This article is part of Pulmonology Advisor‘s coverage of the American Academy of Allergy, Asthma & Immunology annual meeting, taking place in San Francisco, California. Our staff will report on medical research related to asthma, allergy, and other respiratory conditions, conducted by experts in the field. Check back regularly for more news from AAAAI 2019.
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 300 mg 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 dupilumab 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.
Noting that dupilumab already has an indication for severe asthma and may have an indication for nasal polyps in the future (most likely for polyps that are not controlled with standard care), Dr Bachert stated, “I think there should be an indication for those who suffer from [nasal] polyps and nonsevere asthma because these 2 [together] really have a tremendous impact on these patients’ lives.”
“You do not have to wait until the polyps totally block the nose because that patient already has a comorbidity [asthma] that adds to the symptomology,” Dr Bachert added. “Fifty percent of patients already have asthma at the time of nasal polyp diagnosis, so what do you wait for?”
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.
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