Impact of Omalizumab in Patients with Severe Uncontrolled Asthma and Possible Predictive Biomarkers of Response: A Real-Life Study

Most patients with asthma can control their symptoms with a basic standard of medical care and with maintenance and rescue medication. However, between 5% and 10% of asthmatics worldwide do not achieve control of their symptoms and have recurrent exacerbations and respiratory difficulties. The objec...

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Main Authors: Susana Rojo-Tolosa, María Victoria González-Gutiérrez, José Antonio Sánchez-Martínez, Gonzalo Jiménez-Gálvez, Laura Elena Pineda-Lancheros, José María Gálvez-Navas, Alberto Jiménez-Morales, Cristina Pérez-Ramírez, Concepción Morales-García
Format: Article
Language:English
Published: MDPI AG 2023-02-01
Series:Pharmaceutics
Subjects:
Online Access:https://www.mdpi.com/1999-4923/15/2/523
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author Susana Rojo-Tolosa
María Victoria González-Gutiérrez
José Antonio Sánchez-Martínez
Gonzalo Jiménez-Gálvez
Laura Elena Pineda-Lancheros
José María Gálvez-Navas
Alberto Jiménez-Morales
Cristina Pérez-Ramírez
Concepción Morales-García
author_facet Susana Rojo-Tolosa
María Victoria González-Gutiérrez
José Antonio Sánchez-Martínez
Gonzalo Jiménez-Gálvez
Laura Elena Pineda-Lancheros
José María Gálvez-Navas
Alberto Jiménez-Morales
Cristina Pérez-Ramírez
Concepción Morales-García
author_sort Susana Rojo-Tolosa
collection DOAJ
description Most patients with asthma can control their symptoms with a basic standard of medical care and with maintenance and rescue medication. However, between 5% and 10% of asthmatics worldwide do not achieve control of their symptoms and have recurrent exacerbations and respiratory difficulties. The objective of the study was the real-life evaluation of the clinical improvement of patients with severe eosinophilic asthma treated with omalizumab, together with the search for biomarkers associated with the response. An observational retrospective cohort study was conducted that included patients with severe uncontrolled allergic asthma being treated with omalizumab. Three types of response were evaluated: lower use of oral corticosteroids, improvement in lung function, and reduction in exacerbations. A total of 110 patients under treatment with omalizumab were included, with a mean age of 48 ± 16 years. After 12 months had elapsed, significant reductions were found in the number of exacerbations, use of oral cortico-steroids and doses of inhaled corticosteroids (<i>p</i> < 0.001). Lung function and asthma control improved significantly (<i>p</i> < 0.001; <i>p</i> = 0.004) and eosinophil levels were significantly reduced (<i>p</i> = 0.004). Low scores in the Asthma Control Test were associated with the oral corticosteroid-saving effect; lower previous FEV1 levels and absence of chronic obstructive pulmonary disease (COPD) were related to improvement in lung function, and prior FEV1 values higher than 80% and absence of gastroesophageal reflux disease (GERD) with a reduction in exacerbations. The results of this study confirm the clinical benefit obtained after the introduction of omalizumab and the possible predictive biomarkers of response to the treatment.
