Study finds treatment with glatiramer acetate plus albuterol is well tolerated and improves clinical outcomes in patients with multiple sclerosis
Adding albuterol, a compound commonly used to treat asthma and other respiratory diseases, to an existing treatment for patients with multiple sclerosis appears to improve clinical outcomes, according to a report in the September issue of Archives of Neurology.
Patients with multiple sclerosis have been found to have elevated levels of interleukin-12, a biological compound that promotes the generation of a type of helper T cell that may be associated with myelin destruction.
Albuterol sulfate—commonly used to treat bronchospasm—may decrease interleukin-12 levels, the authors note. Samia J Khoury MD, of Brigham and Women's Hospital and Harvard Medical School, Boston, and colleagues assessed the effects of albuterol treatment as an add-on therapy for patients starting treatment with glatiramer acetate, currently approved as a therapy for relapsing-remitting multiple sclerosis.
A total of 44 patients were randomly assigned to receive daily subcutaneous 20-mg injections of glatiramer acetate plus either an oral dose of 4 mg of albuterol or placebo daily for 2 years. Participants were examined by a neurologist at the beginning of the study and at 6, 12, 18, and 24 months, and blood samples were collected at the beginning and 3, 6, and 12 months into the study. MRI of the brain was performed at enrollment, 12 months, and 24 months.
A total of 39 patients participated long enough to contribute to the analysis. In assessments of functional status, improvement was observed in the glatiramer acetate plus albuterol group compared with the placebo group at 6 months and 12 months, but not at 24 months. Compared to patients taking placebo, those taking albuterol also experienced a delay in the time to their first relapse.
Blood tests showed that the production of 2 inflammatory markers—interleukin-13 and interferon-gamma—decreased in both treatment groups, with a treatment effect on interleukin-13 observed at the 12-month time point.
Adverse events were generally mild, with only 3 moderate or severe events that were considered to be related to the treatment (including reaction at the glatiramer acetate injection site, leg weakness, and chest tightness).
"We conclude that treatment with glatiramer acetate plus albuterol is well tolerated and improves clinical outcomes in patients with multiple sclerosis," the authors write. "The combined regimen seems to enhance clinical response during the first year of therapy."
This study was supported in part by an Autoimmunity Center of Excellence Study grant from the National Institute of Allergy and Infectious Diseases.
Source: News Release
Archives of Neurology
September 13, 2010