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|September 27, 2015 5:00 a.m.|
|Teva Presents New Reslizumab Data at European Respiratory Society (ERS) International Congress 2015|
New Analysis Shows Reslizumab Reduced Asthma Exacerbations by 75 percent in Patients with Late Onset Asthma and Elevated Blood Eosinophils
“Asthma diagnosed after the age of 40 falls into a distinct subtype
which is often very challenging to treat,” commented abstract author,
In order to determine the influence that age of asthma onset has as it relates to the efficacy of reslizumab, results were pooled from two Phase III clinical trials that investigated reslizumab IV 3 mg/kg in patients who were inadequately controlled on an ICS-based regimen, who had at least one asthma exacerbation within the previous 12 months, and a blood eosinophil count of ≥400/µL. These post-hoc analysis results indicate that, in the subgroup with late onset asthma, reslizumab showed a 75 percent reduction in asthma exacerbations and improvement in lung function as measured by forced expiratory volume in one second (FEV1). In the overall pooled patient population, asthma exacerbations were reduced by 54 percent; in the subgroup of subjects diagnosed with asthma at <40 years of age, exacerbations were reduced by 42 percent.
Data for this post-hoc analysis were pooled from two identical Phase III clinical trials (which were part of the BREATH clinical program) that comprised four placebo-controlled studies whose population of 1,700 adult and adolescent asthma patients (aged 12-75 years) had elevated blood eosinophils and symptoms that were inadequately controlled with ICS-based therapies. Common adverse events (occurring in >5 percent of patients overall) in the reslizumab treatment group were comparable to placebo and included asthma, nasopharyngitis, upper respiratory infections, sinusitis, influenza and headache. Two patients treated with reslizumab experienced anaphylactic reactions. In both cases, patients responded to standard treatment administered at the study centre. Patients were then withdrawn from participation in the study.
“Asthma is a complex disease, and some phenotypes, such as late onset
asthma with elevated blood eosinophils, can present particularly
significant treatment challenges that are not adequately addressed by
currently available therapies,” said
Reslizumab is an investigational humanized monoclonal antibody developed to target interleukin-5 (IL-5). IL-5 is a key cytokine shown to play a crucial role in the maturation, activation and survival of eosinophils, which are a type of white blood cell that are present at elevated levels in the lungs and blood of many asthmatics. Evidence shows that eosinophils play an active role in the pathogenesis of the disease. Increased levels of eosinophils in the sputum and blood have been shown to positively correlate with disease severity and increased risk of asthma exacerbations. Reslizumab is thought to act by binding circulating IL-5 and preventing IL-5 from interacting with its receptor.
Asthma is a chronic (long term) disease usually characterized by airway inflammation and narrowing of the airways, the severity and prognosis of which can vary over time. Asthma may cause recurring periods of wheezing (a whistling sound when you breathe), chest tightness, shortness of breath and coughing that often occurs at night or early in the morning. Without appropriate treatment, asthma symptoms may become more severe and result in an asthma attack, which can lead to hospitalization and, in extreme cases, even death.
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