Asthma, Rhinitis, Other Respiratory DiseasesOmalizumab rapidly decreases nasal allergic response and FcεRI on basophils☆
Section snippets
Subjects
Subjects were between 19 and 50 years of age and had a history of ragweed SAR requiring pharmacotherapy for at least 2 years. All subjects had a positive skin prick test reaction to mixed giant/short/Western ragweed at the screening visit defined by a ragweed-induced wheal at least 5 mm larger in diameter than diluent control and a positive intranasal challenge to ragweed as defined below. Women of childbearing potential had a negative urine pregnancy test result and used effective means of
Demographics
A total of 24 subjects, 16 active and 8 placebo-treated, were enrolled in this single-center study at Creighton University. The mean age for the treated active group was 30.5 years versus 29.4 years for the placebo group. There were 5 men and 11 women in the omalizumab group and 3 men and 5 women in the placebo group. The mean PD30 ragweed dose for the active group was 1.85 AU versus 0.98 AU for the placebo group. The starting IgE level and basophil FcεRI receptor levels were 281 ng/mL and
Discussion
The primary purpose of this study was to determine the onset of action of omalizumab by using a challenge model to better describe how this drug might be used clinically. The second objective of the study was to determine if this clinical end point correlated with immunologic parameters that could explain this onset of action.
We found that omalizumab rapidly inhibited ragweed-induced nasal responses and that this inhibition was seen as early as 7 to 14 days and was even more pronounced by the
Acknowledgments
We thank Mr Bryan Sandlund from Genentech for analysis of the serum-free IgE levels. Hollister-Stier LLC (Spokane, Wash) contributed the mixed giant/short/Western ragweed extracts.
References (16)
- et al.
Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma
J Allergy Clin Immunol
(2001) - et al.
Use of an anti-IgE humanized monoclonal antibody in ragweed-induced allergic rhinitis
J Allergy Clin Immunol
(1997) - et al.
Recombinant humanized mAb-E25, an anti-IgE mAb, in birch pollen-induced seasonal allergic rhinitis
J Allergy Clin Immunol
(2000) Experiences with monoclonal antibodies in allergic mediated disease: seasonal allergic rhinitis
J Allergy Clin Immunol
(2001)- et al.
Frequency and characterization of antigen-specific IL-4- and IL-13-producing basophils and T cells in peripheral blood of healthy and asthmatic subjects
J Allergy Clin Immunol
(1999) - et al.
Characterization of mast-cell tryptase-expressing peripheral blood cells as basophils
J Allergy Clin Immunol
(2002) - et al.
The relationship between serum IgE and surface levels of Fc epsilon R on human leukocytes in various diseases: correlation of expression with Fc epsilon RI on basophils but not on monocytes or eosinophils
J Allergy Clin Immunol
(2000)
Cited by (256)
Biomarkers for predicting type 2-high and uncontrolled asthma in real-world practice
2023, Annals of Allergy, Asthma and ImmunologyWhich patients with asthma are most likely to benefit from allergen immunotherapy?
2022, Journal of Allergy and Clinical ImmunologyFc receptors gone wrong: A comprehensive review of their roles in autoimmune and inflammatory diseases
2022, Autoimmunity ReviewsNovel Immunomodulatory Therapies for Respiratory Pathologies
2022, Comprehensive PharmacologySerum-free immunoglobulin E: A useful biomarker of atopy and type 2 asthma in adults with asthma
2021, Annals of Allergy, Asthma and ImmunologyResponse of peripheral blood basophils in subjects with chronic spontaneous urticaria during treatment with omalizumab
2021, Journal of Allergy and Clinical Immunology
- ☆
Supported by a grant from Genentech, Inc, South San Francisco, California. Basophil flow cytometric analysis was supported by the NIAID Division of Intramural Research, Bethesda, Md.