón Gutiérrez, Juan Carlos; Cermenatti, Tomás; Catalán, Diego; Wurmann Kiblisky, Pamela Andrea; Sabugo Siraqyan, María Francisca; Gatica, Héctor; Salazar, Lorena; Cuchacovich Turteltaub, Miguel Moisés; Soto Sáez, Lilian Andr
Fonte: Springer Publicador: Springer
Tipo: Artículo de revista
Português
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Artículo de publicación ISI; The introduction of antitumor necrosis factor (TNF) agents has improved the outcome for many patients with rheumatoid arthritis (RA). To date, the only replicated genetic predictor of anti-TNF response is the −308 G > A single-nucleotide polymorphism in the TNF promoter region. The presence of the −308 TNF G/G genotype appears to be a marker of good response to anti-TNF treatment. Anti-citrullinated protein antibodies (ACPA) have been linked with erosive disease, and have been established as the single most reliable prognostic factor in clinical practice. To test the hypothesis that the ACPA status may affect the −308 G/G patients rate of response to TNF blockade, we prospectively investigated a group of 52 RA patients with the −308 G/G genotype who were ACPA (+) or ACPA (−). All patients were treated with adalimumab, and the clinical response was studied using the Disease Activity Score in 28 joints (DAS28) at 24 weeks of treatment. Over 85% of patients were DAS28 responders in both groups. No significant differences were found between patients from both groups, according to the DAS28 criteria of response at week 24 (p=0.79). In conclusion, our findings suggest that the ACPA status does not affect the clinical response to anti-TNF therapy in −308 TNF G/G patients.; This study was partially supported by FONDECYT Grants 1040439 and 1090174.

‣ Pioderma gangrenoso extendido asociado a enfermedad de Crohn tratada con adalimumab

Achenbach,RE; Sánchez,GF; Marina,S; Dutto,M; Boytenko,S; Maggi,C
Fonte: Revista argentina de dermatología Publicador: Revista argentina de dermatología
Tipo: Artigo de Revista Científica Formato: text/html
Publicado em 01/12/2014 Português
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Comunicamos un caso de pioderma gangrenoso extendido, en una paciente que padece una enfermedad de Crohn y se encontraba bajo tratamiento de la misma con un anti TNF: el adalimumab. La respuesta a la meprednisona fue satisfactoria.

‣ Efficacy of adalimumab in patients with crohn's disease and failure to infliximab therapy: a clinical series

Cordero-Ruiz,Patricia; Castro-Márquez,C.; Méndez-Rufián,V.; Castro-Laria,L.; Caunedo-Álvarez,A.; Romero-Vázquez,J.; Herrerías-Gutiérrez,J. M.
Fonte: Revista Española de Enfermedades Digestivas Publicador: Revista Española de Enfermedades Digestivas
Tipo: info:eu-repo/semantics/article; journal article; info:eu-repo/semantics/publishedVersion Formato: text/html; application/pdf
Publicado em 01/06/2011 Português
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Background: adalimumab, a human anti-TNF, is an effective induction and maintenance therapy for patients with moderate to severe Crohn's disease. It seems to be effective in patients with resistance to infliximab, too, though the experience is more limited. Aim: to evaluate the efficacy of adalimumab, in patients with Crohn's disease (CD) and failure to previous treatment with infliximab. B twenty-five patients with CD and failure to previous treatment with infliximab were enrolled; they were treated with 160/80 (24 patients) and 80/40 (1 patient) induction doses. We analyze clinical response to treatment with adalimumab by the Crohn's disease Activity Index (CDAI) and plasma concentration of C-reactive protein (CRP), steroid sparing and complete fistula closure at week 48. Results: eighteen out of twenty-five patients (72%) achieved clinical remission (CDAI score < 150) at week 24 and 15/25 (60%) patients at week 48. There was a statistically significant difference (p < 0.01) in CRP serum levels from 21 to 8 mg/dl at week 48. Nine out of fifteen patients (60%) treated with corticosteroids were able to discontinue steroids. Three out of eleven patients (27%) with fistulizing Crohn's disease had complete fistula closure after the treatment. Seventy two percent of the patients (18/25) needed to increase adalimumab to weekly dose...

