Study: Dupilumab Safe, Effective for Moderate, Severe Asthma
(HealthDay News) – Dupilumab, a fully human monoclonal antibody, appears safe and effective for the treatment of patients with persistent, moderate-to-severe asthma and elevated eosinophils, according to a study published online May 21 in the New England Journal of Medicine to coincide with presentation at the annual meeting of the American Thoracic Society, held from May 17–22 in Philadelphia.
Sally Wenzel, MD, from the University of Pittsburgh, and colleagues enrolled patients with persistent, moderate-to-severe asthma who used medium- to high-dose inhaled glucocorticoids plus long-acting beta-agonists (LABAs). Participants took dupilumab (52 patients; 300mg) or placebo (52 patients) subcutaneously once a week for 12 weeks or until protocol-defined asthma exacerbation occurred. Weeks six through nine, patients discontinued inhaled glucocorticoids, following discontinuations of LABAs at week four.
The researchers found that three patients had asthma exacerbation with dupilumab (6%), vs. 23 with placebo (44%; odds ratio, 0.08). Most measures of lung function and asthma control significantly improved, including reduction of Th2-driven inflammation biomarkers, with dupilumab. Adverse effects from dupilumab included infection-site reactions, nasopharyngitis, nausea, and headache.
"In patients with persistent, moderate-to-severe asthma and elevated eosinophil levels who used inhaled glucocorticoids and LABAs, dupilumab therapy, as compared with placebo, was associated with fewer asthma exacerbations when LABAs and inhaled glucocorticoids were withdrawn, improved lung function, and reduced levels of Th2-associated inflammatory markers," Wenzel and colleagues conclude.
The study was funded by Sanofi and Regeneron Pharmaceuticals, manufacturers of dupilumab.