Efectividad y seguridad en nuestro entorno de adalimumab como tratamiento anti-TNF de primera linea en niños con enfermedad de Crohn / A real-world study focused on the effectiveness and safety of adalimumab as first-line anti-TNF treatment for pediatric Crohn's disease

Introducción y objetivos: Adalimumab (ADA), anticuerpo anti-TNF-α monoclonal recombinante de origen humano, generalmente se emplea como tratamiento de segunda línea en niños con enfermedad de Crohn (EC) que no han respondido o han perdido respuesta a infliximab (IFX). En las series publicadas más del 70% de los pacientes habían sido tratados inicialmente con IFX. Los datos sobre la eficacia a corto y a largo plazo de ADA en pacientes naïve a anti-TNF son muy limitados. El objetivo del presente estudio es describir nuestra experiencia con ADA como tratamiento anti-TNF de primera línea en niños con EC. Material y método: Estudio multicéntrico, retrospectivo que incluye pacientes con EC tratados con ADA como anti-TNF de primera línea. Resultados: Se incluyeron 62 pacientes (34 varones) con una edad media de 13,0 ± 2,4años, un tiempo de evolución de la enfermedad de 7,3 meses (RIQ 2,7-21) y un wPCDAI de 35 puntos (RIQ 24,3-47,5). En el momento de comenzar ADA, 58 pacientes (93,5%) estaban recibiendo tratamiento inmunomodulador. A las 12 semanas de tratamiento el 80,6% (50/62) habían alcanzado la remisión clínica, así como el 95% (57/60) a las 52 semanas. Ocho pacientes (13%) presentaron efectos adversos. Se constató un incremento significativo de los z-scores de talla, velocidad de crecimiento e índice de masa corporal (IMC) a las 52 semanas de tratamiento, en especial en aquellos con retraso de crecimiento. Conclusiones: El tratamiento con ADA favorece una remisión clínica prolongada en pacientes naïve a anti-TNF. El tratamiento con ADA mejora la velocidad de crecimiento en niños con EC y retraso de crecimiento al inicio del tratamiento (AU)

Background and objectives: Adalimumab (ADA), a monoclonal humanised anti-TNF antibody, is usually prescribed as a second-line treatment in paediatric Crohn's disease (CD) patients who have become unresponsive or developed intolerance to infliximab (IFX). In the case series reported, more than 70% of patients had initially been treated with IFX. Data on short- and long-term effectiveness of ADA in anti-TNF naïve patients is limited. The aim of this study is to describe our experience with ADA as a first-line anti-TNF in paediatric CD patients. Material and methods: This is a multicentre retrospective study including anti-TNF naïve paediatric CD patients treated with ADA as first-line anti-TNF. Results: Sixty-two patients (34 males), with a mean age of 13.0 ± 2.4years and a disease duration of 7.3 (IQR 2.7-21) months were included. Median wPCDAI was 35 (IQR 24.3-47.5). Fifty-eight out of 62 (93.5%) were on combo therapy at baseline. Clinical remission at week 12 was achieved in 50 out of 62 (80.6%) and in 57 out of 60 (95.0%) at week 52. Eight patients (13%) reported adverse events. Mean height, growth rate and BMI z-scores improved significantly between baseline and week 52, especially in patients with growth failure. Conclusions: ADA treatment leads to lasting clinical remission in anti-TNF naïve paediatric patients with CD. ADA significantly improved growth rate in children with CD who had growth delay at baseline (AU)

[A real-world study focused on the effectiveness and safety of adalimumab as first-line anti-TNF treatment for pediatric Crohn's disease]. / Efectividad y seguridad en nuestro entorno de adalimumab como tratamiento anti-TNF de primera linea en niños con enfermedad de Crohn.

BACKGROUND AND OBJECTIVES: Adalimumab (ADA), a monoclonal humanised anti-TNF antibody, is usually prescribed as a second-line treatment in paediatric Crohn's disease (CD) patients who have become unresponsive or developed intolerance to infliximab (IFX). In the case series reported, more than 70% of patients had initially been treated with IFX. Data on short- and long-term effectiveness of ADA in anti-TNF naïve patients is limited. The aim of this study is to describe our experience with ADA as a first-line anti-TNF in paediatric CD patients. MATERIAL AND METHODS: This is a multicentre retrospective study including anti-TNF naïve paediatric CD patients treated with ADA as first-line anti-TNF. RESULTS: Sixty-two patients (34males), with a mean age of 13.0±2.4years and a disease duration of 7.3 (IQR 2.7-21) months were included. Median wPCDAI was 35 (IQR 24.3-47.5). Fifty-eight out of 62 (93.5%) were on combo therapy at baseline. Clinical remission at week12 was achieved in 50 out of 62 (80.6%) and in 57 out of 60 (95.0%) at week52. Eight patients (13%) reported adverse events. Mean height, growth rate and BMI z-scores improved significantly between baseline and week 52, especially in patients with growth failure. CONCLUSIONS: ADA treatment leads to lasting clinical remission in anti-TNF naïve paediatric patients with CD. ADA significantly improved growth rate in children with CD who had growth delay at baseline.