‣ Evaluación económica de la monoterapia con tocilizumab frente a adalimumab en artritis reumatoide

Navarro Sarabia,Federico; Blanco,Francisco J.; Álvaro Gracia,José Mª; García Meijide,Juan A.; Poveda,José Luis; Rubio-Rodríguez,Darío; Rubio-Terrés,Carlos
Fonte: Revista Española de Salud Pública Publicador: Revista Española de Salud Pública
Tipo: info:eu-repo/semantics/article; journal article; info:eu-repo/semantics/publishedVersion Formato: text/html; application/pdf
Publicado em 01/08/2013 Português
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Fundamento: Tocilizumab (TCZ) fue superior a adalimumab (ADA) en monoterapia en la reducción de los signos y síntomas de la artritis reumatoide del adulto (AR) en pacientes intolerantes o con respuesta inadecuada a metotrexato (MTX). El objetivo del estudio fue analizar el coste-efectividad de TCZ vs ADA en estos pacientes. Métodos: Evaluación económica del coste por respuesta o remisión con TCZ vs ADA a partir del estudio ADACTA (horizonte temporal: 24 semanas). Criterios de respuesta clínica ACR o de remisión de la enfermedad, índice DAS28. Ámbito: Sistema Nacional de Salud. Los costes incluidos (adquisición, administración y monitorización de los medicamentos en € de 2012) se obtuvieron de fuentes españolas. Se efectuaron análisis de sensibilidad simples univariantes. Resultados: Las tasas de respuesta ACR20, ACR50 y ACR70 con TCZ y ADA se obtuvieron en el 65% y 49,4% (p <0,01); 47,2% y 27,8% (p <0,01); y en el 32,5% y 17,9% (p <0,01) de los pacientes, respectivamente. La remisión DAS28 se produjo en el 39,9% y 10,5%, respectivamente (p <0,0001). El coste por respuesta fue menor con TCZ que con ADA (ACR20: 8.105 y 11.553 €; ACR50: 11.162 y 20.529 €; ACR70: 16.211 y 31.882 €) respectivamente. El coste de la remisión DAS28 fue de 13.204 € y 54.352 € respectivamente. En todos los escenarios el tratamiento con TCZ tuvo mayor eficacia y menores costes que con ADA. Conclusiones: Según este análisis...

‣ Análisis del impacto presupuestario de adalimumab y etanercept en artritis reumatoide y espondiloartropatías

González Álvarez,A.; Gómez Barrera,M.; Borrás Blasco,J.; Giner Serret,E. J.
Fonte: Farmacia Hospitalaria Publicador: Farmacia Hospitalaria
Tipo: info:eu-repo/semantics/article; journal article; info:eu-repo/semantics/publishedVersion Formato: text/html; application/pdf
Publicado em 01/06/2013 Português
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Objetivo: Evaluar el impacto económico derivado de la ampliación de los intervalos de administración de adalimumab (ADA) y etanercept (ETN), en el tratamiento de la artritis reumatoide (AR) y espondiloartropatias (EAP) en nuestro ámbito de trabajo. Material y método: Se desarrolló un modelo de impacto presupuestario (MIP) para estimar la repercusión económica que tendría la ampliación en los intervalos habituales de administración de ADA 40 mg cada dos semanas y ETN 50 mg semanal (escenario A), por ADA 40 mg cada tres semanas y ETN 50 mg cada dos semanas (escenario B) de acuerdo a las guías y recomendaciones que se aplican a estos estudios, especificando la población diana, la perspectiva del estudio, el horizonte temporal y analizando la robustez del estudio a través de un análisis de sensibilidad univariante de tipo umbral. Resultados: Se incluyeron un total de 71 pacientes en el estudio. La aplicación del MIP mostró unos ahorros anuales para ADA y ETN de 19.784€ y 38.271 € respectivamente. El coste neto, es decir, el ahorro que esto supuso en el horizonte temporal considerado (dos años) ascendió a 116.110 €. El análisis de sensibilidad realizado mostró que el MIP estimado para el periodo de estudio fue muy robusto ya que el resultado neto en diferentes escenarios apenas variaba...

