Effectiveness of Benralizumab in Improving the Quality of Life of Severe Eosinophilic Asthmatic Patients: Our Real-Life Experience (original) (raw)
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Canadian Journal of Respiratory, Critical Care, and Sleep Medicine, 2018
BACKGROUND: Benralizumab is a monoclonal antibody to the alpha subunit of the IL-5 receptor used in the management of severe, eosinophilic asthma. Although Benralizumab has been shown to significantly reduce asthma exacerbation rates in several Randomized Controlled Trials (RCTs), its impact on subjective asthma control, asthma-related quality of life and lung function is less clear. The purpose of this meta-analysis is to analyze the combined effect of Benralizumab on Asthma Control Questionnaire (ACQ) scores, Asthma Quality of Life Questionnaire (AQLQ) scores and pre-bronchodilator (pre-BD) FEV1 values in severe asthmatics with eosinophilia. METHODS: A comprehensive search of selected databases was performed to include randomized, phase 3 placebo-controlled clinical trials that compared the impact of Benralizumab on ACQ6 scores, AQLQ scores and pre-BD FEV1 values in severe asthmatics with eosinophilia. Random effect models were produced to compare the combined effect of Benralizumab treatment in comparison to placebo. RESULTS: Overall, Benralizumab treatment in asthmatic patients with eosinophilia resulted in significantly improved ACQ6 scores, AQLQ scores and pre-BD FEV1 values in comparison to placebo
Respiratory Research
Background The ORBE II study aimed to describe the characteristics and clinical outcomes of adult patients with severe eosinophilic asthma (SEA) treated with benralizumab in a real-world setting in Spain. Methods ORBE II (NCT04648839) was an observational, retrospective cohort study in adult SEA patients who had been prescribed benralizumab. Demographic and clinical data of 204 SEA patients were collected 12 months prior to benralizumab initiation (baseline) and at follow-up. Exacerbation rate, asthma symptoms, maintenance oral corticosteroid (OCS) use and lung function were evaluated, among other variables. Results A total of 204 SEA patients were evaluated. Mean (standard deviation, SD) age of the study population was 56.4 (12.4) years, 62.3% were women and mean (SD) duration of asthma was 15.1 (12.7) years. Median (Q1–Q3) follow-up duration was 19.5 (14.2–24.2) months. At baseline, 72.6% of the overall population (OP) presented blood eosinophil counts ≥ 300 cells/µL; 36.8% had co...
Journal of Asthma and Allergy
In the SOLANA trial, we sought to physiologically characterize benralizumab's onset of effect and maintenance of that effect for patients with severe eosinophilic asthma. Methods: SOLANA (NCT02869438) was a multicenter, randomized, double-blind, parallelgroup, placebo-controlled, Phase IIIb study conducted at 49 centers in six countries (Chile, Germany, Hungary, the Philippines, South Korea, and the United States). Eligible patients with baseline blood eosinophil counts ≥300 cells/µL were randomized to subcutaneous benralizumab (30 mg) or placebo administered at Days 0, 28, and 56. The primary endpoint was the average change from baseline in prebronchodilator forced expiratory volume in 1 s (pre-BD FEV 1) during the Day 28-Day 84 period for benralizumab vs placebo. Secondary endpoints included patientreported outcomes (PROs). A subset of patients participated in a whole-body plethysmography substudy. Safety was also assessed. Results: In total, 233 patients were randomized to benralizumab (n=118) or placebo (n=115). Improvement from baseline in pre-BD FEV 1 with benralizumab 30 mg was not statistically significant compared with placebo (least-squares mean change difference [95% confidence interval] 57 mL [−22 to 135]; p=0.16). Compared with placebo, benralizumab demonstrated early (Day 7) nonstatistically significant improvements in whole-body plethysmography assessments of hyperinflation and clinically meaningful improvements in PRO measures (Asthma Control Questionnaire 6 at Day 14 and St. George's Respiratory Questionnaire at Day 28), which were maintained over the treatment period. Benralizumab's safety profile was commensurate with previously reported studies. Conclusion: The observed early changes in lung volume despite relatively small improvements in airflow obstruction suggest that the anti-inflammatory effect of benralizumab may be manifested as deflation over time for patients with hyperinflation, who potentially have a greater degree of airway remodeling. This early effect could partially explain the rapid PRO improvements observed for certain patients.
