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|February 23, 2015 3:00 p.m.|
|The Lancet Respiratory Medicine and AAAAI Publish Positive Data from Phase III Trials of Teva’s Reslizumab for the Treatment of Moderate to Severe Asthma in Patients with Elevated Blood Eosinophils|
Further Analysis of Pivotal Phase III Studies Show Reduction in Asthma Exacerbation Rates by at least half (50% and 59% respectively) and Significant Improvement in Lung Function in Patients Treated with Reslizumab
“Results from these Phase III studies highlight the importance of
phenotype-targeted therapies and represent a potential change in the
treatment paradigm for patients with moderate-to-severe asthma and
elevated blood eosinophil levels who are uncontrolled on an ICS-based
therapy,” said Professor
Across both trials, a total of 953 patients with asthma and elevated blood eosinophil counts, who were uncontrolled despite receiving medium-to-high doses of ICS with or without an additional controller, and who had at least one asthma exacerbation in the prior year, were randomized to receive intravenously administered reslizumab (3.0 mg/kg) or placebo every four weeks for one year. Approximately 80% of patients in these trials were also taking an inhaled long-acting beta-agonist. The primary efficacy variable was the annual frequency of clinical asthma exacerbations. Lung function, quality of life, asthma control, and safety were also assessed.
Primary efficacy was met in both studies. Results were consistent and demonstrated that reslizumab reduced the annual frequency of clinical exacerbations by at least half (50% and 59% respectively), compared to placebo. Lung function also improved by week four and was maintained through one year in both studies. Furthermore, significant improvements were observed in the Asthma Quality of Life, Asthma Control Questionnaire and Asthma Symptom Utility Index scores. Common adverse events in the reslizumab treatment group were comparable to placebo and included worsening of asthma, nasopharyngitis, upper respiratory infections, sinusitis, influenza and headache. Two anaphylactic reactions were reported and resolved following medical treatment at the study site.
“We are immensely impressed by the continued positive results seen
across the entire Phase III clinical trial program for reslizumab,” said
The data published today in The Lancet Respiratory Medicine and
presented at AAAAI are part of the comprehensive Phase III clinical
trial program for reslizumab and further build upon Phase III trial data
previously presented at the
Reslizumab is an investigational humanized monoclonal antibody (mAb) against interleukin-5 (IL-5). IL-5 has been shown to play a crucial role in the maturation, and survival of eosinophils, inflammatory white blood cells implicated in a number of allergic diseases, such as asthma. Elevated levels of blood eosinophils are a risk factor for future asthma exacerbations. Recent data from the Phase III clinical program demonstrated that reslizumab significantly reduced the annual rate of asthma exacerbations and improved lung function and asthma symptoms in patients with moderate to severe asthma with elevated blood eosinophils whose symptoms were inadequately controlled by medium to high doses of inhaled corticosteroids with or without an additional controller, compared with placebo.
About the Studies
In two duplicate, double-blind, Phase III studies, a total of 953 patients with similar baseline characteristics, and with moderate to severe asthma and elevated blood eosinophil levels were randomized to receive either intravenous reslizumab (3.0 mg/kg) (n=477) or placebo (n=476) every four weeks for one year. The primary endpoint was the annual frequency of clinical asthma exacerbations. Additional assessments included lung function, quality of life, asthma control and safety.
Results from these studies demonstrated that patients receiving reslizumab achieved reductions in clinical asthma exacerbations (study 1 RR 0.50 [95%CI 0.37, 0.67], study 2 RR 0.41 [95%CI 0.28, 0.59], both P<0.0001) versus placebo. Lung function improved by the first assessment at week four, and was maintained for one year in both studies (change in FEV1 over 52 weeks was 0.126 L, P<0.0001 and 0.090 L, P=0.006). Significant improvements from baseline over 52 weeks were observed in Asthma Quality of Life Questionnaire scores (0.302, P=0.0004 and 0.234, P=0.0052), Asthma Control Questionnaire (-0.255, P=0.0002 and -0.242, P=0.0003) and Asthma Symptom Utility Index (+0.061 [P<0.0001]; +0.036 [P=0.0011]). Common adverse events in the reslizumab treatment group were similar to placebo; two anaphylactic reactions in the reslizumab arm were reported that resolved with treatment at the study site. Overall, reslizumab significantly reduced the annual rate of clinical exacerbations and resulted in sustained improvement in secondary measures of asthma control compared with placebo.
Asthma is a chronic (long-term) disease usually characterized by airway inflammation and narrowing of the airways, 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 even death.
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