Response to mepolizumab in patients with severe CRSwNP using response criteria.

Introduction: SYNAPSE, a Phase III, randomised, doubleblind trial, assessed the efficacy of mepolizumab in severe chronic rhinosinusitis with nasal polyps (CRSwNP) (Han JK, et al. Lancet Respir Med 2021; S2213-2600(21)00097-7). Aim: To assess the clinical response to mepolizumab in severe CRSwNP. Method: In SYNAPSE, patients received standard of care plus mepolizumab (100 mg subcutaneous) or placebo for 52 weeks. This post hoc, descriptive analysis, classified patients in the intent-totreat (ITT) population without sinus surgery during the study period as responders, using 5 modified European Forum for Research and Education in Allergy and Airway Diseases (EUFOREA) criteria (Bachert C, et al. JACI, 2021;147:29). Results: In the ITT population (n=407), 381 and 343 patients had not had sinus surgery by Weeks 24 and 52, respectively. For each EUFOREA criterion (reduced nasal polyp size and nasal obstruction, improved sense of smell, improved quality of life, improved overall symptoms) proportion of patients classified as responders was higher with mepolizumab than placebo at Weeks 24 and 52. The proportion of patients who met =3 criteria was 55% with mepolizumab vs 35% with placebo at Week 24, and 67% vs 49% at Week 52. Conclusion: Clinical response, as defined by the modified EUFOREA criteria, was greater with mepolizumab than placebo and increased from Week 24 to Week 52, suggesting a sustained, progressive response in patients with severe CRSwNP without sinus surgery during the study. [ABSTRACT FROM AUTHOR]