Treatment with omalizumab was associated with sleep improvements in patients with chronic rhinosinusitis with nasal polyps (CRSwNP), according to findings from the POLYP 1/2 open-label extension trial presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Virtual Annual Meeting held February 26 to March 1, 2021.
Researchers conducted an exploratory analysis of patient-reported sleep outcomes from the POLYP 1/2 open-label extension trial (ClinicalTrials.gov Identifier: NCT03478930). Improvements in sleep and sleep-related outcomes were selected as the primary objective of this analysis, as sleep disturbances are often a cause of concern and contribute to initiating more aggressive therapy in patients with CRSwNP. The sleep outcomes, which included sleep disturbances, shortness of breath, snoring, somnolence, sleep adequacy, and sleep quantity, were assessed using the Medical Outcomes Study (MOS) Sleep Scale from weeks 24 to 76 in the trial.
In the extension trial, patients with CRSwNP were receiving placebo with intranasal corticosteroids but switched to omalizumab at week 24 (n=126). Response durability was examined through week 76 in all patients, including those who discontinued treatment at week 52.
The average points of improvement on the MOS Sleep Scale from weeks 24 to 52 were -6.85 for sleep disturbance, -5.69 for snoring, as well as -4.25 for Sleep Problems Index 1 and -5.29 for Sleep Problems Index 2. The greatest improvement was observed for shortness of breath (-7.07). Effects of treatment waned after discontinuation at week 52, but the investigators observed continued benefits at week 76 compared with baseline. There were little to no improvements in somnolence, sleep adequacy, and sleep quantity.
The researchers concluded that the benefits “…observed during the POLYP 1/2 OLE suggest that omalizumab can provide value beyond rhinological symptoms in patients with CRSwNP.”
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Meltzer E, Holweg C, Ko J, et al. The impact of omalizumab therapy on sleep in patients with nasal polyps. Presented at: the American Academy of Allergy, Asthma & Immunology (AAAAI) Virtual Annual Meeting 2021; February 26-March 1, 2021. Abstract L31.