Omalizumab (Xolair) is a humanized monoclonal antibody designed to bind specifically to immunoglobulin (Ig)E. It is indicated in the United States for the treatment of adolescent and adult patients (>or=12 yr) with moderate-to-severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen, and whose symptoms are inadequately controlled with inhaled corticosteroids. Omalizumab was evaluated in an extensive clinical development program that included 12 controlled phase IIB/III clinical trials with more than 5,243 patients who were appropriate for inclusion in the safety analysis (all ages in all controlled studies). In these studies, omalizumab had an adverse event profile comparable to that of the control group (i.e., placebo or standard therapy). Data presented in this article supports omalizumab as a safe and well-tolerated agent for the treatment of IgE-mediated asthma.
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Introduction: Despite the increasing evidence supporting the use of biologics for treating severe asthma, there is a lack of evidence regarding their use in pregnant women. This study aims to evaluate the safety of biologics for pregnant women, utilizing global pharmacovigilance database.
Methods: Reports documented between 1980 and 2023 were extracted from the VigiBase that mentioned pregnancy- or fetus-related reactions with drugs indicated for asthma, including reslizumab, omalizumab, mepolizumab, dupilumab, benralizumab, and other non-biologics.
Gut microbial alteration in chronic spontaneous urticaria unresponsive to second generation antihistamines and its correlation with disease characteristics- a cross-sectional case-control study.
Clin Transl Allergy
January 2025
Department of Dermatology, Hospital del Mar Research Institute, Barcelona, Spain.
Background: Gut microbial involvement has been speculated in chronic spontaneous urticaria (CSU). The aim of the study was to compare the gut microbiome composition and diversity in CSU patients uncontrolled with second-generation antihistamines (sgAHs) and healthy individuals, as well as to explore any association between gut microbiome and disease characteristics.
Methods: A cross-sectional case-control study including 20 CSU patients unresponsive to standard doses of sgAHs, and 15 age-and-sex matched healthy controls was conducted.
Mepolizumab real-world effectiveness in severe asthma with an eosinophilic phenotype and overlapping severe allergic asthma.
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Global Medical Affairs, Specialty Care, GSK, London, UK. Electronic address:
Background: Some patients with severe asthma have overlapping allergic and eosinophilic phenotypes and may be eligible for anti-eosinophilic or anti-IgE biologics.
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Clinic of Internal Medicine II - Department of Pneumology, Medical University of Vienna - Vienna (Austria). Electronic address:
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