Clinical Research Needs for the Management of Chronic Rhinosinusitis with Nasal Polyps in the New Era of Biologics: A National Institute of Allergy and Infectious Diseases Workshop

In November 2019, the NIH hosted the first-ever conference dedicated to chronic rhinosinusitis with nasal polyps (CRSwNP). Clinical experts from allergy and otolaryngology, along with scientific researchers met to discuss current treatments for the disease and directions for future research. Historically, CRSwNP has been treated with a combination of intranasal and corticosteroids and endoscopic sinus surgery. Recently, dupilumab, a biologic that blocks IL-4 and IL-13 signaling, was FDA approved as a highly effective treatment for CRSwNP. As dupilumab is gaining popularity as a treatment option, other biologics are currently being researched and developed. The emergence of biologics as treatments for CRSwNP introduces new questions including the role of endoscopic surgery paired with biologic treatment and the cost-effectiveness of each (apart and together). 

There are several opportunities for research on this topic. One ideal clinical trial would compare biologics versus surgery treatment on quality of life outcome. However, such a trial is difficult to ethically and logistically design. There is hope that use of the FDA’s adaptive clinical trial design will be advantageous in overcoming those hurtles. Another research opportunity lies in investigating whether response to traditional corticosteroids can be used to predict responsiveness to biologics. There are many more questions to be answered as biologics gain popularity as treatment options. This report highlights several considerations concerning biologic treatment moving forward.