Humoral and cellular monitoring to predict the development of infection in Crohn's disease patients beginning treatment with infliximab.

Although severe infectious complications are rare, it is important to properly screen patients for predisposing conditions before beginning treatment with infliximab. We assessed immunity markers that might provide prognostic value for the development of infection in Crohn's disease patients after treatment with infliximab. In a prospective study, 34 fistulizing Crohn's disease patients (mean age 37 years) were studied. Patients were scheduled to receive three infusions of infliximab (5 mg/kg) at weeks 0, 2, and 6. Immunologic studies: Serum immunoglobulin (IgG, IgA, IgM), IgG-subclasses, and complement (C3, C4, factor B) determined by nephelometry; CD3+, CD3+CD4+, CD3+CD8+, CD19+, and CD56+CD3- lymphocyte subsets performed by flow cytometry. During a mean follow-up of 56 months, 1 patient had disseminated tuberculosis and 2 patients had severe bacterial infections. The presence of infection was associated with significantly higher IgM (246 vs. 121 mg/dL; Mann-Whitney test, P = 0.01), lower C3 (64 vs. 118, P = 0.02), lower C4 concentrations (12 vs. 25, P = 0.02), and with decreased levels of CD19 B cells (47 vs. 290, P = 0.03) in the baseline study. Further prospective studies in a larger number of patients are suggested to examine whether early monitoring of immunocompetence might help to identify the risk of infection in patients treated with infliximab.

Treatment cost of ulcerative colitis is apheresis with Adacolumn cost-effective?

BACKGROUND: Scarce data are available in Europe on the cost of treatment for ulcerative colitis (UC). AIM: To assess the cost of illness of moderate-to-severe UC in two scenarios: traditional treatment versus alternative treatment incorporating granulocyte, monocyte adsorption - apheresis (GMA-Apheresis; Adacolumn). To determine the relative cost-effectiveness of both options in steroid-dependent patients. METHODS: One-year cost-of-illness and cost-effectiveness analysis from the third-payer perspective using a decision tree model was carried out. Probabilities of each event were derived from the literature and an expert panel. Direct medical costs were obtained from official sources (euro2004). Effectiveness was measured by the proportion of patients achieving clinical remission. RESULTS: The average annual cost per patient treated with traditional treatment was estimated to be euro6740; with GMA-Apheresis, the cost was estimated to be euro6959. In steroid-dependent patients, the average annual cost was euro6059 and euro11,436, respectively. The proportion of patients achieving clinical remission with GMA-Apheresis was 22.5% higher. As second- and third-line therapy, a new course of corticosteroids and surgery was avoided in 18.5 and 4% of patients, respectively. CONCLUSIONS: Incorporating GMA-Apheresis (Adacolumn) in the therapeutic management of moderate-to-severe UC patients is cost-effective and implies savings related to the reduction of adverse effects derived from corticosteroid use and to the decreased number of surgical interventions.

Documento de consenso en el uso de la granulocitoaféresis en pacientes con enfermedad inflamatoria intestinal / Consensus document on the use of granulocytapheresis in patients with inflammatory bowel disease

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[Osteoporosis and inflammatory bowel disease]. / Osteoporosis y enfermedad inflamatoria intestinal.

Inflammatory bowel disease is a chronic disease with an unknown ethiology although multiple factors intervene such as individual, genetic and immunologic susceptibility, as well as different environmental factors. Like other multisystemic diseases, its clinical manifestations are diverse and it may affect other organs besides the gastrointestinal tract. In the last few years there is a growing interest for one of these extraintestinal manifestations, osteoporosis and osteopenia that may affect up to 42% of patients and can condition an important increase in morbility. Inactivity, prolonged corticosteroid treatment, nutritional deficiencies and the disease per se have an important role in the development of this complication. This article reviews clinical and ethiological aspects of inflammatory bowel disease associated osteoporosis and offers a strategy for diagnosis and treatment.

