The majority of guidelines and recommendations available limit biologics to cases of severe and uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP) and require prior surgery.
Despite multiple international guidelines on the use of biologics to treat chronic rhinosinusitis with nasal polyps (CRSwNP), most are similar regarding the prescription and monitoring of biologics for the disease, according to a study published in European Archives of Oto-Rhino-Laryngology.
In many patients with CRSwNP, type 2 inflammation may be the underlying cause of the disease. Uncontrolled symptoms include shortness of breath, loss of smell, and nasal discharge.
Endoscopic sinus surgery is a highly effective and minimally invasive treatment approach; however, it is insufficient for a proportion of cases. The development of antibodies that target the specific molecules involved in type 2 inflammation represented a recent breakthrough in treatment for CRSwNP.
“Despite their evident benefits, the large cost of biologic therapies and their presumed life-lasting duration has prompted the drafting of international guidelines, with the target to identify subsets of patients who are more likely to benefit from these agents,” the authors explained.
Previous research has found that the total cost of endoscopic sinus surgery, on a time horizon of 36 years, was $50,000 for 9.80 quality-adjusted life years. In comparison, biologics cost more than $536,000 for only 8.95 quality-adjusted life years.
Researchers from San Raffaele University in Milan, Italy, and Hospital Lariboisière in Paris, France, performed a literature review to evaluate current recommendations. International organizations and regional meetings have developed different guidelines and opinions on the use of biologics to treat CRSwNP.
They identified publications that reported on biologic therapy in CRSwNP and compared specific issues: prior surgery, evidence of type 2 inflammation, smell function, comorbidities, use of systemic corticosteroids, impact on quality of life, and endoscopic and CT findings.
A total of 10 publications were included that had “clear positions, statements, or guidelines for the initial prescription and/or subsequent monitoring of response of biologic therapies in CRSwNP.”
The “general consensus” among the papers was that biologics should limited to cases of severe and uncontrolled CRSwNP.
Six papers strongly recommended prior surgery unless there are exceptional circumstances and the remaining four papers only considered prior surgery as a condition to consider.
In four papers, confirmation of type 2 inflammation was one of five criteria for prescription. Three of the papers identified confirmation of type 2 inflammation as mandatory or required to be highly likely. In the last three papers, it was not strictly necessary or even considered.
The majority of publication considered olfactory performance, presence of type 2 comorbidities, need for systemic corticosteroids to control the disease, polyp extension, and impact on quality of life for prescription of biologics.
For the seven publications that provided indications for monitoring of response to biologics, most considered improvement in polyp size, quality of life, need for systemic corticosteroids, and comorbidities to assess response.
Overall, the researchers determined that guidelines for prescribing and monitoring biologics for patients with CRSwNP have many similarities, and they emphasize have different conditions and define specific cutoffs regarding the proportion of patients these treatments should be prescribed to.
“This fact may reflect changes in the availability and price of biological therapy, but also variable economic burden and healthcare affordability in the different contexts these guidelines are addressed to,” they concluded.