Otolaryngology Commons^™

Reply To: S. N. Katkuri Et Al. And H. Liu Et Al. On Early And Sustained Improvements In Sense Of Smell With Tezepelumab Treatment In Patients With Chronic Rhinosinusitis With Nasal Polyps (Waypoint), Joaquim Mullol, Joseph K. Han, Tanya M. Laidlaw, Claire Hopkins, Anju T. Peters, Oliver Pfaar, Martin Desrosiers, Stella E. Lee, Andrew P. Lane, Claudia Chen, Yun Chon, Sandhia S. Ponnarambil, Andrew Foster, Andrew W. Lindsley, Christopher S. Ambrose

Department of Otolaryngology (ENT) Faculty Publications

[Introduction] We thank Dr. S. N. Katkuri, Dr. H. Liu, and their coauthors [1, 2] for their interest in our recent publication describing the improvements in loss of smell symptoms with tezepelumab versus placebo in patients with uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP) in the WAYPOINT trial (NCT04851964) [3]. We are grateful for the authors' feedback on the clinical significance of the data presented and their appreciation of the consistency observed across a range of baseline clinical characteristic and demographic subgroups.

Use Of Tezepelumab For Chronic Rhinosinusitis With Nasal Polyps By Eosinophilic Endotype: Waypoint Post-Hoc Analysis, Shigeharu Fujieda, Nobuyoshi Otori, Joseph K. Han, Tadataka Yabuta, Claudia Chen, Claudio Marchese, Andrews Foster, Sandhia S. Ponnarambil, Yun Chan, Brian J. Lipworth

Department of Otolaryngology (ENT) Faculty Publications

Background

The phase 3 WAYPOINT study (NCT04851964) reported that tezepelumab improved outcomes in patients with chronic rhinosinusitis with nasal polyps (CRSwNP), including nasal polyp size, nasal congestion, and sinonasal symptoms, and reduced the need for surgery and systemic corticosteroids (SCS).

Objective

To evaluate the efficacy and safety of tezepelumab across Japanese Epidemiological Survey of Refractory Eosinophilic Chronic Rhinosinusitis-defined eosinophilic chronic rhinosinusitis (ECRS) subgroups.

Methods

Adults with severe CRSwNP were randomized to tezepelumab 210 mg or placebo every 4 weeks. Coprimary end points were the change from baseline to week 52 in total Nasal Polyp Score and the biweekly mean Nasal …

Safety And Efficacy Findings From A Phase Ib/Ii Study Of Asp-1929 Photoimmunotherapy With Pembrolizumab In Recurrent And/Or Metastatic Head And Neck Squamous Cell Carcinoma, David M. Cognetti, Joseph M. Curry, Jennifer Johnson, Michael Kwon, Shirley Y. Su, Francisco Civantos, Coral Olazagasti, Joseph Valentino, Susanne Arnold, R. Bryan Bell, Michael K. Gibson, Kyle Mannion, Kathryn M. Van Abel, Katharine A. Price, Haiying Dong, Amy H. Thorne, Toshiaki Suzuki, Ann M. Gillenwater

Otolaryngology--Head & Neck Surgery Faculty Publications

Background: ASP-1929 photoimmunotherapy—cetuximab conjugated to IRDye 700DX and red light (690 nm) for localized drug activation—results in rapid, selective cell killing.

Methods: This phase Ib/II open-label study evaluated ASP-1929 photoimmunotherapy plus pembrolizumab in patients with recurrent/metastatic HNSCC (≥ 1 accessible lesion, PD-L1 combined positive score ≥ 1, ineligible for standard locoregional ther- apy). Primary objectives were safety/tolerability and objective response rate (ORR). Secondary objectives included overall sur- vival (OS) and progression-free survival (PFS).

