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Phase-3-Study-of-Reslizumab-in-Patients-With-Poorl
Phase-3-Study-of-Reslizumab-in-Patients-With-Poorl
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Pdf Summary
The study, led by Dr. Jonathan Corren and colleagues, evaluates the efficacy and safety of reslizumab, a monoclonal antibody targeting IL-5, in patients with poorly-controlled asthma across various eosinophil levels. The primary focus was on changes in forced expiratory volume (FEV1) after 16 weeks of treatment compared to placebo. <br /><br />Participants were randomly assigned to receive either intravenous reslizumab or a placebo every four weeks. The study included 492 patients who received at least one dose of the study drug: 97 received placebo and 395 received reslizumab. <br /><br />Overall, reslizumab did not significantly improve FEV1 compared to placebo in the general population, nor was there a significant relationship between the baseline eosinophil count and FEV1 change. However, patients with eosinophil levels below 400 cells/mL showed significant improvements in FEV1, Asthma Control Questionnaire-7 (ACQ-7) scores, rescue inhaler use, and forced vital capacity (FVC) with reslizumab treatment.<br /><br />While the treatment was well-tolerated, with fewer adverse events compared to placebo (55% vs 73%), the study concluded that significant benefits were primarily observed in patients with higher baseline eosinophil levels. The findings suggest that patients with eosinophils below 400 cells/mL may not see meaningful lung function or symptom improvement, supporting the idea that reslizumab may be more effective in individuals with elevated eosinophil counts.<br /><br />Overall, the study emphasizes the potential of reslizumab to improve asthma outcomes in a subset of patients characterized by high eosinophil levels and underscores the importance of identifying appropriate patient subgroups for targeted therapies in asthma management.
Keywords
reslizumab
asthma
eosinophil levels
FEV1
monoclonal antibody
asthma management
ACQ-7 scores
targeted therapy
intravenous treatment
adverse events
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