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1 Pulmonary Division, University Hospital, Basel, Switzerland, 2 Atlantic Asthma & Allergy Center Inc., Baltimore, USA, 3 Creighton University School of Medicine, Omaha, USA, 4 Johannes-Gutenberg-Universitat III, Medizinische Klinik und Poliklinik, Mainz, Germany, 5 City Park Medical Centre, Capetown, South Africa, 6 Novartis Horsham Research Centre, Horsham, England, 7 Novartis Pharmaceuticals Corporation, East Hanover, USA
CORRESPONDENCE: M. Solèr, Pulmonary Division, University Hospital, Petersgraben 4, CH-4031, Basel, Switzerland. Fax: 41 612654587
Keywords: airway inflammation, allergic asthma, anti-allergic drugs, anti-immunoglobulin-E antibody, immunoglobulin-E, omalizumab
Received: October 26, 2000
Accepted April 5, 2001
This study was supported by Novartis Pharma AG, Basel, Switzerland, and Genentech Inc., South San Francisco, CA, USA.
The clinical benefit and steroid-sparing effect of treatment with the anti-immunoglobulin-E (IgE) antibody, omalizumab, was assessed in patients with moderate-to-severe allergic asthma.
After a run-in period, 546 allergic asthmatics (aged 12–76 yrs), symptomatic despite inhaled corticosteroids (500–1,200 µg daily of beclomethasone dipropionate), were randomized to receive double-blind either placebo or omalizumab every 2 or 4 weeks (depending on body weight and serum total IgE) subcutaneously for 7 months. A constant beclomethasone dose was maintained during a 16-week stable-steroid phase and progressively reduced to the lowest dose required for asthma control over the following 8 weeks. The latter dose was maintained for the next 4 weeks. Asthma exacerbations represented the primary variable.
Compared to the placebo group, the omalizumab group showed 58% fewer exacerbations per patient during the stable-steroid phase (p<0.001). During the steroid-reduction phase, there were 52% fewer exacerbations in the omalizumab group versus the placebo group (p<0.001) despite the greater reduction of the beclomethasone dosage on omalizumab (p<0.001). Treatment with omalizumab was well tolerated. The incidence of adverse events was similar in both groups.
These results indicate that omalizumab therapy safely improves asthma control in allergic asthmatics who remain symptomatic despite regular use of inhaled corticosteroids and simultaneous reduction in corticosteroid requirement.
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