Results: Eighteen patients (median age 63 years, 74% male) comprised the photoimmunotherapy-evaluable population. The confirmed ORR was 27.8% (95% CI 9.7–53.5); four of five responders had complete …

Assessment Of Hearing Health Among Adults In Rural Health Clinics, Mit A. Patel, David Adkins, Laura Bellnier, Anthony Mahairas, Matthew L. Bush

Otolaryngology--Head & Neck Surgery Faculty Publications

Objective: Hearing loss (HL) negatively impacts all aspects of health, yet poor access to hearing healthcare (HHC) among adults is a pervasive public health problem. The inaccessibility of HHC is amplified in rural adults. Rural health clinics (RHC) are a critical healthcare system tasked with improving health in rural communities and the objective of this study is to assess the prevalence of HL and the utilization of HHC within RHCs.

Methods: Using cross-sectional study design, adults were recruited from 10 RHC throughout rural Kentucky, mostly within Appalachia. The primary outcomes were (1) presence of HL on screening and (2) history …

Occupational Human Papillomavirus Exposure Risks For Laryngeal Surgeons And Phoniatricians: A Joint European Laryngological Society (Els) And Union Of European Phoniatricians (Uep) Delphi Clinical Consensus Statement, Shiying Hey, Alberto Maria Saibene, Milan Amin, Jennifer Anderson, Christoph Arens, Simon Best, Guillermo Campos, Craig Derkay, Gauthier Desuter, Frederik G. Dikkers, Isabel Garcia-Lopez, Ahmed Geneid, Anastasios Hantzakos, Markus Hess, Yakubu Karagama, Marina Mat Baki, Napur Kapoor Nerurkar, Daniel Novakovic, Haldun Oguz, Shazia Peer, Jasmine Prasad, Carlo Robotti, David Vokes, Chi-Te Wang, Malgorzata Wierzbicka, Michal Zabrodsky, Nicolien Van Der Poel

Department of Otolaryngology (ENT) Faculty Publications

Purpose

Laser surgical management of human papillomavirus (HPV)-related disease, such as recurrent respiratory papillomatosis (RRP), in the upper aerodigestive tract generates surgical smoke, which may represent a source of occupational viral exposure for laryngeal surgeons, phoniatricians, anesthesia providers and scrub nurses. Despite growing awareness, protective measures remain inconsistently implemented. This study aimed to develop an evidence-informed clinical consensus statement (CCS) to guide occupational HPV risk management in laryngology.

Methods

A modified Delphi consensus process was conducted under the auspices of the European Laryngological Society (ELS) and the Union of the European Phoniatricians (UEP). A panel of 26 international experts undertook …

Procedural-Based Contemporary Management Of Bell's Palsy Long-Term Sequelae: A Narrative Review, Robert M. Frederick, Rhorie Kerr, Eric Dobratz, William Dougherty

Department of Otolaryngology (ENT) Faculty Publications

Objective

To describe the long-term sequelae of Bell's palsy and summarize available treatment options, including recent advances, so that general otolaryngologists and other practitioners are aware of the clinical findings and available interventions.

Data Sources

PubMed.

Review Methods

A literature search was performed on December 18, 2024, via PubMed using keywords such as "synkinesis," "selective myectomy," "selective neurectomy," "botulinum toxin," "intervention" in the context of "Bell's palsy" with preference for articles published within the last 5 to 10 years but inclusion of select older articles that provided necessary context for the current topic. Articles included in the review were written …

Differences In Biologic Clinical Trials For Chronic Rhinosinusitis With Nasal Polyps—Are We Comparing Apples With Oranges?, Marjolein Cornet, Peter W. Hellings, Martin Desrosiers, Martin Wagenmann, Richard Follows, Laura Walrave, Luz Adriana Jimenez, Lee Tombs, Dawn Edwards, Peter Howarth, Joseph K. Han

Department of Otolaryngology (ENT) Faculty Publications

In recent years, several biologics targeting Type 2 inflammation have been developed for treating chronic rhinosinusitis with nasal polyps (CRSwNP). These have been studied in registrational randomized controlled trials (RCTs), which vary in their patient populations, trial design, endpoints, geography, timing, or data-handling processes. While (in)direct treatment comparisons and meta-analyses have been carried out to compare efficacy results from RCTs, often these fail to properly account for these between-study differences. Here, we summarize the key between-study differences that can influence trial outcomes and highlight the resulting challenges faced when comparing outcomes from different Phase III RCTs of biologics in CRSwNP.