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spelling doaj.art-2256b8f937014e01862113d0c319fe572023-11-16T22:41:05ZengMDPI AGPharmaceutics1999-49232023-02-0115252310.3390/pharmaceutics15020523Impact of Omalizumab in Patients with Severe Uncontrolled Asthma and Possible Predictive Biomarkers of Response: A Real-Life StudySusana Rojo-Tolosa0María Victoria González-Gutiérrez1José Antonio Sánchez-Martínez2Gonzalo Jiménez-Gálvez3Laura Elena Pineda-Lancheros4José María Gálvez-Navas5Alberto Jiménez-Morales6Cristina Pérez-Ramírez7Concepción Morales-García8Respiratory Medicine Department, University Hospital Virgen de las Nieves, 18014 Granada, SpainRespiratory Medicine Department, University Hospital Virgen de las Nieves, 18014 Granada, SpainRespiratory Medicine Department, University Hospital Virgen de las Nieves, 18014 Granada, SpainRespiratory Medicine Department, University Hospital Virgen de las Nieves, 18014 Granada, SpainPharmacy Service, Pharmacogenetics Unit, University Hospital Virgen de las Nieves, 18014 Granada, SpainPharmacy Service, Pharmacogenetics Unit, University Hospital Virgen de las Nieves, 18014 Granada, SpainPharmacy Service, Pharmacogenetics Unit, University Hospital Virgen de las Nieves, 18014 Granada, SpainCenter of Biomedical Research, Department of Biochemistry and Molecular Biology II, Institute of Nutrition and Food Technology “José Mataix”, University of Granada, Avda. del Conocimiento s/n., 18016 Granada, SpainRespiratory Medicine Department, University Hospital Virgen de las Nieves, 18014 Granada, SpainMost patients with asthma can control their symptoms with a basic standard of medical care and with maintenance and rescue medication. However, between 5% and 10% of asthmatics worldwide do not achieve control of their symptoms and have recurrent exacerbations and respiratory difficulties. The objective of the study was the real-life evaluation of the clinical improvement of patients with severe eosinophilic asthma treated with omalizumab, together with the search for biomarkers associated with the response. An observational retrospective cohort study was conducted that included patients with severe uncontrolled allergic asthma being treated with omalizumab. Three types of response were evaluated: lower use of oral corticosteroids, improvement in lung function, and reduction in exacerbations. A total of 110 patients under treatment with omalizumab were included, with a mean age of 48 ± 16 years. After 12 months had elapsed, significant reductions were found in the number of exacerbations, use of oral cortico-steroids and doses of inhaled corticosteroids (<i>p</i> < 0.001). Lung function and asthma control improved significantly (<i>p</i> < 0.001; <i>p</i> = 0.004) and eosinophil levels were significantly reduced (<i>p</i> = 0.004). Low scores in the Asthma Control Test were associated with the oral corticosteroid-saving effect; lower previous FEV1 levels and absence of chronic obstructive pulmonary disease (COPD) were related to improvement in lung function, and prior FEV1 values higher than 80% and absence of gastroesophageal reflux disease (GERD) with a reduction in exacerbations. The results of this study confirm the clinical benefit obtained after the introduction of omalizumab and the possible predictive biomarkers of response to the treatment.https://www.mdpi.com/1999-4923/15/2/523severe uncontrolled asthmaomalizumabeffectivenessbiomarkers
spellingShingle Susana Rojo-Tolosa
María Victoria González-Gutiérrez
José Antonio Sánchez-Martínez
Gonzalo Jiménez-Gálvez
Laura Elena Pineda-Lancheros
José María Gálvez-Navas
Alberto Jiménez-Morales
Cristina Pérez-Ramírez
Concepción Morales-García
Impact of Omalizumab in Patients with Severe Uncontrolled Asthma and Possible Predictive Biomarkers of Response: A Real-Life Study
Pharmaceutics
severe uncontrolled asthma
omalizumab
effectiveness
biomarkers
title Impact of Omalizumab in Patients with Severe Uncontrolled Asthma and Possible Predictive Biomarkers of Response: A Real-Life Study
title_full Impact of Omalizumab in Patients with Severe Uncontrolled Asthma and Possible Predictive Biomarkers of Response: A Real-Life Study
title_fullStr Impact of Omalizumab in Patients with Severe Uncontrolled Asthma and Possible Predictive Biomarkers of Response: A Real-Life Study
title_full_unstemmed Impact of Omalizumab in Patients with Severe Uncontrolled Asthma and Possible Predictive Biomarkers of Response: A Real-Life Study
title_short Impact of Omalizumab in Patients with Severe Uncontrolled Asthma and Possible Predictive Biomarkers of Response: A Real-Life Study
title_sort impact of omalizumab in patients with severe uncontrolled asthma and possible predictive biomarkers of response a real life study
topic severe uncontrolled asthma
omalizumab
effectiveness
biomarkers
url https://www.mdpi.com/1999-4923/15/2/523
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