Uncontrolled persistent allergic asthma in practice: eXpeRience registry baseline characteristics

Abstract

Background:

Medical registries can be used to assess and monitor the effectiveness and safety of approved therapy, and provide insights into how quality of care can be optimized.

Methods:

The post-marketing, non-interventional, observational registry (eXpeRience) aims to collect data on the treatment effectiveness and safety of omalizumab in ‘real-world’ practice. The baseline characteristics of patients with uncontrolled allergic asthma receiving omalizumab therapy and included in the first interim analysis of this observational registry are reported.

Results:

A total of 294 patients were included in the first interim analysis. Of these patients, 271 (92.2%) were active in the registry at the time of reporting. At baseline, the mean duration of allergic asthma was approximately 19 years, with over 87% of patients testing positive for a perennial allergen. Mean % predicted FEV₁ and serum total IgE levels were 62.4% and 316.7 IU/mL, respectively. Asthma was uncontrolled for approximately 62% of patients, while around 23% were partly controlled. The majority of patients were being treated with multiple asthma controller medications, including inhaled-corticosteroids, long-acting β₂-agonists and leukotriene receptor antagonists, and 28% of patients were also receiving maintenance oral corticosteroids. Concomitant diseases were present in many patients, the most common being perennial allergic rhinitis (42.5%).

Conclusions:

Demographic and disease characteristics highlight the unmet clinical need in patients with uncontrolled allergic asthma. Future analyses from this study will further determine the real-life effectiveness and safety of omalizumab.

Key words::

• Asthma management
• Immunoglobulin E
• Omalizumab

Transparency

Declaration of funding

The study was sponsored and designed by Novartis Pharma AG.

Declaration of financial/other relationships

G.-J.B. has received honorarium for consultations and lectures from several pharmaceutical companies in the past 3 years, the total reimbursement for these activities was less than €10 000; J.L., J.T., R.M. and G.P. are Novartis Pharma employees. CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

The registry was sponsored by Novartis Pharma AG. The authors were assisted in the preparation of the manuscript by Brian Jepson (ACUMED). Writing support was funded by the registry sponsor.