The following article is a part of conference coverage from the American Academy of Allergy, Asthma & Immunology Virtual Annual Meeting, being held virtually from February 26 to March 1, 2021. The team at Pulmonology Advisor will be reporting on the latest news and research conducted by leading experts in the field. Check back for more from the AAAAI 2021 Virtual Annual Meeting.
Mepolizumab reduces disease symptoms in patients with chronic rhinosinusitis with nasal polyps (CRSwNP), according to the results of a randomized, double-blind, multicenter study presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Virtual Annual Meeting, held February 26 to March 1, 2021.
Researchers assessed the efficacy of 4-weekly add-on mepolizumab 100 mg administered subcutaneously (SC) on patient-reported symptoms of CRSwNP in the SYNAPSE (ClinicalTrials.gov Identifier: NCT03085797) clinical trial. In this study, 407 adult patients with highly symptomatic CRSwNP uncontrolled by previous surgery and treated with intranasal corticosteroids received add-on therapy with mepolizumab. Nasal obstruction, nasal discharge, mucus in throat, loss of smell, facial pain, and overall symptoms visual analogue scale (VAS) scores (0-100) were completed daily and reported as 4-weekly means on a 0 to 10 scale. Blinded psychometric analyses determined meaningful within-patient change for each VAS.
After 52 weeks, the researchers discovered the following thresholds for meaningful change: -3.0 for nasal obstruction, mucus in throat, and loss of smell, and -2.5 for nasal discharge, facial pain, and overall symptoms. In addition, the median change from baseline in VAS at weeks 49 to 52 and percentage of responders for mepolizumab and placebo were: nasal obstruction: -4.41 (60%) vs -0.82 (36%); nasal discharge: -4.51 (64%) vs -0.85 (40%); mucus in throat: -4.21 (57%) vs -0.97 (36%); loss of smell: -0.53 (36%) vs 0.00 (19%); facial pain, -3.63 (58%) vs -0.68 (40%); and overall symptoms: -4.48 (64%) vs -0.90 (40%).
Loss of smell VAS demonstrated greater improvement for patients with one prior surgery with a median change from baseline of -1.87 for mepolizumab and -0.07 for placebo, while no difference vs placebo was noted in those with 2 or more prior surgeries.
“Clinically and statistically significant improvements in symptoms were demonstrated with mepolizumab 100 mg SC compared to placebo,” the researchers concluded. “Improvement in sense of smell was related to prior history of NP surgery.”
Disclosure: This clinical trial was supported by GlaxoSmithKline. Please see the original reference for a full list of authors’ disclosures.
Tabberer M, Trigg A, Busse W, et al. Mepolizumab reduces disease symptoms for patients with chronic rhinosinusitis with nasal polyps: data from the SYNAPSE study. Presented at: the American Academy of Allergy, Asthma & Immunology (AAAAI) Virtual Annual Meeting; February 26-March 1, 2021. Abstract 402.
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