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Key Points: In 2021, Medicare spending on biologics was $926 million in Part B (FFS) and $1.3 billion in Part D (FFS/MA). Between 2017 and 2021, annual Medicare spending on biologics increased by approximately 200%. Between 2023 and 2025, Medicare Part D OOP costs for biologics will decrease by an estimated 50%-60%., (© 2024 ARS‐AAOA, LLC.)

Background: It is unclear whether chronic rhinosinusitis (CRS) endotypes show a differential response to endoscopic sinus surgery (ESS). We explored patient mucous inflammatory cytokine expression and associations with patient-reported and clinically measured post-operative outcome measures., Methods: Patients with CRS were prospectively recruited between 2016 and 2021 into a national multicenter, observational study. Mucus was collected from the olfactory cleft preoperatively and evaluated for 26 biomarkers using cluster analysis. Patient-reported outcome measures included the 22-item Sino-Nasal Outcome Test (SNOT-22) and Questionnaire of Olfactory Dysfunction (QOD). Additional clinical measures of disease severity included threshold, discrimination, and identification (TDI) scores using "Sniffin' Sticks" testing and Lund-Kennedy endoscopic score (LKES)., Results: A total of 115 patients were clustered into type 2 inflammatory, non-type 2 inflammatory, noninflammatory, and two indeterminate clusters based on individual protein levels. Overall, the type 2 inflammatory cluster was found to have the highest mean improvement in both SNOT-22 (-28.3 [standard deviation, ±16.2]) and TDI (6.5 [standard deviation, ±7.9]) scores 6 months after ESS. However, on average, all endotype clusters demonstrated improvement in all outcome measures after ESS without statistically significant between-group differences in SNOT-22 (p = 0.738), QOD (p = 0.306), TDI (p = 0.358), or LKES (p = 0.514) measures., Conclusions: All CRS endotype clusters responded favorably to surgery and showed improvements in patient-reported and objective outcome measures. Thus, ESS should be considered a more generalized CRS therapy, and benefits appear to not be limited to specific endotypes., (© 2023 ARS‐AAOA, LLC.)

Background: The purpose of this study was to investigate real-world adherence to intranasal corticosteroid irrigations using pharmacy data and assess factors associated with low adherence., Methods: Patients undergoing treatment with corticosteroid irrigations for any diagnosis during a 2-year period were prospectively recruited. Subjects completed a one-time set of questionnaires including the Barriers to Care Questionnaire (BCQ), 22-item Sino-Nasal Outcome Test (SNOT-22), and a questionnaire assessing their experience with corticosteroid irrigations. Pharmacy data was used to calculate the medication possession ratio (MPR), a measure of medication adherence graded from 0 to 1., Results: Seventy-one patients were enrolled. Patient diagnoses included chronic rhinosinusitis (CRS) without nasal polyps (n = 37), CRS with nasal polyps (n = 24), or a non-CRS diagnosis, most commonly chronic rhinitis (n = 10). The MPR for the overall group was 0.44 ± 0.33. Just 9.9% of patients had a perfect MPR of 1. Despite low MPR, only 19.7% of patients reported problems taking the medication when directly asked. Lower education resulted in lower MPR (unstandardized B = 0.065, p = 0.046). Increasing BCQ score, indicating higher barriers to care, was associated with lower MPR (unstandardized B = -0.010, p = 0.033). The lower the MPR, the worse the patient SNOT-22 scores (unstandardized B = -15.980, p = 0.036)., Conclusion: Adherence to corticosteroid irrigations was low and patients underreported issues with their medication. Education and barriers to care were associated with lower adherence, which, in turn, was associated with worse sinonasal quality of life., (© 2023 ARS-AAOA, LLC.)