Malnutrición en el niño ingresado en un hospital. Resultados de una encuesta nacional / Malnutrition in children admitted to hospital. Results of a national survey

INTRODUCCIÓN: La desnutrición al ingreso se relaciona con hospitalizaciones más prolongadas y mayor morbilidad. La prevalencia varía entre un 6 y un 50%. El estudio DHOSPE se pregunta sobre la situación nutricional al ingreso y cómo se modifica durante el mismo. PACIENTES Y MÉTODOS: Estudio observacional, descriptivo, transversal, con un breve seguimiento longitudinal, multicéntrico, realizado en 32 hospitales en 2011. Se incluyó a 991 pacientes. En todos se realizó una valoración nutricional al ingreso, a los 7 y 14 días. Se utilizó la herramienta de cribado nutricional STAMP en el momento del ingreso. Las medidas antropométricas se evaluaron como puntuaciones Z y el estado nutricional con los índices de Waterlow de peso para la desnutrición aguda y de talla para la crónica. RESULTADOS: La prevalencia de desnutrición fue del 7,1% para la aguda moderada y del 0,7% para la grave. Para la crónica: 2,7% moderada y 1,4% grave. No se encontraron diferencias significativas en función de la edad pero sí en función de la enfermedad. Algo más del 75% de los pacientes presentaban riesgo intermedio o elevado de desnutrirse durante el ingreso, valorado con STAMP. La peor situación nutricional al ingreso y una puntuación más elevada en el riesgo nutricional se correlacionaron positivamente con la necesidad de soporte nutricional. CONCLUSIONES: La prevalencia de desnutrición fue sensiblemente inferior (< 8%) a lo publicado, probablemente en relación con la distinta complejidad de los hospitales. El riesgo nutricional valorado con la herramienta STAMP fue elevado (el 75% presentaba riesgo moderado o intenso de desnutrición)

INTRODUCTION: Malnutrition on admission is closely related to a longer hospital stay and a higher morbidity. The prevalence of hospital malnutrition has been reported as almost as high as 50%, with 6% being the lowest. DHOSPE study investigates nutrition status in Spanish hospitals and its outcome during the hospital stay. PATIENTS AND METHODS: A longitudinal, multicentre, descriptive, cross-sectional study, with a short follow-up period was conducted in 32 hospitals during 2011. A total of 991 patients were included, with ages from 0 to 17 years. Each patient was measured at admission (weight, length, weight for length -W/L-, length for age -L/A-), and at 7 and 14 days. The STAMP nutritional screening tool was completed on admission. Anthropometric measurements were reported as z-score, and nutrition status classified according to W/L and L/A for acute and chronic malnutrition, respectively. RESULTS: The prevalence of malnutrition was 7.1% for moderate, and 0.7% for severe acute malnutrition. For chronic malnutrition, it was 2.7% moderate, and 1.4% severe. There were significant differences according to the underlying condition but not according to age. Results of STAMP show that around 75% of patients had a moderate to high risk of malnutrition. Nutritional status changed during admission for weight, as well as W/L and L/A. A worst nutritional status at admission and a higher STAMP score were positively correlated with the need for nutrition support. CONCLUSIONS: The prevalence of undernutrition was slightly lower (<8%) than previously reported, probably in relation to the variety of hospitals in the survey. Nevertheless, nutritional risk when evaluated with STAMP showed a high risk of malnutrition

[Malnutrition in children admitted to hospital. Results of a national survey]. / Malnutrición en el niño ingresado en un hospital. Resultados de una encuesta nacional.