Tezepelumab's Effects On Patient-Reported Symptoms In Severe Asthma, Overall And With History Of Comorbid Chronic Rhinosinusitis With Nasal Polyps (Crswnp), Njira L. Lugogo, Joseph K. Han, Anju T. Peters, Stella E. Lee, Monica Kraft, Mary Kay Margolis, Sonia F. Shenoy, Nicole Martin, Shradha Chandarana, Christopher S. Ambrose

Department of Otolaryngology (ENT) Faculty Publications

Background

Tezepelumab (an anti-thymic stromal lymphopoietin monoclonal antibody) treatment resulted in reduced exacerbations and improved sino-nasal symptoms and health-related quality of life in patients with severe uncontrolled asthma (SUA) and chronic rhinosinusitis with nasal polyps (CRSwNP) in the NAVIGATOR study.

Objective

To evaluate the effect of tezepelumab versus placebo on sleep disturbances, activity levels, and physical exertion tolerance in NAVIGATOR patients with SUA overall and in those with past medical history of comorbid CRSwNP.

Methods

Patients (12-80 years old) with SUA were randomized to receive tezepelumab 210 mg or placebo subcutaneously every 4 weeks for 52 weeks. Patient responses to …

Indirect Treatment Comparison Of Tezepelumab Versus Other Biologics In Severe Chronic Rhinosinusitis With Nasal Polyps: A Systematic Literature Review And Network Meta-Analysis, Joseph K. Han, Joaquim Mullol, Claire Hopkins, Oliver Pfaar, Martin Desrosiers, Jason Steenkamp, Danny Gibson, Santiago Zuluaga Sanchez, Andrew Foster, Christopher S. Ambrose

Department of Otolaryngology (ENT) Faculty Publications

Introduction

This study compared the efficacy of tezepelumab with other approved biologics and endoscopic sinus surgery (ESS) using indirect treatment comparisons (ITCs) in adults with severe, uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP).

Methods

Randomized controlled trials (RCTs) identified via a systematic literature review (SLR) were synthesized in a network meta-analysis (NMA). Outcomes included change from baseline in nasal polyp score (NPS), nasal congestion/obstruction score (NCS/NOS), difficulty with sense of smell (DSS), Sino-Nasal Outcome Test-22 (SNOT-22) score, Lund Mackay score (LMS), time to nasal polyposis (NP) surgery decision, proportions requiring NP surgery or systemic corticosteroids (SCS), time to SCS use, …

Professionalism In Practice: A Novel Approach To Integrating Small Doses Of Case-Based Professionalism Education Into Monthly Grand Rounds., Allison H Taylor, Andrew Caruso, Kelley Arredondo, Ellen M Friedman, Stacey R Rose

Faculty, Staff and Students Publications

Introduction: Professionalism is a critical construct across the health professions, though learners and faculty report feeling underprepared to navigate difficult situations; education in professionalism is challenged by the absence of a universal definition, time constraints due to overcrowded curricula, and the lack of consistent messaging to learners and faculty.

Methods: Professionalism in Practice (PiP) was developed to provide small doses (∼5 minutes) of case-based professionalism education as part of an existing educational forum (Grand Rounds) to optimize attendance of both learners and faculty. Each vignette highlighted a common professionalism challenge and was aligned with an AAMC professional competency. Sessions were …

The 2025 American Society Of Pediatric Otolaryngology Workforce And Compensation Survey: Current State And Future Directions, Lyndy J. Wilcox, Cristina M. Baldassari, Amy C. Brenski, Emily Boss, John Carter, David H. Chi, William O. Collins, Charles E. Elmaraghy, Andrew J. Tompkins, Craig S. Derkay, The Aspo 2025 Workforce And Compensation Committee

Department of Otolaryngology (ENT) Faculty Publications

Objective

To provide an updated comprehensive assessment of the Pediatric Otolaryngology workforce in the United States inclusive of compensation, productivity, practice patterns, and on-call burden.

