by Bruce Sylvester: Among adults with chronic sinusitis and nasal polyps who do not respond to intranasal corticosteroids, addition of investigative dupilumab to mometasone furoate nasal spray compared with mometasone alone reduced nasal polyps significantly after 16 weeks. Researchers reported this finding on Feb. 2, 2016 in JAMA, the Journal of the American Medical Association.
As background, the authors noted that dupilumab has shown clinical efficacy for asthma and atopic dermatitis, as well as improving sino-nasal symptoms in patients with asthma.
Claus Bachert, M.D., Ph.D., of Ghent University Hospital, Ghent, Belgium, and colleagues randomized 60 adults with chronic sinusitis and nasal polyposis who were unresponsive to intranasal corticosteroids to dupilumab (by injection; n = 30) or placebo (n = 30) plus mometasone furoate nasal spray for 16 weeks.
The primary endpoint was change in endoscopic nasal polyp score, based on polyp size.
Among the 60 subjects, 51 completed the study.
The investigators reported that, after 16 weeks, dupilumab treatment was associated with significant improvements in nasal polyp score (P < .001) and with endoscopic, clinical, radiographic, and pharmacodynamic end points (P < .001 for all.)
They also reported significant improvements in quality of life and in subjective sense of smell, nasal obstruction or congestion, and nocturnal awakenings (P < .001 for all).
Dupilumab treatment was generally well tolerated, No serious adverse events were related to dupilumab treatment.
“Further studies are needed to assess longer treatment duration, larger samples, and direct comparison with other medications,” the authors said.