Anti-IL-5 and anti-IL-5R biologics for severe asthma. Are there any differences in their effects?

OBJECTIVE: The aim of this retrospective multicentre study is to describe the clinical characteristics of patients diagnosed with severe eosinophilic asthma receiving anti-IL-5/anti-IL-5Rα therapies and to compare their effectiveness. METHODS: We collected and analysed results separately for anti-IL-5 and anti-IL-5Rα therapies from January 2016 until December 2021 in multidisciplinary severe asthma units. We collected demographic and clinical data, treatment with previous anti-IgE and/or anti-IL-5 agents, and comorbidities. We compared the number of exacerbations and admissions to the hospital, daily oral corticosteroid intake, pulmonary function tests, and Asthma Control Test scores before and after 12 months of therapy. 261 patients were included: 176 patients in the anti-IL-5 group and 85 in the anti-IL-5Rα group. RESULTS: Both groups led to statistically significant reductions in asthma exacerbations, hospital admissions, and visits to the Emergency Room. Although both groups showed a significant reduction in blood eosinophiliccount, we found a difference, although not significant, in the magnitude of reduction as benralizumab was able to decrease eosinophil counts to zero. Patients in the anti-IL-5 group achieved higher ACT scores after treatment, although this improvement was seen in both treatment groups. CONCLUSION: The anti-IL-5 and anti-IL-5Rα biologics have shown similar effectiveness despite having different mechanisms of action. The anti-IL-5 group appeared to be better than benralizumab at improving ACT scores and FEV1/FVC and at reducing the number of inhalers. Although these differences were not statistically significant, it is not clear whether they may have clinical relevance and they might highlight the need for further head-to-head studies comparing these treatments.

Influenza vaccination mitigates severe complications in hospitalized patients: A ten-year observational study, Spain, 2009-2019.

BACKGROUND: Influenza epidemics annually impact a substantial portion of adults worldwide, leading to numerous hospitalizations and fatalities. While the primary goal of vaccination is to prevent influenza virus infection, breakthrough infections can still occur despite vaccination. Evaluating the vaccine effectiveness in preventing severe cases among hospitalized patients is crucial for enhancing vaccination strategies. METHODS: This single-center, observational, cross-sectional, and retrospective study analyzed data from 1,357 patients admitted to La Paz University Hospital for influenza infection between 2009 and 2019. Patients' demographics, clinical variables, comorbidities, vaccination status, and influenza-related outcomes were assessed. Logistic regression analysis was performed to determine the vaccine-independent protective effects. RESULTS: Influenza vaccination independently prevented severe complications, including pneumonia, bacterial superinfection, acute respiratory distress syndrome, and multiple organ failure in hospitalized patients (odds ratio = 0.61, 95% confidence interval: 0.47-0.76). Vaccinated patients had significantly lower intensive care unit admission rates (odds ratio = 0.42, 95% confidence interval: 0.18-0.92). However, there were no significant differences in mortality rates between vaccinated and unvaccinated patients (P = .385). CONCLUSIONS: Our study provides robust evidence supporting the influenza vaccine protective effect against severe outcomes in hospitalized patients during epidemic flu. Vaccination is associated with a significant reduction in severe complications and intensive care unit admissions, emphasizing its importance as a preventive measure. Improving vaccination coverage, especially in specific comorbidities and age groups, could further enhance the vaccine effectiveness in preventing severe influenza cases.

Krebs von den Lungen-6 (KL-6) Levels in Post-COVID Follow-Up: Differences According to the Severity of COVID-19.

