Association between pre-biologic T2-biomarker combinations and response to biologics in patients with severe asthma.

Background: To date, studies investigating the association between pre-biologic biomarker levels and post-biologic outcomes have been limited to single biomarkers and assessment of biologic efficacy from structured clinical trials. Aim: To elucidate the associations of pre-biologic individual biomarker levels or their combinations with pre-to-post biologic changes in asthma outcomes in real-life. Methods: This was a registry-based, cohort study using data from 23 countries, which shared data with the International Severe Asthma Registry (May 2017-February 2023). The investigated biomarkers (highest pre-biologic levels) were immunoglobulin E (IgE), blood eosinophil count (BEC) and fractional exhaled nitric oxide (FeNO). Pre- to approximately 12-month post-biologic change for each of three asthma outcome domains (i.e. exacerbation rate, symptom control and lung function), and the association of this change with pre-biologic biomarkers was investigated for individual and combined biomarkers. Results: Overall, 3751 patients initiated biologics and were included in the analysis. No association was found between pre-biologic BEC and pre-to-post biologic change in exacerbation rate for any biologic class. However, higher pre-biologic BEC and FeNO were both associated with greater post-biologic improvement in FEV1 for both anti-IgE and anti-IL5/5R, with a trend for anti-IL4Rα. Mean FEV1 improved by 27-178 mL post-anti-IgE as pre-biologic BEC increased (250 to 1000 cells/µL), and by 43-216 mL and 129-250 mL post-anti-IL5/5R and -anti-IL4Rα, respectively along the same BEC gradient. Corresponding improvements along a FeNO gradient (25-100 ppb) were 41-274 mL, 69-207 mL and 148-224 mL for anti-IgE, anti-IL5/5R, and anti-IL4Rα, respectively. Higher baseline BEC was also associated with lower probability of uncontrolled asthma (OR 0.392; p=0.001) post-biologic for anti-IL5/5R. Pre-biologic IgE was a poor predictor of subsequent pre-to-post-biologic change for all outcomes assessed for all biologics. The combination of BEC + FeNO marginally improved the prediction of post-biologic FEV1 increase (adjusted R2: 0.751), compared to BEC (adjusted R2: 0.747) or FeNO alone (adjusted R2: 0.743) (p=0.005 and <0.001, respectively); however, this prediction was not improved by the addition of IgE. Conclusions: The ability of higher baseline BEC, FeNO and their combination to predict biologic-associated lung function improvement may encourage earlier intervention in patients with impaired lung function or at risk of accelerated lung function decline.

Analysis of comorbidities and multimorbidity in adult patients in the International Severe Asthma Registry.

