Therapeutics Commons^™

Quantifying Patient Preferences For Treatments For Refractory Chronic Spontaneous Urticaria, Olufemi Babalola, Richard W. Hass, John F Mcana, Manav Segal, Juan Marcos Gonzalez, Olajumoke Fadugba

College of Population Health Faculty Papers

BACKGROUND: In recent years, it has become increasingly common to incorporate the patient perspective into drug development and regulatory decision making.

OBJECTIVE: This study aimed to measure and quantify patient preferences (priorities and trade-offs) for attributes that characterize current and emerging refractory chronic spontaneous urticaria (rCSU) treatments.

METHODS: Adult patients with self-reported rCSU symptoms completed an online discrete choice experiment survey. The survey included 10 questions that asked respondents to choose between 2 hypothetical rCSU treatment profiles having similar attributes with varying levels. The attributes included the following: chance of control of symptoms, time to symptom control, return of symptoms …

Real-World Impact Of Latanoprostene Bunod Ophthalmic Solution 0.024% In Glaucoma Therapy: A Narrative Review, W. Daniel Stamer, Thomas Chiu, Da-Wen Lu, Tsing Hong Wang, Prin Rojanapongpun, Ngamkae Ruangvaravate, Youn Hye Jo, Marlene R. Moster, Murray Fingeret, Nora Lee Cothran, Jessica Steen, Ian B. Gaddie, Ömür Uçakhan-Gündüz, Wesam S. Shalaby, Cindy M. L. Hutnik

Wills Eye Hospital Papers

Latanoprostene bunod ophthalmic solution (LBN) 0.024% is a topical nitric oxide (NO)-donating prostaglandin F2α (PGF2α) analog first approved in November 2017 for reduction of intraocular pressure (IOP) in patients with ocular hypertension (OHT) or open-angle glaucoma (OAG). This narrative review describes the unique mechanism of action of LBN and summarizes available real-world data. Upon instillation, LBN is metabolized into latanoprost acid and butanediol mononitrate, which is further reduced to NO and an inactive metabolite. Latanoprost acid increases aqueous humor outflow primarily through the uveoscleral (unconventional) pathway, whereas NO increases outflow through the trabecular (conventional) pathway. Eight studies were identified: 2 …

Effectiveness Of Intrapartum Azithromycin To Prevent Infections In Planned Vaginal Births In Low-Income And Middle-Income Countries: A Post-Hoc Analysis Of Data From A Multicentre, Randomised, Double-Blind Placebo-Controlled Trial, Waldemar A. Carlo, Alan T.N. Tita, Janet L. Moore, Musaku Mwenechanya, Elwyn Chomba, Jennifer J. Hemingway-Foday, Avinash Kavi, Mrityunjay C. Metgud, Shivaprasad S. Goudar, Richard J. Derman, Adrien Lokangaka, Antoinette Tshefu, Melissa Bauserman, Jackie K. Patterson, Poonam Shivkumar, Manju Waikar, Archana Patel, Patricia L. Hibberd, Paul Nyongesa, Fabian Esamai, Osayame Austine Ekhaguere, Sherri Bucher, Saleem Jessani, Shiyam Sunder Tikmani, Sarah Saleem, Robert L. Goldenberg, Sk Masum Billah, Ruth Lennox, Rashidul Haque, William Petri, Manolo Mazariegos, Nancy F. Krebs, Denise C. Babineau, Elizabeth M. Mcclure, Marion Koso-Thomas, A-Plus Trial Group

Global Health Articles

Background

In 2023, the Azithromycin Prevention in Labor Use (A-PLUS) trial showed intrapartum azithromycin reduces maternal sepsis or death in women with planned vaginal delivery in low-resource settings, but whether it reduces maternal infection is unknown. We aimed to evaluate the effectiveness of intrapartum azithromycin in reducing maternal infection.

Methods

We performed a post-hoc analysis of the multicentre, facility-based, randomised, double-blind, placebo-controlled A-PLUS trial. This trial compared prophylactic intrapartum single oral dose of 2 g azithromycin versus placebo on maternal morbidity and mortality in low-resource settings in southeast Asia and Africa from Sept 9, 2020, to Aug 18, 2022. The …

