Economic Impact and Clinical Outcomes of Omalizumab Add-On Therapy for Patients with Severe Persistent Asthma: A Real-World Study.

BACKGROUND: Omalizumab is a fully humanized monoclonal antibody indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma. AIMS: The aim of this study was to evaluate social, healthcare expenditure and clinical outcomes changes after incorporating omalizumab into standard treatment in the control of severe asthma. METHODS: In this multicentre retrospective study, a total of 220 patients were included from 15 respiratory medicine departments in the regions of Andalusia and Extremadura (Spain). Effectiveness was calculated as a 3-point increase in the Asthma Control Test (ACT) and a reduction in the annual number of exacerbations. The economic evaluation included both direct and indirect costs. Incremental cost-effectiveness ratio (ICER) was calculated. Results from the year before and the year after incorporation of omalizumab were compared. RESULTS: After adding omalizumab, improvement of lung function, asthma and rhinitis according to patient perception, as well as the number of exacerbations and asthma control measured by the ACT score were observed. Globally, both healthcare resources and pharmacological costs decreased after omalizumab treatment, excluding omalizumab cost. When only direct costs were considered, the ICER was €1712 (95% CI 1487-1995) per avoided exacerbation and €3859 (95% CI 3327-4418) for every 3-point increase in the ACT score. When both direct and indirect costs were considered, the ICER was €1607 (95% CI 1385-1885) for every avoided exacerbation and €3555 (95% CI 3012-4125) for every 3-point increase. CONCLUSIONS: Omalizumab was shown to be an effective add-on therapy for patients with persistent severe asthma and allowed reducing key drivers of asthma-related costs.

[Comparison of the Asthma Control Test (ACT) with lung function, levels of exhaled nitric oxide and control according to the Global Initiative for Asthma (GINA)]. / Relación del test de control del asma (ACT) con la función pulmonar, niveles de óxido nítrico exhalado y grados de control según la Iniciativa Global para el Asma (GINA).

INTRODUCTION: The current goal of asthma treatment is to achieve and maintain control. This study aimed to explore the relationship between the ACT (Asthma Control Test) questionnaire and the levels of control according to GINA (Global Initiative for Asthma) to establish the cut-off points for the ACT and evaluate its relationship with lung function and fractionated exhaled nitric oxide level (FeNO). PATIENTS AND METHODS: A multi-centre prospective study including 441 patients followed up in an outpatient Chest Clinic. A clinical protocol was followed, and FeNO, spirometry and ACT performed. Disease was classified according to levels of control using GINA. The study analysed sensitivity, specificity and area under the curve (ROC), and the ACT cut-off points. We studied the differences between the functional parameters and FeNO between levels of control. RESULTS: For controlled asthma the cut-off obtained was ACT> or =21 (area under the curve 0.791) and for uncontrolled < or =18 (AUC 0.774). We found significant differences in FeNO levels and pulmonary function among ACT> or =21 and ACT< or =18, although only 26.3% of patients with ACT< or =18 had a FEV1 <80% and 40% higher FeNO (> or =35 ppb). We found a correlation between baseline FEV1 and ACT (r=0.19, P<0.01) and between ACT and FeNO (r=-0.16, P<0.01). CONCLUSIONS: The cut-off points would be, for controlled asthma ACT> or =21, partly controlled asthma ACT=19-20 and uncontrolled asthma ACT< or =18. A more complete assessment would require including monitoring operating parameters and FeNO.

[Predictive value of chest X-ray and electrocardiographic abnormalities in patients with pulmonary embolism in relation to mortality and recurrences]. / Papel de las alteraciones radiográficas y del electrocardiograma en la predicción de mortalidad y recidivas en pacientes con embolia de pulmón.

BACKGROUND AND OBJECTIVE: Radiological and electrocardiographic (EKG) abnormalities are very frequent in patients with pulmonary embolism (PE). Our main objective was to evaluate, in patients with PE, whether any of those abnormalities was correlated with an increased risk of relapses or mortality until 3 months after the acute episode. PATIENTS AND METHOD: Multicenter observational study of patients included in the Venous Thromboembolic Disease Register (RIETE). Demographic, clinical, radiological and EKG data were collected from all patients. Statistics was made with the Pearson correlation and multiple linear regression analysis. RESULTS: We found a significant but non determinant association between mortality and the presence of radiological and/or EKG abnormalities and no relation between them and relapses of PE. CONCLUSIONS: Radiological or EKG manifestations could not predict relapses or mortality 3 months after PE in our patients.