BACKGROUND: Investigation for the presence of asthma comorbidities is recommended by the Global Initiative for Asthma because their presence can complicate asthma management. OBJECTIVE: To understand the prevalence and pattern of comorbidities and multimorbidity in adults with severe asthma and their association with asthma-related outcomes. METHODS: This was a cross-sectional study using data from the International Severe Asthma Registry from 22 countries. A total of 30 comorbidities were identified and categorized a priori as any of the following: (1) potentially type 2-related comorbidities, (2) potentially oral corticosteroid (OCS)-related comorbidities, or (3) comorbidities mimicking or aggravating asthma. The association between comorbidities and asthma-related outcomes was investigated using multivariable models adjusted for country, age at enrollment, and sex (ie male or female). RESULTS: Of the 11,821 patients, 69%, 67%, and 55% had at least 1 potentially type 2-related, potentially OCS-related, or mimicking or aggravating comorbidities, respectively; 57% had 3 or more comorbidities, and 33% had comorbidities in all 3 categories. Patients with allergic rhinitis, nasal polyposis, and chronic rhinosinusitis experienced 1.12 (P = .003), 1.16 (P < .001), and 1.29 times (P < .001) more exacerbations per year, respectively, than those without. Patients with nasal polyposis and chronic rhinosinusitis were 40% and 46% more likely (P < .001), respectively, to have received long-term (LT) OCS. All assessed potential OCS-related comorbidities (except obesity) were associated with a greater likelihood of LTOCS use (odds ratios [ORs]: 1.23-2.77) and, except for dyslipidemia, with a greater likelihood of uncontrolled asthma (ORs: 1.29-1.68). All mimicking or aggravating comorbidities assessed were associated with more exacerbations (1.24-1.68 times more), all (except bronchiectasis) with increased likelihood of uncontrolled asthma (ORs: 1.57-1.81), and all (except chronic obstructive pulmonary disease) with increased likelihood of LTOCS use (ORs: 1.37-1.57). A greater number of comorbidities was associated with worse outcomes. CONCLUSION: In a global study, comorbidity or multimorbidity is reported in most adults with severe asthma and is associated with poorer asthma-related outcomes. CLINICAL TRIAL REGISTRATION: The International Severe Asthma Registry database has ethical approval from the Anonymous Data Ethics Protocols and Transparency (ADEPT) committee (ADEPT0218) and is registered with the European Union Electronic Register of Post-Authorization Studies (European Network Centres for Pharmacoepidemiology and Pharmacovigilance [ENCEPP]/DSPP/23720). The study was designed, implemented, and reported in compliance with the European Network Centres for Pharmacoepidemiology and Pharmacovigilance (ENCEPP) Code of Conduct (EMA 2014; EUPAS44024) and with all applicable local and international laws and regulations, and registered with ENCEPP (https://www.encepp.eu/encepp/viewResource.htm?id=48848). Governance was provided by ADEPT (registration number: ADEPT1121).

Association Between T2-related Comorbidities and Effectiveness of Biologics in Severe Asthma.

Rationale: Previous studies investigating the impact of comorbidities on the effectiveness of biologic agents have been relatively small and of short duration and have not compared classes of biologic agents. Objectives: To determine the association between type 2-related comorbidities and biologic agent effectiveness in adults with severe asthma (SA). Methods: This cohort study used International Severe Asthma Registry data from 21 countries (2017-2022) to quantify changes in four outcomes before and after biologic therapy-annual asthma exacerbation rate, FEV1% predicted, asthma control, and long-term oral corticosteroid daily dose-in patients with or without allergic rhinitis, chronic rhinosinusitis (CRS) with or without nasal polyps (NPs), NPs, or eczema/atopic dermatitis. Measurements and Main Results: Of 1,765 patients, 1,257, 421, and 87 initiated anti-IL-5/5 receptor, anti-IgE, and anti-IL-4/13 therapies, respectively. In general, pre- versus post-biologic therapy improvements were noted in all four asthma outcomes assessed, irrespective of comorbidity status. However, patients with comorbid CRS with or without NPs experienced 23% fewer exacerbations per year (95% CI, 10-35%; P < 0.001) and had 59% higher odds of better post-biologic therapy asthma control (95% CI, 26-102%; P < 0.001) than those without CRS with or without NPs. Similar estimates were noted for those with comorbid NPs: 22% fewer exacerbations and 56% higher odds of better post-biologic therapy control. Patients with SA and CRS with or without NPs had an additional FEV1% predicted improvement of 3.2% (95% CI, 1.0-5.3; P = 0.004), a trend that was also noted in those with comorbid NPs. The presence of allergic rhinitis or atopic dermatitis was not associated with post-biologic therapy effect for any outcome assessed. Conclusions: These findings highlight the importance of systematic comorbidity evaluation. The presence of CRS with or without NPs or NPs alone may be considered a predictor of the effectiveness of biologic agents in patients with SA.

