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Showing papers in "International Forum of Allergy & Rhinology in 2022"


Journal ArticleDOI
TL;DR: The aim of this study was to estimate the prevalence of self‐reported chemosensory dysfunction in a study cohort of subjects who developed a mild‐to‐moderate coronavirus disease 2019 and compared that with a historical series of patients testing positive for severe acute respiratory syndrome–coronavirus‐2 (SARS‐CoV‐2) infection between March and April, 2020.
Abstract: The aim of this study was to estimate the prevalence of self‐reported chemosensory dysfunction in a study cohort of subjects who developed a mild‐to‐moderate coronavirus disease 2019 (COVID‐19) in the period from January 17, 2022, to February 4, 2022 (Omicron proxy period) and compared that with a historical series of patients testing positive for severe acute respiratory syndrome–coronavirus‐2 (SARS‐CoV‐2) infection between March and April, 2020 (comparator period).

65 citations


Journal ArticleDOI
TL;DR: Experts from around the world have gathered to produce the International Consensus on Allergy and Rhinology: Olfaction (ICAR:O), which aims to consolidate and critically review the evidence on clinical olfaction.
Abstract: The literature regarding clinical olfaction, olfactory loss, and olfactory dysfunction has expanded rapidly over the past two decades, with an exponential rise in the past year. There is substantial variability in the quality of this literature and a need to consolidate and critically review the evidence. It is with that aim that we have gathered experts from around the world to produce this International Consensus on Allergy and Rhinology: Olfaction (ICAR:O).

32 citations


Journal ArticleDOI
TL;DR: It is suggested that although eosinophils play a key role in CRSwNP pathophysiology, IL-5, a cytokine that activates these cells, also represents a pertinent and effective treatment target in patients with CRSWNP.
Abstract: Chronic rhinosinusitis with nasal polyps (CRSwNP) is generally associated with eosinophilic tissue infiltration linked to type 2 inflammation and characterized by elevated levels of interleukin (IL)‐5 and other type 2 inflammatory mediators. Although distinct and overlapping contributions of eosinophils and IL‐5 to CRSwNP pathology are still being explored, they are both known to play an important role in NP inflammation. Eosinophils secrete numerous type 2 inflammatory mediators including granule proteins, enzymes, cytokines, chemokines, growth factors, lipids, and oxidative products. IL‐5 is critical for the differentiation, migration, activation, and survival of eosinophils but is also implicated in the biological functions of mast cells, basophils, innate lymphoid cells, B cells, and epithelial cells. Results from clinical trials of therapeutics that target type 2 inflammatory mediators (including but not limited to anti‐IL‐5, anti‐immunoglobulin‐E, and anti‐IL‐4/13) may provide further evidence of how eosinophils and IL‐5 contribute to CRSwNP. Finally, the association between eosinophilia/elevated IL‐5 and greater rates of NP recurrence after endoscopic sinus surgery (ESS) suggests that these mediators may have utility as biomarkers of NP recurrence in diagnosing and assessing the severity of CRSwNP. This review provides an overview of eosinophil and IL‐5 biology and explores the literature regarding the role of these mediators in CRSwNP pathogenesis and NP recurrence following ESS. Based on current published evidence, we suggest that although eosinophils play a key role in CRSwNP pathophysiology, IL‐5, a cytokine that activates these cells, also represents a pertinent and effective treatment target in patients with CRSwNP.

15 citations


Journal ArticleDOI
TL;DR: The recovery pattern of OD in a cohort of COVID-19 patients with an 18-month follow-up is described and the possible variables associated with spontaneous early or late recovery are analyzed to properly counsel patients during medical visits.
Abstract: Few studies exist on the evolution and recovery of COVID19–related olfactory dysfunction (OD) in the long term. Due to the impact of OD on the quality of life of patients,1 it is mandatory to better define its characteristics, clinical course, and recovery times to properly counsel patients during medical visits as well as to conceive new therapeutic strategies to address the problem. The aim of this study was to describe the recovery pattern of OD in a cohort of COVID-19 patients with an 18-month follow-up and to analyze the possible variables associatedwith spontaneous early or late recovery. Patients were consecutively recruited after admission to a single academic institution from March 5 to March 23, 2020.2 Inclusion criteria were both the presence of SARSCoV-2 infection on nasopharyngeal swab polymerase chain reaction, and OD related to COVID-19. Patients did not undergo any specific treatment for OD. Patients were recruited at the time of laboratory diagnosis (T0) and were interviewed regarding the evolution of OD over time. All interviews were carried out by telephone. Surveys were administered at T0 and at 1, 3, 6, 9, 12, and 18 months from the diagnosis. Dates on which patients reported their olfactory function to be returned to the baseline were recorded, when applicable. SARS-CoV-2 positivity duration was described as the number of days from COVID-19 diagnosis with nasopharyngeal swab to the date of the first of 2 consecutive negative swabs, performed after a minimum of 14 days from the first positive test, as per Italian Ministry of Health Guidelines. The study was approved by our local ethics committee (Protocol No. 1363). Patients rated the quality of their sense of smell as “good,” “average,” “mildly impaired,” “moderately impaired,” “severely impaired,” or “totally absent” (corresponding to a score of 5, 4, 3, 2, 1, or 0 points, respectively) at each follow-up. Patients also rated their olfactory function at the baseline (ie, before the COVID-19 outbreak) and gustatory function during COVID-19 with the same method. Scores of 5 to 4 were considered normal. OD was defined as “mild to moderate” (scores 3 to 2) or “severe to complete” (scores 1 to 0). Subjective perception of nasal obstruction during COVID-19 was assessed by a scale extending from 0 (unimpaired nasal breathing) to 4 or 5 (severe nasal obstruction). Furthermore, patients were asked whether they experienced an improvement in olfactory function within the first 7 days from the first presentation of OD. Data on the presence of self-reported

