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DGDispatch
Omalizumab Plus Conventional Therapies Improve Quality of Life in Patients With Coexistent Allergic Asthma and Rhinitis: Presented at AAAAI
By Bonnie Darves
SAN FRANCISCO, CA -- March 24, 2004 -- Addition of omalizumab to conventional treatment for asthma reduces symptoms, improves quality of life (QoL) and is well tolerated in patients with coexistent allergic asthma and persistent allergic rhinitis.
Researchers presented these results, from the multicentre SOLAR trial, the first to evaluate omalizumab, at the American Academy of Allergy, Asthma & Immunology 60th Annual Meeting.
Omalizumab is a recombinant humanised monoclonal antibody to immunoglobulin E (IgE) that reduces circulating free IgE in patients with allergic asthma and was recently approved for this indication in the United States.
"We know that allergic asthma and persistent allergic rhinitis often coexist, and that IgE is a factor in both," said lead author Ulf Harnest, MD, of Clin-Guard GmbH in Munich, Germany.
Omalizumab is the first anti-IgE agent to show potential efficacy in each of these conditions. Accordingly, the SOLAR investigators conducted a 28-week, randomised, double-blind, placebo-controlled study in 405 patients, ages 12 to 75 years (mean 38 years), with moderate to severe allergic asthma coexistent with moderate to persistent allergic rhinitis.
A total of 209 patients were assigned to receive omalizumab and 196 patients were assigned to placebo. Patients continued to use their conventional asthma therapies, including budesonide turbuhaler at about 400 mcg per day, a long-acting beta 2-agonist and/or an intranasal corticosteroid to relieve allergic rhinitis. Dosage of omalizumab was based on the patient's weight and tolerance of the agent, with at least 0.016 mg/kg per IgE (IU/mL) per 4 weeks.
At baseline, there was no difference between treatment groups in overall QoL scores on the Juniper questionnaires for asthma (AQLQ) and rhinitis ( RQLQ). Mean asthma QoL score was: 4.0 in the omalizumab group and 4.0 in the placebo group, and mean rhinitis QoL score was 3.8 for omalizumab and 3.7 for placebo.
The primary end point was reduction in asthma exacerbations, and the secondary end point was improvement in AQLQ and RQLQ. The researchers defined response as > 1.0 point improvement in overall score on both scales.
Dr. Harnest reported that 57.7% of the omalizumab group achieved excellent or good control of their asthma symptoms compared with 40.6% of the placebo group.
He pointed out that the most significant improvement was seen in persistent allergic rhinitis symptoms, with 60.8% of patients on omalizumab achieving good or excellent symptom control compared to 36.2% of those on placebo. Compared to placebo, omalizumab improved all rhinitis QOL domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms and emotions) as well as symptoms and environmental domains for asthma QoL.
Serious adverse events were reported by 1.4% of patients on omalizumab and 4.5% of placebo patients. "Omalizumab was rated effective by patients, and was well tolerated," Dr. Harnest concluded.
Dr. Harnest spoke on behalf of co-investigators L. Boulet, S. Hedgecock, M. Blogg, K. Surrey, and H. Fox.
The study was funded by Novartis Pharma AG and Genentech.
[Study title: Omalizumab, an Anti-IgE Antibody, Improves Both Asthma- and Rhinitis-Related Quality of Life in Patients With Concomitant Moderate-Severe Disease. Poster 602]
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