Efficacy of anti-IL4R,13 therapy in patients with severe bronchial asthma with concomitant chronic inflammatory nasal diseases

BACKGROUND: T2-inflammation underlies bronchial asthma and inflammatory nasal diseases, supporting concept of an "united airway disease". Dupilumab, by blocking interleukin 4 and 13 receptor, can improve clinical and functional parameters and life quality of comorbid patients with T2 diseases. AIM: to evaluate efficacy of anti-IL4R,13 therapy in patients with severe asthma with chronic inflammatory nasal diseases in real clinical practice. MATERIALS AND METHODS: The study of dupilumab efficacy was conducted by method of related populations comparison based on regional register of patients with severe asthma (SA) and concomitant chronic inflammatory nasal diseases (CIND). Asthma control achievement and decrease in rate of patients with uncontrolled asthma were assessed as primary endpoint. The need for bronchodilators and systemic glucocorticosteroids, the number of asthma exacerbations, emergency calls and hospitalizations, AQLQ scores, level of peripheral blood eosinophils, and respiratory function were also assessed. Nasal symptoms were assessed using SNOT22 and VAS. A subgroup analysis of ACT scores was performed depending on CIND phenotypes. RESULTS: During 12 months of dupilumab therapy, ACT increased from 11 (Q1-Q3: 7-13) to 20 (Q1-Q3: 18-24) points (p0.001). The rate of patients with uncontrolled asthma decreased from 100% to 42.1% (p0.001). Need for bronchodilators decreased from 17.5 doses per week (Q1-Q3: 5.8-24.5) to 1.0 (Q1-Q3: 0.0-2.2) (p0.001). Before dupilumab therapy, 68.5% of patients took systemic corticosteroids, after 12 months - 10.5% of patients (p0.001). The number of asthma exacerbations decreased from 2.191.83 (95% CI 1.28-3.11) to 0.220.55 (0.05-0.49) (p0.001) and hospitalizations from 1.001.27 (95% CI 0.37-1.63) to 0.170.51 (95% CI 0.09-0.42) (p0.001). AQLQ scores increased from 2.91 (Q1-Q3: 2.43-3.86) to 5.89 points (Q1-Q3: 4.70-6.58) (p0.001). FEV1 increased from 55.38%16.66 (95% CI 47.10-63.67) to 81.5%19.14 (95% CI 71.98-91.02) (p0.001). SNOT22 scores decreased from 4729 (95% CI 34-61) to 2518 (95% CI 17-34) points (p0.001), VAS - from 72 (95 %CI 6-8) to 42 (95%CI 3-5) (p0.001). CONCLUSIONS: Dupilumab improved asthma and nasal symptoms control, improved quality of life and respiratory function, reduce asthma exacerbations and hospitalizations. Patients with severe asthma and comorbid allergic rhinitis and chronic rhinosinusitis with polyps responded better to dupilumab therapy than patients with chronic rhinosinusitis without polyps.