Long-term omalizumab treatment in severe allergic asthma: the South-Eastern Mediterranean "real-life" experience.

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.

• Authors: Eleni G Tzortzaki, Andreas Georgiou, Dimitrios Kampas, Marinos Lemessios, Miltiadis Markatos, Tonia Adamidi, Katerina Samara, Georgia Skoula, Aggeliki Damianaki, Sophia Schiza, Nikos Tzanakis, Nikolaos M Siafakas
• Journal: Pulmonary pharmacology & therapeutics (Pulm Pharmacol Ther) Vol. 25 Issue 1 Pg. 77-82 (Feb 2012) ISSN: 1522-9629 [Electronic] England
• PMID: 22155001 (Publication Type: Journal Article)
• Copyright: Copyright © 2011 Elsevier Ltd. All rights reserved.

Chemical References

• Adrenal Cortex Hormones
• Anti-Asthmatic Agents
• Antibodies, Anti-Idiotypic
• Antibodies, Monoclonal, Humanized
• anti-IgE antibodies
• Omalizumab

Topics

• Administration, Inhalation
• Adrenal Cortex Hormones (administration & dosage, therapeutic use)
• Aged
• Anti-Asthmatic Agents (administration & dosage, adverse effects, therapeutic use)
• Antibodies, Anti-Idiotypic (administration & dosage, adverse effects, therapeutic use)
• Antibodies, Monoclonal, Humanized (administration & dosage, adverse effects, therapeutic use)
• Asthma (complications, drug therapy, 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