Background: Omalizumab was introduced in Malta in 2011. To date, no local data have been published.
Objective: To obtain baseline characteristics of our local cohort, determine effectiveness of omalizumab at 52 weeks, compare clinical outcomes 52 weeks pre- and postomalizumab therapy and to assess its safety and tolerability.
Setting: The Mater Dei Hospital in Malta.
Method: All consented adult patients who were eligible to start treatment with omalizumab for asthma were enrolled in this open, prospective observational real-life study. A questionnaire was completed and an Asthma Control Test and spirometry performed. Patients were reviewed on a regular basis. Any undesirable symptoms were recorded. Treatment effectiveness was evaluated at 16 and 52 weeks, during which a decision was taken whether patients were responders. Outcomes were compared 52 weeks pre- and post- treatment initiation. Main outcome measure To determine effectiveness of treatment following 1 year of omalizumab by assessing its impact on the rate of asthma-related exacerbations and health care utilization including hospitalizations.
Results: Our cohort included 22 patients, all non-smokers (mean age 52.7 ± 11, 64 % males). The mean baseline IgE level was 448.6 ± 444 IU/ml. At week 12, treatment was stopped in one patient due to arthralgias. The drug was stopped in two patients at week 16 due to treatment ineffectiveness. At week 20, treatment was stopped in another patient in view of arthralgias. A significant reduction in the number of asthma exacerbations (p = .03) and number of systemic steroid courses required (p = .03) was identified at 52 weeks. There was a significant improvement in the ACT score (p < .001) after 52 weeks but no significant improvement in FEV1. There was a non-significant decline in the number of hospitalizations (p = .6), asthma-related healthcare visits (p = .2) and days off work (p = .09). Adverse events occurred in 10 % of patients. Costs related to asthma hospital-stay and medicines administered during hospitalisations were decreased by half following 1 year on omalizumab.
Conclusion: Omalizumab treatment resulted in an improved asthma control, with a significant reduction in asthma exacerbations and systemic steroid courses required and improvement on ACT score. Adverse events were infrequent and the drug was well tolerated.