Background: Many studies have identified a higher degree of Olfactory Dysfunction (OD) in Black patients compared to White patients. This study aims to analyze olfactory outcomes in different races., Methods: The PubMed, Scopus, and CINAHL databases were searched from inception to September 5, 2022, for English-language articles documenting self-reported and psychophysical OD stratified by race. A meta-analysis of proportions, comparison of weighted proportions, and comparison of means were performed in MedCalc 20.218. In the quantitative analysis, 79,297 patients were included, comprising 79.3% Whites, 16.1% Blacks, and 4.6% Hispanics., Results: A total of 14 studies were meta-analyzed. The prevalence of self-reported OD in Hispanic, White, and Black patients was 19.5% (95% CI, 16.6% to 22.6%), 17.2% (95% CI, 10.5% to 25.0%), and 13.9% (95% CI, 9.3% to 19.2%), respectively (p < 0.0007). The prevalence of psychophysical OD in Black, White, and Hispanic patients was 30.3% (95% CI, 24.2% to 36.9%), 24.2% (95% CI, 20.1% to 28.5%), and 18.4% (95% CI, 16.3% to 20.7%), respectively (p < 0.0001). Blacks reported a greater extent of unrecognized OD compared to Whites, with a difference of 16.5% (95% CI, 15.0% to 17.9%) versus 5.8% (95% CI, 3.4% to 8.0%), respectively (p < 0.0001). Hispanic rates of self-reported OD and psychophysical OD were not statistically different., Conclusions: Our findings suggest that Blacks have the highest rate of psychophysical OD and are more likely to underreport their awareness compared to Whites., (© 2023 ARS-AAOA, LLC.)

Background: Inflammatory patterns in chronic rhinosinusitis (CRS) may predict disease severity, need for multiple sinus surgeries, and treatment response. This study analyzes nasal mucus inflammatory cytokine patterns in patients with (CRSwNP) and without (CRSsNP) nasal polyposis and their association with revision sinus surgery., Methods: A total of 319 CRS patients who underwent sinus surgery were included. Cytokines were quantified in intraoperative mucus specimens using a multiplex flow cytometric bead assay. Cytokine expression patterns in patients with 0, 1, and ≥2 previous surgeries were analyzed using Kruskal-Wallis and principal component (PC) regression analyses., Results: There were 122 (38%) patients with CRSsNP and 197 (62%) with CRSwNP. On univariate analysis, interleukin (IL)-1β, IL-6, IL-8, and IL-21 were associated with increasing number of sinus surgeries in CRSsNP, as were IL-2, IL-4, IL-5, IL-6, IL-9, IL-17A, and tumor necrosis factor (TNF)-α in CRSwNP. PC analysis with continuous Poisson regression in CRSwNP demonstrated that high IL-5 and IL-13 and low IL-1β, IL-12, and IL-21 were associated with more prior surgeries. In CRSsNP low IL-13 and high IL-5 and regulated-on-activation, normal T-cell-expressed and secreted (RANTES) were associated with more prior surgeries. Age remained a significant covariate in the full regression model for CRSsNP, but was nonsignificant in CRSwNP., Conclusion: In CRSwNP, elevated IL-5 and IL-13 levels were higher at time of surgery in patients with more prior surgeries. Type 2 cytokines in CRSsNP demonstrated mixed associations with revision surgery. For both phenotypes, IL-10, IL-12, and IL-21 were consistently lower as number of prior surgeries increased, suggesting that treatment-resistant disease may be modulated by impairment in these signaling pathways., (© 2022 ARS-AAOA, LLC.)

Background: Recent advances in molecular biology have enabled the identification of potential inflammatory endotypes of chronic rhinosinusitis (CRS), with prior work suggesting differential short-term surgical outcome trajectories based on cytokine signatures. However, there is a paucity of data assessing long-term treatment failure and need for revision surgery based on inflammatory biomarkers., Methods: Retrospective analysis of prospectively collected cross-sectional data from 231 patients electing surgical therapy for CRS. Intraoperative mucus specimens were quantitatively sampled for inflammatory cytokines using a multiplex flow cytometric bead assay. Univariate Spearman correlations between cytokine levels and prior number of surgeries were assessed. A stepwise adjusted multivariate Poisson regression analysis was used to model patient-reported prior sinus surgery counts as a function of cytokine levels., Results: Several cytokines (interleukin [IL]-1β, IL-4, IL-5, IL-6, IL-8, IL-10, IL-13, IL-17A, tumor necrosis factor α [TNF-α], interferon γ [IFN-γ], and eotaxin) demonstrated significant positive correlations with number of prior surgeries. However, only higher IL-17A levels were independently associated with a higher number of prior sinus surgeries (β = 0.345, p = 0.0003) after adjusting for the significant covariates of age (β = 0.018, p = 0.0036), Lund-Mackay score (β = -0.046, p = 0.02), history of aspirin-exacerbated respiratory disease (β = 1.01, p < 0.0001) and allergic fungal rhinosinusitis (β = 1.08, p < 0.0001). Higher levels of regulated on activation, normal T-cell expressed and secreted (RANTES) were conversely associated with a lower number of prior surgeries (β = -0.17, p = 0.048)., Conclusion: An IL-17A-predominant cytokine profile is linked to an increased number of prior sinus surgeries. Thus, type 3 inflammatory markers may indicate a particularly difficult-to-treat, recalcitrant CRS endotype., (© 2020 ARS-AAOA, LLC.)

