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New treatment for moderate-to-severe asthma is effective, according to study

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New treatment for moderate-to-severe asthma is effective

According to an article published in the New England Journal of Medicine and presented at the American Thoracic Society 2013 International Conference, dupilumab, a fully human monoclonal antibody, is effective and safe in the treatment of persistent, moderate-to-severe asthma with high eosinophilia. The mechanism of action of this monoclonal antibody is to counteract the Th2 immune response by blocking the activation of two interleukins: interleukin 4 and interleukin 13. Asthma is a chronic inflammatory disease of the airways characterized by airway obstruction, coughing, shortness of breath and wheezing.

Asthma is a chronic respiratory disease that usually requires medication during lifetime. There are several drug classes to treat asthma: anti-inflammatory drugs (corticosteroids, mast cell stabilizers,  leukotriene antagonists) and bronchodilators (short-acting beta2-adrenoceptor agonists (SABA), long-acting beta-adrenoceptor agonists (LABA), anticholinergics) etc. It should be noted that the treatment is determined by the severity of symptoms. Lead author Sally Wenzel, MD, director of the University of Pittsburgh Asthma Institute, said that 10-20% of patients with moderate to severe asthma are unresponsive to standard therapy consisting of inhaled glucocorticosteroids (ICS) and long-acting beta agonists (LABA). She said that asthma that is difficult to treat expresses several phenotypes this is why new therapies are needed to control these respiratory symptoms.



To test the effectiveness of dupilumab, researchers conducted a randomized, double-blind, placebo-controlled trial that included 104 patients: half of them were part of the dupilumab group and half were part of the placebo group. It should be noted that all study participants had moderate-to-severe asthma that do not respond well to treatment combined ICS and LABA. Also, all patients had increased levels of eosinophils in the blood or sputum.

During the 12 weeks of treatment and the 8 weeks of follow-up, patients who received injections of dupilumab had a reduction of asthma exacerbations by 87% compared with placebo group. Other improvements that were recorded were those related to lung function (forced expiratory volume in one second (FEV1) and morning peak expiratory flow). Also, it seems that dupilumab decreased the need for medication reliever use. Researchers have found that many of these improvements were seen especially when dupilumab was added to standard treatment ICS / LABA. Side effects have included nasopharyngitis, injection site irritation, nausea, vomiting, but none was serious.

Although dupilumab therapy did not decrease the level of eosinophils in the blood or sputum, though other biomarkers have declined: fractional exhaled nitric oxide, immunoglobulin E, eotaxina 3 and others, which demonstrates that dupilumab is biologically active.