14 citations


Journal ArticleDOI
TL;DR: The impact of parosmia and other clinical and disease characteristics on health state utility values (HUVs) for those with persistent COVID‐19 OD is investigated.
Abstract: Patients with persistent COVID‐19 olfactory dysfunction (OD) commonly report parosmia. Understanding the impact of COVID‐19 OD and parosmia is critical to prioritizing research and interventions. In this study we investigate the impact of parosmia and other clinical and disease characteristics on health state utility values (HUVs) for those with persistent COVID‐19 OD.

12 citations


Journal ArticleDOI
TL;DR: This paper presents a meta-modelling study of the immune system’s response to otolaryngology-Head Neck Surgery at the single and double-clinique setting.
Abstract: 1Department of Medical, Surgical and Health Sciences, Section of Otolaryngology, University of Trieste, Trieste, Italy 2Guy’s and St Thomas’ Hospitals, London, UK 3Neurobiology Group, SISSA, Scuola Internazionale Superiore di Studi Avanzati, Trieste, Italy 4Department of Basic Medical Sciences, Neuroscience and Sensory Organs, University of Bari “A. Moro,”, Bari, Italy 5Department of Prevention, Section of Hygiene and Public Health, Azienda Sanitaria Universitaria Giuliano Isontina, Trieste, Italy 6Department of Otolaryngology-Head Neck Surgery, Elsan Hospital, Paris, France 7Department of Medical, Surgical and Experimental Sciences, Maxillofacial Surgery Operative Unit, University of Sassari, Sassari, Italy

10 citations


Journal ArticleDOI
TL;DR: In this article , the authors compared dupilumab with functional endoscopic sinus surgery (FESS) in patients with CRSwNP by assessing the change in nasal polyp and SINUS-22 scores postintervention.
Abstract: Background Outside of SINUS-24 (A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps) and SINUS-52 (Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps), there are limited data on the efficacy of dupilumab in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The objective was to compare dupilumab with functional endoscopic sinus surgery (FESS) in patients with CRSwNP by assessing the change in nasal polyp and Sino-Nasal Outcome Test (SNOT-22) scores postintervention. Methods A retrospective matched cohort study compared 54 patients who had CRSwNP treated with dupilumab with 54 patients who had CRSwNP treated with FESS; both cohorts were treated with topical corticosteroids. The primary end points were change in nasal polyp score and overall SNOT-22 score. Secondary end points were change in SNOT-22 domain scores and SNOT-22 olfaction score. Results Patients who underwent FESS had a greater improvement in nasal polyp score (5.18 ± 2.01) compared with patients treated with dupilumab (4.27 ± 1.98, p = 0.02). There was no significant difference in terms of the change in overall SNOT-22 score. Patients treated with dupilumab had greater improvement in the extranasal rhinologic SNOT-22 domain scores (4.87 ± 3.91) compared with patients treated with FESS (2.93 ± 4.32, p = 0.02). There was a greater improvement in the SNOT-22 olfaction scores for patients treated with dupilumab (2.35 ± 2.17) compared with patients treated with FESS (1.48 ± 2.24, p = 0.04). Patients taking dupilumab were followed on average for 12.20 months and patients treated with FESS were followed for 17.90 months. Conclusion Overall, both therapies are effective at reducing symptoms in patients with CRSwNP according to SNOT-22. Patients treated with dupilumab reported improved olfaction and decreased cough, postnasal drainage, and thick nasal drainage as compared with patients treated with FESS, while patients treated with FESS had a greater reduction in polyp burden.

