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

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 ± 205.4 IU/ml. The mean monthly dose was 380.5 ± 185.4 mg. 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

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

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.

Prevalence of uncontrolled severe persistent asthma in pneumology and allergy hospital units in Spain.

BACKGROUND: Severe persistent asthma is often poorly controlled and its prevalence in pneumology and allergy hospital units in Spain is unknown. OBJECTIVES: To determine the prevalence of uncontrolled severe persistent asthma in hospital units in Spain and to describe the clinical characteristics of this condition. METHODS: An observational, cross-sectional study was conducted in 164 Spanish hospital pneumology and allergology units. A record was made of all patients with asthma and patients with uncontrolled severe asthma (diagnosed on the basis of clinical criteria) seen in these units over 6 months. Information on sociodemographic variables, clinical characteristics, pharmacological asthma treatment, skin prick testing, total serum immunoglobulin E (IgE) levels, pulmonary function (forced expiratory volume in the first second and forced vital capacity), asthma control (Asthma Control Questionnaire [ACQ]), and quality of life (Asthma Quality of Life Questionnaire) was collected. RESULTS: According to the clinicians' judgement, 1423 out of 36 649 asthma patients (3.9%, 95% confidence interval, 3.7%-4.1%]) had uncontrolled severe persistent asthma.These patients had a mean (SD) ACQ score of 3.8 (1.0); 55.8% had a positive skin prick test to common aeroallergens and 54.2% had high levels of total serum IgE.The agreement between the assessment of asthma control based on clinicians' criteria and according to the Global Initiative forAsthma (GINA) guidelines was moderate (63.2%, Kic = 0.337), with an underestimation of asthma severity by clinicians; 53.2% of the patients classified as having controlled moderate to severe asthma had uncontrolled severe persistent asthma according to GINA criteria. CONCLUSIONS: There is a low prevalence of uncontrolled severe persistent asthma in patients seen at hospital units in Spain according to clinical criteria, although it should be noted that level of asthma control is overestimated by clinicians.