Approximately 25 percent of people with chronic rhinosinusitis have nasal polyps, a condition associated with significant morbidity and decreased quality of life.1 Since 2019, the Food and Drug Administration (FDA) has approved several biologics to treat chronic rhinosinusitis with nasal polyps (CRSwNP), and other biologics are currently in clinical trials. As these new, promising therapies emerge, more research will inform patient selection, indications for use, efficacy and cost-effectiveness.
New guidance for using biologics to manage CRSwNP was recently published, with Lauren T. Roland, MD, head and neck surgeon at UC San Francisco, serving as the lead author. During a two-day workshop sponsored by the National Institutes of Health (NIH), a multidisciplinary group of specialists, including rhinologists, biostatisticians, allergists, immunologists and pharmaceutical representatives, discussed current and future research needs for evaluating the use of biologics in patients with CRSwNP and these discussions are reflected in the guidance.
Existing data on biologics for asthma informed the guidance
Roland and a small team of workshop participants used existing data regarding the use of biologics for asthma, the workshop discussions and their understanding of the pathophysiology of CRSwNP to develop the guidance. “We aimed to figure out where biologics fit in the treatment algorithm,” Roland said.
The guidance addresses some of the more difficult-to-treat CRSwNP-related conditions, including recalcitrant nasal polyps, aspirin-exacerbated respiratory disease (AERD) and allergic fungal rhinosinusitis (AFRS). The cost of long-term biologics use is also evaluated.
CRSwNP treatment algorithm
Roland and the team propose a treatment algorithm for CRSwNP that includes:
- Evaluation and management of comorbidities such as asthma.
- Determination of the presence of specific CRSwNP endotypes such as AERD or AFRS.
- Medical management with saline irrigation, steroids and antibiotics.
- Functional endoscopic sinus surgery (FESS) with postoperative medical management.
- Revision FESS if indicated.
- Initiation of biologic therapy.
According to the algorithm, biologics should be reserved for patients who do not respond to other therapies. Due to the cost of these medications, evaluation at four months of use is recommended to determine treatment effectiveness and consider stoppage if response is lacking.
Ongoing studies are needed
“One of the goals of the meeting was to figure out how biologics should be studied,” Roland said. “More research is needed on who should be treated with biologics and at what stage in their disease.”
As biologics use becomes more widespread, ongoing studies will compare biologics to current standard treatments and among different biologic medications. Until the results of further research are available, the published guidance based on the NIH workshop is a practical resource to consult when considering treatment options for patients with CRSwNP.
To learn more:
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1. Stevens WW, Schleimer RP, Kern RC. Chronic rhinosinusitis with nasal polyps. J Allergy Clin Immunol Pract. 2016;4:565-572.