The results of two research studies were recently presented at the European Respiratory Society by Teva Pharmaceutical Industries revealing that patients diagnosed with asthma over the age of 4o with high eosinophil levels and who weren’t adequately treated with inhaled corticosteroids responded well to reslizumab treatment. In fact, they showed a reduction in asthma exacerbations that was nearly 75 percent over the number of exacerbations incurred by patients who took a placebo.
Reslizumab is a biological therapy containing a monoclonal antibody called anti-interleukin-5 or IL-5. It is currently being tested but is not yet approved to treat asthma patients who were not significantly improved after taking inhaled corticosteroids for their asthma. The results of the studies were prepared and presented for the 2015 European Research Society International Congress recently held in Amsterdam.
According to the author of the abstract, Dr. Guy Brusselle who works at the Ghent University Hospital in Belgium, people diagnosed with asthma after age 40 are often very difficult to manage. The use of reslizumab in these patients along with the usual asthma care might help these patients improve the control of their asthma and can help reduce the number of asthma exacerbations.
People over the age of 40 recently diagnosed with asthma and who have elevated eosinophil counts are a certain subset of asthma patients known for their difficulty in being managed using inhaled corticosteroids. These patients were studied in two identical Phase III trials using reslizumab to manage these challenging patients. Patients who had at least a single asthma exacerbation within the last year and an eosinophil count greater than 400 were included in the study. Those who fell into this category showed reductions in exacerbations of asthma by 75 percent as well as an improvement in FEV1. In the total population of participants, however, the number of asthma exacerbations were lessened by only 54 percent, while those who were diagnosed under the age of 40 had a reduction in asthma exacerbations by just 42 percent.
The studies were part of the BREATH program, which involved four studies comparing asthma treatments with placebo. The total number of participants in the BREATH study were approximately 1,700 patients with asthma who were diagnosed between the ages of 12 and 75 years of age and who had increases in eosinophil counts. All participants were unable to be completely controlled on inhaled corticosteroids.
There were some negative effects of those taking reslizumab, but these effects were the same as in the placebo group. Adverse events included nasopharyngitis, headache, sinusitis, asthma, upper respiratory infections, and influenza. Two participants on reslizumab had anaphylaxis and were removed from the study.
Reslizumab is still considered to be investigational. It is a human-based monoclonal antibody designed to attach to IL-5, an important cytokine that plays a pivotal role in the development of eosinophils, which are found to be elevated in many patients with asthma. High levels of eosinophils mean that the asthma is more severe and there are more exacerbations. Reslizumab works against asthma by binding and blocking the IL-5 receptor, making it difficult for IL-5 to enhance the function of eosinophils in asthmatics.