INTRODUCTION: Malnutrition on admission is closely related to a longer hospital stay and a higher morbidity. The prevalence of hospital malnutrition has been reported as almost as high as 50%, with 6% being the lowest. DHOSPE study investigates nutrition status in Spanish hospitals and its outcome during the hospital stay. PATIENTS AND METHODS: A longitudinal, multicentre, descriptive, cross-sectional study, with a short follow-up period was conducted in 32 hospitals during 2011. A total of 991 patients were included, with ages from 0 to 17 years. Each patient was measured at admission (weight, length, weight for length -W/L-, length for age -L/A-), and at 7 and 14 days. The STAMP nutritional screening tool was completed on admission. Anthropometric measurements were reported as z-score, and nutrition status classified according to W/L and L/A for acute and chronic malnutrition, respectively. RESULTS: The prevalence of malnutrition was 7.1% for moderate, and 0.7% for severe acute malnutrition. For chronic malnutrition, it was 2.7% moderate, and 1.4% severe. There were significant differences according to the underlying condition but not according to age. Results of STAMP show that around 75% of patients had a moderate to high risk of malnutrition. Nutritional status changed during admission for weight, as well as W/L and L/A. A worst nutritional status at admission and a higher STAMP score were positively correlated with the need for nutrition support. CONCLUSIONS: The prevalence of undernutrition was slightly lower (<8%) than previously reported, probably in relation to the variety of hospitals in the survey. Nevertheless, nutritional risk when evaluated with STAMP showed a high risk of malnutrition.

Comparación sobre la efectividad y seguridad del polietilenglicol con y sin electrolitos en el tratamiento del estreñimiento funcional / Comparison of the effectiveness and safety of polyethylene glycol with and without electrolytes in the treatment of chronic constipation

INTRODUCCIÓN: El objetivo del estudio fue comparar la efectividad y seguridad del polietilenglicol con y sin electrolitos (EL) en el estreñimiento funcional pediátrico a lo largo de 12 semanas. MATERIAL Y MÉTODOS: Estudio observacional, prospectivo, longitudinal, de grupos paralelos, que incluye a 62 niños diagnosticados de estreñimiento funcional según los criterios de ROMA III con antecedente de impactación fecal. De ellos, 30 niños recibieron polietilenglicol sin EL (PEG) y 32 PEG con EL (PEG+EL) durante al menos 12 semanas. Los resultados principales fueron determinar el número de deposiciones por semana a las 6 y 12 semanas de tratamiento y la presencia de alteraciones hidroelectrolíticas a las 6 semanas. RESULTADOS: La media de deposiciones por semana fue similar en ambos grupos a las 6 y a las 12 semanas, siendo en la semana 12 de 5,4 y 4,6 deposiciones por semana en los grupos PEG+EL y PEG respectivamente. Después de 6 semanas de tratamiento, el 83% (25 de 30) del grupo PEG tuvo al menos un parámetro alterado en la analítica, comparado con el 56% (18 de 32) en el grupo PEG + EL (p = 0,02). Se reportó una hiponatremia hasta en un 15% (5 de 32) y un 36% (11 de 30) del grupo PEG + EL y el grupo PEG (p = 0,05). Ninguna de las alteraciones analíticas fue clínicamente relevante. CONCLUSIONES: Las formulaciones PEG con o sin EL tienen una efectividad, seguridad y aceptabilidad similar. PEG sin EL presentó un mayor número de alteraciones electrolíticas, pero ninguna fue sintomática

INTRODUCTION: To compare the effectiveness and safety of polyethylene glycol with and without electrolytes (EL) over a 12 week period in treatment of chronic constipation in paediatrics. MATERIAL AND METHODS: This was an observational, prospective, longitudinal, parallel group study, including 62 children with chronic constipation according to ROME III criteria and a history of faecal impaction. The children were divided into groups, one group of 30 received polyethylene glycol without EL (PEG) and 32 PEG with EL (PEG+EL) for at least 12 weeks. The main outcomes were the number of bowel movements at 6 and 12 weeks, and the presence of electrolyte disturbances at 6 weeks. RESULTS: The mean weekly stool frequencies were similar in both groups at 6 and 12 weeks, with 5.4 and 4.6 stools per week in the PEG+EL and PEG groups, respectively at 12 weeks. After 6 weeks of treatment, 83% (25 of 30) of the PEG group had at least one electrolyte disturbance compared with 56% (18 of 32) in the PEG+EL group (P=.02). Hyponatraemia was found in 15% (5 of 32) vs. 36% (11 of 30) of PEG+EL and PEG groups, respectively (P=.05). None of the laboratory abnormalities were clinically relevant. CONCLUSIONS: PEG formulations with or without EL have a quite similar effectiveness, safety and acceptability. PEG without EL produced more electrolyte abnormalities, but none of them were symptomatic

[Comparison of the effectiveness and safety of polyethylene glycol with and without electrolytes in the treatment of chronic constipation]. / Comparación sobre la efectividad y seguridad del polietilenglicol con y sin electrolitos en el tratamiento del estreñimiento funcional.

