Omalizumab improves sleep outcomes in patients with CRSwNP

Treatment with omalizumab improves sleep outcomes in patients with chronic rhinosinusitis with nasal polyps (CRSwNP), according to the POLYP 1 and 2* open-label extension (OLE) studies presented at AAAAI 2021.

“Patients with nasal polyposis exhibit a twofold higher risk of sleep disturbance, [which] often drives patients to seek more intense disease management, compared with healthy controls,” said the researchers. “The present study suggests that omalizumab offers benefit for sleep disturbance for nasal polyposis, which is one of the most bothersome patient-reported symptoms of the disease.”

In this extension study, patients in the placebo arm from POLYP 1 and 2 were switched to omalizumab (n=126, mean age 51.6 years) and those in the omalizumab arm continued to receive the same treatment regimen (n=123, mean age 49.9 years) from week 24 until week 52. Medical Outcomes Study (MOS) Sleep Scale and Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire for sleep subdomains** were used to evaluate patient-reported sleep outcomes from weeks 24–52. [AAAAI 2021, abstract L31]

At week 52, the greatest benefit of omalizumab from baseline (week 24) was observed in MOS Sleep Scale scores for shortness of breath (-7.07), followed by sleep disturbance (-6.85), snoring (-5.69), and Sleep Problems Index I/II*** (-4.25 and -5.29, respectively).

However, the researchers found minimal to no improvements in MOS scores for sleep adequacy (4.74) and sleep quantity (-0.12), in which lower scores indicate a greater disease severity.

With regard to SNOT-22 sleep subdomains, both groups showed continued improvements in the current OLE treatment period of weeks 24–52 (-7.25 for patients who switched to omalizumab and -10.09 for patients who continued omalizumab).

“Overall safety data [of the OLE study was] … consistent with the original POLYP 1 and 2 studies,” the researchers noted.

“[In conclusion,] patients who received omalizumab in POLYP 1 and 2 and the OLE experienced sleep improvements across multiple measures, suggesting that omalizumab can provide value beyond rhinological symptoms in patients with CRSwNP,” the researchers said.

“[Sleep] improvements were generally maintained throughout treatment [for both groups in this OLE study],” they noted.

*POLYP 1 and 2: A clinical trial of omalizumab in participants with chronic rhinosinusitis with nasal polyps

**SNOT-22 questionnaire consisted of ability to fall and stay asleep at nighttime, morning/daytime fatigue, and reduced concentration and productivity, and frustration,

***Sleep Problems Index I/II: Abbreviated indices of 6/9 distinct aspects of sleep quality, respectively, including sleep disturbance, somnolence, adequacy, and awakening with shortness of breath