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Article ; Online: Ophthalmic Artery Vessel Wall Inflammation in a Patient With Giant Cell Arteritis Presenting With Vision Loss: A Case Report.

Bhatt, Ishaan J / Tewkesbury, Grace M / Dayno, Rachel M / Glaser, Julia / Kolasinski, Sharon L / Shindler, Kenneth S / Song, Jae W

Journal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society

2024

Language	English
Publishing date	2024-03-29
Publishing country	United States
Document type	Journal Article
ZDB-ID	1189901-3
ISSN	1536-5166 ; 1070-8022
ISSN (online)	1536-5166
ISSN	1070-8022
DOI	10.1097/WNO.0000000000002136
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Article ; Online: Prion forensics: a multidisciplinary approach to investigate CWD at an illegal deer carcass disposal site.

Schwabenlander, Marc D / Bartz, Jason C / Carstensen, Michelle / Fameli, Alberto / Glaser, Linda / Larsen, Roxanne J / Li, Manci / Shoemaker, Rachel L / Rowden, Gage / Stone, Suzanne / Walter, W David / Wolf, Tiffany M / Larsen, Peter A

Prion

2024 Volume 18, Issue 1, Page(s) 72–86

Abstract: Infectious prions are resistant to degradation and remain infectious in the environment for several years. Chronic wasting disease (CWD) has been detected in cervids inhabiting North America, the Nordic countries, and South Korea. CWD-prion spread is ... ...

Abstract	Infectious prions are resistant to degradation and remain infectious in the environment for several years. Chronic wasting disease (CWD) has been detected in cervids inhabiting North America, the Nordic countries, and South Korea. CWD-prion spread is partially attributed to carcass transport and disposal. We employed a forensic approach to investigate an illegal carcass dump site connected with a CWD-positive herd. We integrated anatomic, genetic, and prion amplification methods to discover CWD-positive remains from six white-tailed deer (
MeSH term(s)	Animals ; Deer ; Wasting Disease, Chronic/transmission ; Prions/genetics ; Prions/metabolism ; Microsatellite Repeats/genetics
Chemical Substances	Prions
Language	English
Publishing date	2024-04-26
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2267671-5
ISSN	1933-690X ; 1933-690X
ISSN (online)	1933-690X
ISSN	1933-690X
DOI	10.1080/19336896.2024.2343298
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Article ; Online: Drug delivery, biodistribution and anti-EGFR activity: theragnostic nanoparticles for simultaneous

Bofinger, Robin / Weitsman, Gregory / Evans, Rachel / Glaser, Matthias / Sander, Kerstin / Allan, Helen / Hochhauser, Daniel / Kalber, Tammy L / Årstad, Erik / Hailes, Helen C / Ng, Tony / Tabor, Alethea B

Nanoscale

2021 Volume 13, Issue 44, Page(s) 18520–18535

Abstract: ... In ... ...

Abstract	In vivo
MeSH term(s)	Animals ; Biosensing Techniques ; Cell Line, Tumor ; ErbB Receptors/genetics ; ErbB Receptors/metabolism ; Mice ; Nanoparticles ; Pharmaceutical Preparations ; Protein Kinase Inhibitors/pharmacology ; Tissue Distribution
Chemical Substances	Pharmaceutical Preparations ; Protein Kinase Inhibitors ; ErbB Receptors (EC 2.7.10.1)
Language	English
Publishing date	2021-11-18
Publishing country	England
Document type	Journal Article
ZDB-ID	2515664-0
ISSN	2040-3372 ; 2040-3364
ISSN (online)	2040-3372
ISSN	2040-3364
DOI	10.1039/d1nr02770k
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Article ; Online: A Phase I trial of Nab-Paclitaxel/Bevacizumab (AB160) Nano-Immunoconjugate Therapy for Gynecologic Malignancies.

Kalogera, Eleftheria / Nevala, Wendy K / Finnes, Heidi D / Suman, Vera J / Schimke, Jill M / Strand, Carrie A / Kottschade, Lisa A / Kudgus, Rachel A / Buhrow, Sarah A / Becher, Laura R / Geng, Liyi / Glaser, Gretchen E / Grudem, Megan E / Jatoi, Aminah / Klampe, Carolyn M / Kumar, Amanika / Langstraat, Carrie L / McWilliams, Robert R / Wahner Hendrickson, Andrea E /

Weroha, S John / Yan, Yiyi / Reid, Joel M / Markovic, Svetomir N / Block, Matthew S

Clinical cancer research : an official journal of the American Association for Cancer Research

2024

Abstract: Purpose: AB160 is a 160 nm nano-immunoconjugate consisting of nab-paclitaxel (ABX) nanoparticles non-covalently coated with bevacizumab (BEV) for targeted delivery into tissues expressing high levels of VEGF. Preclinical data showed that AB160 resulted ... ...

