Two phase III trials of Dupixent show improvements in chronic rhinosinusitis with nasal polyps.- Sanofi

Detailed results were presented from two Phase III trials using Dupixent (dupilumab), from Sanofi, in patients with recurring severe chronic rhinosinusitis with nasal polyps (CRSwNP) despite previous treatment with surgery and/or systemic corticosteroids. These trials, known as SINUS-24 and SINUS-52, demonstrated that Dupixent, when added to the standard of care corticosteroid nasal spray, improved nasal polyp size, nasal congestion severity, chronic sinus disease, sense of smell and co-morbid asthma outcomes.

In these severe patients, Dupixent reduced the need for systemic corticosteroid use and the need for nasal/sinus surgery. Patients treated with Dupixent experienced a 57% and 51% improvement in their nasal congestion / obstruction severity compared to a 19% and 15% improvement with placebo in SINUS-24 and SINUS-52, respectively (absolute change from baseline of -1.34 and -1.25 for Dupixent compared to -0.45 and -0.38 for placebo; p<0.0001 for both) and a 33% and 27% reduction in their nasal polyps score compared to a 7% and 4% increase for placebo in sinus-24 and sinus-52, respectively (absolute change from baseline of -1.89 and -1.71 for dupixent compared to 0.17 and 0.10 for placebo). dupixent treatment effects began as early as four weeks with progressive improvement up to 24 weeks in sinus-24, a 24-week trial, and up to 52 weeks in sinus-52. both trials evaluated dupixent treatment every two weeks for up to 24 weeks, and after week 24 through 52 weeks, sinus-52 included a group of patients treated every four weeks in addition to a group treated every two weeks.>

These data were presented in two late-breaking sessions at the 2019 Annual Meeting of the American Academy of Allergy, Asthma & Immunology.