Change in Patient-Reported Outcomes in Severe Eosinophilic Asthma Patients Treated With Benralizumab Under Real-life Conditions

Author(s):  
2017 ◽  
Vol 3 (3) ◽  
pp. 00004-2017 ◽  
Author(s):  
Guy Brusselle ◽  
Janice Canvin ◽  
Sivan Weiss ◽  
Shawn X. Sun ◽  
Roland Buhl

Reslizumab, an anti-interleukin-5 monoclonal antibody, significantly reduces exacerbation frequency and improves lung function, asthma control and quality of life in adults with severe eosinophilic asthma, as demonstrated in Phase III studies.This secondary analysis assessed reslizumab's efficacy in patients receiving baseline treatment per Global Initiative for Asthma (GINA) Step 4 and Step 5 guidelines.Pooled data from duplicate, Phase III, reslizumab versus placebo studies in patients with severe eosinophilic asthma (blood eosinophils ≥400 cells·µL−1) were stratified by baseline therapy. Efficacy assessments were exacerbation rates and changes from baseline forced expiratory volume in 1 s (FEV1) and patient-reported outcomes.Of 953 patients, 69% (n=657) and 11% (n=106) were receiving Step 4 and Step 5 therapy, respectively. Compared with placebo, reslizumab reduced exacerbation rates by 53% (95% CI 0.36–0.62) and 72% (95% CI 0.15–0.52), in Step 4 and Step 5 groups respectively. By study end, reslizumab increased FEV1 in Step 4 and Step 5 groups by 103 mL (95% CI 52–154 mL) and 237 mL (95% CI 68–407 mL), respectively. Reslizumab also improved patient-reported outcomes compared with placebo in both groups.Reslizumab reduces exacerbation rates and improves lung function and patient-reported outcomes in patients with eosinophilic asthma receiving therapy per Steps 4 and 5 of the GINA guidelines.


Author(s):  
Francesco Menzella ◽  
Maria Aliani ◽  
Elena Altieri ◽  
Pietro Bracciale ◽  
Stefano Centanni ◽  
...  

2020 ◽  
Author(s):  
Ana Isabel Enríquez Rodríguez ◽  
Tamara Hermida Valverde ◽  
Pedro Romero Álvarez ◽  
Francisco Julián López González ◽  
Jose Antonio Gullón Blanco ◽  
...  

Abstract Introduction: Severe eosinophilic asthma is an incapacitating disease requiring the patient to take many drugs, amongst which are oral corticoids (OCS), for its control. Mepolizumab is a monoclonal antibody capable of blocking the binding of Interleukin 5 (IL-5) to the eosinophils, and, in this way reducing the exacerbations, symptoms and need for OCS. Our objective was to evaluate the experience with this drug on patients being treated for severe asthma in real-life conditions. Methods: Retrospective, multicentric study carried out in eight hospitals in the Principality of Asturias, in which the demographic, clinical, analytical, lung function and ACT (Asthma Control Questionnaire) data of the patients with severe eosinophilic asthma being treated with Mepolizumab for three years were collected. Results: Sixty-nine patients (72% women) were included, with a mean age of 56±13 years. The eosinophil blood count before treatment was 856 cels/mm3 (SD 754), decreasing after 6 months to 101 cels/mm3 (SD 98). Annual exacerbations decreased from 4.7 (SD 3.7) to 1.3 (SD 2.5) (p=0.001), while the FEV1% increased from 68% (SD 20) to 76% (SD 21) (<0.001). At the onset 25 patients (36%) were using OCS ( 18 mg/day of prednisone) and after treatment this decreased to 13 (19%) ( 9mg/day of prednisone) ( p=0.000), with complete withdrawal in 12 (48%). The response to Mepolizumab was positive in 56 patients (81%), and no adverse effects were observed. Conclusions: Mepolizumab has demonstrated to be efficacious and safe in real life in the treatment of patients with badly controlled eosinophilic asthma.


2021 ◽  
Vol 15 ◽  
pp. 175346662110093
Author(s):  
Aikaterini Detoraki ◽  
Eugenio Tremante ◽  
Maria D’Amato ◽  
Cecilia Calabrese ◽  
Claudia Casella ◽  
...  

Background: Severe eosinophilic asthma is frequently associated to chronic rhinosinusitis and nasal polyposis (CRSwNP) that contribute to poor asthma control. Mepolizumab is an anti-IL-5 monoclonal antibody, approved for the treatment of severe eosinophilic asthma. A limited number of studies have assessed the efficacy of mepolizumab on CRSwNP in severe asthmatics. We aim to evaluate the efficacy of mepolizumab on sino-nasal symptoms, polyp growth and asthma control in severe eosinophilic asthma patients with CRSwNP in real life. Methods: In this study 44 severe eosinophilic asthma patients with CRSwNP were treated with mepolizumab (100 mg q4w) for 1 year. The following outcomes were assessed before (T0), after 6 (T6) and 12 months (T12) of treatment: sino/nasal outcome test (SNOT-22), Total Endoscopic Nasal Polyp Score (TENPS), %FEV1 (FEV1/FEV1 predicted) and Asthma control test (ACT). Blood eosinophil count, exhaled nitric oxide (FENO) and prednisone intake were measured. In a subgroup of patients, nasal cytology was performed before (T0), after 6 (T6) and after 12 months (T12) of treatment with mepolizumab. Results: We reported a significant reduction of SNOT-22 [from 51.5 ± 21.2 at baseline (T0) to 31.70 ± 17.36 at T6 and 29.7 ± 21.5 at T12 (T0–T12 p < 0.001)] and a decrease of TENPS (from 2.88 ± 3.07 to 1.70 ± 2.37 and 1.77 ± 2.56 at T0, T6 and T12, respectively, T0–T12 p = 0.99). A significant improvement of %FEV1, ACT and a decrease in blood eosinophils and mean prednisone intake were also reported. No statistically significant decreasing trend was measured for FENO. Nasal cytology findings suggest a significant reduction of eosinophil percentage following mepolizumab treatment (from 16.8 ± 7.2% to 3.6 ± 6.2% and 0.8 ± 2.4% at T0, T6 and T12 respectively, T0 to T12: p < 0.001). Conclusions: Mepolizumab improves sino-nasal and asthma symptoms and reduces polyp growth in patients with severe eosinophilic asthma and concomitant CRSwNP in real life. The reviews of this paper are available via the supplemental material section.


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