Abstract	Purpose: AB160 is a 160 nm nano-immunoconjugate consisting of nab-paclitaxel (ABX) nanoparticles non-covalently coated with bevacizumab (BEV) for targeted delivery into tissues expressing high levels of VEGF. Preclinical data showed that AB160 resulted in greater tumor targeting and tumor inhibition compared to sequential treatment with ABX then BEV. Given individual drug activity, we investigated the safety and toxicity of AB160 in patients with gynecologic cancers. Patients and methods: A 3+3 phase I trial was conducted with 3 potential dose levels in patients with previously treated endometrial (EC), cervical (CC), and platinum-resistant ovarian cancer (OC) patients to ascertain the recommended Phase II dose (RP2D). AB160 was administered intravenously on Days 1, 8 and 15 of a 28-day cycle (ABX 75-175 mg/m2, BEV 30-70 mg/m2). Pharmacokinetic analyses were performed. Results: No dose-limiting toxicities (DLTs) were seen among the 3 DLs tested. Grade 3/4 toxicities included neutropenia, thromboembolic events, and leukopenia. DL2 (ABX 150 mg/m2, BEV 60 mg/m2) was chosen as the RP2D. Seven of the 19 patients with measurable disease (36.8%) had confirmed partial responses (95% CI: 16.3%-61.6%). Pharmacokinetic analyses demonstrated that AB160 allowed 50% higher paclitaxel dosing and that paclitaxel clearance mirrored that of therapeutic antibodies. Conclusions: The safety profile and clinical activity of AB160 supports further clinical testing in patients with gynecologic cancers; the RP2D is DL2 (ABX 150 mg/m2, BEV 60 mg/m2).
Language	English
Publishing date	2024-03-26
Publishing country	United States
Document type	Journal Article
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-23-3196
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Article ; Online: Therapeutic Development in Polyarticular Course Juvenile Idiopathic Arthritis: Extrapolation, Dose Selection, and Clinical Trial Design.

Arthritis & rheumatology (Hoboken, N.J.)

2023 Volume 75, Issue 10, Page(s) 1856–1866

Abstract: Objective: Stakeholders met to address persistent challenges facing the development of therapeutics for polyarticular juvenile idiopathic arthritis (pJIA), which result in fewer approved therapies for children with pJIA than adults with rheumatoid ... ...

Abstract	Objective: Stakeholders met to address persistent challenges facing the development of therapeutics for polyarticular juvenile idiopathic arthritis (pJIA), which result in fewer approved therapies for children with pJIA than adults with rheumatoid arthritis (RA) and long lag times from adult RA approval to pediatric labeling. Ensuring that new medications are authorized in a timely manner to meet the needs of JIA patients worldwide is critically important to multiple stakeholders. Methods: The Food and Drug Administration in collaboration with the University of Maryland Center for Regulatory Science and Innovation held a public workshop entitled "Accelerating Drug Development for pJIA" on October 2, 2019, to address challenges surrounding access to new medications for children and adolescents with pJIA. Regulatory, academic, and industry stakeholders, as well as patient representatives, participated in the workshop, which consisted of 4 sessions, including panel discussions. Results: The workshop facilitated broad public discussion of challenges facing the development of pJIA therapeutics, highlighting areas of need and outlining opportunities to expedite development, while underscoring the necessity of close collaboration between all stakeholders, including patients and families. Conclusion: This report summarizes key aspects of the workshop, including the appropriate application of innovative approaches to the development of pJIA therapeutics, including extrapolation, to address current challenges and provide timely access to newer safe and effective treatments. Long-term safety assessment is of pressing concern to stakeholders and cannot be fully extrapolated from adult studies but requires consistent postmarketing long-term follow-up.
MeSH term(s)	Adult ; Adolescent ; Humans ; Child ; Arthritis, Juvenile/drug therapy ; Clinical Trials as Topic ; Arthritis, Rheumatoid ; Treatment Outcome ; Drug Development
Language	English
Publishing date	2023-08-03
Publishing country	United States
Document type	Journal Article
ZDB-ID	2756371-6
ISSN	2326-5205 ; 2326-5191
ISSN (online)	2326-5205
ISSN	2326-5191
DOI	10.1002/art.42534
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Article ; Online: Vulvar Cancer, Version 3.2024, NCCN Clinical Practice Guidelines in Oncology.