10 citations


Journal ArticleDOI
TL;DR: In this article , the authors compared the cost-effectiveness of dupilumab and ESS treatment for patients with chronic rhinosinusitis with nasal polyps refractory to medical therapy.
Abstract: Background Dupilumab is a novel monoclonal antibody that recently received US Food and Drug Administration approval for the treatment of chronic rhinosinusitis with nasal polyps. Endoscopic sinus surgery (ESS) has been the mainstay of treatment for patients refractory to initial medical therapy. Data comparing the cost-effectiveness of these treatments are scarce. The objective of this study is to compare the cost-effectiveness of dupilumab and ESS treatment for patients with chronic rhinosinusitis with nasal polyps refractory to medical therapy. Methods A cohort-style Markov decision tree economic evaluation with 10-year time horizon was performed. The two comparative treatment strategies were dupilumab therapy or ESS followed by postoperative maintenance therapy. Patients with response to treatment continued with either maintenance or dupilumab therapy; patients with no response underwent ESS. The primary outcome measure was incremental cost per quality-adjusted life-year calculated from Sino-Nasal Outcome Test (SNOT-22) scores. Sensitivity analyses were performed including discounting scenarios and a probabilistic sensitivity analysis. Results The dupilumab strategy cost $195,164 and produced 1.779 quality-adjusted life-years. The ESS strategy cost $20,549 and produced 1.526 quality-adjusted life-years. This implies an incremental cost of $691,691 for dupilumab for every 1-unit increase in quality-adjusted life-year compared with ESS. Probability sensitivity analysis indicated that ESS was more cost-effective than dupilumab in all iterations. Conclusions While dupilumab and ESS may demonstrate similar clinical effectiveness, ESS remains the most cost-effective treatment option and should remain the standard of care for patients with chronic rhinosinusitis with nasal polyps refractory to medical therapy.

9 citations


Journal ArticleDOI
TL;DR: Surgical management of NSPs can be broadly divided into open versus endonasal approaches, with additional variables involving unilateral or bilateral flaps, use of grafts, and placement of splints.
Abstract: A wide variety of techniques for the surgical repair of nasal septal perforations (NSPs) have been described. Surgical management of NSPs can be broadly divided into open versus endonasal approaches, with additional variables involving unilateral or bilateral flaps, use of grafts, and placement of splints. The objective of this study was to compare surgical approaches and their outcomes.

8 citations


Journal ArticleDOI
TL;DR: The evidence for postoperative ESBS precautions is heterogeneous, scarce, and generally of low quality, and this review suggests the urgent need for more robust evidence.
Abstract: Postoperative management strategies for endoscopic skull base surgery (ESBS) vary widely because of limited evidence‐based guidance.

7 citations


Journal ArticleDOI
TL;DR: In this paper , a systematic search of PubMed, CINAHL, Scopus, and Cochrane Library was conducted following Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA).
Abstract: Background Otologic symptoms consistent with Eustachian tube dysfunction (ETD) are common in patients with chronic rhinosinusitis (CRS), but can also occur independently of CRS as primary ETD. It is unclear if CRS+ETD is similar to primary ETD or how treatment outcomes compare. Methods A systematic search of PubMed, CINAHL, Scopus, and Cochrane Library was conducted following Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA). Any study describing ETD in CRS was included. Primary ETD studies were limited to those with preoperative and postoperative Eustachian Tube Dysfunction Questionnaire (ETDQ-7) scores in ETD treated only with Eustachian tube balloon dilation (ETBD). Results Sixteen studies were included: nine studies with 1336 consecutive patients with CRS and seven studies with 161 patients with primary ETD. In studies with specific data, 225 (47.2%) patients with CRS had a score >14.5, consistent with ETD. In CRS+ETD, baseline mean ± standard deviation (SD) ETDQ-7 score was 20.7 ± 8.4 and did not differ by polyp status. In primary ETD, mean ETDQ-7 score was significantly higher than CRS+ETD (29.5 ± 8.1, p < 0.0001). Regarding treatment outcomes, CRS+ETD treated with endoscopic sinus surgery (ESS) alone resulted in mean ETDQ-7 in the normal range (13.2 ± 5.3), with a mean change of −7.4 (95% confidence interval [CI], −10.82 to −3.99) (p < 0.00001). Patients with primary ETD treated with ETBD had postoperative ETDQ7 scores of 14.9 ± 7.5 with mean change of −13.9 (95% CI, −18.01 to −9.88), p < 0.00001. Conclusion ETD is noted in approximately half of patients with CRS. Outcomes of CRS+ETD treated with ESS alone are similar to those of patients with primary ETD treated with ETBD.

Journal ArticleDOI
TL;DR: LNIT improves clinical symptoms, reduces medication usage, and increases the nasal provocation threshold, and is a safe, alternative allergen immunotherapy route without significant adverse events.
Abstract: Local nasal immunotherapy (LNIT), an alternative noninjection immunotherapy method, is theoretically an efficient method for inducing immunotolerance directly in the affected organ. LNIT is more convenient and less invasive than injection immunotherapy, with fewer systemic reactions. The development of adjuvants to overcome LNIT's limitations raises the possibility of it being an alternative allergen immunotherapy.

