Mepolizumab improves symptoms of chronic rhinosinusitis states a study published in The Journal of Allergy and Clinical Immunology.
This study assesses the efficacy of 4-weekly add-on mepolizumab 100 mg SC on patient-reported symptoms of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). Co-primary endpoints of change from baseline in endoscopic NP score and nasal obstruction visual analog scale (VAS) score have been previously reported.
SYNAPSE (NCT03085797), a randomized, double-blind, placebo-controlled, multicentre, 52-week study, enrolled 407 adult patients with highly symptomatic CRSwNP uncontrolled by previous surgery, treated with intranasal corticosteroids. Nasal Obstruction, Nasal Discharge, Mucus in Throat, Loss of Smell, Facial Pain, Overall Symptoms VAS scores (0-100) were completed daily, reported as 4-weekly means on 0-10 scale. Blinded psychometric analyses, informed by prior qualitative research in CRSwNP patients, determining meaningful within-patient change for each VAS.
Thresholds for meaningful change: -3.0 for Nasal Obstruction, Mucus in Throat, Loss of Smell, and -2.5 for Nasal Discharge, Facial Pain, Overall Symptoms.
--Median change from baseline in VAS at weeks 49-52 and percentage responders for mepolizumab and placebo were: Nasal Obstruction, -4.41, -0.82; Nasal Discharge, -4.51, -0.85; Mucus in Throat, -4.21, -0.97; Loss of Smell, -0.53, 0.00; Facial Pain, -3.63, -0.68 Overall Symptoms, -4.48, -0.90.
--Loss of Smell VAS showed greater improvement for patients with one prior surgery; median change from baseline for mepolizumab, -1.87, placebo -0.07. No difference vs. placebo in those with > 2 prior surgeries.
Clinically and statistically significant improvements in symptoms were demonstrated with mepolizumab 100 mg SC compared to placebo. Improvement in sense of smell was related to a prior history of NP surgery.