Abstract
BackgroundOmalizumab is a non-steroidal medication indicated for the treatment of poorly controlled moderate-to-severe allergic asthmatics. This observational study examines the “real world” effectiveness of omalizumab in this population.MethodsThis is a one year open-label observational study that compared clinical outcomes including total oral corticosteroid use, exacerbation history, measures of quality of life and inflammation in patients with moderate-to-severe allergic asthma, who were prescribed omalizumab as part of their treatment with the year prior to therapy.ResultsA total of 99 patients were enrolled at 25 sites in Canada. During the study period, the mean total annual OCS dose was reduced from 2301.5 mg (prednisone equivalents) in the year prior to omalizumab to 1130.0 mg (p<0.0001). There was a 71% reduction in asthma exacerbations and 56% of patients on omalizumab remained exacerbation free when compared to the year prior to study entry. Associated with this was reduced health care utilization. There were significant improvements in the Asthma Control Questionnaire (ACQ) and Asthma Quality of Life questionnaire (AQLQ) Patients with an elevated FeNO at baseline showed a better response to treatment. No new safety issues were identified during the study period.ConclusionOur study demonstrates that in “real world” clinical practice, after initiating omalizumab, there is a reduction in total OCS use and exacerbation frequency in patients with moderate-to-severe allergic asthma. Patients on treatment reported improved asthma control and quality of life. FeNO may be a useful biomarker to identify patients who may benefit with omalizumab treatment.
Highlights
Asthma is a chronic inflammatory airway disease characterized by variable airflow obstruction
There was a 71% reduction in asthma exacerbations and 56% of patients on omalizumab remained exacerbation free when compared to the year prior to study entry
There were significant improvements in the Asthma Control Questionnaire (ACQ) and Asthma Quality of Life questionnaire (AQLQ) Patients with an elevated Fractional exhaled nitric oxide (FeNO) at baseline showed a better response to treatment
Summary
Asthma is a chronic inflammatory airway disease characterized by variable airflow obstruction. Asthmatics are able to achieve control of their symptoms by limiting environmental exposures that may aggravate their asthma and by using medications such as inhaled corticosteroids (ICS) to reduce the inflammation associated with the disease. There remains a population of asthmatics who, despite guideline-based treatment, continue to have poor control and experience acute exacerbations [1]. These patients often require oral corticosteroids (OCS) to control their disease. Omalizumab is a non-steroidal medication indicated for the treatment of poorly controlled moderate-to-severe allergic asthmatics. This observational study examines the “real world” effectiveness of omalizumab in this population
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