Several clinical studies have demonstrated omalizumab effectiveness in patients with severe allergic asthma but the treatment period has always been relatively short (4-12 months). Only a few data is present for long-term omalizumab therapy. We aimed to assess the long-term clinical and functional effectiveness of omalizumab treatment in severe allergic asthmatic patients.
Methods: Medical records describing the patients' status starting before treatment and also having been registered at the end of 4th, 12th and 36th months from the commencement of treatment and at the last visit where the patient was evaluated were used for omalizumab effectiveness assessments. Twenty-six patients (female/male: 21/5) with severe allergic asthma, uncontrolled despite GINA 2006 Step 4 therapy, were included in the study. Effectiveness outcomes included spirometry measurements, level of asthma control measured by asthma control test (ACT), systemic glucocorticosteroid (sGCS) use, emergency room (ER) visits and hospitalizations for severe exacerbations. In addition, quality of life was assessed using the quality of life questionnaire AQLQ(S) before and 4 and 36 months after treatment.
Results: The mean age was 47.6±13.9 and duration of allergic asthma 22.7±10.1 years. Serum total IgE levels were 322.0±178.1 IU/mL. Mean duration of omalizumab treatment was 40.81±8.2 months. FEV1 improved significantly at all control points versus baseline (p<0.05). The level of asthma control as evaluated by ACT improved significantly after treatment (p<0.05). We determined significantly reduced numbers of exacerbation, emergency visits, hospitalizations, sGCS and SABA use by the end of 36 months (p<0.05). The proportion of patients with improvements larger than 1.5 points in AQLQ(S) total score was 80.7% at the 4th month and 96.1% at the 36th month of treatment.
Conclusions: This study showed that long-term therapy with omalizumab for up to 3 years was well tolerated with significant improvement both in symptoms and lung functions. Accordingly, long-term omalizumab treatment may be recommended for responders.