Journal ArticleDOI
Jolie L. Chang, Andrew N. Goldberg, Jeremiah A. Alt, Liza H. Ashbrook, Dennis Auckley, Indu Ayappa, Hira Bakhtiar, Jose E. Barrera, J. Bartley, Martha E. Billings, Maurits Boon, Pien F. N. Bosschieter, Itzhak Braverman, Kara D Brodie, Cristina Cabrera-Muffly, Ray Caesar, Michel Burihan Cahali, Yi-min Cai, Michelle Cao, Robson Capasso, Sean M. Caples, Lama M. Chahine, Corissa P Chang, Katherine W. Chang, Nilika Chaudhary, Crystal Sj. Cheong, Susmita Chowdhuri, Peter A. Cistulli, David M. Claman, Jacob F. Collen, Kevin Coughlin, Jennifer L. Creamer, Eric M Davis, K. Dupuy-McCauley, Megan L. Durr, Mohan Dutt, Mazen El Ali, Nabil M. Elkassabany, Lawrence J. Epstein, Justin A. Fiala, Neil S. Freedman, Kirat Gill, M. Boyd Gillespie, Lea Golisch, Nalaka S. Gooneratne, Daniel J. Gottlieb, Katherine K. Green, Arushi Gulati, Indira Gurubhagavatula, Nathan James Hayward, Paul T. Hoff, Oliver Hoffmann, Steven Holfinger, Jennifer C. Hsia, Colin Huntley, Kevin C. Huoh, Phillip Huyett, S Inala, Stacey L. Ishman, Tarun K. Jella, Aesha Jobanputra, Andrew P. Johnson, Mithri R. Junna, Jenna Kado, Thomas M. Kaffenberger, Vishesh K. Kapur, Eric J. Kezirian, Meena Khan, Douglas B. Kirsch, Alan Kominsky, Meir H. Kryger, Andrew D. Krystal, Clete A. Kushida, Thomasz J Kuzniar, Derek J. Lam, Christopher J. Lettieri, Diane C. Lim, Hsin-Ching Lin, Stanley Yung-Chuan Liu, Stuart G. MacKay, Ulysses J. Magalang, Atul Malhotra, Joachim T. Maurer, Anna May, Ron B. Mitchell, Babek Mokhlesi, Anna E. Mullins, Eman Nada, Sreelatha Naik, Brandon Nokes, Michael D. Olson, Allan I. Pack, Edward B. Pang, Kenny P. Pang, Susheel P. Patil, Eli Van de Perck, Jay F. Piccirillo, Grace W. Pien, Amanda J. Piper, Andrea M. Plawecki, Mark Quigg, Madeline J. L. Ravesloot, Susan Redline, Brian W. Rotenberg, Armand M. Ryden, Kathleen Sarmiento, Firas Sbeih, Amy E. Schell, Christopher N. Schmickl, Helena M. Schotland, Richard Schwab, Ji-Hwan Seo, Neomi Shah, Anita V. Shelgikar, Isaac Shochat, Ryan J. Soose, Toby O. Steele, Erika M Stephens, Carl Stepnowsky, Kingman P. Strohl, Kate Sutherland, Maria V. Suurna, Erica R. Thaler, Sritika Thapa, Olivier M. Vanderveken, Nico de Vries, Edward M. Weaver, Ian D Weir, Lisa F. Wolfe, B. Tucker Woodson, Christine Won, Josie Xu, Pratyusha Yalamanchi, Kathleen Yaremchuk, Yerem Yeghiazarians, Jason W. Yu, Michelle Zeidler, Ilene M. Rosen 
TL;DR: A review of the literature in OSA consolidates the available knowledge and identifies the limitations of the current evidence to highlight the basis of OSA evidence-based practice and identify future research needs.
Abstract: Evaluation and interpretation of the literature on obstructive sleep apnea (OSA) allows for consolidation and determination of the key factors important for clinical management of the adult OSA patient. Toward this goal, an international collaborative of multidisciplinary experts in sleep apnea evaluation and treatment have produced the International Consensus statement on Obstructive Sleep Apnea (ICS:OSA).

Journal ArticleDOI
Naime Cakir1
TL;DR: In this paper , the authors investigated the relationship between change from baseline in NPS and change in nasal periostin and nasal eotaxin-3 at week 24 and week 52 in SINUS-52 (observed values; ITT population).
Abstract: SUPPLEMENTARY TABLE 1. Demographics and baseline disease characteristics and biomarkers (SINUS-24/SINUS-52; pooled ITT population) SUPPLEMENTARY TABLE 2. Correlations between NPS and type 2 biomarker levels at baseline SUPPLEMENTARY FIGURE 1. Scatterplots of relationship between change from baseline in NPS and change in (A) nasal periostin and (B) nasal eotaxin-3 at Week 24 (SINUS-52), (C) serum periostin, (D) serum eotaxin-3, and (E) serum TARC at Week 52 in SINUS-52 (observed values; ITT population) Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.

