Real-world clinical remission of severe asthma with benralizumab in Spanish adults with severe asthma.

OBJECTIVE: Patients with severe eosinophilic asthma experience high risk of exacerbations and reduced quality of life. Benralizumab, a monoclonal antibody binding to IL-5 receptor α subunit, is an approved drug for its treatment. The objective was to describe clinical remission after benralizumab prescription in routine clinical practice. METHODS: Retrospective multicenter study with data from four hospitals in Valencian Community (Spain) with asthma units between 2019 and 2020. Data was gathered at baseline and after 12 months. We considered clinical remission after 1 year if the patient remained without exacerbations and use of systemic corticosteroids and with good clinical control and normal lung function. RESULTS: Data from 139 patients was gathered. At the 12-month follow-up, 44.1% were in clinical remission, since 84.0%, 77.5%, 51.0% and 95.5% of patients did not experience exacerbations, had total asthma control test score of ≥20, prebronchodilator FEV1 of ≥80% and did not use systemic corticosteroids. A significant reduction of long-acting muscarinic antagonists (p = 0.0001), leukotriene receptor antagonists (p = 0.0326), oral corticosteroids (p < 0.0001) and short-acting beta agonists (p = 0.0499) was observed. Baseline factors with greatest individual influence on clinical remission were employment situation, tobacco use, comorbidity number, eosinophil value, number of exacerbations, FEV1, emergency visit number, and ACT, MiniAQLQ and TAI scores. Final analysis of multiple logistic regression indicated that having baseline FEV1 value below 80% increases remission chance 9.7 times a year compared to FEV1 >80%. CONCLUSION: Clinical remission after treatment with benralizumab is achievable in a high percentage of patients with severe asthma eosinophilia not controlled in real life.

Achieving clinical outcomes with benralizumab in severe eosinophilic asthma patients in a real-world setting: orbe II study.

BACKGROUND: The ORBE II study aimed to describe the characteristics and clinical outcomes of adult patients with severe eosinophilic asthma (SEA) treated with benralizumab in a real-world setting in Spain. METHODS: ORBE II (NCT04648839) was an observational, retrospective cohort study in adult SEA patients who had been prescribed benralizumab. Demographic and clinical data of 204 SEA patients were collected 12 months prior to benralizumab initiation (baseline) and at follow-up. Exacerbation rate, asthma symptoms, maintenance oral corticosteroid (OCS) use and lung function were evaluated, among other variables. RESULTS: A total of 204 SEA patients were evaluated. Mean (standard deviation, SD) age of the study population was 56.4 (12.4) years, 62.3% were women and mean (SD) duration of asthma was 15.1 (12.7) years. Median (Q1-Q3) follow-up duration was 19.5 (14.2-24.2) months. At baseline, 72.6% of the overall population (OP) presented blood eosinophil counts ≥ 300 cells/µL; 36.8% had comorbid chronic rhinosinusitis with nasal polyps (CRSwNP); 84.8% reported at least one severe exacerbation, and 29.1% were OCS-dependent. At 1 year of follow-up, patients receiving benralizumab treatment had a 85.6% mean reduction in exacerbations from baseline, and 81.4% of patients achieved zero exacerbations. We also found a clinically relevant mean (SD) increase in pre-bronchodilator (BD) FEV1 of 331 (413) mL, with 66.7% of patients achieving a pre-BD FEV1 increase ≥ 100 mL, and 46.3% of patients achieving a pre-BD FEV1 ≥ 80% of predicted. Regarding symptom control, 73.8% of the OP obtained an ACT score ≥ 20 points. After 1 year of follow-up, mean reduction in the daily OCS dose was 70.5%, and complete OCS withdrawal was achieved by 52.8% of the OCS-dependent patients. Almost half (43.7%) of the OP on benralizumab met all four criteria for clinical remission. Patients with concomitant CRSwNP obtained similar or enhanced outcomes. CONCLUSIONS: These data support the real-world benefits of benralizumab in SEA patients, and particularly in those with concomitant CRSwNP. TRIAL REGISTRATION: NCT04648839.

Effect of an Immune-Boosting, Antioxidant and Anti-Inflammatory Food Supplement in Hospitalized COVID-19 Patients: A Prospective Randomized Pilot Study.

BACKGROUND: COVID-19 disease is a serious global health problem. Few treatments have been shown to reduce mortality and accelerate time to recovery. The aim of this study was to evaluate the potential effect of a food supplement (probiotics, prebiotics, vitamin D, zinc and selenium) in patients admitted with COVID-19. METHODS: A prospective randomized non-blinded clinical trial was conducted in a sample of 162 hospitalized patients diagnosed with COVID-19 recruited over eight months. All patients received standard treatment, but the intervention group (n = 67) was given one food supplement stick daily during their admission. After collecting the study variables, a statistical analysis was performed comparing the intervention and control groups and a multivariate analysis controlling for variables that could act as confounding factors. RESULTS: ROC curve analysis with an area under the curve (AUC) value of 0.840 (p < 0.001; 95%CI: 0.741-0.939) of the food supplement administration vs. recovery indicated good predictive ability. Moreover, the intervention group had a shorter duration of digestive symptoms compared with the control group: 2.6 ± 1.3 vs. 4.3 ± 2.2 days (p = 0.001); patients with non-severe disease on chest X-ray had shorter hospital stays: 8.1 ± 3.9 vs. 11.6 ± 7.4 days (p = 0.007). CONCLUSIONS: In this trial, the administration of a food supplement (Gasteel Plus®) was shown to be a protective factor in the group of patients with severe COVID-19 and allowed early recovery from digestive symptoms and a shorter hospital stay in patients with a normal-mild-moderate chest X-ray at admission (ClinicalTrials.gov number, NCT04666116).