Journal of Asthma and Allergy
Background: Benralizumab can be utilized as add-on biological treatment of severe eosinophilic asthma. However, so far only a few real-life studies have been published with regard to the use of this anti-IL-5 receptor humanized monoclonal antibody. Objective: The primary aim of this multicenter observational investigation has been to assess the therapeutic effects of benralizumab in patients with severe uncontrolled, corticosteroid refractory eosinophilic asthma. The secondary objective was to evaluate the efficacy of benralizumab with regard to positive or negative skin prick test (SPT). Methods: Clinical, functional, and laboratory parameters were evaluated in order to verify the therapeutic actions of benralizumab in atopic and non atopic subjects with difficult-totreat eosinophilic asthma. Moreover, a comparative evaluation was carried out in relation to the presence or absence of SPT positivity. Results: After 6 months of add-on biological therapy with benralizumab, our 111 patients experienced a marked improvement of their severe eosinophilic asthma, expressed by significant changes in asthma exacerbation rate, prednisone intake, daily use of shortacting β 2-adrenergic agonists (SABA), asthma control test (ACT) score, asthma quality of life questionnaire (AQLQ) score (56 patients), forced expiratory volume in one second (FEV 1), forced vital capacity (FVC), blood eosinophil count, blood basophil count (59 patients), and fractional exhaled nitric oxide (FeNO) levels (39 patients). In addition, significantly more effective outcomes were detected in patients with positive SPT, when compared to subjects with negative SPT, only in regard to asthma exacerbation number, ACT score, and daily SABA utilization. No significant correlation was found between serum IgE concentrations and each of all measured parameters. Conclusion and Clinical Relevance: Taken together, the results of this real-world study indicate that in both allergic and non-allergic subjects benralizumab can be used as a valuable pharmacotherapeutic option for add-on biological therapy of severe eosinophilic asthma, regardless of SPT positivity or negativity.
Benralizumab in Patients with Severe Eosinophilic Asthma: A Multicentre Real-Life Experience
Journal of Clinical Medicine
Background: Mepolizumab and benralizumab are monoclonal antibodies directed against anti-IL-5 and anti-IL5R, respectively, and their use reduces the exacerbation rate and maintains oral corticosteroid requirements in severe eosinophilic asthma. Previous studies have tested the therapeutic switch between two biologics with excellent results, further demonstrating the heterogeneity of asthmatic disease and the complexity of the therapeutic choice. It remains unclear if such patients may improve following a switch from mepolizumab to benralizumab. Aims: Within a multicentre real-life setting, we decided to evaluate the potential effectiveness of a therapeutic switch to benralizumab in patients with severe eosinophilic asthma initially treated with mepolizumab, who experienced sub-optimal responses. The secondary aim was to identify the clinical factors associated with a better response to benralizumab. Methods: We retrospectively assessed patients with severe eosinophilic asthma treate...
The clinical profile of benralizumab in the management of severe eosinophilic asthma
Therapeutic advances in respiratory disease, 2016
Despite several therapeutic choices, 10-20% of patients with severe uncontrolled asthma do not respond to maximal best standard treatments, leading to a healthcare expenditure of up to 80% of overall costs for asthma. Today, there are new important therapeutic strategies, both pharmacological and interventional, that can result in improvement of severe asthma management, such as omalizumab, bronchial thermoplasty and other biological drugs, for example, mepolizumab, reslizumab and benralizumab. The availability of these new treatments and the increasing knowledge of the different asthmatic phenotypes and endotypes makes correct patient selection increasingly complex and important. In this article, we discuss the features of benralizumab compared with other anti-interleukin-5 biologics and omalizumab, the identification of appropriate patients, the safety profile and future developments.
