Original Articles: Mechanisms of AllergyOmalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma☆,☆☆
Section snippets
Subjects
Male or female allergic asthmatics aged 12 to 75 years who were symptomatic despite treatment with ICSs were eligible if they met the following criteria: duration of asthma, ≥1 year; positive immediate responses on skin prick testing to at least 1 common allergen, including Dermatophagoides farinae , Dermatophagoides pteronyssinus , cockroach (whole body), dog, or cat; total serum IgE ≥30 IU/mL to ≤700 IU/mL; FEV1 reversibility of ≥12% within 30 minutes after administration of albuterol (90-180
Demographics
With respect to demographic characteristics, the 2 groups were not statistically different (Table I).
Empty Cell Omalizumab (n = 268) Placebo (n = 257) Sex (no. of subjects [%]) Male 104 (38.8) 111 (43.2) Female 164 (61.2) 146 (56.8) Race (no. of subjects [%]) Caucasian 238 (88.8) 229 (89.1) Black 21 (7.8) 16 (6.2) Other 9 (3.4) 12 (4.7) Age (mean [range]) (y) 39.3 (12-73) 39.0 (12-74) Age group (no. of subjects [%]) 12-17 y 20 (7.5) 21 (8.2) 18-64 y 241 (89.9) 229
Discussion
Allergic asthmatic patients enrolled in this study were not well controlled before randomization while being treated with a significant dose of BDP (400-800 μg per day). This, in conjunction with a long history of asthma, low FEV1 on entry into the study, or significant symptoms as judged from daily diary card recordings, classified 99.3% of these patients as severe persistent asthmatics. In this often problematic patient population, omalizumab therapy was associated with significantly fewer
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Supported by a grant from Novartis Pharmaceuticals Corporation and Genentech, Inc.
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Reprint requests: William Busse, MD, Department of Medicine, Section of Allergy and Clinical Immunology, University of Wisconsin Hospital & Clinics, Madison, WI 53792.