INTRODUCTION: To compare the effectiveness and safety of polyethylene glycol with and without electrolytes (EL) over a 12 week period in treatment of chronic constipation in paediatrics. MATERIAL AND METHODS: This was an observational, prospective, longitudinal, parallel group study, including 62 children with chronic constipation according to ROME III criteria and a history of faecal impaction. The children were divided into groups, one group of 30 received polyethylene glycol without EL (PEG) and 32 PEG with EL (PEG+EL) for at least 12 weeks. The main outcomes were the number of bowel movements at 6 and 12 weeks, and the presence of electrolyte disturbances at 6 weeks. RESULTS: The mean weekly stool frequencies were similar in both groups at 6 and 12 weeks, with 5.4 and 4.6 stools per week in the PEG+EL and PEG groups, respectively at 12 weeks. After 6 weeks of treatment, 83% (25 of 30) of the PEG group had at least one electrolyte disturbance compared with 56% (18 of 32) in the PEG+EL group (P=.02). Hyponatraemia was found in 15% (5 of 32) vs. 36% (11 of 30) of PEG+EL and PEG groups, respectively (P=.05). None of the laboratory abnormalities were clinically relevant. CONCLUSIONS: PEG formulations with or without EL have a quite similar effectiveness, safety and acceptability. PEG without EL produced more electrolyte abnormalities, but none of them were symptomatic.

Seguridad alimentaria: un hito a conseguir / Food security: an objective to be achieved

No disponible

[Nutrition status on pediatric admissions in Spanish hospitals; DHOSPE study]. / Evaluación del estado nutricional de niños ingresados en el hospitalen en España; estudio DHOSPE (Desnutrición Hospitalaria en el Paciente Pediátrico en España).

UNLABELLED: Malnutrition among hospitalized patients has clinical implications and is associated with adverse outcomes: depression of the immune system, impaired wound healing, muscle wasting, longer length of stay, higher costs and increased mortality. Although the rate of malnutrition in hospitalized children varies in different studies, it seems to be lower than in adult population. Nevertheless, this is a population that has a higher risk of developing malnutrition during hospital stay. There is a need to find the most suitable nutrition screening tool for pediatric patients. AIM: As a first step, we have performed a nationwide study on the prevalence of malnutrition on admission, in order to further evaluate the results of employing a screening tool (STAMP). MATERIAL AND METHODS: The study is a multicenter, transversal study performed in 32 Spanish hospital between June and September 2011 in patients under 17 admitted to a the hospital longer than 48 hours. Weight, height and STAMP questionnaire were done on admission and repeated at day 7, 14 or at discharge. Nutritional status was classified according to Waterlow index for height and for weight. The study was approved by the Ethics Research Committee in each hospital and informed consent obtained prior to be included in the study. RESULTS: 991 patients were finally included. Mean age was 5.0 years (SD: 4.6), distributed uniformly among ages. Moderate to severe malnutrition was present in 7.8%, and overweight-obesity in 37.9%. We found a significant correlation between nutritional status and type of disease. There were no correlationship with age, or with plasmatic albumin levels. comments: This is the first nationwide study on the prevalence of malnutrition on admission in pediatric patients. Malnutrition in pediatric patients was present in around 8% of admissions, slightly inferior to other series. The most likely explanation is that the study included patients from different types of hospitals, mimicking real life conditions.

La desnutrición en los pacientes hospitalizados tiene repercusiones clínicas y se asocia con peores resultados: inmunodepresión, retraso en la cicatrización de las heridas, atrofia muscular, prolongación del ingreso hospitalario y mayor mortalidad. La tasa de desnutrición al ingreso en el paciente pediátrico varía con los estudios, aunque parece inferior a lo que ocurre en el paciente adulto. Sin embargo, es una población de mayor riesgo de desarrollar desnutrición durante el ingreso. Se precisa, por tanto, encontrar una buena herramienta de cribado nutricional. Objetivo: Como primer paso para alcanzar ese objetivo se realizó un estudio de ámbito nacional para determinar la tasa de desnutrición en el ingreso. Material y métodos: Se trató de un estudio transversal, multicéntrico realizado en 32 hospitales españoles entre junio y septiembre de 2011 en pacientes < 17 años que ingresaran en el hospital por un periodo > 48 horas. Se midieron peso y talla y se pasó el cuestionario STAMP en el momento del ingreso y a los 7, 14 días o en el momento del alta. El estado nutricional se clasificó de acuerdo con el índice de Waterlow para peso y talla. El estudio fue aprobado por el Comité Ético de Investigación de cada uno de los hospitales y se requirió la firma del consentimiento informado antes de su inclusión en el estudio. Resultados: 991 pacientes participaron en el estudio. La edad media fue de 5 años (DE: 4,6), distribuidos de forma uniforme entre todas las edades. Se encontró desnutrición moderada o grave en el 7,8% y sobrepeso-obesidad en el 37,9% de los ingresados. Encontramos una situación nutricional significativamente peor para todos los grupos de edad en función de la enfermedad de base. No encontramos correlación entre la desnutrición y la edad, o los niveles de albúmina sérica. Comentarios: Esta es la primera encuesta nacional para estudiar la prevalencia de desnutrición en el momento del ingreso. La cifra encontrada, 8%, fue ligeramente inferior a la encontrada en otros estudios, probablemente debido a la inclusión de pacientes de hospitales de distinto grado de complejidad, acercándose a lo que sería una muestra real de la población española.