Current medical research and opinion, 2017
Benralizumab, an anti-eosinophilic monoclonal antibody, in combination with high-dosage inhaled corticosteroids and long-acting β2-agonists (ICS/LABA), significantly reduced asthma exacerbations, improved lung function, and reduced symptoms for patients with severe, uncontrolled asthma with blood eosinophil counts ≥300 cells/μL in the Phase III SIROCCO and CALIMA studies. To understand the efficacy and safety of benralizumab for patients with eosinophil-driven disease with blood eosinophil counts lower than 300 cells/μL, we evaluated the effect of applying an eosinophil cutoff of ≥150 cells/μL. Adult patients with uncontrolled asthma despite high-dosage ICS/LABA ± additional asthma controller(s) received subcutaneous benralizumab 30 mg every 8 weeks (Q8W; first three doses every 4 weeks) or placebo for 48 (SIROCCO) or 56 (CALIMA) weeks. Efficacy measures including annual exacerbation rate, prebronchodilator FEV1, and total asthma symptom score were analyzed by baseline blood eosinop...
International journal of science and healthcare research, 2022
Asthma is a diverse illness that can range in severity. Because it has a significant impact on patients' quality of life and because people with severe asthma have symptoms, exacerbations, and drug side effects. Although first disregarded, eosinophils have since been directly linked to characteristics of the continuous inflammatory process in asthma, especially in the severe form. We present of the case of a 50year old female patient who presented with complaints of cough, breathing difficult on exertion and history of fever, chest pain and tiredness. The chest x ray showed left lower zone haziness. Patient was successfully treated with IV antibiotics, IV Proton pump inhibitor, Nebulised bronchodilators, IV Steroids, Anti-Hypertensive therapy and all other supportive medications along with pulmonary rehabilitations. In view of uncontrolled Eosinophilic asthma patient was treated with monoclonal antibody. Patient improved symptomatically better. This case study describes how benralizumab treatment for a patient with uncontrolled severe eosinophilic asthma resulted in significant improvements in lung function, asthma control, steroid use, and quality of life.
Real-World Experience with Benralizumab in Patients with Severe Eosinophilic Asthma: A Case Series
Journal of Asthma and Allergy, 2021
Severe eosinophilic asthma (SEA) is characterized by high eosinophilia, severe symptoms, important comorbidities, frequent exacerbations, and poor asthma control. Benralizumab, targeting the interleukin-5 receptor alpha, proved effective in inducing rapid eosinophil depletion and amelioration of symptoms and lung function; it also allowed to reduce exacerbations and the use of oral corticosteroids (OCS). The present case series, spanning different subtypes of SEA, aimed at expanding the real-world experience with benralizumab in Italy. Patients and Methods: We collected data from SEA patients treated with benralizumab, at baseline and during treatment. We focused on the effects of benralizumab in the following conditions and endpoints: i) overlap between high-IgE and high-eosinophilic asthma; ii) presence of nasal polyposis as comorbidity; iii) corticosteroid-sparing effect; iv) patient perception. Results: Ten SEA patients (females: N=7; age range: 19-70 years) referred to 8 Italian Centers and treated with benralizumab were included, presenting with several comorbidities such as non-allergic disease (8/10), atopy (3/10), high IgE (5/10) and nasal polyposis (6/10). Overall, benralizumab yielded optimal disease control in all patients, particularly in terms of rapid clinical and functional improvement, decreased systemic steroid need (OCS therapy was completely discontinued in 7 cases) and amelioration of patient quality of life, except for 1 case, in whom other conditions not related to benralizumab therapy interfered with the patient perception. Conclusion: Our findings further support the efficacy and safety of benralizumab observed in randomized clinical trials, providing even better results for lung function improvement.
Journal of Interdisciplinary Medicine, 2021
Background: Monoclonal antibody therapy is currently an additional treatment option to reduce exacerbations and improve symptom control in patients with severe eosinophilic asthma (SEA) that is uncontrolled despite treatment with high-dose inhaled corticosteroids and long-acting beta-2 agonists. Benralizumab, a monoclonal antibody that binds to the interleukin-5 receptor (IL-5), significantly reduces symptoms and annual exacerbations, as well as the use of systemic corticosteroids in patients with SEA. However, few studies are available on the effectiveness of this biological treatment in real life. The aim of this case series was to evaluate the efficacy of benralizumab by analyzing changes in clinical parameters and blood eosinophils in patients with SEA. Methods: We analyzed four patients with SEA who started treatment with benralizumab. The history of symptoms and exacerbations, eosinophil counts, data regarding the oral corticosteroid dose, need for rescue treatment, spirometry...