To evaluate KL-6 levels in medium-term post-COVID and to compare them in three groups categorised by the severity of COVID-19, we conducted a real-world, retrospective, cohort study. Data from the COVID-19 episode and follow-up during the post-COVID phase were extracted from the COVID@HULP and POSTCOVID@HULP databases, respectively. For the post-COVID period we included demographics, medical history, symptoms, quality of life, physical activity, anxiety and depression status and laboratory results. Patients were categorised into three groups based on the severity of COVID-19: Group 1 (inpatient critical), Group 2 (inpatient non-critical) and Group 3 (hospitalised at home). KL-6 was measured during the follow-up of the three groups. In all, 802 patients were included (Group 1 = 59; Group 2 = 296; Group 3 = 447 patients). The median age was 59 years (48-70), and 362 (45.2%) were males. At admission, fibrinogen and ferritin levels were lower in Group 3 than in the other groups (p < 0.001). Follow-up data were obtained 124 days (97-149) after the diagnosis of COVID-19. The median levels of fibrinogen, ferritin and KL-6 at follow-up were 336 mg/dL (276-413), 80.5 ng/mL (36-174.3) and 326 U/mL (240.3-440.3), respectively. KL-6 levels were lower in Group 3 than in the other groups (298 U/mL (231.5-398) vs. 381.5 U/mL (304-511.8) (Group 1) and 372 U/mL (249-483) (Group 2) (p < 0.001)). KL-6 was associated with ferritin (p < 0.001), fibrinogen (p < 0.001), D-dimer (p < 0.001) and gamma-glutamyl transferase (p < 0.001). KL-6 levels are less elevated at medium-term post-COVID follow-up in patients with mild COVID-19 than in those with moderate or severe disease. KL-6 is associated with systemic inflammatory, hepatic enzyme and thrombosis biomarkers.

Impacto de los corticoides sistémicos en el tiempo de hospitalización en pacientes con COVID-19 / Impact of systemic corticosteroids on length of hospitalization among patients with COVID-19

Objetivo: la COVID-19 supuso una amenaza para la capacidad hospitalaria por el elevado número de ingresos, lo que llevó al desarrollo de diversas estrategias para liberar y crear nuevas camas hospitalarias. Dada la importancia de los corticoides sistémicos en esta enfermedad, se evaluó la eficacia de estos en la reducción de la duración de la estancia hospitalaria (EH) y se comparó el efecto de 3 corticosteroides diferentes sobre este resultado.Métodose realizó un estudio de vida real de diseño tipo cohorte retrospectiva y controlado. Se analizó una base de datos hospitalaria de 3.934 pacientes hospitalizados con diagnóstico de COVID-19 en un hospital terciario entre abril y mayo de 2020. Se comparó un grupo de enfermos que recibieron corticosteroides sistémicos (grupo con corticoides [GC]) frente a un grupo control que no recibió corticosteroides sistémicos (grupo sin corticoides [GSC]) emparejado por edad, sexo y gravedad de la enfermedad mediante una puntuación de propensión. La decisión de prescribir glucocorticoides dependía principalmente del criterio del médico responsable.Resultadosse compararon un total de 199 pacientes hospitalizados en el GC con 199 en el GSC. La EH fue más corta para el GC que para el GSC (mediana=3 [rango intercuartílico=0-10] vs. 5 [2-8,5]; p=0,005, respectivamente), mostrando un 43% más de probabilidad de ser hospitalizado ≤4 días que >4 días cuando se usaron corticosteroides. Además, esta diferencia solo la mostraron aquellos tratados con dexametasona (76,3% hospitalizados ≤4 días vs. 23,7% hospitalizados >4 días [p<0,001]). Los niveles de ferritina sérica, glóbulos blancos y plaquetas fueron más elevados en el GC. No se observaron diferencias en la mortalidad ni en el ingreso a la unidad de cuidados intensivos. (AU)

Objective: The COVID-19 pandemic has posed a threat to hospital capacity due to the high number of admissions, which has led to the development of various strategies to release and create new hospital beds. Due to the importance of systemic corticosteroids in this disease, we assessed their efficacy in reducing the length of stay (LOS) in hospitals and compared the effect of 3 different corticosteroids on this outcome.MéthodWe conducted a real-world, controlled, retrospective cohort study that analysed data from a hospital database that included 3934 hospitalised patients diagnosed with COVID-19 in a tertiary hospital from April to May 2020. Hospitalised patients who received systemic corticosteroids (CG) were compared with a propensity score control group matched by age, sex and severity of disease who did not receive systemic corticosteroids (NCG). The decision to prescribe CG was at the discretion of the primary medical team.ResultsA total of 199 hospitalized patients in the CG were compared with 199 in the NCG. The LOS was shorter for the CG than for the NCG (median=3 [interquartile range=0–10] vs. 5 [2–8.5]; p=0.005, respectively), showing a 43% greater probability of being hospitalised ≤4 days than >4 days when corticosteroids were used. Moreover, this difference was only noticed in those treated with dexamethasone (76.3% hospitalised ≤4 days vs. 23.7% hospitalised >4 days [p<0.001]). Serum ferritin levels, white blood cells and platelet counts were higher in the CG. No differences in mortality or intensive care unit admission were observed.ConclusionsTreatment with systemic corticosteroids is associated with reduced LOS in hospitalised patients diagnosed with COVID-19. This association is significant in those treated with dexamethasone, but no for methylprednisolone and prednisone. (AU)

Relationship between air pollution exposure and the progression of idiopathic pulmonary fibrosis in Madrid: Chronic respiratory failure, hospitalizations, and mortality. A retrospective study.

