1. In patients with chronic sinusitis and nasal polyposis refractory to intranasal steroids, dupilumab reduced endscopic nasal polyp burden at 16 weeks follow-up compared to placebo.
2. Patients also had improved radiographic appearance of their polyps, and experienced better quality of life and sense of smell with dupilumab compared to placebo.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Chronic sinusitis plagues many Americans and is characterized by nasal congestion, discharge, postnasal drip, headaches, facial pain, and decreased sense of smell. Current therapies include intranasal and oral steroids, nasal saline irrigation, and antibiotics. Similar immunologic pathways are implicated in chronic sinusitis, asthma, and atopic dermatitis. Thus, the purpose of this study was to determine whether dupilumab, a medication shown to benefit patients with asthma and atopic dermatitis, might also be efficacious in patients with chronic sinusitis. In a randomized, double-blind, placebo-controlled study of 60 adults with chronic sinusitis and nasal polyposis refractory to intranasal steroids, the patients who received dupilumab benefited compared to those given placebo after 16 weeks of follow-up. Specifically, these patients experienced a significant decrease in their endoscopic nasal polyp burden, a decrease in their disease burden on radiographic imaging, improvements in quality of life and daily symptoms, and improvements in sense of smell. Side effects included mild-to-moderate nasopharyngitis, injection site reactions, and headaches.
Overall, this study suggested that for patients with symptomatic chronic sinusitis and nasal polyposis refractory to intranasal steroids, subcutaneous dupilumab injections may decrease nasal polyp burden and improve overall quality of life and daily symptoms without compromising safety. However, future studies will need larger sample sizes than the 60 patients enrolled here, longer than 16 weeks of follow-up to determine long-term effects, and will need to compare dupilumab directly against other therapies rather than placebo.
Relevant Reading: Dupilumab in persistent asthma with elevated eosinophil levels
In-Depth [randomized controlled trial]: This study randomized 60 patients with chronic sinusitis and nasal polyposis refractory to intranasal corticosteroid treatment. Patients were enrolled at 13 sites in the U.S. and Europe between 2013 and 2014. In a randomized, double-blind, placebo-controlled study, 30 patients were randomly assigned to dupilumab and 30 patients to placebo. All 60 patients took mometasone furoate nasal spray. The primary endpoint assessed the change in bilateral nasal polyp score on endoscopy after 16 weeks based on polyp size. Additionally, the change in the polyp appearance on imaging using the Lund-Mackay computed tomography score, the patients’ quality of life using the 22-item SinoNasal Outcome Test, and the patient’s sense of smell using the University of Pennsylvania Smell Identification Test (UPSIT) score were all determined. The least squares (LS) mean change in bilateral endoscopic nasal polyp score after 16 weeks of follow-up was -0.3 (95%CI -1.0 to 0.4) in the placebo group and -1.9 (95%CI -2.5 to -1.2) in the dupilumab group (LS mean difference, -1.6; 95%CI -2.4 to -0.7; p < 0.001). The LS mean difference between the 2 groups for the Lund-Mackay computed tomography total score was -8.8 (95%CI -11.1 to -6.6, p < 0.001). Furthermore, patients showed improved quality of life with dupilumab, with the LS mean difference between groups for the 22-item SinoNasal Outcome Test -18.1 (95%CI -25.6 to -10.6, p < 0.001). Finally, patients also showed improved sense of smell as assessed by the UPSIT, with the LS mean difference 14.8 (95%CI 10.9 to 18.7, p < 0.001). Common side effects included nasopharyngitis, injection site reactions, and headaches, with no serious adverse events attributed to dupilumab.
©2016 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. Inquire about licensing here. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute Medicine, Inc.