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

Abstract

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 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 0.002) and withdrawn in 74.2% of patients. 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 ± 334.2 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 Oral corticosteroids were withdrawn in three-quarters of the patients.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.

Key words::

• Asthma
• Oral corticosteroids
• Omalizumab
• Drug tolerance

Transparency

Declaration of funding

This study was partially funded by a grant obtained from the FUCAP (Fundació Catalana de Pneumologia 2008).

Declaration of financial/other relationships

D.S. has disclosed that he received a research grant from the Instituto de Salud Carlos III, Ministerio de Sanidad y Consumo, Spain and the Departament de Salut of the Generalitat de Catalunya (FIS ECA07/041). C.D. has disclosed that he has received funding for medical lectures from Astra-Zeneca, Novartis, Esteve, Boehringer-Ingelheim and Pfizer. The other authors have no conflicts of interest to report.

Acknowledgement

The authors thank Adela García and Carmen Veigas, nurses of the Pneumology Service, for their clinical assistance and Michael Maudsley of the University of Barcelona’s Language Service for revising the English.