Introduction: Air pollution has a significant impact on the morbidity and mortality of various respiratory diseases. However, this has not been widely studied in diffuse interstitial lung diseases, specifically in idiopathic pulmonary fibrosis. Objective: In this study we aimed to assess the relationship between four major air pollutants individually [carbon monoxide (CO), nitrogen dioxide (NO2), ozone (O3), and nitrogen oxides (NOx)] and the development of chronic respiratory failure, hospitalization due to respiratory causes and mortality in patients with idiopathic pulmonary fibrosis. Methods: We conducted an exploratory retrospective panel study from 2011 to 2020 in 69 patients with idiopathic pulmonary fibrosis from the pulmonary medicine department of a tertiary hospital. Based on their geocoded residential address, levels of each pollutant were estimated 1, 3, 6, 12, and 36 months prior to each event (chronic respiratory failure, hospital admission and mortality). Data was collected from the air quality monitoring stations of the Community of Madrid located <3.5 km (2.2 miles) from each patient's home. Results: The increase in average values of CO [OR 1.62 (1.11-2.36) and OR 1.84 (1.1-3.06)], NO2 [OR 1.64 (1.01-2.66)], and NOx [OR 1.11 (1-1.23) and OR 1.19 (1.03-1.38)] were significantly associated with the probability of developing chronic respiratory failure in different periods. In addition, the averages of NO2, O3, and NOx were significantly associated with the probability of hospital admissions due to respiratory causes and mortality in these patients. Conclusion: Air pollution is associated with an increase in the probability of developing chronic respiratory failure, hospitalization due to respiratory causes and mortality in patients with idiopathic pulmonary fibrosis.

Impact of systemic corticosteroids on length of hospitalization among patients with COVID-19. / [Artículo traducido] Impacto de los corticoides sistémicos en el tiempo de hospitalización en pacientes con COVID-19.

OBJECTIVE: The COVID-19 pandemic has posed a threat to hospital capacity due to the high number of admissions, which has led to the development of various strategies to release and create new hospital beds. Due to the importance of systemic corticosteroids in this disease, we assessed their efficacy in reducing the length of stay (LOS) in hospitals and compared the effect of 3 different corticosteroids on this outcome. MéTHOD: We conducted a real-world, controlled, retrospective cohort study that analysed data from a hospital database that included 3934 hospitalised patients diagnosed with COVID-19 in a tertiary hospital from April to May 2020. Hospitalised patients who received systemic corticosteroids (CG) were compared with a propensity score control group matched by age, sex and severity of disease who did not receive systemic corticosteroids (NCG). The decision to prescribe CG was at the discretion of the primary medical team. RESULTS: A total of 199 hospitalized patients in the CG were compared with 199 in the NCG. The LOS was shorter for the CG than for the NCG (median=3 [interquartile range=0-10] vs. 5 [2-8.5]; p=0.005, respectively), showing a 43% greater probability of being hospitalised ≤4 days than >4 days when corticosteroids were used. Moreover, this difference was only noticed in those treated with dexamethasone (76.3% hospitalised ≤4 days vs. 23.7% hospitalised >4 days [p<0.001]). Serum ferritin levels, white blood cells and platelet counts were higher in the CG. No differences in mortality or intensive care unit admission were observed. CONCLUSIONS: Treatment with systemic corticosteroids is associated with reduced LOS in hospitalised patients diagnosed with COVID-19. This association is significant in those treated with dexamethasone, but no for methylprednisolone and prednisone.

Impact of systemic corticosteroids on hospital length of stay among patients with COVID-19.