Osteoporosis y enfermedad inflamatoria intestinal / Osteoporosis and inflammatory bowel disease

La enfermedad inflamatoria intestinal es una entidad crónica de etiología desconocida en cuyo desarrollo influyen múltiples variables, como son la susceptibilidad individual, genética e inmunológica, así como diferentes factores ambientales. Sus manifestaciones clínicas son muy variadas y pueden afectar a otros órganos diferentes del tracto digestivo, convirtiéndose por tanto en una enfermedad multisistémica. En los últimos años existe un interés creciente por una de estas manifestaciones, la osteoporosis y la osteopenia, que puede afectar hasta al42% de los pacientes y condiciona un importante aumento de la morbilidad. La inactividad, el tratamiento corticoideo prolongado, las deficiencias nutricionales y la propia enfermedad pueden favorecer el desarrollo de esta complicación. En esta revisión se repasan aspectos clínicos y etiológicos de la osteoporosis asociada a la enfermedad inflamatoria intestinal y se ofrecen pautas para su diagnóstico y tratamiento (AU)

Inflammatory bowel disease is a chronic disease with an unknown ethiology although multiple factors intervene such as individual, genetic and immunologic susceptibility,as well as different environmental factors. Like other multisystemic diseases, its clinical manifestations are diverse and it may affect other organs besides the gastrointestinal tract. In the last few years there is a growing interest for one of these extraintestinal manifestations,osteoporosis and osteopenia that may affect up to 42% of patients and can condition an important increase in morbility. Inactivity, prolonged corticosteroid treatment, nutritional deficiencies and the disease per se have an important role in the development of this complication. This article reviews clinical and ethiological aspects of inflammatory bowel disease associated osteoporosis and offers a strategy for diagnosis and treatment (AU)

Predictors of response to infliximab in patients with fistulizing Crohn's disease.

OBJECTIVE: To evaluate the efficacy and toxicity of infliximab for the treatment of fistulizing Crohn's disease. METHODS: Consecutive patients with fistulizing Crohn's disease receiving infliximab were prospectively enrolled. Partial response was defined as a reduction of 50% or more from base-line in the number of draining fistulae. Complete response was defined as the closure of all fistulae. The influence of different variables on the efficacy of infliximab was evaluated. RESULTS: 108 patients were included. The disease was inflammatory plus fistulizing in 18% and only fistulizing in 82%. After the third infusion of infliximab the response was partial in 26% and complete in 57%. Response (%) rates (partial/complete) depending on fistula location were: enterocutaneous (25/68%), perianal (35/60%), rectovaginal (36/64%), and enterovesical (20/40%). None of the studied variables (including concomitant immunosuppressive therapy) correlated with efficacy of infliximab in the multivariate analysis. Incidence of adverse effects (21%) depending on the dose of infliximab was: first dose (5.6%), second (7.4%), and third (11.1%). CONCLUSIONS: Infliximab is an efficacious treatment for fistulizing Crohn's disease. Partial response was achieved in approximately one third of the patients, and complete response in more than half. No studied variable was predictive of response. Adverse effects were relatively infrequent and mild.

Actitud ante un megacolon tóxico / Approach to toxic megacolon

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Efectos secundarios del tratamiento con aztioprina en la enfermedad inflamataoria intestinal / Azathioprine side effects in the treatment of chronic inflammatory bowel disease

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[Dyspepsia-related quality of life. Spanish adaptation and validation of the questionnaire Dyspepsia-Related Health Scale]. / Cuestionario sobre calidad de vida asociada a dispepsia. Adaptación española y validación del cuestionario Dyspepsia Related Health Scale.

BACKGROUND: Dyspepsia affects about 25 % of the population and may cause an important decrease in quality of life. The aim of this work was to perform a Spanish validation and adaptation of the questionnaire DRHS (Dyspepsia Related Health Scale), a tool that assesses dyspepsia-related quality of life. PATIENTS AND METHOD: The study was carried out in 234 subjects, 163 with symptoms of dyspepsia and 71 health volunteers. Two rheumatologists, 2 general practitioners, 1 gastroenterologist, 1 clinical pharmacologist, 1 pharmacoepidemiologist and 1 psychologist were involved in the work. The process of adaptation and validation included translation and re-translation, pilot study in 16 patients, dimensionality, reliability and validity (of content, of construct, convergent, predictive and discriminative). RESULTS: The mean age was 49.1 years (SD: 18) and 60.7 % were females. The between-judges agreement rate of Hambleton and Rovinelli, which evaluates the content validity, was lower than 0.41. The construct validity assessed by the factorial analysis of responses showed that each subscale may be considered unidimensional in both health volunteers and individuals with dyspepsia. Reliability was satisfactory (Cronbach's alpha = 0.92) and stability of measures (test-retest) was excellent with a correlation coefficient of 0.95. The convergent validity, assessed by means of the EuroQoL, was only moderate with a correlation coefficient of 0.54 (p < 0.001). The predictive validity, assessed by administering the questionnaire 12 days after treating dyspepsia, showed a correlation coefficient of 0.47 between the two measures (p < 0.001). There was also a relationship between scores variation and outcome. CONCLUSIONS: The Spanish version of the DRHS, so-called QoL-PEI (questionnaire of quality of life related with problems of stomach and intestine), displays good metric properties and is able to predict the evolution of dyspepsia. The results of this study show that this tool is essentially unidimensional, yet it can be used on a multidimensional form to perform a differentiated assessment of each evaluated case.

