Abstract

Background: The efficacy of dupilumab as treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) depends on its ability to inhibit type 2 inflammation.

Methods: We assessed the impact of dupilumab in asthmatic patients, with regard to skin prick test (SPT) and CRSwNP. Clinical, functional, and laboratory parameters were measured at baseline and 24 weeks after the first dupilumab administration.

Results: Among the 127 recruited patients with severe asthma, 90 (70.9%) had positive SPT, while 78 (61.4%) complained of CRSwNP. Exacerbations decreased from 4 (2-5) to 0 (0-0; p<0.0001), as well as the daily prednisone intake fell from 12.5 mg (0.0-25.0) to 0.0 mg (0.0-0.0) (p<0.0001). Asthma control test (ACT) score increased from 14 (10-18) to 22 (20-24) (p<0.0001), and sino-nasal outcome test (SNOT-22) score dropped from 55.8 ± 20.3 to 19.8 ± 12.8 (p<0.0001). Moreover, forced expiratory volume in one second (FEV1) increased from the baseline value of 2.1 L (1.6-2.8) to 2.4 L (1.9-3.1) (p<0.0001). Fractional exhaled nitric oxide (FeNO) decreased from 27 ppb (18-38) to 13 ppb (5-20) (p<0.0001). These improvements were similar in subgroups of patients characterized by SPT negativity or positivity, and CRSwNP absence or presence. No statistically significant correlations were detected between serum IgE levels, baseline blood eosinophils or FeNO levels and dupilumab-induced changes, with the exception of FEV1 increase, which was positively correlated with the highest FeNO values (r=0.31; p<0.01).

Conclusions: Our results consolidate the strategic role of dupilumab as an excellent treatment for severe asthma and CRSwNP.