Outcomes In Patients With Classic Hodgkin Lymphoma Refractory Or Intolerant To Brentuximab Vedotin And Anti-Pd-1 Therapy: A Real World Analysis From 15 U.S. Academic Centers, Timothy J. Voorhees, Eric M. Mclaughlin, Pallawi Torka, Jorge Florindez, Na Hyun Kim, Tamara K. Moyo, Heather Reves, Nuttavut Sumransub, Saarang Deshpande, Ashley Rose, Cassandra Duarte, Muhammad Salman Faisal, Showkat Hamid, Suki Subbiah, Sabarish Ayyappan, Lauren Shea, Matt Cortese, Krish Patel, Ajay Major, Hayder Saeed, Jakub Svoboda, Sanjal Desai, Praveen Ramakrishnan Geethakumari, Mehdi Hamadani, Natalie Grover, Narendranath Epperla

School of Medicine Faculty Publications

Anti-PD-1 based therapies and brentuximab vedotin (BV) have significantly improved survival in patients with classic Hodgkin lymphoma (cHL) and have been incorporated into earlier lines of therapy. However, there is insufficient data regarding the clinical outcomes in patients who develop refractory disease or who become intolerant of BV and anti-PD-1 therapies (double refractory/intolerant; DR/INT). Here, we evaluated outcomes in patients with DR/INT cHL from 15 US academic medical centers. A total of 173 patients were identified as DR/INT. The median overall survival from the time of cHL diagnosis (OS-1) was 14.8 years (95% CI: 10.9–20.9 years) and the 10-year OS-1 …

Chemoid-Guided Therapy Improves Objective Response Rate In Recurrent Platinum-Resistant Ovarian Cancer Randomized Clinical Trial, Thomas J. Herzog, Thomas C. Krivak, Stephen Bush Ii, John P. Diaz, Scott Lentz, Navya Nair, Nadim Bou Zgheib, Camille Gunderson-Jackson, Abhijit Barve, Krista L. Denning, Seth T. Lirette, Candace M. Howard, Jagan Valluri, Pier Paolo Claudio

School of Medicine Faculty Publications

Patients with recurrent platinum-resistant ovarian cancer (PROC) have poor clinical outcomes, owing mainly to the presence of therapy-resistant cancer stem cells (CSCs). The NCT03949283 randomized clinical trial enrolled patients with recurrent PROC to receive ChemoID-guided chemotherapy or the best physician-choice regimen selected from the same list of thirteen mono or combination chemotherapies. The primary outcome was objective response rate (ORR) assessed on CT scans using the RECIST 1.1 criteria at 6 months follow-up. Subjects treated with the ChemoID assay had an ORR of 55% (CI(95) 39% - 73%), compared to 5% (CI(95) 0% - 11%) for those treated with physician’s …

Impact Of Body Mass Index On Stroke In Extracorporeal Cardiopulmonary Resuscitation: Data From The Extracorporeal Life Support Organization Registry, Jin Kook Kang, Shi Nan Feng, Winnie Liu, Jiah Kim, Andrew Kalra, Patricia Brown, Christopher Wilcox, Daniel Brodie, Steven Keller, Bo Soo Kim, Glenn Whitman, Sung-Min Cho

SKMC Student Presentations and Publications

Objective: We aimed to characterize the impact of body mass index (BMI) on stroke in patients receiving extracorporeal cardiopulmonary resuscitation (ECPR). Methods: We queried the Extracorporeal Life Support Organization registry for patients receiving ECPR (2020-2024). Patients were categorized into five BMI groups: underweight (< 18.5 kg/m²), normal weight (18.5-24.9 kg/m²), overweight (25-29.9 kg/m²), class 1 obesity (30-34.9 kg/m²), and class 2 obesity or above (≥35 kg/m²). A generalized additive model (GAM) analysis was used to identify the BMI range with the greatest stroke risk. Multivariable regression was used to compare odds of …

Stingers—A Review Of Current Understanding And Management, Teleale Gebeyehu, James Harrop, Stavros Matsoukas, Alexander Vaccaro

Department of Neurosurgery Faculty Papers

Abstract: A stinger is the transient sensory and motor loss of one upper extremity caused by a stretch or compression injury to the brachial plexus or the exiting cervical nerve roots. Athletes from contact sports like American football, rugby, wrestling, and horseback riding are most affected. Given today’s competitive athletic culture and recent advancements in sports medicine, understanding the clinical, diagnostic, and therapeutic aspects of stingers is crucial. Thus, this narrative review highlights current knowledge of pathology, clinical features, diagnostic modalities, radiologic measurements, management, rehabilitation, and return-to-play protocols. Recent and prominent English publications on adult athletes revealed that the brachial …

Use And Benefits Of A Therapeutic Hypnosis Interactive Media Program For Chronic Pain Management: A Pilot Study, Mark P. Jensen, Joy F. Chan, Owen Gottlieb, Laurence I. Sugarman, Emily Stensland

