Ruxolitinib as a treatment strategy for SARS-CoV-2 pneumonia: clinical experience in a real-world setting.

INTRODUCTION: Severe acute respiratory syndrome-related coronavirus (SARS-CoV-2) infection is characterised by a viral phase and a severe pro-inflammatory phase. The inhibition of the JAK/STAT pathway limits the pro-inflammatory state in moderate to severe COVID-19. METHODOLOGY: We analysed the data obtained by an observational cohort of patients with SARS-CoV-2 pneumonia treated with ruxolitinib in 22 hospitals of Mexico. The applied dose was determined based on physician's criteria. The benefit of ruxolitinib was evaluated using the 8-points ordinal scale developed by the NIH in the ACTT1 trial. Duration of hospital stay, changes in pro-inflammatory laboratory values, mortality, and toxicity were also measured. RESULTS: A total of 287 patients were reported at 22 sites in Mexico from March to June 2020; 80.8% received ruxolitinib 5 mg BID and 19.16% received ruxolitinib 10 mg BID plus standard of care. At beginning of treatment, 223 patients were on oxygen support and 59 on invasive ventilation. The percentage of patients on invasive ventilation was 53% in the 10 mg and 13% in the 5 mg cohort. A statistically significant improvement measured as a reduction by 2 points on the 8-point ordinal scale was described (baseline 5.39 ± 0.93, final 3.67± 2.98, p = 0.0001). There were 74 deaths. Serious adverse events were presented in 6.9% of the patients. CONCLUSIONS: Ruxolitinib appears to be safe in COVID-19 patients, with clinical benefits observed in terms of decrease in the 8-point ordinal scale and pro-inflammatory state. Further studies must be done to ensure efficacy against mortality.

Administración exitosa de omalizumab en pacientes con síndrome de sobreposición asma-EPOC en un hospital universitario de Puebla / Successful use of omalizumab in patients with overlap syndrome asthma-COPD in a University Hospital of Puebla

Resumen: El término asma/EPOC, denominado SOAE (sobreposición asma/EPOC), incluye a un subconjunto de pacientes con persistencia y limitación del flujo aéreo con características clínicas de asma y de EPOC. La falta de consenso de una definición de sobreposición asma/EPOC ha llevado a la amplia gama en prevalencia que varía entre 11 y 56% en la EPOC, 13 y 61% en el asma y 2% entre la población general. Los estudios iniciales han demostrado que omalizumab puede ser útil en pacientes con sobreposición asma/EPOC porque ha demostrado aliviar los síntomas, reducir las exacerbaciones y la hospitalización, así como mejorar los parámetros de función pulmonar y disminuir el requerimiento de esteroides en estos pacientes. Este artículo describe el efecto de omalizumab en cinco pacientes con diagnóstico de síndrome de sobreposición asma/EPOC y administración de omalizumab. Se describe la experiencia de nuestro centro y los beneficios que el tratamiento ha dado a nuestros pacientes, que han permitido mejor calidad de vida y disminuir de manera radical su morbilidad.

Abstract The term asthma/COPD, called SOAE (overlap asthma/EPOC acronym in English ACOS [asthma COPD overlap syndrome]), includes a subset of patients with persistence and airflow limitation that presents clinical features of both asthma and COPD. Lack of consensus on a definition of ACOS has led to the wide range in prevalence ranging between 11 and 56% in COPD, 13 and 61% in asthma, and 2% in the general population. The initial studies have shown that omalizumab may be useful in patients with ACOS, it has been shown to improve symptoms, reduce exacerbations and hospitalization, as well as improve lung function parameters and reduce steroid requirement in these patients. This paper describes the effect of omalizumab in 5 patients with a diagnosis of overlying asthma/COPD syndrome (SOAE) and administration of omalizumab. We describe the experience of our center and the benefits that the treatment has given to our patients. These benefits have allowed the patient a better quality of life and radically reduce their morbidity.

Administración de omalizumab en pacientes mexicanos con diagnóstico de asma moderada a grave no atópica / Administration of omalizumab in Mexican patients diagnosed with moderate-severe non-atopic asthma

Resumen: OBJETIVO Determinar la mejoría clínica en los pacientes con diagnóstico de asma moderada a severa no atópica en tratamiento con omalizumab. MATERIAL Y MÉTODO estudio prospectivo y observacional en el que del 1 de enero de 2017 al 1 de enero de 2018 se incluyeron pacientes adultos que, a pesar del tratamiento diario con o sin mantenimiento con corticoesteroides orales, tenían asma moderada a severa no atópica descontrolada; los pacientes se asignaron a recibir omalizumab por concentraciones de IgE. El punto final primario fue el cambio en los parámetros clínicos y funcionales de los pacientes por medio de examen de la prueba ACT (Asthma Control Test). RESULTADOS Se incluyeron 20 pacientes. Tras 52 semanas de administración de omalizumab los pacientes mostraron aumento moderado en el FEV1 y mejoría de los parámetros clínicos y funcionales. El alivio sintomático de los pacientes se consideró principalmente con el aumento en la prueba ACT de 10 a 20 puntos. También se observó buena tolerancia al medicamento, sin ningún efecto adverso grave y mejoría en la calidad de vida de los pacientes. CONCLUSIONES Omalizumab tiene un papel terapéutico en el asma no atópica moderada a severa. Nuestros resultados apoyan la eficacia clínica de omalizumab en los pacientes asmáticos no atópicos mexicanos.

