PURPOSE: Omalizumab, a monoclonal antibody against IgE, is approved for patients with poorly controlled allergic asthma with serum IgE levels between 30-700 IU/ml and positive testing for perennial allergens. Its efficacy in patients with IgE levels > 700 IU/ml is unclear.The aim of this study is to evaluate the clinical characteristics and response of asthmatic subjects treated with omalizumab with IgE levels > 700 IU/ml.
METHODS: A retrospective, case-controlled study was performed in an asthma referral clinic. Consecutive asthmatics treated with omalizumab ≥ 6 months with elevated IgE levels were identified, and clinical characteristics/demographic variables recorded. Emergency room visits, hospitalizations, change in FEV1, corticosteroid bursts, and Asthma Control Test (ACT) scores were recorded for a period of 6 months pre and post treatment.
RESULTS: Twenty-six subjects with an IgE >700 IU/ml (Group 1) were matched by age, gender and duration of asthma to subjects with an IgE of 30 to 700 IU/ml (Group 2). The mean IgE level was 2371 IU/ml (786-10979) vs. 221 IU/ml (30-578) respectively (p<0.001). Clinical characteristics were similar except that skin testing to molds was significantly greater in Group 1 (p< 0.025). While hospital admissions were similar, the mean ED visits pre and post treatment were 0.96 vs. 0.23 [p = 0.008] in Group 1 and 0.65 vs. 015 [p = 0.018] in Group 2. Both Group 1 and Group 2, had an improvement in asthma control based on the mean ACT pre and post treatment (15.6 vs. 18.9[p=0.016] and 15.4 vs. 19 [p=0.006]) respectively. There was also a significant reduction in the frequency of systemic corticosteroid bursts during the 6 months pre and post treatment (2.58 vs. 0.96 [p<0.001] and 2.62 vs. 1.23 [p<0.001]) respectively.
CONCLUSIONS: Omalizumab was effective in reducing ED visits, controlling asthma symptoms and reducing the need for systemic corticosteroids in patients with IgE levels > 700 IU/ml. While not meeting the criteria of allergic bronchopulmonary aspergillosis; these subject demonstrated higher rate of mold sensitivity.
CLINICAL IMPLICATIONS: Omalizumab is effective in subjects with IgE levels above 700 IU/ml and should be consider a viable therapeutic option in this subset of asthmatics.
DISCLOSURE: The following authors have nothing to disclose: Jay Peters, Joseph Diaz, Diego Maselli
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