Radiological and histological characteristics of patients with interstitial lung disease undergoing lung biopsy in a reference institution from eastern Colombia / Características radiológicas e histológicas de pacientes con enfermedad pulmonar intersticial llevados a biopsia pulmonar en una institución del oriente colombiano

Abstract Introduction: Interstitial lung disease (ILD) diagnosis requires a mukidisciplinary approach and, in some cases, lung biopsy. Objective: To describe the sociodemographic and clinical characteristics, as well as the radiological and histological findings, of patients with ILD who required lung biopsy after a mukidisciplinary board (pneumology, radiology, and pathology) of a reference center for respiratory diseases in Bucaramanga, Colombia, failed to reach the ILD diagnosis. Materials and methods: Cross-sectional study. The medical records of 56 patients treated at the Instituto Neumológico del Oriente who underwent lung biopsy between 2015 and 2019 were reviewed. Measures of central tendency and dispersion were calculated for demographic and clinical variables, respectively, to characterize them. A bivariate analysis was performed using Fisher's exact test to determine whether there were differences in the distribution of the sociodemographic and clinical variables according to the radiological patterns and the final histological diagnosis. Results: Participants' median age was 67 years (IQR: 59-72) and 55.35% were men. 43 patients had a radiological pattern inconsistent with usual interstitial pneumonia (UIP); 4 had a pattern consistent with possible UIP; and 9 had a pattern consistent with UIP. The most common histologic diagnoses were hypersensitivity pneumonitis (HP) (32.14%), nonspecific interstitial pneumonia (NSIP) (17.86%), and UIP (19.64%). Conclusion: In the study population, the primary reason for performing a lung biopsy was the presence of a radiologic pattern inconsistent with UIP, with HP being the predominant histopathological diagnosis. This is the first study to characterize patients with ILD who underwent lung biopsy in eastern Colombia, making a significant contribution to our understanding of the disease's epidemiology in the country.

Resumen Introducción. El diagnóstico de la enfermedad pulmonar intersticial (EPI) requiere un enfoque multidisciplinar y, en ocasiones, de una biopsia pulmonar. Objetivo. Describir las características sociodemográficas y clínicas, y los hallazgos radiológicos e histológicos de pacientes con EPI que requirieron biopsia pulmonar luego de no lograrse un diagnóstico de esta enfermedad por la junta médica multidisciplinar (neumología, radiología y patología) de un centro de referencia en enfermedades respiratorias de Bucaramanga, Colombia. Materiales y métodos. Estudio transversal. Se revisaron las historias clínicas de 56 pacientes atendidos en el Instituto Neumológico del Oriente y que fueron remitidos a biopsia pulmonar entre 2015 y 2019. Se analizaron variables demográficas y clínicas, calculando medidas de tendencia central y de dispersión para su respectiva caracterización. Se realizó un análisis bivariado mediante test exacto de Fisher para determinar si existían diferencias en la distribución de las variables sociodemográficas y clínicas de acuerdo con los patrones radiológicos y el diagnóstico histológico definitivo. Resultados. La mediana de edad fue 67 años (RIC: 59-72), 55.35% fueron hombres. 43 pacientes presentaron patrón radiológico inconsistente con neumonía intersticial usual (NIU); 4, patrón de posible NIU y, 9, patrón de NIU. Los diagnósticos histológicos más frecuentes fueron neumonitis por hipersensibilidad (NH) (32.14%), neumonía intersticial no específica (17.86%) y NIU (19.64%). Conclusión. La principal razón para realizar biopsia pulmonar en la población de estudio fue la presencia de un patrón radiológico inconsistente con NIU, siendo la NH el principal diagnóstico histopatológico. Este es el primer trabajo que caracteriza a pacientes con EPI del oriente colombiano llevados a biopsia pulmonar, lo que representa un importante aporte al conocimiento de la epidemiología de esta enfermedad en Colombia.

