2018 · 12 citations · 0 references
MedicinePharmacologyPharmacotherapyAllergyImmunopharmacologyImmunotherapyAsthma ManagementAsthma PharmacotherapyAtopic DermatitisChronic RhinosinusitisNasal PolyposisNasal PolypsAllergic Airway InflammationAtopic PatientsDupilumab ResponseEosinophilic Disease TherapyEosinophilic RhinitisInterleukin-4 Targeted TherapyPulmonary ExacerbationsRefractory Asthma
<b>Background:</b> Dupilumab (DPL), a fully human anti-IL-4Rα mAb that inhibits IL-4/IL-13, is approved for treatment of adults with inadequately controlled moderate-to-severe atopic dermatitis. In a phase 3 study (NCT02414854), asthma patients (pts) aged ≥12 years, with no minimum baseline (BL) eosinophil requirement, uncontrolled with medium-to-high-dose ICS, plus 1 or 2 controllers received DPL 200/300mg or placebo (PBO) every 2 weeks for 52 weeks. DPL reduced severe exacerbations, improved FEV1 and quality of life measures, and was generally well tolerated. <b>Aim:</b> Assess DPL effect on 22-item Sino-Nasal Outcome Test (SNOT-22) scores, a CRS disease-specific health-related quality of life (HRQoL) outcome, in asthma pts with CRS/NP. <b>Methods:</b> 382/1902 pts reported CRS/NP medical history. Outcome was change from BL in DPL vs PBO in SNOT-22 scores at Weeks 12, 24, and 52. <b>Results:</b> DPL improved SNOT-22 scores by Week 12, and over the 52-week treatment period (Table). SNOT-22 scores in the DPL-treated pts exceeded the minimal clinically important difference (≥8.9) at all time points compared to BL, and vs PBO at Week 52. The most common AE, with higher rates in 200/300mg DPL vs PBO, was injection-site reactions (21%/24% vs 6%/14%). <b>Conclusion:</b> Dupilumab significantly improved CRS/NP-specific symptoms and HRQoL in asthma pts with comorbid CRS/NP, and was generally well tolerated.