ATLANTA, GA—The monoclonal antibody dupilumab is associated with reduced anosmia (the loss of the sense of smell) and improved smell function among patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who are taking mometasone furoate nasal spray (MFNS) daily, according to findings of a Phase 2a study presented at the 2017 AAAAI Annual Meeting.
“In (CRSwNP) patients refractory to intranasal corticosteroids, dupilumab significantly and rapidly improved the sense of smell and reduced anosmia over a 16-week treatment period,” reported lead study author Robert Naclerio, MD, FAAAAI of University of Chicago Medicine, in Chicago, IL. “The proportion of patients with anosmia decreased from 83% at baseline to 11% at week 16 in the dupilumab group vs. 73% to 65% in placebo.”
The most common adverse events reported were nasopharyngitis, injection-site reactions, and headache, Dr. Naclerio said. All 30 patients taking dupilumab experienced at least one treatment-emergent adverse event. Twelve (40%) experienced injection-site reactions compared to 2 (7%) patients in the placebo group.
Ninety percent of patients report decreased sense of smell and taste as the most important impact on their health and quality of life, he noted.
“Most concerning is their inability to smell fire smoke, or rancid food,” he noted.
The authors sought to evaluate dupilumab’s effects on olfactory functions among adults with intranasal corticosteroid-refractory CRSwNP. They evaluated dupilumab’s effects on smell function with 60 patients with nasal polyps who were refractory to intranasal corticosteroids. Patients were assigned (1:1) to receive 16 weeks of either placebo or treatment with dupilumab, including a 600mg loading dose followed by 300mg given weekly subcutaneously. Patients continued to receive MFNS daily.
Smell function assessments were conducted with the University of Pennsylvania Smell Identification Test (UPSIT; range 0–40), patient evaluation of smell loss severity daily (range 0–3), and Sino-Nasal Outcome Test (SNOT-22) item 12 (“decreased sense of smell/taste,” range 0–5).
Dupilumab was associated with significant improvements in endoscopic, radiographic, and clinical endpoints.
At week 16, significant improvements were observed among patients taking dupilumab in UPSIT (LS mean difference was 14.78 (95% CI: 10.90–18.65, P<0.0001 vs. placebo). Dupilumab was also associated with improvements in patients’ daily assessments of smell loss severity (LSM difference of -1.28, 95% CI: -1.73 to -0.84, P<0.0001). Additionally, the proportion of patients in the UPSIT category evaluating anosmia significantly decreased in the dupilumab group compared to placebo (83.3% to 10.7% with dupilumab vs. 73.3% to 65.2% with placebo).
Dupilumab was also associated with improved SNOT-22 item 12 scores evaluating smell and taste sensation, with an LSM difference of -2.06 from placebo (P<0.001).