Articles

Chronic pain is a common condition that has significant negative effects on individuals and society. Opioids continue to be the primary treatment provided to the billions of individuals with chronic pain, despite their general lack of efficacy and significant negative side effects. A growing body of research supports the potential of therapeutic hypnosis for helping individuals better manage their chronic pain. However, access to this treatment is limited. The availability of a hypnosis digital therapeutic has the potential to address this access problem. The current study was designed to evaluate the feasibility of a digital therapeutic hypnosis prototype (not yet …

Resistance Signatures To Oncolytic Vesiculoviruses In Pancreatic Ductal Adenocarcinoma, Chelsae R. Watters, Oumar Barro, Musa Gabere, Mia Y. Masuda, Natalie M. Elliott, Elizabeth A. Raupach, Khandoker Usran Ferdous, Mulu Z. Tesfay, Omeed Moaven, Yumei Zhou, Michael T. Barrett, Kenneth H. Buetow, Bolni Marius Nagalo, Mitesh J. Borad

School of Medicine Faculty Publications

Pancreatic ductal adenocarcinoma (PDAC) shows limited response to conventional therapies and immunotherapy due to dense stromal barriers and poor immunogenicity. Oncolytic vesiculoviruses hold therapeutic potential for PDAC by lysis of PDAC cells to release tumor-associated antigens, increasing tumor immunogenicity. We previously reported the efficacy of a chimeric vesicular stomatitis virus (VSV) expressing Morreton virus (MorV) glycoprotein in sarcoma. Here, we evaluated the oncolytic potency of MorV and chimeric virus, VMG, in PDAC models. VMG exhibited heterogeneous oncolysis across human PDAC cell lines and PDX cells, similar to parental viruses VSV and MorV. To evaluate potential signatures correlated with resistance to …

Comparing Postoperative Opioid Use In Primary And Revision Lumbar Fusion: A Propensity-Matched Analysis, Jonathan Dalton, Jarod Olson, Nicholas B. Pohl, Rajkishen Narayanan, Omar Tarawneh, Yunsoo Lee, Michael V. Carter, Gokul Karthikeyan, Logan Witt, Aayush Mehta, John J. Mangan, Mark F. Kurd, Jose A. Canseco, Alan S. Hilibrand, Alex R. Vaccaro, Gregory D. Schroeder, Christopher K. Kepler

Department of Orthopaedic Surgery Faculty Papers

OBJECTIVE: This study compared postoperative opioid use for patients undergoing short segment primary versus revision lumbar fusion.

METHODS: Patients who underwent primary or revision 1-2 level lumbar fusion (2017-2021) were included in this study. The state Prescription Drug Monitoring Program was reviewed for all patients to quantify preoperative and postoperative opioid, benzodiazepine, muscle relaxant, and gabapentin use. A 1:1 propensity match was performed to match primary lumbar fusion patients with revision lumbar fusion patients. Revision lumbar fusion patients were substratified into those with or without persistent postoperative opioid use to identify demographic differences between these patient cohorts.

RESULTS: The final …

Effects Of Exercise On Inflammation, Circulating Tumor Cells, And Circulating Tumor Dna In Colorectal Cancer, Justin C. Brown, Stephanie L. Compton, Andrew Kang, Anjana Jayaraman, L Anne Gilmore, Brian J. Kirby, Frank L. Greenway, Shengping Yang, Guillaume Spielmann

School of Medicine Faculty Publications

BACKGROUND: The biological mechanisms by which postdiagnosis physical activity improves disease-free survival in colorectal cancer survivors remain incompletely understood. This trial tested the hypothesis that 12 wk of moderate-intensity aerobic exercise, when compared with a control group, would change inflammation, CTCs, and ctDNA in a manner consistent with an improved cancer prognosis. METHODS: This trial randomized Stages I-III colorectal cancer survivors to 12 wk of home-based moderate-intensity aerobic exercise or a waitlist control group. The co-primary endpoints were high-sensitivity C-reactive protein (hs-CRP) and interleukin-6 (IL-6), secondary endpoints were soluble tumor necrosis factor-α receptor 2 (sTNFαR2) and circulating tumor cells (CTCs), …

Respiratory Muscle Training Reduces Painful Swallowing And Opioid Use During Radiation Therapy For Head And Neck Cancer: A Matched Pair Analysis, Andrew D. Ray, Chi-Chen Hong, Nicolas F. Schlecht, Han Yu, Kristopher Attwood, Kent L. Nastiuk, Bryan A. Spinelli, Ann Marie Flores, Hillary Jacobson, Julia Fulfaro, M. Jeffrey Mador, Austin J. Iovoli, Mark K. Farrugia, Anurag K. Singh

Department of Physical Therapy Faculty Papers

BACKGROUND: Patients with head and neck cancer (HNC) receiving radiation therapy (RT) are at increased risk for symptoms of oral mucositis (OM), opioid use, and declines in physical function, outcomes that contribute to increased morbidity and mortality. The study objective was to determine the effects of respiratory muscle training (RMT) on OM and opioid use, as well as functional performance in patients with HNC receiving RT with or without concurrent chemotherapy (CCRT).

