STUDY DESIGN

Chronic rhinosinusitis with nasal polyp (CRSwNP) is a chronic disease characterized by elevated interleukin 5 (IL-5) levels and is often associated with severe sinonasal symptoms and nasal obstruction.¹ Mepolizumab is a humanized anti-IL-5 antibody approved as an add-on medication for CRSwNP.¹ In the pivotal phase 3 SYNAPSE study, mepolizumab demonstrated improvement in sinonasal outcomes and reduction in corticosteroid use or surgery need in patients with CRSwNP.¹ However, its effect on the number of low-symptom/symptom-free or symptom-reduced days remained unclear.¹

SYNAPSE study was a phase 3, randomized, double-blind, multicenter trial conducted to examine the impact of mepolizumab on symptom reduction and improvements in quality of life (QoL) among patients with CRSwNP.¹ Adult patients with severe CRSwNP, and had at least 1 prior surgery for nasal polyps (NP) with recurrent nasal polyps despite treatment with an endoscopic bilateral NP score ≥5.¹ They also scored >7 for the current need for NP surgery and >5 for nasal obstruction on a visual analogue scale (VAS).¹ They were randomized to receive mepolizumab (n=206) or placebo (n=201) plus standard of care for 52 weeks.¹

The study outcomes were the presence of low-symptom or symptom-free days (defined as a VAS ≤3), symptom-reduced days (defined as VAS score ≤3 or improvement of ≥1 in VAS score from baseline), and improvements in symptom severity from severe to low/moderate [assessed by the VAS and Sino-Nasal Outcome Test-22 (SNOT-22) scores] were assessed from baseline and at weeks 49 to 52.¹

FINDINGS

“Among patients with a very high burden of disease,  IL-5 inhibition had a beneficial impact on clinical measures meaningful for patients’ QoL”

_{Dr. Larry Borish
Departments of Medicine and Microbiology,
University of Virginia Health Systems,
Charlottesville, Virginia,
United States}