Oral corticosteroid sparing with omalizumab in severe allergic (IgE-mediated) asthma patients

Abstract

Background:

Long-term oral corticosteroid (OCS) therapy and related adverse events are associated with a significant burden on patients and healthcare resources.

Methods:

This subgroup analysis of a randomized, open-label, parallel-group study evaluated the OCS-sparing effect of omalizumab (OMA) added to optimized asthma therapy (OAT), compared with OAT alone. Patients (12–75 years) with severe allergic asthma, uncontrolled despite GINA 2004 Step 4 therapy, received OMA or OAT for 32 weeks. The change from baseline in OCS use by Week 32 in patients requiring maintenance OCS at baseline was assessed in terms of percent OCS dose change and numbers of patients with reduced/stopped or maintained/increased OCS.

Results:

Eighty-two patients were receiving maintenance OCS at baseline (OMA/OAT n = 59, OAT n = 23). Change from baseline in mean maintenance OCS dose at Week 32 was significantly greater in the OMA/OAT group compared with the OAT group (−45% vs. + 18.3%, p = 0.002). In the OMA/OAT group, 37 patients (62.7%) reduced/stopped OCS use at Week 32, compared with seven patients (30.4%) receiving OAT (p = 0.013). Improvements in other efficacy outcomes were seen at Week 32 in the OMA/OAT group, irrespective of OCS use. An investigator global evaluation of treatment effectiveness at Week 16 was an effective predictor of persistent treatment response at 32 weeks for the majority of OMA/OAT patients (93%), also irrespective of OCS use.

Conclusion:

In this open-label study of patients with severe allergic asthma, OMA/OAT therapy reduced maintenance OCS use, compared with OAT alone. Improvements in efficacy measures were observed in the OMA/OAT group, irrespective of OCS change.

Clinicaltrials.gov identifier:

NCT00264849.

Keywords::

• Allergic asthma
• Immunoglobulin E
• Omalizumab
• Oral corticosteroid

Transparency

Declaration of funding

The study was sponsored by Novartis Pharma AG. The authors were assisted in the preparation of the manuscript by Gary Cotter (ACUMED). Writing support was funded by the study sponsor.

Nicola Smith^c

Clare Peckitt^c

Jo Leo^c

Guy Peachey^c

Robert Maykut^d

Declaration of financial/other relationships

Z.S. has participated in Advisory Board Meetings and receives fees from Chiesi Pharmaceuticals. He holds no stock or other equities in pharmaceutical companies. E.Ś. has disclosed that she has no significant relationships with or financial interests in any commercial companies related to this study or article. NS, CP, J.L, RM and GP are all employees of Novartis.

CMRO peer reviewers have disclosed any relevant financial information to the Editors.

Acknowledgements

Novartis provided financial support for the conduct of this research, and was involved in designing the studies, collecting, analyzing and interpreting the study data, writing the study reports, and the decision to submit this paper for publication.