Evaluación del estado nutricional de niños ingresados en el hospital en España; estudio DHOSPE (Desnutrición Hospitalaria en el Paciente Pediátrico en España) / Nutrition status on pediatric admissions in spanish hospitals; DHOSPE study

La desnutrición en los pacientes hospitalizados tiene repercusiones clínicas y se asocia con peores resultados: inmunodepresión, retraso en la cicatrización de las heridas, atrofia muscular, prolongación del ingreso hospitalario y mayor mortalidad. La tasa de desnutrición al ingreso en el paciente pediátrico varía con los estudios, aunque parece inferior a lo que ocurre en el paciente adulto. Sin embargo, es una población de mayor riesgo de desarrollar desnutrición durante el ingreso. Se precisa, por tanto, encontrar una buena herramienta de cribado nutricional. Objetivo: Como primer paso para alcanzar ese objetivo se realizó un estudio de ámbito nacional para determinar la tasa de desnutrición en el ingreso. Material y métodos: Se trató de un estudio transversal, multicéntrico realizado en 32 hospitales españoles entre junio y septiembre de 2011 en pacientes < 17 años que ingresaran en el hospital por un periodo > 48 horas. Se midieron peso y talla y se pasó el cuestionario STAMP en el momento del ingreso y a los 7, 14 días o en el momento del alta. El estado nutricional se clasificó de acuerdo con el índice de Waterlow para peso y talla. El estudio fue aprobado por el Comité Ético de Investigación de cada uno de los hospitales y se requirió la firma del consentimiento informado antes de su inclusión en el estudio. Resultados: 991 pacientes participaron en el estudio. La edad media fue de 5 años (DE: 4,6), distribuidos de forma uniforme entre todas las edades. Se encontró desnutrición moderada o grave en el 7,8% y sobrepeso-obesidad en el 37,9% de los ingresados. Encontramos una situación nutricional significativamente peor para todos los grupos de edad en función de la enfermedad de base. No encontramos correlación entre la desnutrición y la edad, o los niveles de albúmina sérica. Comentarios: Esta es la primera encuesta nacional para estudiar la prevalencia de desnutrición en el momento del ingreso. La cifra encontrada, 8%, fue ligeramente inferior a la encontrada en otros estudios, probablemente debido a la inclusión de pacientes de hospitales de distinto grado de complejidad, acercándose a lo que sería una muestra real de la población española (AU)

Malnutrition among hospitalized patients has clinical implications and is associated with adverse outcomes: depression of the immune system, impaired wound healing, muscle wasting, longer length of stay, higher costs and increased mortality. Although the rate of malnutrition in hospitalized children varies in different studies, it seems to be lower than in adult population. Nevertheless, this is a population that has a higher risk of developing malnutrition during hospital stay. There is a need to find the most suitable nutrition screening tool for pediatric patients. Aim: As a first step, we have performed a nationwide study on the prevalence of malnutrition on admission, in order to further evaluate the results of employing a screening tool (STAMP). Material & methods: The study is a multicenter, transversal study performed in 32 Spanish hospital between June and September 2011 in patients under 17 admitted to a the hospital longer than 48 hours. Weight, height and STAMP questionnaire were done on admission and repeated at day 7, 14 or at discharge. Nutritional status was classified according to Water-low index for height and for weight. The study was approved by the Ethics Research Committee in each hospital and informed consent obtained prior to be included in the study. Results: 991 patients were finally included. Mean age was 5.0 years (SD: 4.6), distributed uniformly among ages. Moderate to severe malnutrition was present in 7.8%, and overweight-obesity in 37.9%. We found a significant correlation between nutritional status and type of disease. There were no correlationship with age, or with plasmatic albumin levels. Comments: This is the first nationwide study on the prevalence of malnutrition on admission in pediatric patients. Malnutrition in pediatric patients was present in around 8% of admissions, slightly inferior to other series. The most likely explanation is that the study included patients from different types of hospitals, mimicking real life conditions (AU)