Search results for "Eosinophilic asthma"

Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma

2018

Background Mepolizumab has demonstrated favorable safety and efficacy profiles in placebo-controlled trials of 12 months' duration or less; however, long-term data are lacking. Objective We sought to evaluate the long-term safety and efficacy of mepolizumab in patients with severe eosinophilic asthma (SEA). Methods COLUMBA (Open-label Long Term Extension Safety Study of Mepolizumab in Asthmatic Subjects, NCT01691859 ) was an open-label extension study in patients with SEA previously enrolled in DREAM (Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma, NCT01000506 ). Patients received 100 mg of subcutaneous mepolizumab every 4 weeks plus standard of care until a protocol-def…

Change in measured Patient-Reported Outcomes in severe eosinophilic asthma patients treated with benralizumab under real life conditions in Germany (…

2020

Predicting Responders to Reslizumab after 16 Weeks of Treatment Using an Algorithm Derived from Clinical Studies of Patients with Severe Eosinophilic…

2018

Reslizumab is a humanized anti-IL-5 monoclonal antibody used as add-on maintenance treatment for patients with uncontrolled eosinophilic asthma.To predict response and nonresponse to intravenous reslizumab at 52 weeks with an algorithm we developed based on clinical indicators from pivotal clinical trials.Patients aged 18 years and older who met Global Initiative for Asthma 4 or 5 criteria and received intravenous reslizumab (n = 321) in two trials ( www.clinicaltrials.gov identifiers, NCT01287039 and NCT01285323) were selected as the data source. A mathematical model was constructed that was based on change from baseline to 16 weeks in Asthma Control Questionnaire and Asthma Quality of Lif…

Therapeutic effects of benralizumab assessed in patients with severe eosinophilic asthma: Real-life evaluation correlated with allergic and non-aller…

2021

Corrado Pelaia,1 Claudia Crimi,2 Alida Benfante,3 Maria Filomena Caiaffa,4 Cecilia Calabrese,5 Giovanna Elisiana Carpagnano,6 Domenico Ciotta Jnr,7 Maria D’Amato,8 Luigi Macchia,9 Santi Nolasco,2 Girolamo Pelaia,1 Simona Pellegrino,7 Nicola Scichilone,3 Giulia Scioscia,10 Giuseppe Spadaro,11 Giuseppe Valenti,12 Alessandro Vatrella,7 Nunzio Crimi2 1Department of Health Sciences, University “Magna Graecia” of Catanzaro, Catanzaro, Italy; 2Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy; 3Department of Biomedicine and Internal and Specialistic Medicine, University of Palermo, Palermo, Italy; 4Allergology and Clinical Immunol…

Severe eosinophilic asthma: a roadmap to consensus

2017

Asthma is widely accepted as a complex heterogeneous condition with diverse pathophysiological mechanisms, clinical presentations, comorbidities, physiological characteristics, pathology and outcomes that is typically best managed by a multidisciplinary team [1–4]. Severe asthma is recognised as a major unmet need with a high personal and social impact, as well as a high burden on healthcare resources [4]. As a consequence of advances in the development of precision medicines for patients with severe asthma, the need to identify asthma subtypes by phenotype based on clinical, functional or inflammatory parameters is becoming a mandatory part of management [4–6]. Severe eosinophilic asthma (…

Stratification of eosinophilic asthma patients treated with reslizumab and GINA Step 4 or 5 therapy

2017

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 …

Response to mepolizumab treatment is sustained across 4-weekly dosing periods

2020

Background Mepolizumab (100 mg delivered s.c. every 4 weeks) is indicated for add-on maintenance treatment for patients with severe eosinophilic asthma. Mepolizumab has been shown to reduce exacerbations and the requirement for daily oral corticosteroids, and improve asthma control and symptoms. However, data on the durability of the response to mepolizumab during dosing periods are limited. The aim of this study was to investigate the efficacy profile in patients with severe eosinophilic asthma over the 4-weekly dosing period for various fixed mepolizumab doses. Methods This was a post hoc analysis of data from the phase IIb/III DREAM study. Patients ≥12 years of age with severe eosinophil…

Real-World Multicenter Experience with Mepolizumab and Benralizumab in the Treatment of Uncontrolled Severe Eosinophilic Asthma Over 12 Months

2021

Moritz Z Kayser,1 Nora Drick,1 Katrin Milger,2,3 Jan Fuge,1,4 Nikolaus Kneidinger,2,3 Stephanie Korn,5 Roland Buhl,6 Jürgen Behr,2,3 Tobias Welte,1,4 Hendrik Suhling1 1Department of Respiratory Medicine, Hannover Medical School, Hannover, Germany; 2Department of Medicine V, University Hospital, LMU, Munich, Germany; 3Comprehensive Pneumology Center-Munich (CPC‐M), Member of the German Center for Lung Research (DZL), Munich, Germany; 4Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH), Member of the German Center for Lung Research (DZL), Hannover, Germany; 5Clinical Research Centre for Respiratory Medicine, Mainz, Germany; 6Pulmonary Department, Mainz Universit…

Clinically meaningful FEV1 response with reslizumab achieved early and sustained over 52 weeks

2017

Background: Reslizumab (RES) is a humanized anti-interleukin-5 monoclonal antibody that significantly reduces the risk of asthma exacerbations and improves asthma control, lung function, and quality of life in patients with uncontrolled eosinophilic asthma. The mean difference in FEV 1 in RES treated patients vs placebo (PBO) at 16 and 52 weeks has been shown to be statistically and clinically significant (Castro et al., Lancet Respir Med. 2015; 3:355–366), but individual responders have not been assessed. Aims/Objectives: To assess the proportion of RES-treated patients who achieved a ≥0.1L increase in FEV 1 from baseline and the duration of treatment before response occurs. Methods: This …

Reslizumab for uncontrolled eosinophilic asthma in patients who experienced a single exacerbation in the previous year: sub-analysis of two phase 3 t…

2017

Background: Reslizumab (RES), a humanized anti-interleukin-5 monoclonal antibody, has been demonstrated to significantly reduce the risk of clinical asthma exacerbation (CAE), and improve lung function, asthma symptoms and quality of life (QOL) in patients (pts) with inadequately controlled eosinophilic asthma (ICEA) and ≥1 CAE in the prior 12 mos despite standard of care therapy (Castro et al., Lancet Respir Med 2015; 3:355-366). Aims/Objectives: To assess the efficacy of RES in a subgroup of pts with ICEA who experienced only 1 CAE in the 12 mos prior to trial enrolment. Methods: This was a post-hoc analysis of the two duplicate 52-wk, placebo (PBO)-controlled phase 3 trials of RES (3 mg/…