Real-life efficacy and safety of omalizumab in Portuguese patients with persistent uncontrolled asthma.
BACKGROUND
The real life effectiveness, safety and the use of omalizumab for Portuguese patients with uncontrolled persistent allergic asthma are not sufficiently well known. The objective of this report was to make an evaluation, in a post-marketing, non-interventional, observational registry, of the Portuguese population included in the eXpeRience study.


METHODS
The methods used in this report are the same as the global eXpeRience ones, applied to a Portuguese sub-population. Patients with uncontrolled allergic asthma who had started omalizumab within the previous 15 weeks were enrolled and received omalizumab add-on therapy for 24 months. The physicians' global evaluation of treatment effectiveness (GETE), asthma symptoms and control (ACT score), quality of life (mini-AQLQ score), exacerbations, and serious adverse events (SAE) were reported.


RESULTS
Of the 943 patients recruited in the eXpeRience registry, 62 patients were from Portugal. 62.1% of them were observed to be responders with good/excellent GETE assessment at Week 16. Clinically meaningful improvements in asthma control (ACT score) and quality of life (mini-AQLQ score) were observed with omalizumab therapy at Months 12 (mean change: +7.7 [n=35]; +2.1 [n=20], respectively) and 24 (mean change: +7.0 [n=26]; +2.7 [n=13], respectively). Asthma symptoms and rescue medication usage were reduced to ≤1 day/week at Month 24 from a baseline of ≥3.5 days/week. The proportion of patients with no clinically significant exacerbations increased from 6.5% during pre-treatment (n=62) to 50% at Month 12 (n=54) and 60% at Month 24 (n=45).


CONCLUSIONS
The findings from the Portugal subpopulation of eXpeRience registry confirm that omalizumab add-on therapy is efficacious and well tolerated in the management of uncontrolled persistent allergic asthma. Another pertinent issue is the fact that the Portuguese subpopulation response is similar to the international population average of the study.
Serviço de Imunoalergologia, Centro Hospitalar de Lisboa Norte, Lisbon, Portugal.
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Pereira Barbosa
Clínica Universitária de Pneumologia, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal.
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A
Bugalho de Almeida
Novartis Farma - Produtos Farmaceuticos S.A., Avenida Professor Doutor Cavaco Silva, n.° 10E, Taguspark, 2740-255 Porto Salvo, Portugal. Electronic address: catarina.pereira@novartis.com.
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Pereira
Novartis Pharmaceuticals Corporation, One Health Plaza East Hanover, NJ 07936-1080, USA.
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Chen
Novartis Pharmaceuticals UK Limited, Wimblehurst Road Horsham, West Sussex RH12 5AB, UK.
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P
Georgiou
Novartis Pharmaceuticals UK Limited, Wimblehurst Road Horsham, West Sussex RH12 5AB, UK.
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G
Peachey
D000293:Adolescent; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D002648:Child; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab / Q000627:therapeutic use*; D011174:Portugal; D012042:Registries; D016896:Treatment Outcome; D055815:Young Adult
D018927:Anti-Asthmatic Agents; D000069444:Omalizumab
Allergic asthma; Anti-immunoglobulin E; Asthma control; Exacerbations; Observational study; Omalizumab