‣ Adalimumab versus etanercept en el tratamiento de la artritis reumatoide: análisis coste-efectividad

González Álvarez,A.; Gómez Barrera,M.; Borrás Blasco,J.; Giner Serrer,E. J.
Fonte: Farmacia Hospitalaria Publicador: Farmacia Hospitalaria
Tipo: info:eu-repo/semantics/article; journal article; info:eu-repo/semantics/publishedVersion Formato: text/html; application/pdf
Publicado em 01/08/2013 Português
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Objetivo: Valorar el grado de efectividad y eficiencia de las dos alternativas principalmente utilizadas en nuestro ámbito, etanercept (ETN) y adalimumab (ADA), para el tratamiento de pacientes diagnosticados de artritis reumatoide (AR) en condiciones reales de la práctica clínica diaria. Material y método: Se realizó un estudio observacional retrospectivo, cuyo horizonte temporal fue de 12 meses referidos al año 2012, en el que se analizaron las características de los pacientes, así como la efectividad y eficiencia de ETN y ADA en la población de estudio. Se estudiaron todos los pacientes de ambos sexos mayores de 18 años, diagnosticados de AR, atendidos en las consultas externas del Servicio de Reumatología del Sector Sanitario de Teruel. Se determinó el descenso medio del valor de DAS28 (DAS28r) de cada fármaco y se definió como unidad de efectividad en el estudio farmacoeconómico un valor DAS28 al inicio (DAS28a) inferior a 3,2 puntos y DAS28r mayor a 1,2 puntos. Como parámetro del estudio para determinar el coste-efectividad de ambas alternativas se utilizó el beneficio neto sanitario (BNS). Resultados: El valor medio de DAS28a fue 2,25 y 2,72 puntos para ETN y ADA respectivamente, con un valor DAS28r de 1,01 puntos superior para ETN...

‣ Tratamiento con adalimumab en la amiloidosis secundaria a artritis reumatoide: a propósito de dos casos

Fikri-Benbrahim,Oussamah; Rivera-Hernández,Francisco; Martínez-Calero,Alberto; Cazalla-Cadenas,Fátima; García-Agudo,Rebeca; Mancha-Ramos,Javier
Fonte: Nefrología (Madrid) Publicador: Nefrología (Madrid)
Tipo: info:eu-repo/semantics/article; journal article; info:eu-repo/semantics/publishedVersion Formato: text/html; application/pdf
Publicado em 01/01/2013 Português
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Las patologías reumatológicas, y en primer lugar la artritis reumatoidea (AR), siguen siendo unas de las principales causas de amiloidosis secundaria. La aparición de agentes biológicos como el adalimumab en el tratamiento precoz de la AR puede ser una alternativa eficaz para frenar el desarrollo y la progresión de la amiloidosis secundaria. No todos los pacientes responderán igual al tratamiento; debemos considerar la comorbilidad asociada, los factores de mal pronóstico para predecir la repuesta terapéutica y los posibles efectos adversos. Dentro de los efectos adversos de las terapias biológicas, hay que destacar el aumento de la tasa de infecciones letales y cuadros de insuficiencia cardíaca. Presentamos dos casos clínicos con amiloidosis renal secundaria a AR que han seguido un curso clínico diferente: nuestro primer caso tuvo una buena repuesta al adalimumab, mientras que el segundo caso evolucionó desfavorablemente después del inicio del tratamiento, falleciendo por complicaciones cardiovasculares.

‣ Efficacy and safety of adalimumab in the treatment of Crohn's disease in children

