Treatment with omalizumab for up to 1 year was associated with continued improvements in symptoms of chronic rhinosinusitis with nasal polyps, according to study results presented at the American College of Allergy, Asthma, & Immunology (ACCAI) Annual Scientific Meeting.

According to the study investigators, there is currently a significant unmet need for effective long-term management of chronic rhinosinusitis with nasal polyps. Omalizumab, a humanized monoclonal antibody that binds to free immunoglobulin E, may address this unmet treatment need, according to results from previous clinical trials.

The presented study results were from an open-label extension study (ClinicalTrials.gov Identifier: NCT03478930) of 249 patients who received omalizumab or placebo during a 24-week period in the POLYP1 (ClinicalTrials.gov Identifier: NCT03280550) or POLYP2 (ClinicalTrials.gov Identifier: NCT03280537) trials.

In the open-label extension study, patients continued to receive omalizumab for 28 weeks followed by a 24-week omalizumab-free follow-up period. Efficacy end points for the study included changes from baseline in the nasal polyp score (NPS), nasal congestion score (NCS), and the Sino-Nasal Outcome Test-22 (SNOT-22). Adverse events (AEs) and AEs resulting in discontinuation of omalizumab were also assessed.


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Patients who received omalizumab in the POLYP1 and POLYP2 trials continued to experience improvements in the NPS, NCS, and SNOT-22 through week 52 in the open-label extension. Also, patients randomly assigned to placebo in the POLYP1 and POLYP2 trials experienced rapid and large improvements in these end points.

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Participants who withdrew from omalizumab therapy had gradual worsening of their NPS, NCS, and SNOT-22 scores. These scores, however, remained below pretreatment levels at week 76. The investigators noted that the safety profile of the omalizumab in the open-label extension trial “was similar to previous reports.”

Reference

Gevaert P, Saenz R, Corren J, et al. Continued safety/efficacy of omalizumab in chronic rhinosinusitis with nasal polyps: an open-label extension study. Presented at: the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting (Virtual Experience). November 13-15, 2020. Abstract D202.

This article originally appeared on Pulmonology Advisor