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Dupilumab Improves Sense of Smell and Reduces Anosmia Among Patients with Nasal Polyposis and Chronic Sinusitis: Results from a Phase 2a Trial
Saturday, March 4, 2017: 2:00 PM
Thomas B. Murphy Ballroom 1 (Georgia World Congress Center, Building B)
Robert M. Naclerio, MD FAAAAI, , , , , , , , , , , , , , , ,
Rationale:

Loss of smell is a major consequence for chronic sinusitis patients with nasal polyps and is a severity marker with significant impact on quality of life. In a phase 2a study in nasal polyposis (NP) patients, dupilumab significantly improved endoscopic, radiographic and clinical endpoints. The effect of dupilumab on smell function is evaluated here.

Methods:

Sixty adult NP patients refractory to intranasal corticosteroids were assigned (1:1) to 16 weeks of weekly subcutaneous 300mg dupilumab (including one 600mg loading dose) or placebo on top of daily mometasone furoate nasal spray (MFNS). Smell function was assessed by University of Pennsylvania Smell Identification Test (UPSIT; range 0–40), daily patient assessment of smell loss severity (range 0–3), and Sino-Nasal Outcome Test (SNOT-22) item 12: “decreased sense of smell/taste (range 0–5)”.

Results: At week 16, significant (p<0.0001) improvements in dupilumab versus placebo were observed in UPSIT (LS mean [LSM] difference of 14.78 [95%CI: 10.90, 18.65]) and daily AM patient assessment of smell loss severity (LSM difference of -1.28 [95%CI: -1.73, -0.84]). Patients’ proportions in the anosmia UPSIT category decreased from 83.3% (n=25) to 10.7% (n=3) with dupilumab vs. from 73.3% (n=22) to 65.2% (n=15) with placebo. Similarly, dupilumab significantly improved SNOT-22 item related to smell/taste (LSM difference from placebo: -2.06; p<0.001). Injection site reactions, headache, and nasopharyngitis were the most frequently reported adverse events with dupilumab.

Conclusions:

In NP patients on daily MFNS background therapy, dupilumab significantly improved the sense of smell and reduced anosmia over a 16 week treatment period.