Navas-López,Víctor Manuel; Blasco-Alonso,Javier; Girón-Fernández-Crehuet,Francisco; Serrano-Nieto,María Juliana; Sierra-Salinas,Carlos
Fonte: Revista Española de Enfermedades Digestivas Publicador: Revista Española de Enfermedades Digestivas
Tipo: info:eu-repo/semantics/article; journal article; info:eu-repo/semantics/publishedVersion Formato: text/html; application/pdf
Publicado em 01/12/2013 Português
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Objectives: to describe the efficacy and safety of adalimumab (ADA) in inducing clinical remission and reducing inflammation of intestinal mucosa in children with Crohn's disease (CD). Methods: we carried out a descriptive, observational study with all patients diagnosed with CD and treated with ADA between January 2007 and March 2013. Disease activity was determined using the Pdiatric Crohn's Disease Activity Index (PCDAI), and the degree of mucosa inflammation by fecal calprotectin (FC). Results: sixteen patients were included. Mean age at diagnosis was 10.6 ± 2.5 years, with a mean age at start of ADA treatment of 12.4 ± 1.8 years, and a median of 1.4 years (IQR 0.5-3) duration from CD diagnosis to start of treatment. Twelve patients were naïve to anti-TNF-α. The PCDAI score at start of ADA treatment was significantly reduced at 12 weeks of follow-up (31.25 IQR 26.8-37.5 vs. 1.2 IQR 0.0-5.0; p = 0.001). Similarly, the FC level decreased at 12 weeks (749 µg/g IQR 514-898 vs. 126 µg/g IQR 67.7-239.2; p = 0.02). Surgery was performed in 4 patients. Adverse events were reported in 4 patients. One patient developed lymphoma at 4 years of ADA treatment in monotherapy. Conclusions: ADA has been shown to be effective in children with moderate-to-severe CD. Treatment benefits should be weighed against side effects. Multicenter longitudinal studies with longer follow-up periods are required to determine the true efficacy and safety of long-term ADA treatment.

‣ Tratamiento de inducción y mantenimiento con adalimumab en la enfermedad de Crohn: un estudio abierto

López Palacios,N.; Mendoza,J. L.; Taxonera,C.; Lana,R.; Fuentes Ferrer,M.; Díaz-Rubio,M.
Fonte: Revista Española de Enfermedades Digestivas Publicador: Revista Española de Enfermedades Digestivas
Tipo: info:eu-repo/semantics/article; journal article; info:eu-repo/semantics/publishedVersion Formato: text/html; application/pdf
Publicado em 01/11/2008 Português
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Introducción: el adalimumab ha demostrado, en ensayos clínicos controlados con placebo y en estudios no controlados, ser efectivo en la EC luminal y fistulosa perianal. Objetivo: evaluar la eficacia y seguridad del adalimumab como tratamiento de inducción y mantenimiento en la EC. Metodología: se incluyeron 22 pacientes con EC tratados con adalimumab (16 por enfermedad luminal y 6 por enfermedad fistulosa perianal activa). Veintiún pacientes habían recibido previamente IFX. Se realizó tratamiento de inducción con 160 mg s.c. en la semana 0 y 80 mg s.c. a las 2 semanas. Los respondedores recibieron 40 mg s.c. cada 14 días como tratamiento de mantenimiento. Se valoró la respuesta a las 4 semanas de la dosis inicial, y se clasificó la respuesta como remisión, respuesta parcial o ausencia de respuesta. Resultados: tras la inducción, el 25% de los pacientes con enfermedad luminal tuvieron remisión completa y el 56,3% respuesta parcial. La respuesta clínica se mantuvo al año en el 71,6% de los pacientes, a los 18 meses en el 53,7% y a los 48 meses en el 35,8%. No se objetivaron diferencias en la respuesta entre pacientes que presentaron reacciones de hipersensibilidad o pérdida de respuesta a IFX. Todos los pacientes con enfermedad fistulosa perianal (n = 6) habían recibido previamente tratamiento con IFX. Tras la inducción un 16...

‣ NOD2, CD14 and TLR4 mutations do not influence response to adalimumab in patients with Crohn's disease: a preliminary report

Barreiro-de Acosta,M.; Ouburg,S.; Morré,S. A.; Crusius,J. B. A.; Lorenzo,A.; Potel,J.; Peña,A. S.; Domínguez-Muñoz,J. E.
Fonte: Revista Española de Enfermedades Digestivas Publicador: Revista Española de Enfermedades Digestivas
Tipo: info:eu-repo/semantics/article; journal article; info:eu-repo/semantics/publishedVersion Formato: text/html; application/pdf
Publicado em 01/10/2010 Português
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Introduction: adalimumab is a recombinant fully-human monoclonal immunoglobulin (IgG1) antibody utilized in the treatment of Crohn's disease. Unfortunately no clinical or genetic markers exist to predict response to anti-tumor necrosis factor-alpha (TNF) therapy. The aim of this study was to evaluate the association between selected genes involved in cytokine regulation and response to adalimumab treatment in Crohn's disease. Methods: twenty-four patients with Crohn's disease either naïve (n = 8) or had lost response or were unable to tolerate the chimeric anti-TNF antibody infliximab (n=16) were enrolled in the study. Patients were genotyped for main polymorphisms in NOD2, CD14 and TLR4 genes. Response to adalimumab treatment was defined as a decrease of Crohn's disease activity index of at least 100 points or a closure of at least 50% of fistulas in case of fistulizing Crohn's disease. Results: overall, 75% of patients did respond to treatment. However, no statistically significant association was found between any of the genotypes and the response to adalimumab. Conclusions: in our small study group no association between the studied polymorphisms and response to adalimumab was apparent. Systematic studies to search for genetic markers of response to anti-TNF therapy are necessary.

