In:
International Archives of Allergy and Immunology, S. Karger AG, Vol. 160, No. 1 ( 2013), p. 102-110
Abstract:
〈 b 〉 〈 i 〉 Background: 〈 /i 〉 〈 /b 〉 Omalizumab has been shown to suppress responses to inhaled allergens in allergic asthma patients with pretreatment immunoglobulin E (IgE) ≤700 IU/ml. To extend current dosing tables, we evaluated the potential of high omalizumab doses to block allergen-induced bronchoconstriction in patients with higher IgE levels. 〈 b 〉 〈 i 〉 Methods: 〈 /i 〉 〈 /b 〉 Asthmatic adults (18–65 years; body weight 40–150 kg) were divided into groups according to screening IgE (group 1: 30–300 IU/ml; group 2: 700–2,000 IU/ml) and randomized 2:1 to omalizumab/placebo every 2 or 4 weeks for 12–14 weeks. Allergen bronchoprovocation (ABP) testing was performed before treatment and at weeks 8 and 16. The primary efficacy endpoint, the early-phase allergic response (EAR), was defined as the maximum percentage drop in forced expiratory volume in 1 s during the first 30 min after ABP. Serum free IgE was determined as a pharmacodynamic endpoint, and the exhaled fractional concentration of nitric oxide (FE 〈 sub 〉 NO 〈 /sub 〉 ) was an exploratory endpoint. 〈 b 〉 〈 i 〉 Results: 〈 /i 〉 〈 /b 〉 Fifty patients were included in the study. Omalizumab improved EAR; at week 8, EAR was 23.1% for placebo, 9.3% in group 1 (p = 0.018 versus placebo) and 5.6% in group 2 (p 〈 0.001). At week 16, EAR was 20%, 11.8% (p = 0.087) and 5.1% (p 〈 0.001), respectively. Free IgE decreased in groups 1 and 2 and remained 〈 50 ng/ml in all patients during weeks 6–16. Omalizumab completely suppressed FE 〈 sub 〉 NO 〈 /sub 〉 increases after ABP in both groups. 〈 b 〉 〈 i 〉 Conclusions: 〈 /i 〉 〈 /b 〉 Omalizumab blocked early asthmatic responses over a broad range of IgE/body weight combinations. Extending the dosing tables enables omalizumab to benefit a wider range of patients.
Type of Medium:
Online Resource
ISSN:
1018-2438
,
1423-0097
Language:
English
Publisher:
S. Karger AG
Publication Date:
2013
detail.hit.zdb_id:
1482722-0
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