‘Real-life’ effectiveness studies of omalizumab in adult patients with severe allergic asthma: systematic review

Abstract

We reviewed 24 'real-life' effectiveness studies of omalizumab in the treatment of severe allergic asthma that included 4117 unique patients from 32 countries with significant heterogeneity in patients, clinicians and settings. The evidence underscores the short-and long-term benefit of anti-IgE therapy in terms of the following: improving lung function; achieving asthma control and reducing symptomatology, severe exacerbations and associated work/school days lost; reducing healthcare resource utilizations, in particular hospitalizations, hospital lengths of stay and accident specialist or emergency department visits; reducing or discontinuing other asthma medications; and improving quality of life -thus confirming, complementing and extending evidence from randomized trials. Thus, omalizumab therapy is associated with signal improvements across the full objective and subjective burden of illness chain of severe allergic asthma. Benefits of omalizumab may extend up to 2-4 years, and the majority of omalizumab-treated patients may benefit for many years. Omalizumab has positive short-and longterm safety profiles similar to what is known from randomized clinical trials. Initiated patients should be monitored for treatment response at 16 weeks. Those showing positive response at that time are highly likely to show sustained treatment response and benefit in terms of clinical, quality of life and health resource utilization outcomes.Over the past four decades, the prevalence, morbidity and mortality of asthma have increased significantly (1-4). In particular, severe asthma, which affects about 10% of all patients with asthma, presents with significant morbidity, high healthcare resource utilization and impaired quality of life (5). As there is no cure for asthma, the objective of treatment is to control the clinical aspects of the disease (6). Despite guidelines for the evaluation, classification and management of asthma, most patients and certainly those with severe asthma are controlled suboptimally (7-10).Immunoglobulin E (IgE) is an antibody class associated with hypersensitivity and allergic reactions (11). IgE elicits an immune response by binding mainly to the high-affinity receptor (FceRI) found on the surface of mast cells and basophils. In the mast cell, activation of these receptors through cross-linking with IgE causes the cell to release inflammatory mediators (11).Omalizumab (Xolair Ò , Novartis basel, Switzerland) is a recombinant humanized monoclonal anti-IgE antibody that inhibits the binding of IgE to high-affinity receptors. It is indicated as add-on treatment to inhaled corticosteroids (ICS) and long-acting b2-agonists (LABA). Initial treatment response is evaluated at 16 weeks, and treatment is continued in patients showing a response at that time. Phase III trials with study periods up to 12 months have shown omalizumab to reduce the frequency of asthma exacerbations and concomitant medication burden and improve symptom severity and quality of life, while also being safe (12-15). Effica...

Effects of omalizumab in severe asthmatics across ages: A real life Italian experience

“…In fact, Omalizumab (Xolair®) is a recombinant DNA-derived humanized monoclonal antibody indicated as an add-on therapy in patients aged ≥ 6 years with severe persistent allergic asthma uncontrolled at treatment step 4 or 5 according to guidelines GINA (2). Omalizumab demonstrated to be efficacious both in adults and children (3)(4)(5). In particular, in real-life studies, anti-IgE therapy showed short-and long-term benefits in terms of improving lung function and quality of life, achieving asthma control and reducing symptomatology, severe exacerbations, healthcare resource utilizations, hospitalizations, emergency department visits and reducing or discontinuing other asthma medications thus confirming, complementing, and extending evidence from randomized trials (3,5).…”

Nordic consensus statement on the systematic assessment and management of possible severe asthma in adults

“…In patients with severe allergic asthma, the add-on treatment with omalizumab has been shown to reduce the risk of exacerbations [113–117], the asthma symptoms [113,114,116,118], and the use of OCS [118] and ICS [115], as well as to improve the quality of life and lung function [113,114,116], without significant safety concerns. These beneficial effects of omalizumab first shown in randomized clinical trials have been confirmed in longer term real-life studies [119–121], and appear to be independent on patients’ comorbidities [118]. …”

“…However, a multidimensional approach, where treatable traits are identified and targeted is being suggested [139]. This includes addition of LAMA in patients with fixed airflow obstruction, PDE4 inhibitors in patients with significant sputum production and exacerbations, smoking cessation programs, and pulmonary rehabilitation in patients with exertional dyspnea [119]. …”

Omalizumab Rike in Therapy of Grave Therapeutically Resistent Allergic Asthma With Involvement of Small Respiratory Ways and Fixed Bronchial Obstruction. A Literature Review and Clinical Observation

“…Данные о клинической эффективности и безопасно-сти ОМ обобщены в ряде обзоров, в которых подробно анализируются результаты как рандомизированных кон-тролируемых исследований (РКИ), так и проведенных в условиях реальной практики [3,4,10,11]. В нескольких РКИ на крупных выборках больных (взрослых и детей) с тяжелой АБА, у которых терапия высокими дозами инга-ляционных кортикостероидов (ИКС) в сочетании с дли-тельно действующими бета-агонистами (ДДБА) оказалась неэффективной, было убедительно показано, что допол-нительное лечение ОМ улучшает контроль симптомов астмы, качество жизни пациентов, сокращает количество обострений, в том числе тяжелых.…”