METHODS: Patients aged ≥ 18 years of age with stage I to IV HNC being treated with RT or CCRT receiving a home-based respiratory muscle training (RMT) (n …

Chemoradiation Treatment With Or Without Concurrent Tumor-Treating Fields (Ttfields) Therapy In Newly Diagnosed Glioblastoma (Gbm) Patients In China, Liping Liang, Lingchao Chen, Chunxia Ni, Wenyin Shi, Zhirui Zhou, Shu Chen, Wenjia Zhu, Jiabing Liu, Xianxin Qiu, Wanzun Lin, Junyan Zhang, Zhiyong Qin, Yang Wang

Department of Radiation Oncology Faculty Papers

BACKGROUND: Tumor-treating fields (TTFields) therapy and radiotherapy may have synergistic anti-glioma effect based on preclinical studies. The combination of chemoradiation therapy (CRT) with TTFields therapy has noticeably attracted clinicians' attention. This study aimed to provide insights into the clinical outcomes of patients with newly diagnosed glioblastoma who received either concurrent CRT and TTFields therapy or adjuvant TTFields therapy following CRT. The findings were based on a cohort of patients who were treated at Huashan Hospital (Shanghai, China).

METHODS: This retrospective study analyzed ndGBM patients' clinical outcomes who were treated at Huashan Hospital and received TTFields therapy. Patients were categorized into …

A Randomized Phase Ii/Iii Study Of Paclitaxel/Carboplatin/Metformin Versus Paclitaxel/Carboplatin/Placebo As Initial Therapy For Measurable Stage Iii Or Iva, Stage Ivb, Or Recurrent Endometrial Cancer: An Nrg Oncology/Gog Study, Victoria L. Bae-Jump, Michael W. Sill, Paola A. Gehrig, Jason D. Merker, David L. Corcoran, Adam D. Pfefferle, Michele C. Hayward, Joan L. Walker, Andrea R. Hagemann, Steven E. Waggoner, Roisin E. O'Cearbhaill, Megan E. Mcdonald, Mitchell I. Edelson, Paul A. Disilvestro, Amy L. Mcnally, Aimee Fleury, Ramey D. Littell, Frederick R. Ueland, Heather A. Lankes, Carol Aghajanian

Abington Jefferson Health Papers

INTRODUCTION: We evaluated the efficacy of the addition of the anti-diabetic drug metformin to standard-of-care paclitaxel and carboplatin (PC) in patients with advanced and recurrent endometrial cancer (EC).

METHODS: In this phase II/III trial, EC patients with chemotherapy-naïve stage III/IVA (with measurable disease) and stage IVB or recurrent (with or without measurable disease) disease were randomly assigned to PC/metformin (850 mg BID) versus PC/placebo. Metformin or placebo was continued as maintenance therapy after completion of PC until disease progression. The primary endpoint of phase II was progression-free survival (PFS). The primary endpoint of phase III was overall survival (OS). Secondary …

Superior Vena Cava Syndrome Due To Germ Cell Tumor In A Young Adult: Case Report, Manlio F. Lara Duck, Netzahualcoyotl Mayek Pérez, Juan Rosales Martínez

Research Symposium

Background: In superior vena cava syndrome (SVCS), the superior vena cava becomes mechanically obstructed by venous thrombus formation or by compression caused by intrathoracic tumors. SVCS is most common in men over 45 years of age; 22.5% of patients with SVCS have stage IV lung cancer or lymphoma. SVCS may occur secondary to extrathoracic tumors (testicular, ovarian, kidney, intestinal).