Journal ArticleDOI
TL;DR: Interestingly, the Omicron variant of SARS-CoV-2 appears to have a markedly different clinical profile than the previous variants, probably due to a combination of growing vaccination coverage, partial immunity from prior infection, and lower virulence of the virus itself.
Abstract: Soon after the coronavirus disease (COVID-19) pandemic began to unfold, an altered sense of smell and taste was quickly identified as one of the most common yet unusual symptoms. Our previous 2020 correspondence reported typical nasal manifestations of other upper respiratory tract infections, such as rhinorrhea, to be uncommon in patients with COVID-19.1 This was followed by the addition of this symptom to the clinical profile to screen for COVID-19 by the Center for Disease Control and Prevention and the World Health Organization.2 A novel SARS-CoV-2 B.1.1.529 variant of concern, designated Omicron, was reported in November 2021, with initial cases reported from South Africa but with scientists quickly identifying the variant all across the globe. Compared to previous variants, Omicron has proven to have much higher transmissibility and infectivity but reduced tropism for the lower airway.3 A study by Nicole Wolter et al. reported a significant reduction in disease severity and hospitalizations in patients infected by the Omicron variant, which has been born out in global data reported since that time, likely owing to the high frequency of mutations in the spike glycoprotein.4 Although real-time emerging data have confirmed a spike in the number of infections worldwide, a relatively lower rate of severe COVID-19 has been observed, probably due to a combination of growing vaccination coverage, partial immunity from prior infection, and lower virulence of the virus itself. Interestingly, the Omicron variant of SARS-CoV-2 appears to have a markedly different clinical profile than the previous variants. We report the results of 205 individuals (male: 66.3%, female: 33.7 %) who tested positive for SARS-CoV-2 with the Omicron variant through established genomic sequencing, from December 21, 2021 to January 10, 2022. Surprisingly, 68.8% had no altered sense of smell, 18% had only mild smell dysfunction, and 13.2% complained of complete anosmia. The impact on the selfreported sense of taste was similar, with no symptoms in 66.8% of individuals, partial loss of taste in 21%, and complete loss in 10.2%. In general, among the predominant symptoms, nasal congestion was the most common, reported by 62% (n = 127) patients, followed by rhinorrhea (57.5%, n = 118), fatigue (55.1%, n = 113), fever (53.6%, n = 110), malaise and/ormyalgia (52.1%, n= 107), and cough (50.7%, n= 104) (Figure 1). History of prior infection with SARS-CoV-2 was reported in 15.6% (n = 32) individuals. Within this smaller cohort, loss of sense of smell was seen at a lower rate than the overall study population, with a partial loss noted in 18.7% and a complete loss in 6.2% (Table 1).

Journal ArticleDOI
TL;DR: The efficacy of a submucosal injection of bevacizumab, a VEGF inhibitor, in reducing the severity of epistaxis and improving quality of life when given at the time of operative electrocautery is evaluated.
Abstract: Given its role in the disease pathophysiology, inhibition of vascular endothelial growth factor (VEGF)‐mediated angiogenesis has received attention as a potential strategy to reduce epistaxis associated with hereditary hemorrhagic telangiectasia (HHT). In this study we evaluated the efficacy of a submucosal injection of bevacizumab, a VEGF inhibitor, in reducing the severity of epistaxis and improving quality of life when given at the time of operative electrocautery.

Journal ArticleDOI
TL;DR: Patients with low Hyams grade and mKadish stage have favorable 5 year OS, PFS, and DMFS; prognostic factors associated with survival have improved in the modern era.
Abstract: Esthesioneuroblastoma (ENB) is a rare malignant neoplasm arising from the olfactory epithelium of the cribriform plate. The goal of this study was to update our oncologic outcomes for this disease and explore prognostic factors associated with survival.