Study Design

Cross-sectional electronic survey.

Methods

A structured electronic survey was developed by members of the American Society of Pediatric Otolaryngology (ASPO) Workforce and Compensation Committee. The survey evaluated six domains: demographics, compensation, workforce dynamics, productivity, on-call burden, and future priorities, and was distributed to all 480 presumedly actively-practicing, domestic ASPO members.

Results

The survey response rate was 68% (327/480). Ninety-one percent of respondents held an academic appointment with relatively equal percentages of each rank …

Reply To: Malik Mmud On Early And Sustained Improvements In Sense Of Smell With Tezepelumab Treatment In Patients With Chronic Rhinosinusitis With Nasal Polyps (Waypoint), Joaquim Mullol, Joseph K. Han, Tanya M. Laidlaw, Claire Hopkins, Anju T. Peters, Oliver Pfaar, Martin Desrosiers, Stella E. Lee, Andrew P. Lane, Claudia Chen, Yun Chon

Department of Otolaryngology (ENT) Faculty Publications

[Introduction] To the Editor:

We thank Professor MMUD Malik [1] for his interest in our recent publication describing the improvements in loss of smell symptoms with tezepelumab versus placebo in patients with uncontrolled chronic rhinosinusitis with nasal polyps in the WAYPOINT trial (NCT04851964) [2]. We appreciate Professor Malik's comments on the language used to describe the findings and the specific analyses presented as well as his note regarding the consistent improvements in sense of smell observed with tezepelumab treatment versus placebo, demonstrated by large effect sizes across three instruments.

Mepolizumab Improves Outcomes In Patients With Crswnp With One Or More Prior Nasal Polyp Surgeries, Joseph K. Han, Joaquim Mullol, Martin Wagenmann, Laura Walrave, Lingjiao Zhang, Ana R. Sousa, Peter Howarth, Claire Hopkins

Department of Otolaryngology (ENT) Faculty Publications

BACKGROUND: Patients with chronic rhinosinusitis with nasal polyps (CRSwNP) often undergo multiple nasal surgeries. The Phase III SYNAPSE study (GSK ID:205687; NCT0308579) demonstrated that mepolizumab reduces the need for repeat surgery. We explored whether outcomes differed based on the number of prior surgeries. METHODOLOGY: This post hoc analysis of SYNAPSE stratified patients by history of 1 or more than 1 prior surgery. Patients were randomised to receive mepolizumab or placebo every 4 weeks, alongside standard of care, for 52 weeks. Outcomes included change from baseline in endoscopic nasal polyp (NP) score, visual analogue scale (VAS) scores for nasal obstruction, loss …

Extracellular Matrix-Mycaf Signatures Correlate With Resistance To Neoadjuvant Apd-L1 Immune Checkpoint Inhibition With Durvalumab + Metformin In Hpv+ Hnscc, Pablo Llerena, Hani Samarah, Kathryn Nunes, Zhao Lin, Kelly Bridgham, Sruti Tekumalla, Amiti Jain, Larry A. Harshyne, Sanket Kumar Shukla, Ioannis Vathiotis, Madalina Tuluc, Stacey Gargano, John R. Eisenbrey, Scott W Keith, David Cognetti, Voichita Bar-Ad, Adam J. Luginbuhl, Rita S. Axelrod, Rajanikanth Vadigepalli, Hushan Yang, Diana Whitaker-Menezes, Megan Roche, My G. Mahoney, Athanassios Argiris, Charalambos C. Solomides, Jennifer Johnson, Md, Mouadh Barbirou, Amanda Miller, Andrew P. South, Ramkrishna Mitra, Alban J Linnenbach, Ubaldo E. Martinez-Outshoorn, Joseph Curry

Department of Otolaryngology - Head and Neck Surgery Faculty Papers

PURPOSE: Immune checkpoint inhibitors (ICI) have demonstrated clinical benefit in head and neck squamous cell carcinoma (HNSCC); however, single-agent efficacy is limited, leaving significant unmet needs. Metformin may synergize with ICIs, offering promise to improve response rates. We leveraged multiomic data from a randomized, presurgical neoadjuvant trial (NCT03618654) evaluating a single infusion of the anti-PD-L1 ICI durvalumab with or without daily, standard dose metformin in previously untreated, nondiabetic patients with HNSCC to understand predictors of response and the effect of combination therapy.