‣ Efficacy of adalimumab for the treatment of extraintestinal manifestations of Crohn's disease

Barreiro-de-Acosta,Manuel; Lorenzo,Aurelio; Domínguez-Muñoz,J. Enrique
Fonte: Revista Española de Enfermedades Digestivas Publicador: Revista Española de Enfermedades Digestivas
Tipo: info:eu-repo/semantics/article; journal article; info:eu-repo/semantics/publishedVersion Formato: text/html; application/pdf
Publicado em 01/09/2012 Português
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Background and aims: Crohn's disease (CD) is commonly associated with inflammatory processes located in organs and systems others than the gut, which are known as extraintestinal manifestations (EIM) of the disease. The aim of this study was to assess the effectiveness of adalimumab (ADA) for the treatment of EIM in patients with CD. Methods: forty two consecutive CD patients with at least one EIM were prospectively included in a open-label study. Patients received ADA (160 mg at week zero, 80 mg at week two and 40 mg every other week) over six months and the effectiveness and safety of ADA for EIMs were assessed. The influence of gender, age, smoking habits, family history of inflammatory bowel disease, phenotype and previous anti-TNF treatment on EIM resolution was also investigated. Results: at month six, 76.2% of the patients showed remission or response in CD (33.3% remission and 42.9% any response). EIM showed a parallel course with CD in most cases, and showed remission or response in 66.7% of patients (38.1% remission and 28.5% any response). Patients with any response of their EIM condition were younger than those with no response (p = 0.04). No relationship was found between sex, tobacco, family history of IBD, phenotype and previous treatment with anti-TNF...

‣ Treatment with adalimumab in a patient with regenerative nodular hyperplasia secondary to azathioprine

León-Montañes,Rafael; Trigo-Salado,Claudio; Leo-Carnerero,Eduardo; de-la-Cruz-Ramírez,María Dolores; Herrera-Justiniano,José Manuel; Márquez-Galán,José Luis
Fonte: Revista Española de Enfermedades Digestivas Publicador: Revista Española de Enfermedades Digestivas
Tipo: info:eu-repo/semantics/article; journal article; info:eu-repo/semantics/publishedVersion Formato: text/html; application/pdf
Publicado em 01/03/2013 Português
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Introduction: regenerative nodular hyperplasia (RNH) is a rare liver disease with an etiology that is not well understood. Among the etiological factors are purine-analogue drugs such as azathioprine. Case report: we present a case of a 47-year-old patient diagnosed with Crohn's disease in treatment with azathioprine due to corticosteroid dependency who developed RNH with clinical and laboratory signs of portal hypertension one year after starting treatment. After discontinuation of azathioprine, the patient started treatment and, given the poor disease progression, started treatment with adalimumab. This was continued with an excellent response and without deleterious effects on the liver. Discussion: the relevance of this case is twofold: First, this is a rare and early side effect of azathioprine treatment and this is an irreversible disease with potentially serious complications. Second, because treatment was carried out with biological drugs (adalimumab) despite the patient having advance liver disease with portal hypertension without any evidence of its worsening, nor signs of deleterious effects or complications, given that there is scarce or no experience with adalimumab treatment in this type of situation.