Clinical Features and Risk Factors for Mortality Among Long-term Care Facility Residents Hospitalized Due to COVID-19 in Spain.

BACKGROUND: COVID-19 severely impacted older adults and long-term care facility (LTCF) residents. Our primary aim was to describe differences in clinical and epidemiological variables, in-hospital management, and outcomes between LTCF residents and community-dwelling older adults hospitalized with COVID-19. The secondary aim was to identify risk factors for mortality due to COVID-19 in hospitalized LTCF residents. METHODS: This is a cross-sectional analysis within a retrospective cohort of hospitalized patients ≥75 years with confirmed COVID-19 admitted to 160 Spanish hospitals. Differences between groups and factors associated with mortality among LTCF residents were assessed through comparisons and logistic regression analysis. RESULTS: Of 6 189 patients ≥75 years, 1 185 (19.1%) were LTCF residents and 4 548 (73.5%) were community-dwelling. LTCF residents were older (median: 87.4 vs 82.1 years), mostly female (61.6% vs 43.2%), had more severe functional dependence (47.0% vs 7.8%), more comorbidities (Charlson Comorbidity Index: 6 vs 5), had dementia more often (59.1% vs 14.4%), and had shorter duration of symptoms (median: 3 vs 6 days) than community-dwelling patients (all, p < .001). Mortality risk factors in LTCF residents were severe functional dependence (adjusted odds ratios [aOR]: 1.79; 95% confidence interval [CI]: 1.13-2.83; p = .012), dyspnea (1.66; 1.16-2.39; p = .004), SatO2 < 94% (1.73; 1.27-2.37; p = .001), temperature ≥ 37.8°C (1.62; 1.11-2.38; p = .013); qSOFA index ≥ 2 (1.62; 1.11-2.38; p = .013), bilateral infiltrates (1.98; 1.24-2.98; p < .001), and high C-reactive protein (1.005; 1.003-1.007; p < .001). In-hospital mortality was initially higher among LTCF residents (43.3% vs 39.7%), but lower after adjusting for sex, age, functional dependence, and comorbidities (aOR: 0.74, 95%CI: 0.62-0.87; p < .001). CONCLUSION: Basal functional status and COVID-19 severity are risk factors of mortality in LTCF residents. The lower adjusted mortality rate in LTCF residents may be explained by earlier identification, treatment, and hospitalization for COVID-19.

Effects of Omalizumab Treatment in Patients With Recalcitrant Nasal Polyposis and Mild Asthma: A Multicenter Retrospective Study.

BACKGROUND: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a clinical entity with specific features that impacts significantly on patient quality of life (QoL). CRSwNP is often associated with asthma and is difficult to control and manage despite pharmacological and/or surgical treatment. Omalizumab, a monoclonal anti-IgE antibody, has emerged as a putative therapeutic option. OBJECTIVE: To evaluate the effects of omalizumab on nasal polyp (NP) size and QoL assessed by Sino-Nasal Outcome Test-22 (SNOT-22) in patients with recalcitrant CRSwNP and mild asthma. METHODS: A multicenter retrospective analysis of patient data from the Community of Valencia (Spain) was performed. Adult patients with recalcitrant CRSwNP and comorbid mild asthma receiving compassionate use of omalizumab were included. NP size measured by total nasal endoscopic polyp score (TPS) and QoL evaluated through the SNOT-22 questionnaire were assessed at baseline and monthly over 12 months. An ordinal regression model was built to analyze the results. RESULTS: A total of 23 CRSwNP patients with a mean age (± SD) of 54.78 ± 9.46 years were included. Nineteen suffered from aspirin-exacerbated respiratory disease (AERD). In all patients, a significant and sustained reduction in TPS was observed over time, accompanied by improvements in QoL reflected in lower SNOT-22 scores. In the ordinal regression model, time but not total IgE, age or tissue eosinophilia impacted on NP size and SNOT-22 outcomes. Additionally, improvements in QoL were not explained by reductions in the size of polyps. CONCLUSION: Omalizumab was effective for the treatment of patients with recalcitrant CRSwNP and mild asthma, even when AERD was present, by reducing NP size and improving QoL; treatment time was a key factor. SNOT-22 improvements were not explained by decreases in TPS, indicating that omalizumab may be effective in all patients, regardless of polyp size.

