Omalizumab Shows Continued Efficacy for Chronic Rhinosinusitis With Nasal Polyps

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, held virtually from November 13 to 15.

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.

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.

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.