The potential role of biological treatment of chronic rhinosinusitis with nasal polyps: a nationwide cohort study

Abstract

Background: Chronic rhinosinusitis with nasal polyps (CRSwNP) can be a challenge to treat despite appropriate pharmacological therapy and endoscopic sinus surgery. With the introduction of biological treatment, costs will increase. In this study, we determine the number of patients with CRSwNP treated with endoscopic sinus surgery and revision surgery and thereby fulfil the main criterion for treatment with biologics in the newest European guidelines. Furthermore, we estimate a potential number of recipients of biologics nationwide. Methods: All adult patients registered in the Danish National Patient Registry as having undergone first endoscopic sinus surgery for CRSwNP from 2012–2018 were included. The number of operations, surgery dates, and comorbidities were extracted. The Kaplan-Meier method was used to calculate the revision rate over time. Revision surgery was used as a surrogate to determine the pool of potential recipients of biologics, as these would fulfil the eligibility criteria and ensure the necessary cost-effectiveness. Results: A total of 4667 operated patients with CRSwNP were included out of a population of 4.7 million adults (incidence 14/100,000 person-years). Approximately 18% (120 per year) was estimated to have revision surgery within seven years. The median time to revision surgery was 22 months. Of all analysed patients, 21% had registered asthma and/or allergic rhinitis, while these diseases were registered in 34% of patients treated with revision surgery. Conclusion: In Denmark, an average of 120 operated patients annually will have revision surgery within seven years and may benefit from treatment with biologics as an alternative option to revision surgery.

Two‐year results of tapered dupilumab for CRSwNP demonstrates enduring efficacy established in the first 6 months

“…Whereas previously patient and physician had to revert to yet another surgery or OCS course, entailing risk of iatrogenesis, what we considered medico-surgical refractory CRSwNP can now often effectively be controlled. 19,[32][33][34]52,53 Real-world evidence and practice will further mold currently deployed treatment strategies to advance patient selection, preferred therapy, and cost efficacy to enable durable employment of this yet costly modality. 27,54 The swift and enduring improvements achieved by tapered dupi-…”

“…14,15 Despite optimal care, a subpopulation of patients with severe CRSwNP-especially those with T2-predominant CRSwNP and associated co-morbidity-remains poorly controlled, or not at all. [16][17][18][19][20][21] This group of patients is often subject to cumulative high-dose OCS therapy and/or repeated and extensive revision surgery imposing risks of iatrogenic damage with potentially long-term sequelae. 19,[22][23][24] The last decades gave rise to biologicals targeting T2inflammatory pathway components, which have been registered for and implemented in the treatment strategies of atopic dermatitis, asthma, eosinophilic esophagitis, and, as of late 2019, CRSwNP, and is of interest for allergic rhinitis.…”

“…[16][17][18][19][20][21] This group of patients is often subject to cumulative high-dose OCS therapy and/or repeated and extensive revision surgery imposing risks of iatrogenic damage with potentially long-term sequelae. 19,[22][23][24] The last decades gave rise to biologicals targeting T2inflammatory pathway components, which have been registered for and implemented in the treatment strategies of atopic dermatitis, asthma, eosinophilic esophagitis, and, as of late 2019, CRSwNP, and is of interest for allergic rhinitis. [25][26][27][28][29][30] Currently available registered biologicals for CRSwNP in temporal order of registration are dupilumab (Dupixent®; Sanofi), omalizumab (Xolair®; Novartis), and mepoluzimab (Nucala®; GSK).…”

Biologicals and Endoscopic Sinus Surgery for Severe Uncontrolled Chronic Rhinosinusitis With Nasal Polyps: An Economic Perspective

“…An exploratory study in Denmark estimated that this would amount to 120 patients/y in a population of approximately 4.7 million adults (about 1:40.000/y). 37…”

Unmet needs in biological treatment of CRS

“…When following these criteria, a limited number of CRSwNP patients would be eligible for biological treatment (5,6) . Important One of the aspects that also needs further research in the treatment with biologicals is the evaluation of smell.…”