Omalizumab Therapy in Severe Asthma: Experience from the Spanish Registry—Some New Approaches
Year: 2012
Type: article
Study design: Observational Study
Abstract: OBJECTIVE: The efficacy of omalizumab in severe asthma has been widely demonstrated. The main objective of this study was to evaluate the efficacy and tolerability of omalizumab in a real-life setting in Spain, particularly in those patients with immunoglobulin E (IgE) levels out of range. METHODS: Totally 266 uncontrolled severe asthma patients receiving high-dose inhaled corticosteroids (ICSs) plus long-acting β2-agonist (LABA) were recruited. Main efficacy outcomes were asthma exacerbation rate (AER), asthma control test (ACT), and global evaluation of treatment effectiveness (GETE). RESULTS: AER was reduced from 3.6 (3.6) in previous year to 0.67 (1.2) at 4 months (p < .05) and to 1.04 (1.8) at 2 years (p < .05). ACT increased significantly from 14.3 (4.7) at baseline to 18.4 (4.4) at 4 months (p < .05) and to 20.3 (4.0) (p < .05) at 2 years. After 4 months, 74.6% of patients had reached a good or excellent rate on the GETE scale (p < .05). This rate continued increasing up to 81.6% at 2 years. These efficacy results were similar for patients with "off-label" IgE > 700 IU/ml. At follow-up, maintenance treatment with oral steroids was discontinued in a considerable number of patients: from 89 to 19 (p < .05). Omalizumab was discontinued because of lack of efficacy only in 28/266 (10.5%) patients. Overall, 30 patients (11.4%) reported adverse events. Severe adverse events were not observed. CONCLUSION: This real-life study confirms that omalizumab is very efficacious and very well tolerated in patients with uncontrolled severe asthma. Results did not vary in the subgroup of patients with IgE levels >700 IU/ml.
Source: Journal of Asthma
Authors: María Del Carmen Vennera, Luis Pérez De Llano, Santiago Bardagí, Pilar Ausin, Carles Sanjuas, Héctor González, José A. Gullón, Eva Martínez-Moragón, José A. Carretero, Elisabet Vera, Juan F. Medina, Francisco J. Álvarez, Luis M. Entrenas, Alicia Padilla, Rosa Irigaray, César Picado, on behalf of the Spanish Registry
Institutions: Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Hospital Clínic de Barcelona, Consorci Institut D'Investigacions Biomediques August Pi I Sunyer, Universitat de Barcelona, Hospital Xeral Calde, Hospital de Mataró, Hospital Del Mar, Municipal Institute for Medical Research, Hospital del Mar Research Institute, Hospital Universitario de Canarias, Hospital de Sagunto, Hospital Universitario Miguel Servet, Hospital Universitario Virgen del Rocío, Hospital Universitario Reina Sofía, Hospital Costa del Sol, Fundación Hospital Manacor
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W2040565769