Profile of patients treated with omalizumab in routine clinical practice in Spain

Abstract

Background: Omalizumab is indicated in patients with severe allergic asthma not controlled by high-dose inhaled glucocorticoids and long-acting beta-agonists. Few data are available on the profile of patients treated with this drug in routine clinical practice in Spain.

Objective: To describe the profile of patients with severe allergic asthma treated with omalizumab and the course of the disease after a period of treatment.

Methods: Retrospective, multicentre study, recording the data on patients of either sex and ≥12 years with uncontrolled severe allergic asthma, previously treated with omalizumab. Data were evaluated in relation to pulmonary function, symptoms, quality of life, and concomitant anti-asthma treatment before the prescription of omalizumab and at the time of the study visit.

Results: 214 patients were evaluable (mean age=48.2±17.7 years; mean age at the time of diagnosis=26.6±16.5 years). 90.7% had experienced exacerbations the year before receiving omalizumab, and the mean total IgE level was 273±205.4IU/ml. The mean monthly dose was 380.5±185.4mg. Compared with the baseline situation, differences were observed after treatment with omalizumab in mean FEV1 (62.7±15.9% vs. 70.8±18.7%), in the proportion of patients requiring oral corticosteroids (47.7% vs. 14.0%), and in the ACQ and AQLQ scores. 32.7% of the patients received doses not recommended by the Summary of Product Characteristics (SPC).

Conclusions: Profile of asthmatic patients treated with omalizumab predominantly corresponds to uncontrolled severe asthma cases, in accordance with SPC's indications. The results of the study suggest a favourable clinical course similar to that observed in other studies.

Keywords: Anti-IgE; Effectiveness; Observational study; Omalizumab; Uncontrolled severe allergic asthma.