¿Se puede seguir hablando de un fenotipo exacerbador en enfermedad pulmonar obstructiva crónica? / Does the Exacerbator Phenotype in Chronic Obstructive Pulmonary Disease Really Exist?

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[Inflammation markers in the exhaled air of patients with bronchiectasis unassociated with cystic fibrosis]. / Estudio de marcadores de inflamación en el aire exhalado de pacientes con bronquiectasias no asociadas a fibrosis quística.

INTRODUCTION: The aim of the study was to analyse the relationship between the intensity of the respiratory tract inflammation, expressed by oxidative stress markers, and the severity of the disease in patients with bronchiectasis unassociated with cystic fibrosis. PATIENTS AND METHODS: The study included 25 patients with stable bronchiectasis (15 females and 10 males). As determining factors of severity, the following parameters were collected: degree of dyspnoea, number of exacerbations/admissions in the last year, mean daily sputum volume, sputum colour (graduated colour scale), bacterial colonisation, respiratory function tests, quality of life (St. George questionnaire) and radiological extension of the lesions (Bhalla scale). Inflammation was analysed using the measurement of nitric oxide, pH and concentration of nitrites, nitrates and isoprostane in the exhaled air condensate. The C reactive protein and erythrocyte sedimentation rate were also determined in peripheral blood. RESULTS: There were no significant relationships between the markers in the exhaled air condensate and the clinical, radiological and functional involvement or the quality of life of the patients. Only bacterial colonisation (16 cases) was associated with higher values of nitrates in exhaled air (mean+/-standard deviation: 18+/-4 compared to 7+/-2microM; r(2)=0.6) and a higher number of exacerbations (3.1+/-1.9 compared to 1.7+/-1.9; r(2)=0.3). CONCLUSIONS: In our study, the measurement of inflammation markers in exhaled air is only associated with some parameters of severity in patients with bacterial bronchiectasis.

Estudio de marcadores de inflamación en el aire exhalado de pacientes con bronquiectasias no asociadas a fibrosis quística / Inflammation Markers in the Exhaled Air of Patients with Bronchiectasis Unassociated with Cystic Fibrosis

IntroducciónEl propósito del estudio ha sido analizar la relación entre la intensidad de la inflamación de las vías aéreas respiratorias, expresada por marcadores de estrés oxidativo, y la gravedad de la enfermedad en pacientes con bronquiectasias no asociadas a fibrosis quística.Pacientes y métodosSe ha estudiado a 25 pacientes con bronquiectasias estables (15 mujeres y 10 varones). Como determinantes de gravedad se recogieron las siguientes variables: grado de disnea, número de exacerbaciones/ingresos en el último año, volumen diario medio de esputo, color del esputo (escala gradual de color), colonización bacteriana, exploración de la función respiratoria, calidad de vida (cuestionario St. George) y extensión radiológica de las lesiones (escala de Bhalla). La inflamación se analizó mediante la medición del óxido nítrico, pH y concentración de nitritos, nitratos e isoprostano en el condensado de aire exhalado. Asimismo se determinaron los valores de proteína C reactiva y velocidad de sedimentación globular en sangre periférica.ResultadosNo hubo relaciones significativas entre los marcadores en condensado de aire exhalado y la afectación clínica, radiológica, funcional o de calidad de vida de los pacientes. Sólo la colonización bacteriana (16 casos) se relacionó con valores más altos de nitratos en aire exhalado (media±desviación estándar: 18±4 frente a 7±2μM; r2=0,6) y un mayor número de exacerbaciones (3,1±1,9 frente a 1,7±1,9; r2=0,3).ConclusionesEn nuestra muestra, el estudio de marcadores de inflamación en aire exhalado sólo se relaciona con algunos parámetros de gravedad en pacientes con bronquiectasias colonizadas(AU)

IntroductionThe aim of the study was to analyse the relationship between the intensity of the respiratory tract inflammation, expressed by oxidative stress markers, and the severity of the disease in patients with bronchiectasis unassociated with cystic fibrosis.Patients and methodsThe study included 25 patients with stable bronchiectasis (15 females and 10 males). As determining factors of severity, the following parameters were collected: degree of dyspnoea, number of exacerbations/admissions in the last year, mean daily sputum volume, sputum colour (graduated colour scale), bacterial colonisation, respiratory function tests, quality of life (St. George questionnaire) and radiological extension of the lesions (Bhalla scale). Inflammation was analysed using the measurement of nitric oxide, pH and concentration of nitrites, nitrates and isoprostane in the exhaled air condensate. The C reactive protein and erythrocyte sedimentation rate were also determined in peripheral blood.ResultsThere were no significant relationships between the markers in the exhaled air condensate and the clinical, radiological and functional involvement or the quality of life of the patients. Only bacterial colonisation (16 cases) was associated with higher values of nitrates in exhaled air (mean±standard deviation: 18±4 compared to 7±2μM; r2=0.6) and a higher number of exacerbations (3.1±1.9 compared to 1.7±1.9; r2=0.3).ConclusionsIn our study, the measurement of inflammation markers in exhaled air is only associated with some parameters of severity in patients with bacterial bronchiectasis(AU)