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 FEV(1) reversibility ≥12% and 200  mL, with an oral steroid requirement ≥7.5  mg 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 30-700  IU/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 ± 11.03  mg (p < 0.002) and withdrawn in 74.2% of patients. FEV(1) (percent predicted) was 64.4 ± 22.7 at the beginning and 62.9 ± 24.3 at the end. IgE at entry was 322.2 ± 334.2  IU/mL and increased 2.34-fold. Respiratory function and NO did not present statistically significant changes. We identified three groups of patients: the first (n = 17) receiving oral steroid at entry in whom the accumulated dose of oral steroids progressively decreased; another (n = 10) 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 (n = 4) 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 Oral corticosteroids were withdrawn in three-quarters of the patients.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.