Otolaryngology Commons^™

A Real-World Characterization Of Patients Receiving Biologics For Type 2 Inflammatory Diseases In A Tertiary Rhinology Practice, T. Blaise Marshall, Matthew Lelegren, Joseph K. Han, Kent Lam

Eastern Virginia Medical Journal

Background: Biologic therapies, such as omalizumab, mepolizumab, dupilumab, and benralizumab, are increasingly used in the treatment of various type 2 inflammatory diseases, including chronic rhinosinusitis with nasal polyposis (CRSwNP), asthma, and atopic dermatitis. While these biologic therapies have demonstrated efficacy and safety in their respective clinical trials, real-world characterization of the use of biologic therapies provides insight into how these treatments are prescribed and utilized among the general population.

Objective: We aim to characterize the patient population in a single tertiary otolaryngology practice that is receiving biologic therapies for all type 2 inflammatory diseases.

Methods: We conducted a retrospective chart …

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: 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 …

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, …

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.

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 …

An Account Of Roman Surgical Treatments For Ozena: Historical Review, Perry Hammond, Rebecca R. Benefiel, Kent Lam

Department of Otolaryngology (ENT) Faculty Publications

Objective: To analyze a first-century Roman account of surgery for ozena-a tetrad of nasal crusting, ulceration, bony involvement, and foul odor-with a focus on historical context, etymology, and surgical management.

Data Sources: This historical review draws from the authors' translation of De Medicina. Primary sources detailing Roman surgical instruments from the House of the Surgeon in Pompeii, as well as secondary sources of surgical techniques, were utilized.

Review methods: An in-depth review of Celsus' descriptions of surgical techniques for ozena was conducted using independent translation and exegetical analysis of primary sources. Archaeological findings were investigated to correlate surgical tools with …

Characterization Of Litigation After Tympanoplasty And Mastoidectomy In The United States, Alyssa D. Reese, Lauren A. Dinardo, Soumya Gupta, Kristina F. Powers, Samuel Colca, Michele M. Carr

Department of Otolaryngology (ENT) Faculty Publications

Introduction

Tympanoplasty and mastoidectomy are common procedures performed by otolaryngologists that can result in complications for which patients may seek compensation. Medical malpractice case analyses may offer insight into how clinicians can avoid risk and improve patient satisfaction. We aimed to comprehensively characterize litigation after mastoidectomies and tympanoplasties in the United States.

Methods

The Westlaw Campus Research legal database was searched for all available court decisions associated with claims of medical malpractice after tympanoplasty and/or mastoidectomy in the United States between 1975 and 2022. Information on the plaintiffs' relationships to the patients, patient characteristics, states where the procedures took place, …

Size Of Pediatric Tracheostomy Tube And Predictors Of Postoperative Complications, Soukaina Eljamri, Jordyn Lucas, Amber Shaffer, Basil Hashimi, Marina Rushchak, Reema Padia

Department of Otolaryngology (ENT) Faculty Publications

Objective

(1) To investigate weight as an alternative guide for trach tube choice. (2) Evaluate complications 3-month posttracheostomy and associations with patient and trach tube factors.

Study design

Retrospective cohort study.

Setting

Single academic medical center.

Methods

Patients < 2 years old who underwent tracheostomy placement from 2017 to 2022 were identified. Associations between trach characteristics, trach size/length, chest x-ray (CXR) and intraoperative endoscopy measurements, and complications within 3 months posttracheostomy placement were evaluated.

Results

In total, 68 patients were included in the study, with a median age of 4 months (range: 1 day to 1.74 years) and weight of 4.1 kg (range: 1.8-11.6 kg) at the time of the procedure. The length of the trachea measured on CXR was more closely associated with weight (ρ = 0.403, P = .0007) than with age (ρ = …

Risk Analysis Of Radiosurgery For Vestibular Schwannoma: Systematic Review And Comparative Study Of 10-Year Outcomes, Kevin M. Guy, April A. Pace, Derek S. Tsang, Peter G. Volsky

Department of Otolaryngology (ENT) Faculty Publications

Background: Determine the benefit of stereotactic radiosurgery (SRS) compared to no treatment for sporadic vestibular schwannoma (VS) by calculating epidemiologic risk using 10-year data; apply the analysis to VS that have demonstrated linear growth.

Methods: PubMed, Google Scholar, Web of Science, and Cochrane Library are systematically reviewed for VS tumor control 10 years after SRS and compared to an historical cohort of untreated VS (primary risk analysis). Subgroups of VS limited by size and observed growth are compared to the untreated cohort (secondary analysis).

