Purpose: Omalizumab is a recombinant humanized monoclonal antibody that inhibits the binding of immunoglobulin E (IgE) to the high-affinity IgE receptor (FceRI) on the surface of mast cells and basophils. Omalizumab has been approved for use in asthma, and new reports show promise in a variety of dermatologic diseases. Herein, we review the literature on omalizumab in dermatology and discuss the safety, efficacy and mechanisms of action for this emerging therapy.
Materials And Methods: PubMED, MEDLINE and Embase databases were searched for the period 1 January 1990 to 1 September 2016. Articles sourced were graded according to the Oxford Center for Evidence-Based Medicine Levels of Evidence Grades of Recommendation criteria.
Results: A total of 99 articles met our inclusion criteria. They included reports on the use of omalizumab in chronic spontaneous urticaria, atopic dermatitis, mastocytosis, hyper-IgE syndrome, bullous pemphigoid, Netherton syndrome, urticarial vasculitis, Churg-Strauss syndrome and toxic epidermal necrolysis.
Conclusions: Omalizumab is effective in a variety of recalcitrant immune-mediated and autoimmune skin disorders. It is a safe and effective treatment for use in chronic idiopathic urticaria (Grade of recommendation: A). Randomized clinical trials with long-term follow-ups are warranted to firmly establish the role of omalizumab in the treatment of dermatologic disease.
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http://dx.doi.org/10.1080/09546634.2016.1249819 | DOI Listing |
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.
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.
Ann Allergy Asthma Immunol
January 2025
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.
Objective: This post hoc sub-analysis assessed real-world mepolizumab effectiveness in patients with overlapping allergic and eosinophilic phenotypes, using 1-year data from the international, prospective REALITI-A study.
Methods: The clinically significant asthma exacerbation (CSE) rate was assessed 1 year prior to (pre-treatment) and following (follow-up) mepolizumab treatment, stratified by baseline total IgE levels (tIgE; <60, 60-<190, 190-<550, and ≥550 kU/L), atopic status (yes/no/unknown), prior omalizumab use (yes/no), geographic baseline omalizumab eligibility (eligible/non-eligible), and baseline tIgE level and blood eosinophil count (BEC) threshold combinations (<81 or ≥81 kU/L and <300 or ≥300 cells/µL).
J Allergy Clin Immunol Pract
January 2025
Clinic of Internal Medicine II - Department of Pneumology, Medical University of Vienna - Vienna (Austria). Electronic address:
Background: Clinical studies of biologics in severe asthma exclude smokers or ex-smokers (ExS) with over 10 pack-years (py). Thus, the effectiveness of this therapy in ex-smokers with severe asthma is not well understood.
Objectives: To assess the impact of smoking on clinical efficiency of biologics in patients with severe asthma from the German Asthma Net (GAN), a comprehensive international registry.
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