BACKGROUND AND OBJECTIVE: The COVID-19 pandemic has posed a threat to hospital capacity due to the high number of admissions, which has led to the development of various strategies to release and create new hospital beds. Due to the importance of systemic corticosteroids in this disease, we assessed their efficacy in reducing the length of stay (LOS) in hospitals and compared the effect of 3 different corticosteroids on this outcome. METHODS: We conducted a real-world, controlled, retrospective cohort study that analysed data from a hospital database that included 3934 hospitalised patients diagnosed with COVID-19 in a tertiary hospital from April to May 2020. Hospitalised patients who received systemic corticosteroids (CG) were compared with a propensity score control group matched by age, sex and severity of disease who did not receive systemic corticosteroids (NCG). The decision to prescribe CG was at the discretion of the primary medical team. RESULTS: A total of 199 hospitalized patients in the CG were compared with 199 in the NCG. The LOS was shorter for the CG than for the NCG (median = 3 [interquartile range = 0-10] vs. 5 [2-8.5]; p = 0.005, respectively), showing a 43% greater probability of being hospitalised ≤ 4 days than > 4 days when corticosteroids were used. Moreover, this difference was only noticed in those treated with dexamethasone (76.3% hospitalised ≤ 4 days vs. 23.7% hospitalised > 4 days [p < 0.001]). Serum ferritin levels, white blood cells and platelet counts were higher in the CG. No differences in mortality or intensive care unit admission were observed. CONCLUSIONS: Treatment with systemic corticosteroids is associated with reduced LOS in hospitalised patients diagnosed with COVID-19. This association is significant in those treated with dexamethasone, but no for methylprednisolone and prednisone.

Air pollution exposure and its effects on idiopathic pulmonary fibrosis: clinical worsening, lung function decline, and radiological deterioration.

Introduction: Major urban pollutants have a considerable influence on the natural history of lung disease. However, this effect is not well known in idiopathic pulmonary fibrosis (IPF). Aim: This study aimed to investigate the effects of air pollution on clinical worsening, lung function, and radiological deterioration in patients with IPF. Methods: This exploratory retrospective cohort study included 69 patients with IPF, monitored from 2011 to 2020. Data on air pollution levels, including carbon monoxide (CO), nitrogen dioxide (NO2), particulate matter ≤ 2.5 µM (PM2.5), ozone (O3), and nitrogen oxides (NOx), were collected from the nearest air quality monitoring stations (<3.5 km from the patients' homes). Patient outcomes such as clinical worsening, lung function decline, and radiological deterioration were assessed over various exposure periods (1, 3, 6, 12, and 36 months). The statistical analyses were adjusted for various factors, including age, sex, smoking status, and treatment. Results: There was an association between higher O3 levels and an increased likelihood of clinical worsening over 6 and 36 months of exposure (odds ratio [OR] and 95% confidence interval [CI] = 1.16 [1.01-1.33] and OR and 95% CI = 1.80 [1.07-3.01], respectively). Increased CO levels were linked to lung function decline over 12-month exposure periods (OR and 95% CI 1.63 = [1.01-2.63]). Lastly, radiological deterioration was significantly associated with higher CO, NO2, and NOx levels over 6-month exposure periods (OR and 95% CI = 2.14 [1.33-3.44], OR and 95% CI = 1.76 [1.15-2.66] and OR and 95% CI = 1.16 [1.03-1.3], respectively). Conclusion: This study suggests that air pollution, specifically O3, CO, NO2, and NOx, could affect clinical worsening, lung function, and radiological outcomes in patients with IPF. These findings highlight the potential role of air pollution in the progression of IPF, emphasizing the need for further research and air quality control measures to mitigate its effects on respiratory health.

Adherence to inhalers in patients with severe asthma treated with anti-interleukin-5 biologics.

OBJECTIVE: Given poor medication adherence in severe asthma is difficult to  evaluate in daily practice, using at least two methods concurrently is recommended. We aimed to determine the prevalence of nonadherence  to  inhalers using the Test of Adherence to Inhalers questionnaire and the medication possession ratio obtained from the pharmacy refill data in patients with severe asthma treated with anti-interleukin-5 biologics and to evaluate their concordance. METHOD: This was a cross-sectional retrospective observational study of 53  patients with severe asthma recruited from the severe asthma unit of a tertiary  hospital in Madrid from June to December 2020. We registered demographic data, comorbidities and concomitant therapy for  sthma. Nonadherence was defined as pharmacy refill data < 80% and/or Test of Adherence to Inhalers questionnaire results < 50. Concordance was assessed by determining the Cohen's kappa statistic. Results: The median age was 61 years (interquartile range 51.8-67.0), and 33  (61%) were women. According to the pharmacy refill data lack of  adherence to the primary inhaler was 58.5%. However, when using the Test of  Adherence to Inhalers questionnaire, it was 22.6%. Combining both methods,  17% of patients were considered to have nonadherence to inhalers. Likewise,  when identifying nonadherence by either of these methods, it reached a  prevalence of 64.2%. The pharmacy refill data and Test of Adherence to  Inhalers questionnaire agreed in 53.1% and disagreed in 46.9% of patients (k  = 0.137; 95% confidence interval -0.057 to 0.331; p = 0.318). CONCLUSIONS: We observed a higher prevalence of non-adherence to inhalers  in patients with severe asthma treated with anti-interleukin-5 biologics. The  agreement between the Test of Adherence to Inhalers questionnaire and the  pharmacy refill data is lower when evaluating nonadherence in patients with  severe asthma treated with anti-interleukin-5 biologics. The pharmacy refill  data detect a higher proportion of nonadherence compared with the Test of  Adherence to Inhalers questionnaire.