‣ Crohn's-like disease in a patient with common variable immunodeficiency treated with azathioprine and adalimumab

Vázquez-Morón,Juan María; Pallarés-Manrique,Héctor; Martín-Suárez,Ignacio Javier; Benítez-Rodríguez,Beatriz; Ramos-Lora,Manuel
Fonte: Revista Española de Enfermedades Digestivas Publicador: Revista Española de Enfermedades Digestivas
Tipo: info:eu-repo/semantics/article; journal article; info:eu-repo/semantics/publishedVersion Formato: text/html; application/pdf
Publicado em 01/06/2013 Português
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Common variable immunodeficiency (CVID) is the most frequent primary antibody deficiency. It is characterized by recurrent bacterial infections, and occurrence of autoimmune and neoplastic diseases is also frequent; there is also a high prevalence of gastrointestinal diseases. There are reports of inflammatory bowel disease in this entity, but incidence is low (2-4 %). We present the case of a patient with common variable immunodeficiency suffering a chronic diar-rhoea episode and who was diagnosed with ileocaecal Crohn's-like disease after performing intestinal transit, CT abdomen and colonoscopy with biopsy. It was first treated with prednisone but on -showing cortisone dependency, treatment with azathioprine and adalimumab was started, with good results.

‣ Demyelinating brain lesions in a Crohn’s patient under adalimumab

Nunes,Ana; Vieira,Ana; Freitas,João
Fonte: Sociedade Portuguesa de Gastrenterologia Publicador: Sociedade Portuguesa de Gastrenterologia
Tipo: Artigo de Revista Científica Formato: text/html
Publicado em 01/03/2013 Português
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Demyelinating conditions of the central nervous system can be associated with inflammatory bowel disease, but since the introduction of tumour necrosis factor antagonista therapies, a number of cases of demyelinating disease associated with the treatment are being described. We report the case of a 36-year-old female, with Crohn’s disease, treated with adalimumab for eighteen months. She developed severe headache and the investigations disclosed several demyelinating lesions in the sub cortical white-matter of the frontal and parietal lobes. The suspension of adalimumab resulted in symptomatic relief in a few weeks, but the brain lesions persisted after eight months of follow-up. The cause of these lesions in inflammatory bowel disease patients treated with tumour necrosis factor antagonists is not yet clearly established, but a raised awareness to this possibility is important, as an early change of treatment is recommended.

‣ Evaluación económica de la monoterapia con tocilizumab frente a adalimumab en artritis reumatoide

Navarro Sarabia,Federico; Blanco,Francisco J.; Álvaro Gracia,José Mª; García Meijide,Juan A.; Poveda,José Luis; Rubio-Rodríguez,Darío; Rubio-Terrés,Carlos
Fonte: Ministerio de Sanidad y Consumo Publicador: Ministerio de Sanidad y Consumo
Tipo: Artigo de Revista Científica Formato: text/html
Publicado em 01/08/2013 Português
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Fundamento: Tocilizumab (TCZ) fue superior a adalimumab (ADA) en monoterapia en la reducción de los signos y síntomas de la artritis reumatoide del adulto (AR) en pacientes intolerantes o con respuesta inadecuada a metotrexato (MTX). El objetivo del estudio fue analizar el coste-efectividad de TCZ vs ADA en estos pacientes. Métodos: Evaluación económica del coste por respuesta o remisión con TCZ vs ADA a partir del estudio ADACTA (horizonte temporal: 24 semanas). Criterios de respuesta clínica ACR o de remisión de la enfermedad, índice DAS28. Ámbito: Sistema Nacional de Salud. Los costes incluidos (adquisición, administración y monitorización de los medicamentos en € de 2012) se obtuvieron de fuentes españolas. Se efectuaron análisis de sensibilidad simples univariantes. Resultados: Las tasas de respuesta ACR20, ACR50 y ACR70 con TCZ y ADA se obtuvieron en el 65% y 49,4% (p <0,01); 47,2% y 27,8% (p <0,01); y en el 32,5% y 17,9% (p <0,01) de los pacientes, respectivamente. La remisión DAS28 se produjo en el 39,9% y 10,5%, respectivamente (p <0,0001). El coste por respuesta fue menor con TCZ que con ADA (ACR20: 8.105 y 11.553 €; ACR50: 11.162 y 20.529 €; ACR70: 16.211 y 31.882 €) respectivamente. El coste de la remisión DAS28 fue de 13.204 € y 54.352 € respectivamente. En todos los escenarios el tratamiento con TCZ tuvo mayor eficacia y menores costes que con ADA. Conclusiones: Según este análisis...