Health Improvements in Patients with Chronic Rhinosinusitis with Nasal Polyps Observed with Omalizumab

Improvements in sleep and self-reported health may result from omalizumab treatment of patients with chronic rhinosinusitis with nasal polyps, according to recent findings.¹

Summary of Research

Omalizumab treatment for chronic rhinosinusitis with nasal polyps improves sleep and self-reported health, as revealed in a recent study led by Dr. Eli O. Meltzer from the University of California, San Diego.
The randomized, double-blinded POLYP 1 and POLYP 2 phase 3 studies showed that omalizumab significantly enhanced sleep scores, with notable improvements persisting up to the 52-week mark.
Positive impacts on sleep outcomes were complemented by improvements in both the Healthy Days Core Module (HDCM) and sinonasal-specific Patient Global Impression of Change (PGIC), indicating broader benefits beyond nasal symptoms in treated patients.

These new data resulted from a recent study assessing sleep and health status in those with chronic rhinosinusitis with nasal polyps treated with omalizumab, especially given the higher incidence of sleep impairment among this patient population.

The research was led by Eli O. Meltzer, MD, from the division of allergy and immunology at the University of California, San Diego. Meltzer and colleagues noted the lack of a detailed evaluation of sleep quality up until this research.²

“Therefore, to evaluate the impact of omalizumab on sleep characteristics and associated health status in patients with CRSwNP, this prespecified exploratory analysis assessed outcomes from patients included in POLYP 1 and POLYP 2 and the OLE studies,” Meltzer and colleagues wrote.

Background

The investigators noted that in the randomized, multicenter, double-blinded, and placebo-controlled POLYP 1 and POLYP 2 phase 3 studies, adults with diagnoses of chronic rhinosinusitis with nasal polyps were placed into 1 of 2 cohorts: the omalizumab treatment arm or the placebo arm, and they were given these treatments for a course of 24 weeks.

Later, these same participants were then given open-label omalizumab for a further 28 weeks, up to Week 52, in the open label extension treatment period. Following this period, the drug was discontinued and an observation period for the investigators took an additional 24 weeks (up to Week 76).

The dosage used in the studies had ranged from 75 - 600 mg by subcutaneous injection, and it was given every 2 or every 4 weeks. This would be decided upon by using subjects’ serum total IgE level (30−1500 IU/mL) and their body weight (30–150 kg) prior to their treatment initiation in POLYP 1 and POLYP 2. Each of those participating was given intranasal mometasone.

In order to be eligible for recruitment in POLYP 1 and POLYP 2, subjects had to be aged 18−75 years with the condition, in addition to having insufficient responses to treatment with nasal corticosteroids, having a SNOT-22 score of ≥20, having a Nasal Polyps Score of ≥5, and having a Nasal Congestion Score of ≥2.

Previous systemic corticosteroid treatment and/or surgery were not required by the research team. Those in both studies who successfully completed their treatment period were eligible to participate in the extension, with 249 of them ending up being included in total.

The investigators mainly looked at outcomes in sleep using the sleep domain of the Sino-Nasal Outcome Test-22 (SNOT-22), using a minimum clinically important difference [MCID] > 4 in patients with chronic rhinosinusitis. They also utilized the Medical Outcomes Study Sleep Scale (MOS-Sleep) for their evaluations.

Additionally, the team looked at participants’ health status through both the Healthy Days Core Module (HDCM) and the sinonasal-specific Patient Global Impression of Change (PGIC), looking at patient reported data.

Findings

Overall, the investigators reported that omalizumab showed efficacy in its ability to enhance sleep scores in the SNOT-22 sleep domain. At the 24-week mark, they found that the the adjusted mean (95%CI) SNOT-22 sleep scores among subjects were shown to have lowered from the point of baseline by −8.5 (–9.9 to –7.1) for the treatment arm compared to –2.7 (–4.1 to –1.3) for the placebo arm of the study.

At the 52-week mark, the research team noted that participants’ adjusted mean (95%CI) SNOT-22 sleep scores had diminished from the point of baseline by −10.1 (–11.4 to –8.7) with use of the drug. The team added that improvement was seen in 8 items in the SNOT-22 sleep domain, including those related to frustration/restlessness/irritability, diminished productivity, falling asleep issues, participant fatigue, lack of strong sleep, diminished concentration, waking up tired, and waking up in the night.

In addition, the investigators showed that the drug led to positive impacts on 6 out of 8 of the sleep outcomes found on the MOS-Sleep scale. This was also accompanied by enhancements in both HDCM and PGIC.

“Considerations for future studies may include the impact of comorbidities and previous treatments, and the association between clinical status of patients with CRSwNP and sleep,” they wrote. “Health-care providers are also encouraged to assess sleep in patients with CRS with or without NP and to consider whether patients who present with sleep disorders or sleep-disordered breathing may have an underlying respiratory condition…”