Journal ArticleDOI
TL;DR: In this article , the authors investigated the onset of action, magnitude, and time course of treatment effects of dupilumab across CRSwNP disease measures and HRQoL.
Abstract: Chronic rhinosinusitis with nasal polyps (CRSwNP) is an inflammatory disease of the nasal and paranasal sinuses that displays a predominantly type 2 inflammatory signature and is associated with a high symptom burden, poor health-related quality of life (HRQoL), and high economic burden.1-4 Dupilumab is a fully human monoclonal antibody that blocks interleukin (IL)-4 receptor-α, the shared receptor component for IL-4 and IL-13, which are key and central drivers of type 2 inflammation. In the randomized, placebo-controlled, phase 3 SINUS-24 (NCT02912468) and SINUS-52 (NCT02898454) studies in adults with severe CRSwNP, dupilumab significantly improved endoscopic, radiographic, clinical, and patient-reported symptoms as well as HRQoL, including in subgroups with prior sinonasal surgery and comorbid asthma or nonsteroidal anti-inflammatory drug-exacerbated respiratory disease (NSAID-ERD).5 To optimize shared decision-making it is important for clinicians and patients to know when one might expect improvements in symptoms after initiating treatment and how long improvements might be expected to last. Similarly, it is important to know whether the presence of common comorbidities affects the onset of action or the magnitude and time course of treatment effects. Here, we investigate the onset of action, magnitude, and time course of treatment effects of dupilumab across CRSwNP disease measures and HRQoL in the SINUS-24 and SINUS-52 studies. Results are presented for all patients and for those with and without prior sinonasal surgery, asthma, NSAID-ERD, and allergic rhinitis (AR). The study designs have been described.5 In brief, eligible patients had severe CRSwNP with bilateral nasal polyp score (NPS) ≥5 (maximum 8), nasal congestion/obstruction (NC), and either loss of smell (LoS) or nasal discharge despite intranasal corticosteroids, and either systemic corticosteroids in the preceding 2 years or prior sinonasal surgery. History of surgery, asthma, NSAID-ERD, and AR were self-reported by patients at study entry. Dupilumab or matching placebo was administered subcutaneously every 2 weeks for 24 weeks (SINUS-24) or 52 weeks (SINUS-52). Patients recorded symptoms of NC, LoS, and rhinorrhea (anterior and posterior) daily using an eDiary with a score of 0−3 for each symptom. Total symptom score (TSS) was the sum of these symptom scores, with anterior and posterior rhinorrhea being averaged for a total possible score of 9. Patients also recorded peak nasal inspiratory flow (PNIF) daily. NPS, University of Pennsylvania Smell Identification Test (UPSIT; scale 0−40), and the 22-item Sino-Nasal Outcome Test (SNOT-22) were assessed at scheduled clinic visits. Both studies met their primary objectives of reduction in co-primary endpoints of NPS and NC at 24 weeks. Statistical and imputation methods have been described.3 Data for placebo and dupilumab 300 mg once every 2 weeks (q2w) are presented from pooled SINUS-24/SINUS-52 studies for onset and from SINUS-52 for results to week 52. In total, 724 patients were randomized in the two trials, with mean ± standard deviation (SD) CRSwNP duration 11.0 ± 9.45 years and baseline NPS 5.97 ± 1.25, NC 2.40 ± 0.58, and LoS 2.74 ± 0.53 (Supplementary Table S1). Overall, 63% of patients had prior sinonasal surgery, 59% had comorbid asthma, 28% NSAID-ERD, and 58% AR. The dupilumab treatment effect was rapid, with significant improvement across all daily assessed measures within 4 days of initiating treatment: by day 3 for LoS, day 2 for NC, day 2 for TSS, and day 4 for PNIF; all p < 0.05 versus placebo (Figure 1). Onset of treatment effect with dupilumab was similar regardless of prior surgery, asthma, NSAID-ERD, or AR (Supplementary Figures S1–S4). In clinic-assessed measures, significant improvements versus placebo were observed at the first scheduled postbaseline assessments: week 2 in pooled studies for UPSIT (least squares [LS] mean difference vs. placebo [all patients] 5.53 (95% confidence interval [CI], 4.38–6.69); p < 0.0001), week 4 in SINUS-52 for NPS (−1.15; 95% CI, −1.40 to −0.91; p < 0.0001), week 8 in SINUS-24 for NPS (−1.42; 95% CI, −1.75 to −1.10; p < 0.0001), and week 8 in pooled studies for SNOT-22 (−14.8; 95% CI, −17.4 to −12.2; p < 0.0001). Improvements with dupilumab continued and were sustained to the end of treatment in both studies (Figure 2; Supplementary Table S2). The onset of action, magnitude, and maintenance of treatment effect were similar regardless of prior surgery, or comorbid asthma, NSAID-ERD, or AR. Rapid onset of effect is an important feature of treatment, providing early symptom relief to patients and assurance to their physicians that the treatment is effective. This report shows that dupilumab treatment was associated with rapid onset of improvement in CRSwNP across multiple outcomes in a population with an average disease duration of 11 years. Onset of symptom improvement was similar in patients with prior sinonasal surgery, asthma, NSAID-ERD, and AR, who may have more severe disease and be more difficult to treat. In SINUS-52, improvements with dupilumab were sustained up to week 52 across all outcome measures regardless of prior sinonasal surgery, asthma, NSAID-ERD, or AR. Notably, no plateau of treatment effect was observed up to week 52 in LoS, NC, TSS, PNIF, NPS, and SNOT-22, which suggests that 52 weeks of follow-up may not capture the full potential treatment effect. Limitations of this study include that it was a post hoc analysis and that ascertainment of comorbidities was based on patient-reported medical history rather than documented physician diagnosis. It should be noted that the rapid improvements shown here are mean group values that do not provide information on the percentage of patients achieving a threshold of response. Responder analyses are reported elsewhere.5, 6 Assessment of response with biologic therapies for CRSwNP is recommended after 6 months in European Forum for Research and Education in Allergy and Airway Diseases (EUFOREA) guidance and after 16 weeks in European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS) guidance.7, 8 In conclusion, dupilumab produced rapid and sustained improvements in the co-primary and secondary outcome measures of CRSwNP in SINUS-24 and SINUS-52, with improvements versus placebo observed as early as the second day of treatment and sustained over 52 weeks of treatment. Rapid and sustained improvement was observed irrespective of prior sinonasal surgery, comorbid asthma, NSAID-ERD, or AR. We thank Matt Lewis, PhD, of Adelphi Group, Macclesfield, UK, for medical writing/editorial assistance funded by Sanofi-Genzyme and Regeneron Pharmaceuticals, Inc., in accordance with Good Publications Practice (GPP3) guidelines. Peter W. Hellings acquired data; all authors contributed to the conception and design of the study and participated in the interpretation of the data, provided critical feedback and final approval for submission, and took responsibility for the accuracy, completeness, and protocol adherence of data and analyses. Peter W. Hellings: Regeneron Pharmaceuticals, Inc., Sanofi – advisory board member. Anju T. Peters: Regeneron Pharmaceuticals, Inc., Sanofi – advisory board member; AstraZeneca – research support and advisory board member; Optinose – consultant and research support. Adam M. Chaker: Technical University Munich (TUM) – research/clinical study grants: ALK Abello, Allergopharma, ASIT Biotech, AstraZeneca, Bencard/Allergen Therapeutics, European Institute of Technology (EIT), GlaxoSmithKline, LETI, Roche; ALK Abello, AstraZeneca, Bencart/Allergen Therapeutics, GlaxoSmithKline, Immunotek, LETI, Lofarma, Novartis, Regeneron Pharmaceuticals, Inc., Sanofi-Genzyme, Zeller advisory board member and/or speaker – all via TUM. Enrico Heffler: AstraZeneca, GlaxoSmithKline, Novartis, Sanofi – advisory board member. Yamo Deniz, Scott Nash, Shahid Siddiqui, and Haixin Zhang: Regeneron Pharmaceuticals, Inc. – employees, may hold stock and/or stock options in the company. Asif H. Khan, Juby A. Jacob-Nara, Amy Praestgaard, and Paul J. Rowe: Sanofi – employees, may hold stock and/or stock options in the company. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.

