Anti-IL-4,13 strategy in management of comormid patients in the regional register of severe bronchial asthma

BACKGROUND: T2 inflammation underlies bronchial asthma and inflammatory nasal diseases, supporting the concept of a “united airway disease.” Dupilumab, by blocking interleukin-4 and -13 receptors, can improve the 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 comparing related populations based on a regional register of patients with severe asthma and concomitant chronic inflammatory nasal diseases. Asthma control achievement and decrease in the rate of patients with uncontrolled asthma were assessed as primary endpoint. The need for bronchodilators and systemic glucocorticosteroids, 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 SNOT-22 and VAS. A subgroup analysis of ACT scores was performed depending on chronic inflammatory nasal disease phenotypes.

RESULTS: Within 12 months of dupilumab therapy, ACT increased from 11 (Q1–Q3: 7–13) to 20 (Q1–Q3: 18–24) points (p <0.001). The rate of patients with partially and fully controlled asthma increased from 0 to 57.9% (p <0.001). The 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) (p <0.001). Before the dupilumab therapy, 68.5% of the patients took systemic corticosteroids and, after 12 months, 10.5% of patients (p <0.001). The number of asthma exacerbations decreased from 2.19±1.83 (95% CI 1.28–3.11) to 0.22±0.55 (0.05–0.49) (p <0.001) and hospitalizations from 1.00±1.27 (95% CI 0.37–1.63) to 0.17±0.51 (95% CI 0.09–0.42) (p <0.001). AQLQ scores increased from 2.91 (Q1–Q3: 2.43–3.86) to 5.89 points (Q1–Q3: 4.70–6.58) (p <0.001). The volume of forced exhalation in 1 sec increased from 55.38%±16.66% (95% CI 47.10–63.67) to 81.5%±19.14% (95% CI 71.98–91.02) (p <0.001). SNOT-22 scores decreased from 47±29 (95% CI 34–61) to 25±18 (95% CI 17–34) points (p <0.001) and the VAS score from 7±2 (95% CI 6–8) to 4±2 (95% CI 3–5) (p <0.001).

CONCLUSIONS: Dupilumab improved asthma and nasal symptoms control, improved quality of life and respiratory function, and 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.