Abstract: OBJECTIVE To determine the clinical improvement in patients diagnosed with moderate-severe non-atopic asthma in treatment with omalizumab. MATERIAL AND METHOD A prospective and observational study was made from January 1st 2017 to January 1st 2018 in adult patients who, despite daily treatment with or without maintenance oral corticosteroids, had uncontrolled moderate to severe non-atopic asthma; patients were assigned to receive omalizumab at doses of IgE levels. The primary endpoint was the change in the clinical and functional parameters of the patients by means of Asthma Control Test. RESULTS There were included 20 patients. After 52 weeks of administration of omalizumab they showed a moderate increase in FEV1 and in clinical and functional parameters. The symptomatic improvement of the patients was mainly considered by an increase of 10 to 20 points in Asthma Control Test. Good tolerance to the drug was also observed, without any serious adverse effects, as well as improvement in the quality of life of the patients. CONCLUSIONS Omalizumab has a therapeutic role in moderate to severe non-atopic asthma. Our results support the clinical efficacy of omalizumab in Mexican non-atopic asthmatic patients.

Prevalencia de eosinofilia y características clínicas en una cohorte de pacientes con enfermedad pulmonar obstructiva crónica en un hospital de tercer nivel de Puebla / Eosinophilia prevalence and clinical characteristics in a cohort of patients with chronic obstructive pulmonary disease in a third-level hospital in Puebla

Resumen: ANTECEDENTES La prevalencia de eosinofilia en la enfermedad pulmonar obstructiva crónica (EPOC) es de gran importancia para la prevención de complicaciones y tratar episodios de sobreagudización. La existencia de un biomarcador permitiría este seguimiento. La revisión de la bibliografía pone de manifiesto la posible relación eosinofilia-enfermedad pulmonar obstructiva crónica. Se tiene poca información en estudios médicos. MATERIAL Y MÉTODO Estudio descriptivo y observacional de la población atendida en la consulta externa de Neumología en el Hospital Universitario de Puebla. Se analizaron las siguientes variables: edad, sexo, años de diagnóstico de enfermedad pulmonar obstructiva crónica, hemograma (se estableció el diagnóstico de eosinofilia con > 2% o más de 200 células totales), gravedad (por GOLD) y número de exacerbaciones en un año de estudio. RESULTADOS Se incluyeron 50 pacientes con diagnóstico de enfermedad pulmonar obstructiva crónica (74% mujeres y 26% hombres), 50% asociado con tabaquismo y 50% asociado con humo de leña; 36% tenían eosinofilia representativa (mayor de 2% o mayor de 200 células totales), 64% tenían eosinofilia no representativa (menos de 2% o menos de 200 células totales). CONCLUSIÓN Este trabajo demuestra en una población la importancia de la eosinofilia como biomarcador en el fenotipo de la enfermedad pulmonar obstructiva crónica que permita el tratamiento adecuado y dirigido a mejorar la calidad de vida y a disminuir la progresión y aparición de complicaciones y exacerbaciones.

Abstract: OBJECTIVE The prevalence of eosinophilia in chronic obstructive pulmonary disease is of great importance for the prevention of complications and to treat episodes of overactivity. The existence of a bio-marker would allow this monitoring. The review of the literature reveals the possible eosinophilia-chronic obstructive pulmonary disease relationship. There is little information in medical studies. MATERIAL AND METHOD We designed a descriptive observational study of the population attended in the external consultation of Pneumology in the University Hospital of Puebla. The following variables were analyzed: age, sex, years of diagnosis of chronic obstructive pulmonary disease, blood count (diagnosis of eosinophilia with > 2% or more than 200 total cells), severity (by GOLD) and number of exacerbations in one year of study. RESULTS Fifty patients with a diagnosis of chronic obstructive pulmonary disease (74% female and 26% male), 50% associated with smoking and 50% associated with wood smoke were present; 36% had representative eosinophilia (greater than 2% or greater than 200 total cells), 64% had non-representative eosinophilia (less than 2% or less than 200 total cells). CONCLUSION This work demonstrates in a population the importance of eosinophilia as a biomarker in the phenotype of chronic obstructive pulmonary disease that allows adequate treatment and aimed at improving quality of life and to decrease the progression and appearance of complications and exacerbations.