Clinical experience with omalizumab in a Portuguese severe asthma unit.

BACKGROUND It is widely recognized that asthma control is not always possible in patients with very severe asthma despite available treatment. The aim of this study was to evaluate the efficacy of Omalizumab on asthma control as an add-on therapy in patients from the "Severe Asthma Outpatient Clinic" of Pulido Valente Hospital in Lisbon, Portugal. METHODS A retrospective study was conducted to assess asthma control by the ACT score and by GINA classification, frequency and severity of exacerbations, medication use and pulmonary function in patients treated with Omalizumab. Clinical information was collected from medical records from the start of treatment and at 6, 12 and 24 month follow-up. RESULTS 26 patients started treatment with Omalizumab, all (100%) were classified by GINA with uncontrolled asthma prior to treatment. Mean ACT score was 11.5. All patients had treatment with fixed-dose ICS and LABA and 34.6% also had an anti-cholinergic inhaler. 42.3% of patients were also treated with oral glucocorticosteroids for control. Patients reported an average of 1.8 moderate and 3.1 severe exacerbations/year. Statistical differences were found at 6 month follow-up in most end-points: GINA score improved: 60.9% of patients with partially controlled asthma and only 39.1% with uncontrolled asthma (Wilcoxon 0.00); ACT score improved to 19.52 (Wilcoxon 0.00); mean FEV1 improved to 76.7% (Wilcoxon 0.025); the proportion of patients requiring oral glucocorticosteroid therapy reduced to 17.4% (Wilcoxon 0.014); and the number of moderate and severe exacerbations also decreased to 1.04 and 1.83 respectively (Wilcoxon 0.007; Wilcoxon 0.002 respectively). CONCLUSIONS The current analysis shows evidence that omalizumab is successful in improving asthma control as an add-on therapy GINA step 5 treatment.