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1 Pulmonary Division, University Hospital, Mainz, and 2 Allergy and Asthma Clinic, Charité Berlin, Germany. 3 Pulmonary Division, University Hospital, Basel, Switzerland. 4 Allergy, Immunology & Asthma Medical Group, Stockton, CA, and 6 Allergy & Asthma Associates, San Jose, CA, USA. 5 Novartis Pharma AG, Basel, Switzerland. 7 Novartis Horsham Research Centre, Horsham, UK
CORRESPONDENCE: R. Buhl, Pulmonary Division, University Hospital, Langenbeckstrasse 1, D-55131, Mainz, Germany. Fax: 49 6131175545. E-mail: R.Buhl@3-med.klinik.uni-mainz.de
Keywords: allergic asthma, anti-immunoglobulin E, omalizumab, quality of life
Received: February 25, 2002
Accepted June 27, 2002
This study was supported by Novartis Pharma AG, Basel, Switzerland and Genentech Inc., South San Francisco, CA, USA.
The aim of the present study was to determine the effect of treatment with omalizumab, an anti-immunoglobulin E antibody, on asthma-related quality of life (AQoL) in patients with moderate-to-severe allergic asthma.
A total of 546 patients with allergic asthma were randomised to double-blind subcutaneous treatment with either placebo or omalizumab for 52 weeks. A constant beclomethasone dipropionate dose was maintained during the first 16 weeks (steroid-stable phase). This was followed by a 12-week steroid-reduction phase. The core study was followed by a 24-week double-blind extension phase. AQoL was evaluated at baseline and at the end of the steroid-stable (week 16), steroid-reduction (week 28) and extension phases (week 52) using the Juniper Asthma Quality of Life Questionnaire (AQLQ).
Baseline AQLQ scores were comparable for the two treatment groups. Relative to placebo, omalizumab-treated patients demonstrated statistically significant improvements from baseline across all four AQLQ domains, as well as overall AQoL score, at weeks 16 (except environmental exposure), 28 and 52. Patients on omalizumab were also more likely to achieve clinically significant improvements in AQoL during the course of the study. Overall, almost 70% of patients and investigators rated treatment with omalizumab as "excellent/good", compared with
Clinical studies show that omalizumab enhances disease control whilst reducing corticosteroid consumption in patients with allergic asthma. The results of the present study show that these changes are paralleled by improvements in asthma-related quality of life that are meaningful to such patients.
40% of placebo recipients.
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