Abu-Rustum, Nadeem R / Yashar, Catheryn M / Arend, Rebecca / Barber, Emma / Bradley, Kristin / Brooks, Rebecca / Campos, Susana M / Chino, Junzo / Chon, Hye Sook / Crispens, Marta Ann / Damast, Shari / Fisher, Christine M / Frederick, Peter / Gaffney, David K / Gaillard, Stephanie / Giuntoli, Robert / Glaser, Scott / Holmes, Jordan / Howitt, Brooke E /

Journal of the National Comprehensive Cancer Network : JNCCN

2024 Volume 22, Issue 2, Page(s) 117–135

Abstract: Vulvar cancer is annually diagnosed in an estimated 6,470 individuals and the vast majority are histologically squamous cell carcinomas. Vulvar cancer accounts for 5% to 8% of gynecologic malignancies. Known risk factors for vulvar cancer include ... ...

Abstract	Vulvar cancer is annually diagnosed in an estimated 6,470 individuals and the vast majority are histologically squamous cell carcinomas. Vulvar cancer accounts for 5% to 8% of gynecologic malignancies. Known risk factors for vulvar cancer include increasing age, infection with human papillomavirus, cigarette smoking, inflammatory conditions affecting the vulva, and immunodeficiency. Most vulvar neoplasias are diagnosed at early stages. Rarer histologies exist and include melanoma, extramammary Paget's disease, Bartholin gland adenocarcinoma, verrucous carcinoma, basal cell carcinoma, and sarcoma. This manuscript discusses recommendations outlined in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for treatments, surveillance, systemic therapy options, and gynecologic survivorship.
MeSH term(s)	Female ; Humans ; Adenocarcinoma/pathology ; Genital Neoplasms, Female ; Paget Disease, Extramammary/diagnosis ; Paget Disease, Extramammary/etiology ; Paget Disease, Extramammary/therapy ; Skin Neoplasms ; Vulvar Neoplasms/diagnosis ; Vulvar Neoplasms/epidemiology ; Vulvar Neoplasms/etiology
Language	English
Publishing date	2024-03-19
Publishing country	United States
Document type	Journal Article ; Practice Guideline
ZDB-ID	2250759-0
ISSN	1540-1413 ; 1540-1405
ISSN (online)	1540-1413
ISSN	1540-1405
DOI	10.6004/jnccn.2024.0013
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Article ; Online: Inconsistencies in fertility preservation for young people with cancer in the UK.

Newton, Hannah L / Picton, Helen M / Friend, Amanda Jane / Hayden, Catherine M / Brougham, Mark / Cox, Rachel / Grandage, Victoria / Kwok-Williams, Michelle / Lane, Sheila / Mitchell, Rod Thomas / Skinner, Roderick / Wallace, W Hamish / Yeomanson, Daniel / Glaser, Adam W

Archives of disease in childhood

2021 Volume 107, Issue 3, Page(s) 265–270

Abstract: Objective: To assess the utilisation of and funding structure for fertility preservation for children diagnosed with cancer in the UK.: Design: Survey of paediatric oncologists/haematologists. Questionnaires were sent electronically with reminder ... ...