Medición de la saturación arterial de oxígeno en enfermedad pulmonar obstructiva crónica / Measurement of blood oxygen saturation in chronic obstructive pulmonary disease

Resumen La terapia con oxígeno a largo plazo mejoró la supervivencia de los pacientes con enfermedad pulmonar obstructiva crónica. Las medidas propuestas en las guías clínicas para evaluar la indicación y seguimiento de esta terapia son la presión arterial de oxígeno y la saturación arterial de oxígeno. Se ha generalizado el uso de la oximetría de pulso, pero la información para determinar si estas medidas son intercambiables es insuficiente. El objetivo es revisar los fundamentos fisiológicos de las variables relacionadas con la oxigenación y sus formas de medición. En la evaluación del paciente con patología respiratoria, la saturación de pulso es una ayuda clínica valiosa, sin embargo, sus limitaciones no le permiten, en ciertos rangos, reemplazar la valoración directa en sangre arterial (gasometría arterial) de la saturación arterial y la presión arterial de oxígeno, para determinar la indicación de la oxigenoterapia. MÉD.UIS.2019;32(3):19-25

Abstract Long-term oxygen therapy improves the survival of patients with chronic obstructive pulmonary disease. Measures proposed in clinical clinics to evaluate the indication and monitoring of arterial blood pressure therapy and arterial oxygen saturation. The use of pulse oximetry has been widespread, but the information to determine if these measures are interchangeable is insufficient. The objective is to review the physiological foundations of variables related to oxygenation and their forms of measurement. In the assessment of the patient with respiratory pathology, pulse saturation is a valuable clinical aid., however, its limitations do not allow, in certain ranges, to replace direct arterial blood pressure (arterial blood gas) measurement of arterial saturation and arterial oxygen pressure, to determine the indication of oxygen therapy. MÉD.UIS.2019;32(3):19-25

Calidad de vida de pacientes con enfermedad pulmonar obstructiva crónica, participantes en un programa educativo integral / Quality of life of patients with chronic obstructive pulmonary disease participating in a comprehensive educational program

Resumen Introducción: La Enfermedad Pulmonar Obstructiva Crónica (EPOC) es una enfermedad altamente prevalente que se caracteriza principalmente por la disnea, la cual genera un impacto sobre la calidad de vida del individuo. El programa de cuidado respiratorio integral ofrece una intervención esencialmente educativa, individualizada y multidisciplinaria enfocada en las necesidades del paciente y su familia, buscando mejorar la calidad de vida. Objetivo: Describir el efecto de un programa educativo de cuidado integral en la calidad de vida de pacientes con enfermedad pulmonar obstructiva crónica. Materiales y métodos: Se realizó un estudio descriptivo transversal incluyendo pacientes con diagnóstico de EPOC en quienes se aplicó el cuestionario para medición de calidad de vida Saint George al ingreso y a los seis meses de estar vinculado al programa. Se realizaron pruebas estadísticas no paramétricas debido al comportamiento no gaussiano de las variables. Resultados: Se incluyeron un total de 31 pacientes con promedio de edad 82,7 años, 43,3% tenían antecedente de tabaquismo, de las variaciones en la encuesta Saint George se observó un cambio significativo en el dominio de actividad y en el puntaje global de la encuesta al ser aplicada a los seis meses de seguimiento. Conclusiones: La implementación del programa educativo integral parece apoyar la mejoría en la calidad de vida de los participantes con diagnóstico de EPOC. Futuros estudios prospectivos podrán validar esta hipótesis.

Abstract Introduction: The Chronic Obstructive Pulmonary Disease (COPD) is a highly prevalent disease, characterized mainly by dyspnea, which has an impact on the quality of life of the person. The program of comprehensive respiratory care offers an essentially educational, individualized and multidisciplinary intervention focused on the needs of the patient and its family, seeking to improve the quality of life and associated morbidities. Objective: To describe the quality of life in a comprehensive care program for patients with chronic obstructive pulmonary disease. Methods: A cross-sectional retrospective descriptive study was carried out, including patients diagnosed with COPD, in whom the Saint George quality of life questionnaire was applied at admission and six months after being linked to the program. Student's t test was performed for the analysis by normality tests. Results: A total of 31 patients with an average age of 82.7 years were included, 43.3% had a history of smoking, variations in the Saint George survey showed a significant change in the domain of activity and in the overall score when applied to the six-month follow-up. Conclusions: The implementation of the comprehensive educational program seems to support the improvement in the quality of life of participants diagnosed with COPD. Future prospective studies may validate this hypothesis.

