Omalizumab in the management of oral corticosteroid-dependent IGE-mediated asthma patients

Background: Several studies have demonstrated the beneficial effects of omalizumab in asthma patients. Here we describe the drug's tolerance and oral corticosteroid sparing capacity in a long-term observational study. Methods: Thirty-two patients aged 18 years with obstructive airway disease and FEV1 reversibility 12 and 200mL, with an oral steroid requirement 7.5mg per day of prednisolone during a period of 1 year, a positive prick test or in vitro reactivity (RAST) to at least one perennial aeroallergen and a baseline immunoglobulin E level ranking between 30700IU/mL were prospectively followed for 17.2±8.5 months. Patients were visited once or twice a month, depending on their schedule for omalizumab administration. Intervention: blood analysis every six months; spirometry and nitric oxide measurement at every visit. Results: One patient who dropped out early was excluded. Follow-up period: the treatment benefited 83.9 (26/31) of the cohort; oral corticosteroids were reduced from 7.19±11.1 to 3.29±11.03mg (p<0.002) and withdrawn in 74.2 of patients. FEV1 (percent predicted) was 64.4±22.7 at the beginning and 62.9±24.3 at the end. IgE at entry was 322.2±334.2IU/mL and increased 2.34-fold. Respiratory function and NO did not present statistically significant changes. We identified three groups of patients: the first (n17) receiving oral steroid at entry in whom the accumulated dose of oral steroids progressively decreased; another (n10) including patients who had quit oral steroids before starting omalizumab although they had not been instructed to do so and whose oral steroid dose at the end of follow-up was zero; and a third group (n4) that did not benefit from omalizumab treatment. The only relevant side effect was a flu-like syndrome which required discontinuation of treatment in one patient. Conclusion: In our series, a substantial, safe decrease in oral corticosteroid requirements was observed due, at least to some extent, to omalizumab therapy. Oral corticosteroids were withdrawn in three-quarters of the patients. We were unable to identify a factor able to predict which patients would benefit most from omalizumab treatment. © 2011 Informa UK Ltd.