Abstract	Objective: To assess the utilisation of and funding structure for fertility preservation for children diagnosed with cancer in the UK. Design: Survey of paediatric oncologists/haematologists. Questionnaires were sent electronically with reminder notifications to non-responders. Setting: UK Paediatric Oncology Principal Treatment Centres (PTCs). Participants: Paediatric oncologists/haematologists with an interest in the effects of treatment on fertility representing the 20 PTCs across the UK. Main outcome measures: Referral practices, sources and length of funding for storage of gametes or gonadal tissue for children diagnosed with cancer in the preceding 12 months. Results: Responses were received from 18 PTCs (90%) with responses to 98.3% of questions. All centres had referred patients for fertility preservation: ovarian tissue collection/storage 100% (n=18 centres), sperm banking 100% (n=17; one centre was excluded due to the age range of their patients), testicular tissue storage 83% (n=15), mature oocyte collection 35% (n=6; one centre was excluded due to the age range of their patients). All centres with knowledge of their funding source reported sperm cryopreservation was NHS funded. Only 60% (n=9) centres reported the same for mature oocyte storage. Of the centres aware of their funding source, half reported that ovarian and testicular tissue storage was funded by charitable sources; this increased in England compared with the rest of the UK. Conclusions: Inequality exists in provision of fertility preservation for children with cancer across the UK. There is lack of formalised government funding to support international guidelines, with resultant geographical variation in care. Centralised funding of fertility preservation for children and young adults is needed alongside establishment of a national advisory panel to support all PTCs.
MeSH term(s)	Adolescent ; Child ; Cross-Sectional Studies ; Cryopreservation/methods ; Female ; Fertility Preservation/statistics & numerical data ; Healthcare Disparities ; Humans ; Male ; Neoplasms/epidemiology ; Pediatrics/methods ; Surveys and Questionnaires ; United Kingdom/epidemiology
Language	English
Publishing date	2021-09-20
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	524-1
ISSN	1468-2044 ; 0003-9888 ; 1359-2998
ISSN (online)	1468-2044
ISSN	0003-9888 ; 1359-2998
DOI	10.1136/archdischild-2021-321873
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Article ; Online: A case series analysis of serious exacerbations of viral hepatitis and non-viral hepatic injuries in tocilizumab-treated patients.

Biehl, Ann / Harinstein, Lisa / Brinker, Allen / Glaser, Rachel / Muñoz, Monica / Avigan, Mark

Liver international : official journal of the International Association for the Study of the Liver

2020 Volume 41, Issue 3, Page(s) 515–528

Abstract: Background and aims: Reports of moderate to severe liver injury associated with tocilizumab, an interleukin-6 (IL-6) receptor antagonist, have been reported in the post-marketing setting. This case series aims to characterize cases of tocilizumab- ... ...

Abstract	Background and aims: Reports of moderate to severe liver injury associated with tocilizumab, an interleukin-6 (IL-6) receptor antagonist, have been reported in the post-marketing setting. This case series aims to characterize cases of tocilizumab-associated clinically significant hepatic injury. Methods: We analysed cases of severe acute liver injury associated with tocilizumab reported in the FDA Adverse Event Reporting System and the medical literature. Results: We identified 12 cases in which tocilizumab was a suspected primary cause of liver injury and eight cases in which serious sequelae of underlying or coincident viral hepatitis were temporally associated with its use. Using the Drug-Induced Liver Injury Network (DILIN) severity scale, five of 12 cases were Grade 5 (two liver transplants, three deaths), one was Grade 4 (liver failure) and six were Grade 3 (serious events with elevated bilirubin). Two cases reported liver atrophy with low hepatocellular expression of Ki-67, a marker of cellular proliferation. Among the eight cases of tocilizumab-associated viral hepatitis exacerbation, three were scored as DILIN severity Grade 5 (one liver transplant, two deaths), one was Grade 4 (liver failure), and four were Grade 3. The reported viral hepatitis events were hepatitis B virus (HBV) reactivation (n = 3), hepatitis C virus (HCV) flare (n = 1), cytomegalovirus (CMV)-induced liver failure (n = 1), Epstein-Barr virus hepatitis (n = 1), acute hepatitis E (HEV, n = 1) and HEV-induced macrophage activation syndrome (n = 1). Conclusion: Tocilizumab may be a primary cause of severe liver injury, as well as exacerbate underlying viral hepatitis. The disruption by tocilizumab of IL-6-mediated immune protection and hepatocyte regeneration may aggravate clinical outcomes in some cases.
MeSH term(s)	Antibodies, Monoclonal, Humanized/adverse effects ; Chemical and Drug Induced Liver Injury ; Epstein-Barr Virus Infections ; Herpesvirus 4, Human ; Humans ; Liver
Chemical Substances	Antibodies, Monoclonal, Humanized ; tocilizumab (I031V2H011)
Language	English
Publishing date	2020-12-31
Publishing country	United States
Document type	Case Reports ; Journal Article
ZDB-ID	2102783-3
ISSN	1478-3231 ; 1478-3223
ISSN (online)	1478-3231
ISSN	1478-3223
DOI	10.1111/liv.14766
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Article ; Online: Performance of CHROMagar ESBL media for the surveillance of extended-spectrum cephalosporin-resistant

Mannathoko, Naledi / Lautenbach, Ebbing / Mosepele, Mosepele / Otukile, Dimpho / Sewawa, Kgotlaetsile / Glaser, Laurel / Cressman, Leigh / Cowden, Laura / Alby, Kevin / Jaskowiak-Barr, Anne / Gross, Robert / Mokomane, Margaret / Paganotti, Giacomo M / Styczynski, Ashley / Smith, Rachel M / Snitkin, Evan / Wan, Tiffany / Bilker, Warren B / Richard-Greenblatt, Melissa

Journal of medical microbiology

2023 Volume 72, Issue 11

Abstract: Introduction. ...