Journal ArticleDOI
TL;DR: Polyps originating from the central compartment were related to asthma and allergic rhinitis in Taiwanese patients and a higher eosinophil count was suggested in both serum and local nasal tissue from patients with CCAD.
Abstract: The characteristics and surgical outcomes of central compartment atopic disease (CCAD) vary by region and race. Therefore, we aimed to identify the risk factors, symptom severity, and prognosis of CCAD in the Asian population.

Journal ArticleDOI
TL;DR: A deep learning approach is explored, using 3‐dimensional convolutional neural networks (CNNs), to address the challenge of distinguishing benign inverted papilloma tumors from those that have undergone malignant transformation to squamous cell carcinoma.
Abstract: Distinguishing benign inverted papilloma (IP) tumors from those that have undergone malignant transformation to squamous cell carcinoma (IP‐SCC) is important but challenging to do preoperatively. Magnetic resonance imaging (MRI) can help differentiate these 2 entities, but no established method exists that can automatically synthesize all potentially relevant MRI image features to distinguish IP and IP‐SCC. We explored a deep learning approach, using 3‐dimensional convolutional neural networks (CNNs), to address this challenge.

Journal ArticleDOI
TL;DR: In this article , the authors evaluated the use of platelet-rich plasma (PRP), an autologous blood product with supraphysiologic concentrations of growth factors, in the treatment of prolonged coronavirus disease 2019 (COVID19)related smell loss.
Abstract: The current study evaluated the use of platelet‐rich plasma (PRP), an autologous blood product with supraphysiologic concentrations of growth factors, in the treatment of prolonged coronavirus disease 2019 (COVID‐19)–related smell loss.

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TL;DR: Patients who received intra-operative frontal MES had lower concentrations of IL-4 and IL-13 than those who did not at a median 8 months post-ESS, however, these changes did not correspond to significantly different measures of symptomatic or radiographic disease severity.
Abstract: Mometasone‐eluting stents (MES) have demonstrated improvement in short‐term endoscopic outcomes and reduce short‐ to medium‐term rescue interventions. Their effect on the local inflammatory environment, longer‐term patient‐reported outcomes, and radiographic severity have not been studied.

