Canadian multidisciplinary expert consensus on the use of biologics in upper airways: A Delphi study

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ObjectiveTo investigate the frequency and nature of adverse events related to type 2 biologic use in patients with chronic rhinosinusitis with nasal polyps (CRSwNP), including dupilumab and mepolizumab.MethodsThis is a single‐institution retrospective study of real‐world patient data. Patients were included if they have a diagnosis of CRSwNP, have undergone at least one endoscopic sinus surgery, and have taken at least two doses of dupilumab or mepolizumab between January 1, 2016, and July 1, 2023. Data collected include clinicodemographic information and past medical/surgical history. The primary outcomes are the incidence and types of adverse events. Adjusted odds ratio was calculated to compare the biologics using logistic regression. Risk factors for developing adverse events were investigated.ResultsEighty‐seven patients on dupilumab and 51 patients on mepolizumab were included. Thirty‐nine (45%) and 10 (20%) patients respectively encountered adverse events, which differed from phase 3 trial data. The adjusted odds ratio for adverse event rates between these two treatment groups was 3.8 (95% CI, 1.5–10.5). The most common adverse events for dupilumab were arthralgia (16%), rash (14%), and conjunctivitis or xerophthalmia (10%). The main adverse events for mepolizumab were headache (6%) and fatigue (6%). Seven dupilumab and three mepolizumab patients discontinued therapy due to adverse events. The average duration of treatment was 22.5 (range: 1–77) months for mepolizumab and 15.9 (range: 1–35) months for dupilumab.ConclusionDupilumab and mepolizumab have distinct adverse event profiles. This study contributes to informing clinicians' decisions regarding the use of type 2 biologics in CRSwNP patients.Level of Evidence3 Laryngoscope, 2024

Real‐World Adverse Events After Type 2 Biologic use in Chronic Rhinosinusitis with Nasal Polyps

Dorling,

Hernaiz‐Leonardo,

Pascual

et al. 2024

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Prescribing Practices and Barriers of Biologics for Chronic Rhinosinusitis Amongst Otolaryngologists

Bell,

Thamboo,

Monteiro

et al. 2024

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Objective(s)Biologics for chronic rhinosinusitis with nasal polyposis (CRSwNP) are an evolving therapeutic option, but there are limited data on physician experiences in prescribing them. The goal of this study was to gain a better understanding of these experiences including prescribing practices, patient factors which guide prescriber decision, and physician and patient‐reported issues which might limit cost‐effectiveness of these therapies.MethodsA survey was distributed to attending otolaryngologists using the Canadian Society of Otolaryngology (CSOHNS) email distribution and eSurvey program. Responses were tabulated for the entire cohort and compared between rhinologists and non‐rhinologists where appropriate. Frequencies and proportions were expressed as a percentage of total respondents. Fisher's exact test was used for statistical analysis between groups.ResultsSeventy‐nine total survey responses were recorded representing a response rate of 43%. Significantly more rhinologists reported prescribing biologic medications on their own (100% vs. 50%; p < 0.001) and a higher proportion (1 to 10% vs. <1%) of their patients were on biologics compared with non‐rhinologists (p = 0.023). Rhinologists were more likely to consider poor response to medical therapies, need for rescue steroids, and comorbid type 2 conditions in their decision to pursue biologics than non‐rhinologists, but they also experienced poorer assistance from patient support programs and less availability to medications.ConclusionRhinologists are more comfortable with prescribing and managing biologics for CRSwNP compared with non‐rhinologist colleagues. Clinicians prescribing biologic medications for CRSwNP should be familiar with guidelines, indications, and potential adverse events.Level of EvidenceN/A Laryngoscope, 2024

In Response to Prescribing Practices and Barriers of Biologics for Chronic Rhinosinusitis Amongst Otolaryngologists

Bell,

Thamboo,

Monteiro

et al. 2024

We would like to thank Dr. Conti and colleagues for their commentary on our article. 1 While we agree with the sentiment that more education for prescribers is necessary to enable access to biologics for CRSwNP, our findings also stress the importance of educating all relevant stakeholders. Most central to this are patients, who need adequate counseling on the benefits and risks of treatment, and the consequences of uncontrolled disease to encourage acceptance of biologics and compliance. Insurers and policy makers also need to better understand the disease course and the challenges in management of CRSwNP, in order to compel them to provide greater financial support to make biologics more accessible.Secondly, it is pertinent to consider the context in which our study took place. As stated in the methodology, our survey was distributed just prior to the publication of the Canadian multidisciplinary expert consensus on the use of biologics in the upper airways. 2 These national guidelines did not have sufficient time to be applied into practice when our study was conducted. While European guidelines already established biologic indications and follow-up criteria for CRSwNP, its adoption by Canadian prescribers may have been hindered by geographical differences in healthcare delivery and systems. It is likely that if we had surveyed our respondents at a later point, it would have yielded significantly different responses and may have empowered more general otolaryngologists to prescribe biologics, who are often the first healthcare provider to diagnose CRSwNP in our system. We presume that Conti and colleagues are not suggesting that primary care physicians and non-Otolaryngologists prescribe biologics for refractory CRSwNP, as this strategy would not be feasible given their lack of training and diagnostic tools to accurately identify type 2 CRSwNP, and it would be inappropriate to remove the otolaryngologists out of the management process entirely. Such a strategy could lead to inappropriate use of biologics, unnecessary side effects, and impose greater costs.Lastly, we disagree with the notion that the high cost of biologics is a minor consideration. A cost-effectiveness analysis has previously shown that dupilumab was more costly and less effective than the ESS strategy, and the sensitivity analysis demonstrated ESS to be cost-effective compared with dupilumab regardless of the frequency of revision surgery. 3 In a single payer healthcare system supported by private pharmaceutical insurance coverage, the cost of biologics must be considered, especially as our healthcare systems strive to achieve the Triple Aim framework. 4