GlaxoSmithKline recently issued a new long-term study at the American Thoracic Society (ATS) meeting, Nucala anti-IL-5 (IL-5) the positive results of the biological treatment of severe eosinophilic asthma. Long-term data display, get asthma control deteriorated continued to decline continued to improve during the study.
Severe eosinophilic asthma is an inflammatory disease that is associated with higher than normal levels of eosinophils (a type of white blood cell) present in the blood. Overproduction of blood cells can cause inflammation of vital organs and tissues, sometimes Causes permanent damage. In the United States, an estimated 25.7 million people suffer from some form of asthma, 15% of whom have severe asthma and are difficult to control with standard drugs. Eosinophilic asthma is considered to be the main cause of severe asthma. , affecting 50-60% of patients.
Nucala (mepolizumab) is a human monoclonal antibody drug that selectively recognizes and binds to IL-5 and blocks the binding of IL-5 to the receptor on the surface of eosinophils, thereby relieving severe eosinophilicity Asthma, and at the same time, reduced eosinophil levels. Nucala was initially approved by the U.S. FDA in 2015 for the treatment of severe asthma patients aged 12 years and older with an eosinophil phenotype.
The results of this publication were derived from the open-label COLUMBA study. The COLUMBA study was designed to evaluate the long-term safety and efficacy of Nucala in patients with severe eosinophilic asthma. The trial was conducted during a 12-month DREAM study. In the patient, DREAM was a phase III trial of Nucella completed in 2014. Twelve months after the completion of the DREAM trial, 347 participants in the COLUMBA study began to receive a subcutaneous injection of 100 mg every four weeks outside the standard care routine. Nucala. The average length of data for this study is 3.5 years and the longest is 4.5 years. The results show that:
The rate of acute attacks decreased by 61%, and about one-third of patients did not experience asthma-related deterioration;
The annual deterioration rate during the study period remained stable (0.71 in the first year, 0.82 in the second year and 0.71 in the third year);
From the first assessment (week 12), asthma control improved and remained for more than four years (up to week 228);
As of week 4, blood eosinophils decreased by 78% and continued until the end of the study;
The safety and immunogenicity profile of the long-term Nucala treatment observed in the COLUMBA study is consistent with previous studies.
Dr. Dave Allen, director of R&D for respiratory therapy at GlaxoSmithKline, said: 'These new data provide us with evidence that Nucala is a targeted biologic therapy that can provide long-lasting benefits for patients with severe eosinophilic asthma. Benefits. The results of the study showed that the drug continued to reduce exacerbations and control asthma for a considerable period of time, with no newly discovered safety risks.
Dr. Sumita Khatri, associate professor of the Cleveland Clinic and chief researcher of COLUMBA Research, said in a statement: 'Severe patients with severe eosinophilic asthma that cannot be controlled by inhaled or oral treatments have been seeking ways to improve asthma control. We think This may be achieved through biological therapy, and is pleased to see that Nuclaa, an anti-IL-5 therapy, has both long-term efficacy and long-term safety.
We look forward to the release of new data that will bring new treatments to help patients with severe eosinophilic asthma as soon as possible!