OBJETIVO: Dado que la mala adherencia a la medicación en el asma grave es  difícil de evaluar en la práctica diaria, se recomienda utilizar al menos dos métodos simultáneamente. El objetivo es determinar la prevalencia de la  falta de adherencia a los inhaladores mediante el cuestionario Test de  Adherencia a los Inhaladores y la ratio de posesión de la medicación obtenida a  partir de los datos de dispensación de la farmacia en pacientes con asma  grave tratados con biológicos anti interleucina 5 y evaluar su concordancia.Método: Estudio observacional retrospectivo transversal de 53 pacientes con  asma grave reclutados en la unidad de asma grave de un hospital terciario de  Madrid de junio a diciembre de 2020. Se registraron datos demográficos, comorbilidades y el tratamiento concomitante para el asma. La  falta de adherencia se definió como una ratio de posesión de la medicación <  80% y/o un valor en los resultados del cuestionario Test de Adherencia a los  Inhaladores < 50. La concordancia se evaluó con el coeficiente kappa de  Cohen. RESULTADOS: La mediana de edad fue de 61 años (rango intercuartílico 51,8- 67,0), y 33 (61%) eran mujeres. Según la ratio de posesión de la medicación,  la falta de adherencia al inhalador primario fue del 58,5%. Sin embargo, al  utilizar el cuestionario Test de Adherencia a los Inhaladores, ésta fue del  22,6%. Combinando ambos métodos, se consideró que el 17% de los  pacientes presentaban no adherencia a los inhaladores. Asimismo, al identificar  la no adherencia por cualquiera de estos métodos, se alcanzó una  prevalencia del 64,2%. El cuestionario Test de Adherencia a los Inhaladores y  la ratio de posesión de la medicación coincidieron en el 53,1% y discreparon en  el 46,9% de los pacientes (k = 0,137; intervalo de confianza del 95% ­0,057 a 0,331; p = 0,318). CONCLUSIONES: Se observó una alta prevalencia de no adherencia a los inhaladores en los pacientes con asma grave tratados con biológicos anti interleucina 5. La concordancia entre el cuestionario Test de Adherencia a los Inhaladores y la ratio de posesión de la medicación es menor cuando se  evalúa la no adherencia en pacientes con asma grave tratados con biológicos  anti interleucina 5. La ratio de posesión de la medicación detecta una mayor  proporción de no adherencia en comparación con el cuestionario Test de  Adherencia a los Inhaladores.

Successful Long-Term Treatment Combining Omalizumab and Anti-IL-5 Biologics in Allergic Bronchopulmonary Aspergillosis

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Adherencia a los inhaladores en pacientes con asmagrave tratados con biológicos anti interleucina 5 / Adherence to inhalers in patients with severe asthma treated with anti-interleukin-5 biologics

