New safety and efficacy data for Nucala (mepolizumab) shows that the risk/benefit profile generated through the pivotal studies for Nucala was maintained over an extended 52-week period, according to GlaxoSmithKline (GSK). Exacerbation risk reduction, asthma control improvement and oral corticosteroid dose reduction seen in earlier trials was also demonstrated in the study, which was presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting this week.
In a sub-set of severe asthma patients, the over-production of eosinophils (a type of white blood cell) is known to cause inflammation in the lungs that can affect the airways, limiting breathing and increasing the frequency of asthma attacks. Interleukin-5 (IL-5) is the main promoter of eosinophil growth, activation and survival and provides an essential signal for the movement of eosinophils from the bone marrow into the lung.
Nucala is a monoclonal antibody that binds to IL-5, preventing it from binding to its receptor on the surface of eosinophils. Inhibiting IL-5 binding in this way reduces blood, tissue and sputum eosinophil levels. Nucala is licensed in the US as an add-on maintenance treatment for patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.
As part of the COSMOS study, a total of 414 received mepolizumab in either the 32-week phase III MENSA exacerbation study or the 24-week SIRIUS steroid-reduction study, providing up to 84 weeks of on-treatment safety and efficacy data. The study also included 237 patients who had received placebo in the previous phase III trials. For patients switching from placebo to mepolizumab, findings from COSMOS showed similar improvements in asthma control to those in the mepolizumab arms of the previous studies.
All participants in COSMOS received a 100mg dose of mepolizumab subcutaneously every four weeks in addition to their standard of care respiratory medications. Findings from COSMOS showed that the safety profile of mepolizumab was similar to that reported in the previous Phase III randomized studies. The most frequently reported adverse events during the treatment period were nasal congestion (30%), upper respiratory tract infection (16%), asthma (worsening/exacerbation) (14%), and headache (14%).
“Severe asthma with an eosinophilic phenotype is a chronic condition that affects a small, but significant, number of patients who need to take multiple medications to control their day-to-day symptoms and reduce the risk of frequent and serious asthma attacks. As a first-in-class anti-IL-5 biologic therapy, Nucala was specifically developed for these difficult-to-treat patients. Results from COSMOS support the long-term safety profile and durability of response for Nucala and further our understanding of this novel therapeutic approach,” said Frank Albers, GSK’s Global Medical Affairs Lead for Nucala.
More information is available on the GSK website.