Asthma, Rhinitis, Other Respiratory Diseases
Omalizumab improves asthma-related quality of life in patients with severe allergic asthma,☆☆,

https://doi.org/10.1067/mai.2003.54Get rights and content

Abstract

Background: We have previously shown that omalizumab, a recombinant humanized monoclonal anti-IgE antibody, reduces asthma exacerbations and decreases inhaled corticosteroid (ICS) requirement in patients with severe allergic asthma who were symptomatic despite moderate-to-high doses of ICSs. Objective: The aim of the present study was to assess the effects of omalizumab on asthma-related quality of life (QOL). Methods: These analyses were part of a multicenter, 52-week, randomized, double-blind, placebo-controlled study assessing the efficacy, safety, and tolerability of subcutaneous omalizu-mab (≥0.016 mg/kg of IgE [in international unit per milliliter] per 4 weeks) in 525 adults with severe allergic asthma. A 16-week steroid-stable phase was followed by a 12-week steroid-reduction phase and a 24-week double-blind extension phase. The effect of treatment on asthma-related QOL was evaluated by using the Asthma Quality of Life Questionnaire (AQLQ) administered at baseline and at weeks 16, 28, and 52. Results: The 2 treatment groups were comparable in terms of baseline AQLQ scores. At weeks 16, 28, and 52, omalizumab-treated patients demonstrated statistically significant improvements across all AQLQ domains, as well as in overall score. Moreover, a greater proportion of patients receiving omali-zumab achieved a clinically meaningful improvement in asthma-related QOL during each phase of the study. Greater than 50% of both patients and investigators rated treatment similarly with omalizumab as excellent or good compared with less than 40% of placebo recipients. Conclusion: In patients requiring moderate-to-high doses of ICSs for severe allergic asthma, the measurably improved disease control afforded by add-on omalizumab therapy is paralleled by clinically meaningful improvements in asthma-related QOL. (J Allergy Clin Immunol 2003;111:278-84.)

Section snippets

Study design and patients

These analyses were conducted as part of a multicenter, 28-week, randomized, double-blind, placebo-controlled core study with an additional 24-week double-blind extension phase to assess the efficacy, safety, and tolerability of subcutaneous omalizumab in adolescents and adults with severe allergic asthma. The protocol and main clinical-tolerability findings for the core study are reported in full elsewhere.16 Briefly, patients aged 12 to 75 years who were symptomatic despite moderate-to-high

Results

A total of 525 patients were randomized to study medication in the 28-week core study (omalizumab, n = 268; placebo, n = 257). Nineteen (7.1%) patients receiving omalizumab and 34 (13.2%) placebo recipients withdrew prematurely. Unsatisfactory therapeutic effect (1 vs 14), withdrawal of consent (7 vs 11), administrative problems (4 vs 2), and loss to follow-up (4 vs 4) were the most common reasons for early termination in the omalizu-mab and placebo groups, respectively.

Some 460 patients

Discussion

Asthma is a chronic disease that can result in significant impairment of physical and psychosocial well-being in affected individuals. A thorough QOL assessment, in parallel with routine clinical evaluations, should therefore form an important aspect of determining the treatment response in asthma clinical trials. In the present trial data from a validated asthma-specific QOL instrument demonstrated clearly a significant improvement over the 1-year course of the study for patients receiving

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Supported by a grant from Novartis Pharmaceuticals Corp, East Hanover, NJ, and Genentech, Inc, South San Francisco, Calif.

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*The additional members of the Omalizumab Study Group are listed in the Appendix.

Reprint requests: Niroo Gupta, MD, PhD, Novartis Pharmaceuticals Corporation, 1 Health Plaza, Bldg 122/N208, East Hanover, NJ 07936-1080.

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