Objetivo: Dado que la mala adherencia a la medicación en el asma gravees difícil de evaluar en la práctica diaria, se recomienda utilizar al menos dosmétodos simultáneamente. El objetivo es determinar la prevalencia de la faltade adherencia a los inhaladores mediante el cuestionario Test de Adherenciaa los Inhaladores y la ratio de posesión de la medicación obtenida a partirde los datos de dispensación de la farmacia en pacientes con asma gravetratados con biológicos anti interleucina 5 y evaluar su concordancia.Método: Estudio observacional retrospectivo transversal de 53 pacientescon asma grave reclutados en la unidad de asma grave de un hospital terciario de Madrid de junio a diciembre de 2020. Se registraron datos demográficos, comorbilidades y el tratamiento concomitante para el asma. La faltade adherencia se definió como una ratio de posesión de la medicación< 80% y/o un valor en los resultados del cuestionario Test de Adherencia alos Inhaladores < 50. La concordancia se evaluó con el coeficiente kappade Cohen.Resultados: La mediana de edad fue de 61 años (rango intercuartílico51,8-67,0), y 33 (61%) eran mujeres. Según la ratio de posesión de lamedicación, la falta de adherencia al inhalador primario fue del 58,5%.Sin embargo, al utilizar el cuestionario Test de Adherencia a los Inhaladores, ésta fue del 22,6%. Combinando ambos métodos, se consideróque el 17% de los pacientes presentaban no adherencia a los inhaladores. Asimismo, al identificar la no adherencia por cualquiera de estos métodos, se alcanzó una prevalencia del 64,2%. El cuestionario Test deAdherencia a los Inhaladores y la ratio de posesión de la medicacióncoincidieron en el 53,1% y discreparon en el 46,9% de los pacientes(k = 0,137; intervalo de confianza del 95% –0,057 a 0,331; p = 0,318).Conclusiones: Se observó una alta prevalencia de no adherencia a losinhaladores en los pacientes con asma grave tratados con biológicos antiinterleucina 5. (AU)

Objective: Given poor medication adherence in severe asthma is difficult to evaluate in daily practice, using at least two methods concurrently isrecommended. We aimed to determine the prevalence of nonadherenceto inhalers using the Test of Adherence to Inhalers questionnaire and themedication possession ratio obtained from the pharmacy refill data inpatients with severe asthma treated with anti-interleukin-5 biologics and toevaluate their concordance.Method: This was a cross-sectional retrospective observational study of53 patients with severe asthma recruited from the severe asthma unit of atertiary hospital in Madrid from June to December 2020. We registereddemographic data, comorbidities and concomitant therapy for asthma.Nonadherence was defined as pharmacy refill data < 80% and/or Testof Adherence to Inhalers questionnaire results < 50. Concordance wasassessed by determining the Cohen’s kappa statistic.Results: The median age was 61 years (interquartile range 51.8-67.0),and 33 (61%) were women. According to the pharmacy refill data lackof adherence to the primary inhaler was 58.5%. However, when usingthe Test of Adherence to Inhalers questionnaire, it was 22.6%. Combiningboth methods, 17% of patients were considered to have nonadherenceto inhalers. Likewise, when identifying nonadherence by either of thesemethods, it reached a prevalence of 64.2%. The pharmacy refill data andTest of Adherence to Inhalers questionnaire agreed in 53.1% and disagreed in 46.9% of patients (k = 0.137; 95% confidence interval −0.057to 0.331; p = 0.318). (AU)

Inhaled bronchodilators use and clinical course of adult inpatients with Covid-19 pneumonia in Spain: A retrospective cohort study.

BACKGROUND: In the current coronavirus health crisis, inhaled bronchodilators(IB) have been suggested as a possible treatment for patients hospitalized. Patients with evidence of Covid-19 pneumonia worldwide have been prescribed these medications as part of therapy for the disease, an indication for which this medications could be ineffective taken on account the pathophysiology and mechanisms of disease progression. OBJECTIVE: The main objective was to evaluate whether there is an association between IB use and length of stay. Primary end points were the number of days that a patient stayed in the hospital and death as a final event in a time to event analysis. Pneumonia severity, oxygen requirement, involved drugs, comorbidity, historical or current respiratory diagnoses and other drugs prescribed to treat coronavirus pneumonia were also evaluated. METHODS: A descriptive, observational, cross-sectional study was performed in this tertiary hospital in Madrid (Spain). Data were obtained regarding patients hospitalized with Covid-19, excluding those who were intubated. The primary and secondary outcomes such as duration of hospitalization and death were compared in patients who received IB with those in patients who did not. RESULTS: 327 patients were evaluated, mean age was 64.4 ± 15.8 years. Median length of hospitalization stay was 10 days. Of them 292 (89.3%) overcame the disease, the remaining 35 died. Patients who had received IB did not have less mortality rate (odds ratio 0.839; 95% CI: 0.401 to 1.752) and less hospitalization period when compared with patients who did not received IB (odds ratio 1.280; 95% CI: 0.813 to 2.027). There was no significant association between IB use and recovery or death. Hypertension and diabetes were the most common comorbidities. The prevalence of chronic respiratory disease in our cohort was low (21.1%). Anticholinergics were the IB more frequently prescribed for Covid-19 pneumonia. Better response in patients treated with inhaled corticosteroids was not observed. CONCLUSION: Off-label indication of inhaled-bronchodilators for Covid-19 patients are common in admitted patients. Taken on account our results, the use of IB for coronavirus pneumonia apparently is not associated with a significantly patient's improvement. Our study confirms the hypothesis that inhaled bronchodilators do not improve clinical outcomes or reduce the risk of Covid-19 mortality. This could be due to the fact that the virus mainly affects the lung parenchyma and the pulmonary vasculature and probably not the airway. More researches are necessary in order to fill the gap in evidence for this new indication.