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TL;DR: Endoscopic endonasal resection for pediatric craniopharyngiomas can achieve high rates of resection with low rates of disease recurrence when compared to the outcomes of open transcranial resection reported in the literature, however, hypothalamic-pituitary dysfunction remains a significant postoperative morbidity in both approaches.
Abstract: Craniopharyngiomas have traditionally been treated via open transcranial approaches. More recent, endoscopic endonasal approaches have been increasingly used; however, there has been limited evaluation of long‐term outcomes for this approach.

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TL;DR: Chronic IL-13 exposure has several effects on the OE that are likely to affect function, and there is a time-dependent loss of neurons from OE regions, accompanied by a modest inflammatory infiltrate.
Abstract: Olfactory dysfunction is highly associated with chronic rhinosinusitis with nasal polyps (CRSwNP), and the severity of loss has been linked with biomarkers of type 2 inflammation. The ability of dupilumab to rapidly improve the sense of smell prior to improvement in polyp size suggests a direct role of IL‐4/IL‐13 receptor signaling in the olfactory epithelium (OE).

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TL;DR: When INCS monotherapy is ineffective, addition of intranasal ATH can improve nasal symptoms; LTRA can improve ocular symptoms; and saline irrigation can improve QoL.
Abstract: Antihistamines (ATH) and intranasal corticosteroids (INCS) are primary treatments for patients with allergic rhinitis (AR). When monotherapy of either primary treatment fails to control symptoms, combined medical therapy is an option. In this meta‐analysis we assessed the additional effects of different medical combinations compared with primary treatments.

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TL;DR: The experience with sellar reconstruction following transsphenoidal pituitary surgery is reviewed and a highly effective, yet simple and low morbidity, algorithm is proposed.
Abstract: Several sellar reconstruction algorithms stratify patients based on risk of postoperative cerebrospinal fluid (CSF) leak. Many proposed algorithms employ techniques that are overly complex and confer morbidity. We review our experience with sellar reconstruction following transsphenoidal pituitary surgery and propose a highly effective, yet simple and low morbidity, algorithm.

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TL;DR: In this paper , the authors presented a study on the role of epigenetics and stem cell aging in the development of stem cells in the context of head and neck surgery in brain cancer.
Abstract: 1Department of Environmental Health and Engineering, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore MD, USA 2Epigenetics and Stem Cell Aging, Translational Gerontology Branch, National Institute on Aging, Baltimore, Maryland, USA 3Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine Baltimore, Maryland, USA 4Sinonasal and Skull Base Tumor Program, The National Institute on Deafness and Other Communication Disorders, Bethesda, Maryland, USA 5Cardiovascular Research Institute, Case Western Reserve University, Cleveland, Ohio, USA 6Division of Otolaryngology, Department of Surgery, University of Chicago Pritzker School of Medicine, Chicago, Illinois, USA

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TL;DR: Omalizumab is an anti–immunoglobulin E monoclonal antibody with demonstrated efficacy in patients with CRSwNP in replicate phase 3, double-blind, randomized, placebo-controlled studies (POLYP 1 and POLYP 2).
Abstract: Chronic rhinosinusitis with nasal polyps (CRSwNP) reduces health-related quality of life (HRQoL), with patients reporting that symptoms of nasal congestion/obstruction, loss of sense of smell, breathing difficulties, and rhinorrhea have the greatest impact.1–4 Patientreported outcome tools used to gauge HRQoL, including the 22-item Sino-Nasal Outcome Test (SNOT-22)5 and Total Nasal Symptom Score (TNSS), should be considered by physicians when evaluating treatment outcomes. Omalizumab is an anti–immunoglobulin E monoclonal antibody with demonstrated efficacy in patients with CRSwNP in replicate phase 3, double-blind, randomized, placebo-controlled studies (POLYP 1 [NCT03280550] and POLYP 2 [NCT03280537]).6 To investigate effects of omalizumab therapy vs placebo on patient-reported HRQoL in further depth, we conducted a pooled analysis of patient

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TL;DR: In this patient, IgG4‐RD presented in an unusual manner with vision loss due to mucocele formation in the sphenoid sinus.
Abstract: Immunoglobulin G4‐related disease (IgG4‐RD) is a fibro‐inflammatory disorder and manifestation in de paranasal and sphenoid sinus is well recognized. In this patient, IgG4‐RD presented in an unusual manner with vision loss due to mucocele formation in the sphenoid sinus.

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TL;DR: ENS patients had diminished sinonasal quality of life and a higher prevalence of comorbid anxiety and depression, compared to CR and CRS, and were more likely to exceed thresholds for OCD and somatic symptom disorder compared to controls.
Abstract: Empty nose syndrome (ENS) is characterized by the paradoxical perception of nasal obstruction despite patent sinonasal anatomy after surgery. We investigated the relationship between ENS, and anxiety, depression, obsessive‐compulsive disorder, and somatic symptom disorder (SSD) compared to individuals with chronic rhinitis (CR) and chronic rhinosinusitis (CRS).