Chest
Clinical InvestigationsASTHMAPredicting Response to Omalizumab, an Anti-IgE Antibody, in Patients With Allergic Asthma
Section snippets
Materials and Methods
The present analysis used data from adults and adolescents (aged ≥ 12 years) with allergic asthma, symptomatic despite moderate-to-high daily doses of ICS (beclomethasone dipropionate [BDP]), who were randomized to treatment in two phase III, double-blind, placebo-controlled, multicenter studies. The identical study design and similarities in patient populations and clinical findings justified pooling of the two studies, the protocol and main efficacy findings of which are reported in full
Results
The pooled patient population comprised 1,070 adults and adolescents with allergic asthma who were randomized to treatment with either omalizumab (n = 542) or placebo (n = 528) in addition to stable BDP therapy. Overall, the two treatment groups were comparable in terms of baseline characteristics (Table 1). Completer rates for the 16-week, steroid-stable phase were 95.2% (516 of 542 patients) for those treated with omalizumab and 90.7% (479 of 528 patients) for placebo recipients.
Discussion
Identification of those patients most likely to achieve the greatest benefit from omalizumab therapy has obvious implications for clinical decision making on the utility of this new treatment option for allergic asthma. In the present study, based on the findings of two large placebo-controlled phase III clinical trials,56 a pooled exploratory analysis was therefore performed in an attempt to characterize such patients. Various aspects of response to omalizumab (as add-on therapy to standard
Conclusion
Treatment with omalizumab significantly reduces the risk of asthma exacerbations in patients with allergic asthma. Asthma patients who benefit most from add-on treatment with omalizumab are those receiving high doses of ICS, those with a history of frequent emergency asthma treatment, and patients with poor lung function. A minimum treatment duration of 12 weeks appears necessary before deciding whether a satisfactory response will be achieved with omalizumab. Taken together, these findings
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Cited by (0)
This study was supported by Novartis Pharma AG, Basel, Switzerland, and Genentech Inc., South San Francisco, CA.
According to their statement, the authors and all study investigators have not made any financial arrangement whereby the value of the compensation could be influenced by the outcomes of the study, have not received significant payments of other sorts from the sponsors (excluding the costs of conducting the study), do not have a proprietary or financial interests in the test product such as patent, trademark, or licensing agreements, and do not hold a significant equity interest in the sponsor of the study (exceeding $50,000).
Drs. Freeman and Fox hold permanent positions with Novartis Pharma AG.