PATIENTS AND METHODS: Clinical, pathologic, and correlative data were analyzed to investigate response and resistance mechanisms. We present …

Ultrasound-Guided Needle Aspiration Of A Peritonsillar Abscess In The Emergency Department, Elizabeth Piwowarski, Kenith Dsouza, Taryn Hoffman

Florida Journal of Emergency Medicine (FJEM)

Background

Peritonsillar abscess (PTA) is a relatively common diagnosis to encounter in the emergency department (ED). If untreated, PTA can lead to serious outcomes such as airway compromise, deep space infections and septicemia. Point of care ultrasound (POCUS) can be used by the emergency physician to confirm the suspected diagnosis, evaluate the size and depth of the abscess, and be used as a guide during needle aspiration.

Case

A 26-year-old male presented to the ED with a sore throat and was found to have a peritonsillar abscess on exam, which was confirmed using computerized tomography (CT) imaging. Providers were unable …

Impact Of Intravenous Drug Use On Neck Abscess Outcomes: 30-Day Readmission & 5-Year Survival Rates, Elliott Sina, Bryce Hambach, Eric Mastrolonardo, Sruti Tekumalla, Meghan Crippen, Richard A. Goldman

Department of Otolaryngology - Head and Neck Surgery Faculty Papers

OBJECTIVES: Injection drug use (IDU) is a known risk factor for neck abscesses, often requiring urgent surgical intervention by acute-care Otolaryngologists. However, data on the prevalence and long-term outcomes of IDU-related neck abscesses are limited. This study investigates differences in 30-day readmission rates and 5-year all-cause mortality between patients with and without a history of IDU hospitalized for neck abscesses.

METHODS: This is a retrospective cohort study utilizing the TriNetX national clinical database. Patients hospitalized for neck abscesses (ICD-10: L02.11) were categorized into two cohorts: IDU (current/previous) and non-IDU. Demographics, 30-day readmission rates, and 5-year survival were analyzed. 1:1 Propensity …

Transoral Robotic-Assisted Removal Of A Submucosal Pyriform Sinus Foreign Body, Elisabeth Wenneker, Rebecca Doctor, Ari Schuman, Adam Szymanowski, Ray Wang

Faculty, Staff and Students Publications

Background: Submucosal foreign bodies of the medial pyriform sinus represent a challenge given limited visualization and difficult retraction with endoscopic approaches, and risk of injury to the recurrent laryngeal nerve with open approaches. Transoral robotic surgery (TORS) offers improved visualization and multiple working arms to facilitate retraction. We present a novel case utilizing the Da Vinci SP system for removal of an embedded fishbone of the medial pyriform sinus.

Results: An 84-year-old woman presented with five days of odynophagia and globus sensation after swallowing a fish bone. Non-contrast computed tomography scan revealed a 3.0 cm submucosal object within the post-cricoid …

Development Of A Clinically Relevant Rabbit Model Of Acute Laryngeal Injury, Ryan Stepp, Naushin Ali, Areli A. Rodriguez, Ethan Nicklow, Noah Thornton, Adithya Reddy, Hannah L. Kenny, Patrick S. Cottler, Donald R. Griffin, James J. Daniero

Department of Otolaryngology - Head and Neck Surgery Faculty Papers

OBJECTIVES: Acute laryngeal injury (ALgI) is created as a result of endotracheal tube pressure ulcer formation leading to fibrosis and inflammation. This condition often leads to airway obstruction and voice and swallowing dysfunction. This study demonstrates a reliable animal model of ALgI to reproduce the acute wound process seen clinically, to explore the pathophysiology of this disease process, and to serve as a reproducible injury suitable for the evaluation of therapeutic interventions.