Efectos de la rehabilitación pulmonar en la tolerancia al ejercicio y la calidad de vida de pacientes con enfermedad pulmonar del nororiente colombiano en el año 2017 / Effects of the pulmonary rehabilitation on exercise tolerance and thequality of life of patients with pulmonary disease from the Colombian northeastern in the 2017

Resumen Introducción: la rehabilitación pulmonar mejora la sintomatología y disminuye el impacto de la enfermedad pulmonar en las actividades cotidianas. Objetivo: determinar el efecto de un programa de rehabilitación pulmonar de cuatro fases, realizado en un centro ambulatorio, sobre la tolerancia al ejercicio y la calidad de vida en pacientes con enfermedad obstructiva, restrictiva y vascular pulmonar. Materiales y métodos: estudio observacional prospectivo en 57 pacientes que completaron un programa de rehabilitación pulmonar de cuatro meses. Al inicio y al final del programa se realizó caminata de seis minutos y el test de calidad de vida de Saint George. Para la evaluación de las diferencias de medianas entre grupos fue utilizada la prueba no paramétrica de Wilcoxon. Resultados: la mediana de la edad fue 69 años, el 50,9% eran del género femenino y posterior al programa se observó un aumento en la distancia recorrida en la caminata de seis minutos, con una diferencia de 15,6 metros (p = 0,07). El test de calidad de vida de Saint George al finalizar el programa presentó disminución en el dominio de síntomas [18,5% (p<0,01)], actividad [4,1 % (p<0,01)], impacto [5,4% (p<0,01)] y total [7,6% (p<0,01)]. Discusión: se evidenció que las patologías respiratorias logran una estabilización de síntomas con la rehabilitación pulmonar, hallazgos que son congruentes a los reportados por otros autores. Conclusión: la rehabilitación pulmonar mejora la tolerancia al ejercicio y la calidad de vida en términos de reducción de síntomas e impacto de la enfermedad en pacientes con patología pulmonar. MÉD.UIS. 2018;31(3):27-36.

Abstract Introduction: pulmonary rehabilitation is a multidisciplinary approach that improves symptoms and decreases the impact of lung disease in everyday activities. Objective: to determine the effect of a 4-phase pulmonary rehabilitation program, performed in an outpatient center, on exercise tolerance and quality of life in patients with obstructive, restrictive and pulmonary vascular disease. Materials and methods: prospective study in 57 patients that completed a 4-month pulmonary rehabilitation program. At the beginning and at the end of the program, a 6-minute walk and the Saint George quality of life test were carried out. For the evaluation of the difference of medians between groups, the non-parametric Wilcoxon test was used. Results: the median age was 69 years, 50.9% were female and after the program an increase in the distance traveled in the 6-minute walk was observed, with a difference of 15,6 meters (p=0,07). The Saint George quality of life test at the end of the program showed a decrease in the symptoms domain [18,5% (p<0,01)], activity [4,1% (p<0,01)], impact [5,4% (p<0,01)] and total [7,6% (p<0,01)]. Discussion: it was evidenced that the respiratory pathologies achieve a stabilization of symptoms with the pulmonary rehabilitation, findings congruent to those reported by other authors. Conclusion: pulmonary rehabilitation improves the exercise tolerance and the quality of life in terms of reduction of symptoms and the impact of the disease in patients with pulmonary disease. MÉD.UIS. 2018;31(3):27-36.

