Abstract

Dupilumab, a human IgG4 monoclonal antibody against IL-4Rα subunit, inhibits IL-4 and IL-13, the major drivers of human type 2 inflammatory diseases such as CRSwNP and asthma. CRSwNP is associated with nasal discharge, obstruction and reduced sense of smell, with a reduction in quality of life (QoL) and decrease in sleep quality. Dupilumab improves all aspects of disease-specific QoL but no data is available for sleep quality. The aim of this study is to investigate sleep quality in CRSwNP patients treated with Dupilumab. Patients were consecutively enrolled. Anthropometrics data, lung function tests, ENT scores, and bio-humoral data were collected. In order to evaluate sleep impairment, the Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), and Pittsburgh Sleep Quality Index (PSQI) were used at the first visit, and after one and three months of treatment. We enrolled 29 patients (15F, mean age 53.7±9.8). 13 patients with CRSwNP and 16 with both CRSwNP and asthma. Before Dupilumab treatment ESS was 9 [IQ5-10], ISI was 13 [IQ10-18] and PSQI 9 [IQ7-12]. After one month of therapy, we reported a significant improvement in sleep quality: ISI (8vs13,p<0.05); PSQI (6vs9,p<0.05) but no changes in ESS (6vs9,p1.5). The improvement continued at three months: ISI (7vs13,p<0.001); PSQI (5.5vs9,p<0.05) when also a reduction in ESS (3vs9,p<0.05) ) was observed. Concerning sleep quality assessment, no differences were detected when divided by pathologies (CRSwNP vs CRSwNP and asthma). In conclusion Dupilumab demonstrated a rapid and significant improvement in sleep quality, insomnia, and sleepiness in patients with CRSwNP

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