METHODS: An ALgI model was developed in New Zealand White rabbits using precise mucosal stripping of the posterior larynx, followed by intubation with an oversized 4.0 endotracheal tube …

Association Of Preoperative Nocturnal Hypoxaemia Nadir And Fentanyl Ventilatory Sensitivity In Children With Obstructive Sleep Apnoea Undergoing General Anaesthesia: A Multicentre Clinical Cohort Study, Adam C Adler, Elaina E Lin, Anna H Messner, Tara L Rosenberg, Shelly Pecorella, Aidan Keleghan, Spencer Faircloth, T Wesley Templeton, Lynnette Harris, Sabina A Khan, Greesha S Pednekar, Duc T Nguyen, Arvind Chandrakantan, Britta S Von Ungern-Sternberg

Faculty, Staff and Students Publications

Background: Obstructive sleep apnoea (OSA) has been thought to increase the risk of respiratory depression from opioids. The primary aim of this study was to assess whether preoperative hypoxaemia by sleep study pulse oximetry imparts greater opioid sensitivity.

Methods: A multicentre observational cohort study with in-cohort dose randomisation was performed in children 2-8 yr of age with OSA undergoing adenotonsillectomy. Ninety patients were assigned to one of two Spo2 cohorts by preoperative sleep study Spo2 nadir of < or ≥85% to receive fentanyl 1.0 or 1.5 μg kg-1 (maximum 25 μg) after sevoflurane induction. The primary outcome was the extent of opioid-induced central ventilatory depression over time by Spo2 status as defined by the differences in tidal volume, respiratory rate, end-tidal CO2, and minute ventilation for 10 min after fentanyl administration when compared with pre-fentanyl baseline values. Secondary outcomes included assessment of body mass index, fentanyl dose, sex, age, and race on opioid-induced central ventilatory depression. Intention-to-treat and per protocol analysis were performed.

Results: Ninety patients underwent in-cohort randomisation (Spo2 < 85%; n=47 and Spo2 ≥85%; n=43). Final per protocol analysis included 73 subjects, fentanyl 1.0 μg kg-1 (Spo2 < 85%; n=36 and Spo2 ≥85%; n=37) and 15 subjects, fentanyl 1.5 μg kg-1 (Spo2 < 85%; n=9 and Spo2 ≥85%; n=6). Multivariable mixed effect model for the primary outcomes (tidal volume, respiratory rate, end-tidal CO2, and minute ventilation) from baseline to 10 min (as % change per minute) were not different between groups by Spo2 nadir (< or ≥85%) and fentanyl dose for the intention-to-treat and per protocol analyses.

Conclusions: Single-dose fentanyl ventilatory effects in paediatric OSA patients during sevoflurane anaesthesia were not associated with …

Predictors Of Decannulation Success In Tracheostomy: A 10-Year Analysis Of The Global Tracheostomy Collaborative Database, Charissa J Zaga, Carly E Milliren, Brendan A Mcgrath, Christina J Yang, Bradley A Schiff, Stephen J Warrillow, Jennifer K Henningfeld, Prudence A Gregson, Joshua R Bedwell, Karen M Beaudet, Michael J Brenner, Vinciya Pandian

Faculty, Staff and Students Publications

Objective: Decannulation is a critical milestone in functional recovery after tracheostomy, but standardized guidelines are lacking. This study examined factors associated with tracheostomy decannulation success, comparing hospital utilization, adverse events, and survival outcomes between decannulated and non-decannulated patients.

Study design: Retrospective, observational study.

Setting: Data were collected from 25 hospitals participating in the Global Tracheostomy Collaborative (GTC) in the United States, Australia, and the United Kingdom.

Methods: Prospectively collected data from adult patients who underwent tracheostomy from 2013 to 2022 were analyzed. Outcomes included decannulation success, hospital utilization metrics (intensive care unit [ICU] admissions, mechanical ventilation use, tracheostomy duration, and …