Abstract	Introduction.
MeSH term(s)	Humans ; Cephalosporins/pharmacology ; Botswana ; Escherichia coli ; Monobactams ; Agar ; Gammaproteobacteria ; Hydrolases
Chemical Substances	Cephalosporins ; Monobactams ; Agar (9002-18-0) ; Hydrolases (EC 3.-)
Language	English
Publishing date	2023-11-22
Publishing country	England
Document type	Journal Article
ZDB-ID	218356-0
ISSN	1473-5644 ; 0022-2615
ISSN (online)	1473-5644
ISSN	0022-2615
DOI	10.1099/jmm.0.001770
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Article ; Online: Risk Factors for Community Colonization With Extended-Spectrum Cephalosporin-Resistant Enterobacterales (ESCrE) in Botswana: An Antibiotic Resistance in Communities and Hospitals (ARCH) Study.

Lautenbach, Ebbing / Mosepele, Mosepele / Smith, Rachel M / Styczynski, Ashley / Gross, Robert / Cressman, Leigh / Jaskowiak-Barr, Anne / Alby, Kevin / Glaser, Laurel / Richard-Greenblatt, Melissa / Cowden, Laura / Sewawa, Kgotlaetsile / Otukile, Dimpho / Paganotti, Giacomo M / Mokomane, Margaret / Bilker, Warren B / Mannathoko, Naledi

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2023 Volume 77, Issue Suppl 1, Page(s) S89–S96

Abstract: Background: The epidemiology of extended-spectrum cephalosporin-resistant Enterobacterales (ESCrE) in low- and middle-income countries (LMICs) is poorly described. Identifying risk factors for ESCrE colonization is critical to inform antibiotic ... ...

Abstract	Background: The epidemiology of extended-spectrum cephalosporin-resistant Enterobacterales (ESCrE) in low- and middle-income countries (LMICs) is poorly described. Identifying risk factors for ESCrE colonization is critical to inform antibiotic resistance reduction strategies because colonization is typically a precursor to infection. Methods: From 15 January 2020 to 4 September 2020, we surveyed a random sample of clinic patients at 6 sites in Botswana. We also invited each enrolled participant to refer up to 3 adults and children. All participants had rectal swabs collected that were inoculated onto chromogenic media followed by confirmatory testing. Data were collected on demographics, comorbidities, antibiotic use, healthcare exposures, travel, and farm and animal contact. Participants with ESCrE colonization (cases) were compared with noncolonized participants (controls) to identify risk factors for ESCrE colonization using bivariable, stratified, and multivariable analyses. Results: A total of 2000 participants were enrolled. There were 959 (48.0%) clinic participants, 477 (23.9%) adult community participants, and 564 (28.2%) child community participants. The median (interquartile range) age was 30 (12-41) and 1463 (73%) were women. There were 555 cases and 1445 controls (ie, 27.8% of participants were ESCrE colonized). Independent risk factors (adjusted odds ratio [95% confidence interval]) for ESCrE included healthcare exposure (1.37 [1.08-1.73]), foreign travel [1.98 (1.04-3.77]), tending livestock (1.34 [1.03-1.73]), and presence of an ESCrE-colonized household member (1.57 [1.08-2.27]). Conclusions: Our results suggest healthcare exposure may be important in driving ESCrE. The strong links to livestock exposure and household member ESCrE colonization highlight the potential role of common exposure or household transmission. These findings are critical to inform strategies to curb further emergence of ESCrE in LMICs.
MeSH term(s)	Female ; Humans ; Male ; Anti-Bacterial Agents/pharmacology ; Anti-Bacterial Agents/therapeutic use ; Botswana/epidemiology ; Cephalosporins ; Drug Resistance, Microbial ; Hospitals ; Monobactams ; Prospective Studies ; Risk Factors ; Child ; Adolescent ; Young Adult ; Adult
Chemical Substances	Anti-Bacterial Agents ; Cephalosporins ; Monobactams
Language	English
Publishing date	2023-07-05
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciad259
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