Case presentation: Male (24 years old) with a history of cancer in his maternal grandmother; denied drug addiction. Factory worker who denied being in direct contact with any chemicals and/or toxins. He reported non-productive cough; paroxysmal unilateral left facial edema without …

Changes In Brain Functional Connectivity Associated With Transcutaneous Auricular Vagus Nerve Stimulation In Healthy Controls, Daniel A. Monti, Nancy Wintering, Faezeh Vedaei, Alicia Steinmetz, Feroze Mohamed, Andrew B. Newberg

Marcus Institute of Integrative Health Faculty Papers

PURPOSE: A growing number of research studies have explored the potential effects of vagus nerve stimulation (VNS) on brain physiology as well as clinical effects particularly related to stress and anxiety. However, there currently are limited studies showing functional changes during different frequencies of stimulation and laterality effects transcutaneous auricular VNS (TaVNS). In this study, we evaluated whether TaVNS alters functional connectivity in the brain of healthy controls. We hypothesized that TaVNS would significantly alter connectivity in areas involved with emotional processing and regulation including the limbic areas, insula, frontal lobe regions, and cerebellum.

METHODS: We enrolled 50 healthy controls. …

The Advancement And Utility Of Multimodal Imaging In The Diagnosis Of Degenerative Disc Disease, Eric M. Teichner, Robert C. Subtirelu, Connor R. Crutchfield, Chitra Parikh, Arjun Ashok, Sahithi Talasila, Victoria Anderson, Milan Patel, Sricharvi Mannam, Andrew Lee, Thomas Werner, William Y. Raynor, Abass Alavi, Mona-Elisabeth Revheim

SKMC Student Presentations and Publications

Degenerative disc disease (DDD) is a common spinal condition characterized by the deterioration of intervertebral discs, leading to chronic back pain and reduced mobility. While magnetic resonance imaging (MRI) has long been the standard for late-stage DDD diagnosis, its limitations in early-stage detection prompt the exploration of advanced imaging methods. Positron emission tomography/computed tomography (PET/CT) using ¹⁸F- fluorodeoxyglucose (FDG) and ¹⁸F-sodium fluoride (NaF) has shown promise in identifying metabolic imbalances and age-related spinal degeneration, thereby complementing CT grading of the disease. The novel hybrid imaging modality PET/MRI provides new opportunities and are briefly discussed. The complex pathophysiology of …

Scaling New Heights: A Prospective Survey Of Rock Climbing's Impact On Mental Health, Kathy Chen, Swetha Sundaram, David F Lo, Ahmed Gawash, Charalampos Papachristou, Altamash E Raja

Rowan-Virtua School of Osteopathic Medicine Departmental Research

BACKGROUND: Sport climbing, officially added to the 2020 Summer Olympics, has grown rapidly, with U.S. climbing gyms increasing from 310 in 2013 to 591 in 2021. Over the past decade, European research has identified bouldering as a potential psychotherapeutic treatment for anxiety and depression. Randomized controlled trials have compared bouldering psychotherapy (BPT) to cognitive behavioral therapy (CBT), showing that BPT produces comparable results and positively impacts mental health.

PURPOSE: There have been very few studies dedicated to the use of rock climbing as a therapy in the United States; further, there are few surveys that investigate whether American climbers would …

First Documented Case Of A Third-Generation Lvad Rotor Dislodgement, Tyler Lee, Chaitra Janga, Enad Haddad, Kevin Hagan, Donald C. Haas

Abington Jefferson Health Papers

The third-generation left ventricular assist device (3G-LVAD) has significantly reduced adverse events and hospitalizations compared with previous generations. This case presents a rare 3G-LVAD rotor dislodgement malfunction, not previously documented, in a 77-year-old man. Further research behind the malfunction is warranted for early prevention and appropriate management.

The Impact Of Testosterone Therapy On The Vaginal Microbiota Of Transgender Men And Non-Binary People: A Prospective Study, Olivia T. Van Gerwen, Kristal J. Aaron, Emma Sophia Kay, Krishmita Siwakoti, Angela Pontius, Saralyn Richter, Z Alex Sherman, Keonte J. Graves, Ashutosh Tamhane, Jacob H. Elnaggar, Meng Luo, Evelyn Toh, David E. Nelson, Nicholas J. Van Wagoner, Christopher M. Taylor, Christina A. Muzny

School of Medicine Faculty Publications

BACKGROUND: Understanding the impact of testosterone on the vaginal microbiota of transgender men (TGM) and non-binary people assigned female sex at birth over time is imperative as vaginal dysbiosis and incident bacterial vaginosis (iBV) may cause bothersome genital symptoms and increase HIV/STI acquisition risk. We investigated shifts in the composition of the vaginal microbiota over time in TGM initiating testosterone for gender-affirming hormone therapy, including development of vaginal dysbiosis and iBV.

METHODS: Participants ages ≥18 years, assigned female sex at birth and reporting TGM or non-binary identity, interested in starting injectable testosterone, demonstrating optimal vaginal microbiota, with no current STI(s) …