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1 Pulmonary Division, University Hospital, Mainz, Germany. 2 Pulmonary Division, University Hospital, Basel, Switzerland. 3 Atlantic Asthma and Allergy Centre Inc., Baltimore, MD, 4 Creighton University School of Medicine, Omaha, NE, USA. 5 City Park Medical Centre, Capetown, South Africa. 6 Allergy and Asthma Clinic Charité, Berlin, Germany. 7 Novartis Horsham Research Centre, Horsham, UK
CORRESPONDENCE: R. Buhl, Pulmonary Division, Mainz 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 antibody, omalizumab
Received: September 6, 2001
Accepted February 8, 2002
This study was supported by Novartis Pharma AG, Basel, Switzerland and Genentech Inc., South San Francisco, CA, USA.
The ability of omalizumab, an anti-immnoglobulin-E agent, to maintain long-term disease control in patients with moderate-to-severe allergic asthma was investigated in a 24-week double-blind extension to a 28-week core trial.
During the extension, 483 of the initial 546 patients were maintained on randomised treatment and the lowest sustainable dose of beclomethasone dipropionate (BDP) as established during the steroid-reduction phase of the core trial. The use of concomitant asthma medication was permitted and investigators were allowed to adjust the BDP dose or switch patients from BDP to other asthma medications if deemed necessary.
More omalizumab-treated patients (33.5%) than placebo-treated patients (13.5%) were able to complete the extension period without requiring inhaled corticosteroid treatment. The mean BDP equivalent dose throughout the extension was lower in the omalizumab group (25 µg·day–1) than in the placebo group (43 µg·day–1). Disease control was sustained in 76% of omalizumab patients compared with 59.4% of placebo patients free from an asthma exacerbation during the extension period. Compared with placebo, fewer patients in the omalizumab group used other concomitant asthma medication during the extension. Treatment with omalizumab was well tolerated and the incidence of adverse events was similar between groups.
In conclusion, these results suggest that omalizumab is a promising new agent for the long-term control of allergic asthma.
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