Calidad de vida relacionada con la salud en pacientes con enfermedad pulmonar obstructiva crónica en Hospital Universitario de Santander / Health-related quality of life in patients with chronic obstructive pulmonary disease in Hospital Universitario de Santander

RESUMEN Introducción: la enfermedad pulmonar obstructiva crónica, es una entidad frecuente, caracterizada por limitación del flujo aéreo. La aproximación a través de las pruebas de función pulmonar, no es suficiente al evaluar su impacto sobre la calidad de vida de los pacientes. Objetivo: caracterizar la calidad de vida relacionada con la salud en los pacientes con enfermedad pulmonar obstructiva crónica del Hospital Universitario de Santander. Materiales y métodos: estudio observacional de corte transversal. Se empleó el cuestionario para la evaluación de la Calidad de Vida Relacionada con la Salud, en pacientes que asistieron al servicio de Neumología del Hospital Universitario de Santander entre agosto del 2011 y marzo del 2012. Se incluyeron medidas auto-notificadas de la condición física y mental, calculando medidas de días saludables. Resultados: se incluyeron 44 personas con enfermedad pulmonar obstructiva crónica. Edad promedio 65,5 (± 10,3) años, 24 (54,5%) hombres, 88% población entre el estrato socioeconómico 1 y 2. El promedio del porcentaje del VEF1 37,17%. Percepción de la salud regular 43% y buena 34%. La Mediana en días de salud física no saludables fue 2,5, salud mental no saludable 0, días de dolor 3, percepción de tristeza 2,5, preocupación 2, insomnio 0, vitalidad 10, índice de días saludables 23 y angustia mental frecuente 18. Conclusiones: los pacientes con EPOC perciben su estado de salud como regular, con un bajo número de días saludables, lo cual se relaciona con un alto impacto en su calidad de vida. MÉD.UIS. 2017;30(2):11-9.

ABSTRACT Introduction: chronic obstructive pulmonary disease is a frequent entity, characterized by airflow limitation. The approximation using pulmonary function tests is not sufficient when assessing its impact on patients' quality of life. Objective: to characterize health-related quality of life in patients with chronic obstructive pulmonary disease of the Hospital Universitario de Santander. Materials and methods: an observational cross-sectional study was performed. In the pulmonology department of the Hospital Universitario de Santander. The questionnaire was used for the assessment of Health-Related Quality of Life; self-reported measures of physical and mental condition were included, calculating measures of healthy days. Results: 44 patients with chronic obstructive pulmonary disease were included. The average age 65,5 (± 10,3) men, 88% in socioeconomic status 1 or 2. The mean FEV1 percentage of 37.17%. Perceived health: 43% regular and 34% good. The median of physically unhealthy days was 2.5, mentally unhealthy days 0, pain days 3, perception of depression 2.5, anxiety 2, sleeplessness 0, and vitality 10, index of unhealthy days 23.5 and frequent mental distress 18%. Conclusions: patients with chronic obstructive pulmonary disease perceive their health status as regular, with a low number of healthy days, which is related to a high impact on their quality of life. MÉD.UIS. 2017;30(2):11-9.

Enfoque práctico del síndrome metabólico en pediatría: [revisión] / Practical approach to metabolic syndrome in pediatrics: [review]

El síndrome metabólico en pediatría identifica a un grupo de niños con alto riesgo de presentar eventos cardiocerebrovascular y de diabetes tipo 2 a partir de los seis años de edad. La detección temprana y tratamiento óptimo constituyen el pilar fundamental para disminuir la morbimortalidad cardiovascular a mediano y largo plazo. Esta terapéutica creará hábitos saludables familiares y promoverá el control de los factores de riesgo como alteraciones metabólicas, hipertensión arterial y obesidad en cada integrante independiente de su edad. El presente artículo muestra un abordaje práctico en el ámbito clínico de los pacientes pediátricos a partir de los seis años...

The metabolic syndrome in pediatrics identify a high risk population for cardiocerebrovascular events and type 2 diabetes since six years old. Early detection and treatment of risk factors constitute the main point of intervention to decrease the morbidity and mortality related with cardiovascular disease in the medium and long terms. This treatment will create healthy family habits and it will promote the control of these risk factors in each family member. This article presents a practical approach on this issue in pediatric clinical care since six years of age...