Background: Tumor necrosis factor alpha (TNF-α) inhibitors have revolutionized treatment of many inflammatory diseases. Sinusitis after initiation of TNF-α inhibitors has been observed, but has not been well described in the literature. We aim to characterize the clinical features of sinusitis in patients on anti-TNF-α therapy., Methods: This is a retrospective chart review of 28 patients on a TNF-α inhibitor diagnosed with sinusitis by otolaryngologists at Duke University. Patient demographics, sinusitis characteristics, and treatment course were studied by chart review., Results: The prevalence of sinusitis diagnosed and treated by an otolaryngologist was less than 1%. Of the 28 patients studied, 12 (42.9%) had a history of preexisting sinusitis and 16 (57.1%) had new-onset sinusitis. 71.4% were diagnosed with chronic rhinosinusitis without polyps (CRSsNP), with disease mainly involving the maxillary and ethmoid sinuses. No patients had major extrasinus complications or required hospital admission or intravenous (IV) antibiotics. 35.7% (n = 10), including 44% (7/16) of new-onset patients required a surgical intervention after initiating anti-TNF therapy. 14.3% (n = 4) of the cohort had improvement in sinonasal symptoms after stopping, changing, or holding doses of the TNF-α inhibitor., Conclusion: Anti-TNF-α therapy can be associated with new-onset sinusitis, mainly CRSsNP. Overall, the percentage of patients on a TNF-α inhibitor seeking consultation from an otolaryngologist is low. While some patients with new-onset sinusitis will require surgery, modification of anti-TNF-α therapy should be considered as an option in the medical management of these patients., (© 2016 ARS-AAOA, LLC.)

Background: The retroantral ethmoid cell (RAEC) is defined as a posterior ethmoid cell that pneumatizes inferolaterally behind the posterior wall of the maxillary sinus. The RAEC can present a challenge to otolaryngologists during endoscopic ethmoidectomy due to its concealed location. It is also encountered during the endoscopic transpterygoid approach to the skull base, which requires dissection behind the posterior wall of the maxillary sinus. Because the RAEC is not described in the literature, this study aims to better characterize this anatomic variant., Methods: This is a retrospective review of 58 consecutive patients who underwent revision functional endoscopic sinus surgery (FESS) within a 2-year period at a tertiary referral center. Sinus computed tomography (CT) scans for this cohort (116 sides total) were reviewed independently by 3 authors to determine the incidence of the RAEC and the degree of surgical dissection during prior surgery., Results: Of the 116 sides included in the study, RAEC was identified in 19 (16%). Furthermore, 14 of 19 (74%) cells were diseased with evidence mucosal thickening or neo-osteogenesis. Of the 12 sides with RAEC that had evidence of previous posterior ethmoidectomy, 4 (33%) cells were not opened, 6 (50%) were partially opened, and only 2 (17%) were completely opened., Conclusion: This study demonstrates the relatively high prevalence of the RAEC in our patient population. The majority of RAECs showed both evidence of disease and that they were not completely opened during previous surgery. Recognition of this anatomic entity may allow for more thorough ethmoidectomy., Competing Interests: The authors have no conflicts of interests, financial or otherwise to disclose., (© 2016 ARS-AAOA, LLC.)