1. Long-term omalizumab treatment in severe allergic asthma: the South-Eastern Mediterranean "real-life" experience.
- Author
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Tzortzaki EG, Georgiou A, Kampas D, Lemessios M, Markatos M, Adamidi T, Samara K, Skoula G, Damianaki A, Schiza S, Tzanakis N, and Siafakas NM
- Subjects
- Administration, Inhalation, Adrenal Cortex Hormones administration & dosage, Adrenal Cortex Hormones therapeutic use, Aged, Anti-Asthmatic Agents administration & dosage, Anti-Asthmatic Agents adverse effects, Antibodies, Anti-Idiotypic administration & dosage, Antibodies, Anti-Idiotypic adverse effects, Antibodies, Monoclonal, Humanized administration & dosage, Antibodies, Monoclonal, Humanized adverse effects, Asthma complications, Asthma etiology, Cohort Studies, Data Collection, Drug Therapy, Combination, Female, Forced Expiratory Volume, Humans, Hypersensitivity complications, Long-Term Care, Male, Mediterranean Region, Middle Aged, Omalizumab, Spirometry, Treatment Outcome, Vital Capacity, Anti-Asthmatic Agents therapeutic use, Antibodies, Anti-Idiotypic therapeutic use, Antibodies, Monoclonal, Humanized therapeutic use, Asthma drug therapy
- Abstract
Background: Omalizumab is a recombinant humanized anti-IgE monoclonal antibody indicated as an add-on treatment for severe allergic asthma, inadequately controlled despite high dose of inhaled corticosteroids (ICS) and long-acting b2-agonists., Objectives: Medical registries were used to evaluate the 4 months, 1 and 4 years effectiveness of omalizumab treatment, in a non-interventional, observational "real-life" study., Methods: Sixty patients with severe persistent allergic asthma from 5 South-Eastern Mediterranean centres from Crete and Cyprus were evaluated. Effectiveness outcomes included spirometry, severe asthma exacerbations rate, level of asthma control (ACT), and additional asthma medication (inhaled steroids)., Results: Outcome variables improved after 4 months and sustained after 1 and 4 years treatment with Omalizumab. FEV1 improved statistically significant at all time points versus baseline [ΔFEV1 (% pred.) = +21 p = 0.008 at 4 months, ΔFEV1 (% pred.) = +24.5 p < 0.0001 at 4 years after treatment]. Similarly, FVC increased statistically significant versus baseline [ΔFVC (% pred.) = +20 p = 0.002 at 4 months, ΔFVC (% pred.) = +22.6 p = 0.0002 at 4 years]. The level of asthma control as evaluated by ACT was significantly improved after treatment (+12% p = 0.001 at 4 months, +24% p < 0.0001 at 4 years). Omalizumab treatment reduced significantly asthma exacerbations rate (-65% p = 0.0002 at 1 year, and -70% p < 0.0001 at 4 years). The use of inhaled steroids decreased statistically significant after 4 months (p = 0.017), 1 year (p = 0.029) and 4 years (p = 0.014) of omalizumab treatment., Conclusions: This long-term "real-life" study demonstrated significant improvement in lung function and other clinical outcomes after omalizumab treatment, evident at 4 months, and sustained after 1 and 4 years suggesting its efficacy in severe allergic asthma, in the "real-life" practice., (Copyright © 2011 Elsevier Ltd. All rights reserved.)
- Published
- 2012
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