SAN FRANCISCO — Patients with chronic rhinosinusitis with nasal polyps experienced improvements in endoscopic, radiologic, and clinical outcomes when treated with dupilumab as add-on therapy to intranasal mometasone furoate, according to research presented at the annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) held February 22-25 in San Francisco.
In this phase 3 study (SINUS-24; ClinicalTrials.gov Identifier: NCT02912468), 276 patients with chronic rhinosinusitis with nasal polyps who were previously treated with systemic corticosteroids and/or surgery were randomly assigned to subcutaneous dupilumab 300mg or placebo every 2 weeks for 24 weeks. The primary end points included change from baseline to week 24 in nasal polyp score and patient-reported nasal congestion. Other outcomes of interest included changes in the smell identification test, Sino-nasal Outcome Test, and Asthma Control Questionnaire-6 scores. The baseline values for these scores were comparable between the dupilumab and placebo groups.
Systemic corticosteroid use and the need for surgery were both reduced with dupilumab treatment (P<.001). Patients with comorbid asthma experienced improvements in lung function (forced expiratory volume in 1 second; P<.001) and asthma control (Asthma Control Questionnaire-6; P<.0001). Epistaxis was the most common adverse event and occurred more frequently in the group treated with Systemic corticosteroid use and the need for surgery were both reduced with dupilumab treatment (P<.001). Patients with comorbid asthma experienced improvements in lung function (forced expiratory volume in 1 second; P<.001) and asthma control (Asthma Control Questionnaire-6; Pdupilumab vs placebo (7.7% vs 3.0%, respectively).
Joseph K. Han, MD, the presenting author, noted that patients treated with dupilumab showed improvement as early as 4 weeks and continued through week 24. In addition, the need for surgery in these patients was reduced by 73%.
In an interview with Pulmonology Advisor, principal investigator and head of clinics of the Department of Otorhinolaryngology at Ghent University in Belgium, Claus Bachert, MD, called the findings a “game changer” for this patient population.
Dr Bachert noted patients with the most severe symptoms often undergo multiple surgeries in their lifetime and the recurrence rate for nasal polyps can be as high as 45%. This means dupilumab could “change the fate of the patient … you are taking away a huge disease burden.” However, he stressed the importance of continuing treatment and not simply discontinuing when the patient feels better.
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Han JK, Bachert C, Desrosiers M, et al. Efficacy and safety of dupilumab in patients with chronic rhinosinusitis with nasal polyps: results from the randomized phase 3 Sinus-24 study. Presented at: American Academy of Allergy, Asthma & Immunology annual meeting 2019; February 22-25, 2019; San Francisco, CA. Abstract L4.