[Macromolecular creatinine kinase in patients diagnosed with ulcerative colitis]. / Macrocreatincinasa tipo 1 en pacientes diagnosticados de colitis ulcerosa.

Macromolecular creatinine kinase (macro-CK) type 1 is a macroenzyme formed by the union of an immunoglobulin with a creatinine kinase (CK) enzyme. Its presence in the blood may lead to misdiagnosis of heart disease. This macromolecule has been described in various diseases and is relatively more frequent those with autoimmune etiology. We describe three cases of ulcerative colitis that presented elevated MB-isoenzyme of CK activity greater than the total CK quantified by the immunoinhibition method. Electrophoresis revealed an atypical band that corresponded with the presence of a type 1 macroenzyme. Detection of this macromolecule could be useful in cases of ulcerative colitis when results of blood testing lead to suspicion of ischemic disease.

Epidemiología de la enfermedad inflamatoria intestinal en España / Epidemiology of inflammatory bowel disease in spain

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[The prolonged administration of intravenous immunoglobulins as a treatment for refractory fistulous Crohn's diseases]. / Administración prolongada de inmunoglobulinas intravenosas como tratamiento de la enfermedad de Crohn fistulosa refractaria.

Fistulating Crohn's disease is present in 17-35% of non-surgically treated patients and in up to 45% of surgically treated ones. Among the several therapeutic alternatives for this disease is intravenous immunoglobulin administration. We present a 28-year-old woman with refractory fistulating Crohn's disease who improved after prolonged immunoglobulin administration (32 months).

Randomized clinical trial of Plantago ovata seeds (dietary fiber) as compared with mesalamine in maintaining remission in ulcerative colitis. Spanish Group for the Study of Crohn's Disease and Ulcerative Colitis (GETECCU).

OBJECTIVE: Butyrate enemas may be effective in the treatment of active distal ulcerative colitis. Because colonic fermentation of Plantago ovata seeds (dietary fiber) yields butyrate, the aim of this study was to assess the efficacy and safety of Plantago ovata seeds as compared with mesalamine in maintaining remission in ulcerative colitis. METHODS: An open label, parallel-group, multicenter, randomized clinical trial was conducted. A total of 105 patients with ulcerative colitis who were in remission were randomized into groups to receive oral treatment with Plantago ovata seeds (10 g b.i.d.), mesalamine (500 mg t.i.d.), and Plantago ovata seeds plus mesalamine at the same doses. The primary efficacy outcome was maintenance of remission for 12 months. RESULTS: Of the 105 patients, 102 were included in the final analysis. After 12 months, treatment failure rate was 40% (14 of 35 patients) in the Plantago ovata seed group, 35% (13 of 37) in the mesalamine group, and 30% (nine of 30) in the Plantago ovata plus mesalamine group. Probability of continued remission was similar (Mantel-Cox test, p = 0.67; intent-to-treat analysis). Therapy effects remained unchanged after adjusting for potential confounding variables with a Cox's proportional hazards survival analysis. Three patients were withdrawn because of the development of adverse events consisting of constipation and/or flatulence (Plantago ovata seed group = 1 and Plantago ovata seed plus mesalamine group = 2). A significant increase in fecal butyrate levels (p = 0.018) was observed after Plantago ovata seed administration. CONCLUSIONS: Plantago ovata seeds (dietary fiber) might be as effective as mesalamine to maintain remission in ulcerative colitis.

[Ulcerative jejunitis: a complication of celiac disease]. / Yeyunitis ulcerativa: una complicación de la enfermedad celiaca.

We report the case of a 57-year-old woman with celiac disease of long standing, who developed episodes of intestinal obstruction during two months. They were misdiagnosed as intestinal obstructions caused by adhesions. The barium meal and follow-through examination disclosed several jejunal stenoses. Therefore, the patient underwent early surgery where an intestinal resection was carried out. The histological examination showed the presence of benign ulcers at the stenoses. After surgery, the patient began to gain weight and her nutritional state improved remarkably.