Omalizumab Therapy in Severe Asthma: Experience from the Spanish Registry—Some New Approaches

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.

• efficacy
• IgE-mediated diseases
• omalizumab
• out-of-range IgE levels
• uncontrolled severe asthma

Acknowledgments

The authors thank Gerard Traveria from Adknoma Health Research, who performed the statistical analysis, Dr. Ramón Mora from Novartis, who supplied all kinds of scientific information, and Marc Castellví from NICASE, who was our Software Product Manager.

In the last 5 years, Picado has been awarded grants for research projects from Uriach SA, Phadia, Chiesi, AstraZeneca, Leti, Novartis, and MSD; he has also participated as investigator in clinical trials for Uriach SA and Chiesi.

Declaration of Interest

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of this article.