Psycho-demographic profile in severe asthma and effect of emotional mood disorders and hyperventilation syndrome on quality of life.

BACKGROUND: Severe asthma affects a small population but carries a high psychopathological risk. Therefore, the psychodemographic profile of these patients is of interest. A substantial prevalence of anxiety, depression, alexithymia and hyperventilation syndrome in severe asthma is known, but contradictory results have been observed. These factors can also affect patients' quality of life. For this reasons, our purpose is to evaluate the psychodemographic profile of patients with severe asthma and assess the prevalence of anxiety, depression, alexithymia and hyperventilation syndrome and their impact on the quality of life of patients with severe asthma. METHODS: A cross-sectional study of 63 patients with severe asthma. Their psychodemographic profile was evaluated using the Hospital Anxiety and Depression Scale (HADS), Toronto Alexithymia Scale (TAS-20), Nijmegen questionnaire and Asthma Control Test (ACT) to determine the state of anxiety and depression, alexithymia, hyperventilation syndrome and control of asthma, respectively. Quality of life was assessed with the Mini Asthma Quality of Life Questionnaire (Mini-AQLQ). RESULTS: The mean age was 60 ± 13.6 years. Personal psychopathological histories were found in 65.1% of participants, and 8% reported previous suicidal attempts. The rate of anxiety and/or depression (HADS ≥ 11) was 68.3%. These patients present higher scores on the TAS-20 (p < 0.001) for the level of dyspnea (p = 0.021), and for emotional function (p = 0.017) on the Mini-AQLQ, compared with patients without anxiety or depression. Alexithymia (TAS-20 ≥ 61) was observed in 42.9% of patients; these patients were older (p = 0.037) and had a higher HADS score (p = 0.019) than patients with asthma without alexithymia. On the other hand, patients with hyperventilation syndrome (Nijmegen ≥ 23) scored higher on the HADS (p < 0.05), on the Mini-AQLQ (p = 0.002) and on the TAS-20 (p = 0.044) than the group without hyperventilation syndrome. Quality of life was related to anxiety-depression symptomatology (r = - 0.302; p = 0.016) and alexithymia (r = - 0.264; p = 0.036). Finally, the Mini-AQLQ total score was associated with the Nijmegen questionnaire total score (r = - 0.317; p = 0.011), and the activity limitation domain of the Mini-AQLQ correlated with the ACT total score (r = 0.288; p = 0.022). CONCLUSIONS: The rate of anxiety, depression, alexithymia and hyperventilation syndrome is high in patients with severe asthma. Each of these factors is associated with a poor quality of life.

Off-label use of inhaled bronchodilators in hospitalised patients in Spain: a multicentre observational study.

BACKGROUND: Off-label prescription of inhaled bronchodilators (IB) is frequent, despite the fact that they can be ineffective and increase avoidable healthcare costs. OBJECTIVE: To analyse the frequency of off-label prescription of IB in hospitalised patients. Indications and level of evidence, involved drugs, medical specialties prescribing off-label IB and patients' adherence to IBs were also evaluated. METHOD: A descriptive, observational, cross-sectional study was performed in four tertiary hospitals in Spain. The main outcome measure was the number of patients prescribed off-label IBs. Prescriptions were checked against the European Medicines Agency-approved indications. The level of evidence supporting off-label prescription of IBs (according to MICROMEDEX 2.0) was also analysed. Patients were interviewed to test differences (off-label vs on-label) in adherence and knowledge about their inhaled therapy. RESULTS: 217 patients were prescribed IBs, 92 of whom were givend off-label IBs (54.7% men, mean age 73.9±12.9 years). The most common off-label prescriptions for IBs were: unspecified dyspnoea (not related to COPD or asthma) (27.2%), respiratory infections (23.9%) and heart failure (22.8%). 76.8% of patients did not have evidence supporting them. Beta2-agonist+corticosteroids and anticholinergics were most commonly prescribed off-label. Internal Medicine was the main medical specialty involved. There were no differences between off-label and on-label users in terms of patients' knowledge about treatment and adherence. CONCLUSION: Off-label indications for IBs are common in hospitalised patients and are generally indicated without scientific support. Dyspnoea not related to COPD or asthma, respiratory infections and heart failure were the main off-label indications, most frequently treated with anticholinergics and beta2-agonists+corticosteroids, for which their efficacy and safety has not been proved. Our results show that prescribing needs to be improved to follow the evidence that exists. Moreover, further research focused on off-label indications is needed to clarify whether they are effective, safe and cost-effective.

