Omalizumab shows sustained benefits in chronic rhinosinusitis with polyps

The benefits of omalizumab in symptom improvements continue to hold up over 52 weeks in patients with chronic rhinosinusitis with nasal polyps (CRSwNP), according to data from the extension phase of POLYP1 and POLYP2 studies presented at the ACAAI 2020 Meeting.

Long-term treatment of CRSwNP presents a significant unmet need, said presenting author Dr Philippe Gevaert of Ghent University in Ghent, Belgium.

Nasal polyps can lead to nasal congestion and a loss of smell. Often, it also co-occurs with other respiratory conditions, for instance, allergies and asthma.

“With omalizumab, we observed significantly reduced nasal polyps and congestion symptoms in adults who had nasal polyps in two pivotal phase III studies,” said study co-investigator Dr Joseph Han from Eastern Virginia Medical School in Norfolk, Virginia, US.

“Omalizumab provides a new option for treating these patients, who often have other respiratory and allergic conditions that may further worsen symptoms,” he added.

Omalizumab is a humanized monoclonal antibody which binds to local circulating immunoglobulin E (IgE) to reduce inflammation in nasal polyps.

The current phase III, open-label extension study enrolled 249 adult patients who had completed the double-blind phase which previously randomized them in a 1:1 ratio to receive either omalizumab or placebo for 24 weeks. Participants were CRSwNP patients with inadequate response to intranasal corticosteroids. [ACAAI 2020, abstract D202] 

All patients were treated with omalizumab in the open-label extension phase for another 28 weeks, followed by treatment withdrawal and a further 24 weeks of follow-up.

Among patients previously randomized to omalizumab and continued on treatment in the open-label phase, improvements persisted through 52 weeks across multiple efficacy endpoints, including nasal congestion scores (mean change, -0.99, 95 percent confidence interval [CI], -1.14 to -0.83) and nasal polyp scores (mean change -0.97, 95 CI, -1.25 to -0.69).

Similarly, patient-reported outcome measure using the Sino-Nasal Outcome Test (SNOT) also showed significant improvement over 52 weeks (mean change, -22.39, 95 percent CI, -25.39 to -19.40).

Those previously randomized to the placebo arm in the double-blind phase also saw substantial and rapid improvements with omalizumab at week 52 in the extension study.

“Scores gradually worsened following omalizumab withdrawal, but remained below pretreatment levels [ie, better] at week 76,” said Gevaert.

Safety profile was similar to those previously observed in the double-blind phase, with a generally well tolerated profile. Nasopharyngitis was the most common adverse event reported during treatment, occurring at a rate of 4.8 percent, reported Gevaert.

“The safety and efficacy profile from this study supports continued omalizumab treatment for patients with CRSwNP,” he concluded.

Based on data from POLYP1 and POLYP2, omalizumab has just recently been approved as add-on maintenance therapy for nasal polyps in adults with inadequate response to intranasal corticosteroids. Omalizumab was previously approved for treatment of moderate-to-severe persistent allergic asthma.