Results: Twenty-four studies of 4,079 SRS-treated VS exhibited tumor control in 90.93% (87.0%-100%; SD 4.1%), while …

Opioid Usage And Non-Opioid Alternatives In Septorhinoplasty: A Narrative Review, Robert M. Frederick, Eric Dobratz

Department of Otolaryngology (ENT) Faculty Publications

Background and Objective: Opioids are routinely prescribed following septorhinoplasty and oftentimes surgeons prescribe a larger number of tablets than patients require. Considering the high risk of developing opioid dependence and risk of diversion, it is imperative that surgeons practice safer, evidence-based prescribing habits. This review is intended to detail the current state of opioid usage after septorhinoplasty, focusing on articles that show pertinent and practice-altering findings. This will allow surgeons to reflect on their prescribing patterns and make evidence-based decisions to improve them.

Methods: A literature search was performed in November 20, 2024 via PubMed using keywords such as ‘opioid …

Categorizing Clinical Response To Mepolizumab For Patients With Chronic Rhinosinusitis With Nasal Polyps: Synapse Trial, Claire Hopkins, Larry Borish, Jared Silver, Peter Howarth, Robert Chan, Priya Dsilva, Joseph K. Han

Department of Otolaryngology (ENT) Faculty Publications

[Introduction] Chronic rhinosinusitis with nasal polyps (CRSwNP) can substantially affect quality of life (QoL), and is often challenging to manage.¹ First-line treatment for the management of CRSwNP involves intranasal corticosteroids, with short courses of systemic corticosteroids (SCS) for exacerbations, and sinus surgery for uncontrolled disease.² Biologics targeting type 2 inflammation (eg, dupilumab, omalizumab, and mepolizumab) have become a treatment option for refractory CRSwNP. With the advent of disease-modifying treatments such as biologics, control, defined as patients reporting no/low-symptom levels, has increasingly become the treatment goal for CRSwNP.³ However, the optimal use of biologics for symptom control in individual patients remains …

Interobserver Variability Regarding Adequacy Of Oropharyngeal Exposure For Transoral Robotic Surgery May Necessitate Staging Endoscopy: Evaluating Tors Exposure, Colleen Schinderle, Kevin J. Carlson, Reem Sharaf Alddin, Jeffery J. Houlton, Matthew J. Bak, Daniel W. Karakla, Jonathan R. Mark

Department of Otolaryngology (ENT) Faculty Publications

[First paragraph] Transoral robotic surgery (TORS) for the treatment of oropharyngeal cancer has become centered at tertiary referral centers. To avoid treatment delays or multiple anesthetics, the need for repeat operative endoscopy may be questioned when the diagnosis has been made at an outside institution. However, inadequate visualization of relevant anatomy can preclude TORS candidacy and may lead to procedure abortion or conversion to an open technique.²,³ To evaluate this dilemma, we explored the ability to assess oropharyngeal exposure for TORS candidacy via operative endoscopic photo-documentation.

Feasibility And Reliability Of Health-Related Physical Fitness Tests In Children And Adolescents With Hearing Impairment, Jiafu Huang, Jianmei Yang, Justin A. Haegele, Lijuan Wang, Sitong Chen, Chunxiao Li

Human Movement Studies & Special Education Faculty Publications

Although research supports the feasibility and reliability of health-related physical fitness (HRPF) tests in typically developing children and adolescents, little is known regarding the feasibility and reliability of these tests for those with hearing impairments (HI). The aim of this study was to evaluate the feasibility and reliability of a HRPF test battery for children and adolescents with HI. A test–retest design with a one-week interval was conducted with 26 participants with HI (mean age: 12.7 ± 2.8 years; 9 male). The feasibility and reliability of seven field-based HRPF tests (i.e., body mass index, grip strength, standing long jump, vital …

Insulinlike Growth Factor 1- And 2-Augmented Collagen Gel Repair Of Facial Osseous Defects, James S. Toung, Roy C. Ogle, Raymond F. Morgan, William H. Lindsey

School of Medical Diagnostics & Translational Sciences Publications

BACKGROUND: Defects of the facial bone structure are common problems for the facial plastic surgeon. Native type 1 collagen gels (T1CGs) have been shown to mediate repair of facial critical-size defects in rat models.

OBJECTIVE: To evaluate the efficacy of T1CG augmented with insulinlike growth factor (IGF) 1, IGF-2, and a combination of IGF-1 and IGF-2 on the repair of facial critical-size defects in a rodent model.

METHODS: Twenty-four retired male breeder Sprague-Dawley rats were divided into 4 groups of 6 animals. Facial critical-size defects were created by removing the nasalis bones with a bone-cutting drill. Defects were treated with …