Omalizumab improves sleep and health status for patients with chronic rhinosinusitis with nasal polyps: An analysis of randomized clinical trials.

Background: Patients with chronic rhinosinusitis with nasal polyps (CRSwNP) have high incidence of sleep impairment. We evaluated the impact of omalizumab treatment on sleep characteristics and associated health status in patients with CRSwNP.

Methods: Prespecified exploratory analysis assessed outcomes from patients included in the POLYP 1 and POLYP 2 phase 3 clinical trials and the open-label extension. Sleep was assessed by the sleep domain of the Sino-Nasal Outcome Test-22 (SNOT-22; MCID > 4 in patients with CRS) and the Medical Outcomes Study Sleep Scale (MOS-Sleep). Health status was assessed by Healthy Days Core Module (HDCM) and sinonasal-specific Patient Global Impression of Change (PGIC).

Results: Omalizumab improved sleep as assessed by the SNOT-22 sleep domain. At week 24, adjusted mean (95%CI) SNOT-22 sleep scores had reduced from baseline by -8.5 (-9.9 to -7.1) with omalizumab versus -2.7 (-4.1 to -1.3) with placebo. At week 52 (all patents on OMA), adjusted mean (95%CI) SNOT-22 sleep scores had reduced from baseline by -10.1 (-11.4 to -8.7) with omalizumab. Improvements were observed in all eight items of the SNOT-22 sleep domain: difficulty falling asleep, fatigue, frustration/restlessness/irritability, lack good night's sleep, reduced concentration, reduced productivity, wake up tired, and wake up at night. In addition, omalizumab improved six of eight sleep outcomes on the MOS-Sleep scale. There were concurrent improvements in HDCM and PGIC.

Conclusion: Omalizumab improved sleep and self-reported health status in patients with CRSwNP. This contributes to evidence that omalizumab provides value for patients beyond the reduction of sinonasal symptoms.