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Short and long-term quality of life and asthma control with omalizumab therapy in a real life setting in Portugal
Institution:1. Pneumology Unit, Hospitais da Universidade de Coimbra, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal;2. Centre of Pneumology, Faculty of Medicine, University of Coimbra, Portugal;3. Center for Research and Development in Mathematics and Applications, Department of Mathematics, University of Aveiro, Aveiro, Portugal;4. Immunoallergology Unit, Hospitais da Universidade de Coimbra, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal;5. University Hospital Arnaud de Villeneuve, Montpellier, France;6. Inserm, CESP Centre for Research in Epidemiology and Population Health, U1018, Respiratory and Environmental Epidemiology Team, Villejuif, France;1. Servicio de Neumología, Hospital Universitario Lucus Augusti, Lugo, Spain;2. Instituto Max Weber, Madrid, Spain;3. Departamento de Economía, Universidad de Castilla la Mancha, Toledo, Spain;1. Department of Allergy and Clinical Immunology, H.R. Lic. Adolfo López Mateos, ISSSTE, Mexico City, Mexico;2. Allergy Staff, Hospital Medica Sur, Mexico City, Mexico;1. Pulmonary Department, Internal Medicine, University Hospital Mainz, Langenbeckstraße 1, 55131 Mainz, Germany;2. Pulmonary Research Institute at LungenClinic Grosshansdorf, Airway Research Center North, Member of the German Center for Lung Research, Grosshansdorf, Germany;3. PAREXEL International GmbH, Klinikum Westend, Haus 17, D-14050 Berlin, Germany;4. Fraunhofer Institut für Toxikologie und Experimentelle Medizin, Nikolai-Fuchs-Str. 1, 30625 Hannover, Germany;5. Novartis Pharma AG, Basel, Switzerland;1. Center for Research in Health Technologies and Information Systems, Faculdade de Medicina da Universidade do Porto, Porto, Portugal;2. Allergy Department, Centro Hospitalar de São João, EPE, Porto, Portugal;3. Allergy Unit, CUF Porto Instituto e CUF Porto Hospital, Portugal;4. Health Information and Decision Sciences Department, Faculdade de Medicina da Universidade do Porto, Porto, Portugal;5. Allergy Department, Hospital Pedro Hispano Unidade Local de Saúde de Matosinhos, EPE, Matosinhos, Portugal;6. Pulmonology Department, Hospital Geral de Coimbra Centro Hospitalar e Universitário de Coimbra, EPE, Coimbra, Portugal;7. Pulmonology Department, Centro Hospitalar de Trás os Montes e Alto Douro, EPE, Vila Real, Portugal;8. Allergy Department, Centro Hospitalar do Porto, EPE, Porto, Portugal;9. Pulmonology Department, Centro Hospitalar de São João, EPE, Porto, Portugal;10. Allergy Department, Centro Hospitalar do Alto Ave, EPE, Guimarães, Portugal;11. Pulmonology Department, Centro Hospitalar e Universitário de Coimbra, EPE, Coimbra, Portugal
Abstract:BackgroundThe impact of severe asthma on patients’ quality of life (QoL) has been previously demonstrated, as well the difficulties in controlling the disease. We aimed to evaluate the effect of omalizumab on QoL and asthma control, and its safety and tolerability in real-life conditions in Portugal.MethodsProspective and open-label study in 15 adult patients with uncontrolled severe persistent allergic asthma on omalizumab treatment ≥16 weeks (w). The short (at 16 w) and long-term (at 1 and 2 years) (y) effects of omalizumab were assessed through the Asthma Life Questionnaire (ALQ) and the Asthma Control Test (ACT). Other secondary outcomes were evaluated.ResultsA significant reduction in ALQ total score (at 16 w, p = 0.002; at 1 y, p = 0.033 and at 2 y, p = 0.024), as well as in the ‘non-scheduled medical visits’ and the ‘medication use’ domains in both the short and long terms was observed. Regarding ACT, we verified a significant improvement in total score (at 16 w, p = 0.004; at 1 y, p = 0.004 and at 2 y, p = 0.008) and in almost all of the five individual questions. Asthma exacerbations and unscheduled health care visits were significantly decreased. There was a significant rise in lung function and a decrease in daily inhaled steroids dose. The most frequent adverse effects were headaches and nausea.ConclusionsOmalizumab promoted a global benefit on QoL and asthma control outcomes. It also yielded a reduction in asthma exacerbations and unscheduled health care visits, a steroid-sparing effect, and an improvement in lung function. The drug was found to be generally safe and well-tolerated.
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