ABSTRACT
Introduction: Chronic rhinosinusitis with nasal polyposis (CRSwNP) poses a significant healthcare challenge, with diminished quality of life for patients and high costs and resource utilization for disease management. The understanding of CRSwNP pathophysiology has progressed with identification of various inflammatory biomarkers and subsequent development of monoclonal antibodies that target the underlying mechanisms of inflammation.
Areas covered: Omalizumab is a biologic agent for CRSwNP treatment that targets immunoglobulin (Ig)-E. The US FDA has approved the use of omalizumab as an add-on biologic therapy for nasal polyposis in December 2020. Two Phase III clinical trials, POLYP 1 and POLYP 2, have shown that omalizumab improves both subjective patient-reported outcomes and objective physician-evaluated metrics for CRSwNP. Ongoing studies are still exploring the efficacy, safety, and cost-effectiveness of biologics for CRSwNP.
Expert opinion: Biologics will continue develop as a viable management option for CRSwNP. Omalizumab is regarded as a promising addition to current treatment strategies for refractory disease.
Article highlights
Omalizumab is a recently FDA-approved biologic approved for use in CRSwNP
Omalizumab is a monoclonal antibiotic which targets free IgE to downregulate the Th2 inflammation pathway
Omalizumab has shown significant improvement in disease severity in both Phase II and Phase III studies
Generally, most participants tolerated omalizumab well with only minor adverse effects
There is great need for cost-effective analyses for omalizumab and other biologics
Declaration of interest
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.
Correction Statement
This article has been republished with minor changes. These changes do not impact the academic content of the article.