A Cohort of Patients with COVID-19 in a Major Teaching Hospital in Europe.

BACKGROUND: Since the confirmation of the first patient infected with SARS-CoV-2 in Spain in January 2020, the epidemic has grown rapidly, with the greatest impact on the region of Madrid. This article describes the first 2226 adult patients with COVID-19, consecutively admitted to La Paz University Hospital in Madrid. METHODS: Our cohort included all patients consecutively hospitalized who had a final outcome (death or discharge) in a 1286-bed hospital of Madrid (Spain) from 25 February (first case admitted) to 19 April 2020. The data were manually entered into an electronic case report form, which was monitored prior to the analysis. RESULTS: We consecutively included 2226 adult patients admitted to the hospital who either died (460) or were discharged (1766). The patients' median age was 61 years, and 51.8% were women. The most common comorbidity was arterial hypertension (41.3%), and the most common symptom on admission was fever (71.2%). The median time from disease onset to hospital admission was 6 days. The overall mortality was 20.7% and was higher in men (26.6% vs. 15.1%). Seventy-five patients with a final outcome were transferred to the intensive care unit (ICU) (3.4%). Most patients admitted to the ICU were men, and the median age was 64 years. Baseline laboratory values on admission were consistent with an impaired immune-inflammatory profile. CONCLUSIONS: We provide a description of the first large cohort of hospitalized patients with COVID-19 in Europe. Advanced age, male sex, the presence of comorbidities and abnormal laboratory values were more common among the patients with fatal outcomes.

A Phase 3 Study to Compare Delafloxacin With Moxifloxacin for the Treatment of Adults With Community-Acquired Bacterial Pneumonia (DEFINE-CABP).

BACKGROUND: The clinical and economic burden of community-acquired bacterial pneumonia (CABP) is significant and is anticipated to increase as the population ages and pathogens become more resistant. Delafloxacin is a fluoroquinolone antibiotic approved in the United States for the treatment of adults with acute bacterial skin and skin structure infections. Delafloxacin's shape and charge profile uniquely impact its spectrum of activity and side effect profile. This phase 3 study compared the efficacy and safety of delafloxacin with moxifloxacin for the treatment of CABP. METHODS: A randomized, double-blind, comparator-controlled, multicenter, global phase 3 study compared the efficacy and safety of delafloxacin 300 mg twice daily or moxifloxacin 400 mg once daily in adults with CABP. The primary end point was early clinical response (ECR), defined as improvement at 96 (±24) hours after the first dose of study drug. Clinical response at test of cure (TOC) and microbiologic response were also assessed. RESULTS: In the intent-to-treat analysis population (ITT), ECR rates were 88.9% in the delafloxacin group and 89.0% in the moxifloxacin group. Noninferiority of delafloxacin compared with moxifloxacin was demonstrated. At TOC in the ITT population, the success rates were similar between groups. Treatment-emergent adverse events that were considered at least possibly related to the study drug occurred in 65 subjects (15.2%) in the delafloxacin group and 54 (12.6%) in the moxifloxacin group. CONCLUSIONS: Intravenous/oral delafloxacin monotherapy is effective and well tolerated in the treatment of adults with CABP, providing coverage for Gram-positive, Gram-negative, and atypical pathogens. CLINICALTRIALSGOV IDENTIFIER: NCT03534622.

Varón de 60 años de edad con enfermedad pulmonar obstructiva crónica y eosinofilia / A 60-Year-Old Male Smoker With Chronic Obstructive Pulmonary Disease and Hypereosinophilia

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