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Article: Heparin-enriched plasma proteome is significantly altered in Alzheimer's Disease.

Guo, Qi / Ping, Lingyan / Dammer, Eric B / Yin, Luming / Xu, Kaiming / Shantaraman, Anantharaman / Fox, Edward J / Golde, Todd E / Johnson, Erik C B / Roberts, Blaine R / Lah, James J / Levey, Allan I / Seyfried, Nicholas T

Research square

2024

Abstract: Introduction: Heparin binding proteins (HBPs) with roles in extracellular matrix assembly are strongly correlated to β-amyloid (Aβ) and tau pathology in Alzheimer's disease (AD) brain and cerebrospinal fluid (CSF). However, it remains challenging to ... ...

Abstract	Introduction: Heparin binding proteins (HBPs) with roles in extracellular matrix assembly are strongly correlated to β-amyloid (Aβ) and tau pathology in Alzheimer's disease (AD) brain and cerebrospinal fluid (CSF). However, it remains challenging to detect these proteins in plasma using standard mass spectrometry-based proteomic approaches. Methods: We employed heparin affinity chromatography, followed by off-line fractionation and tandem mass tag mass spectrometry (TMT-MS), to capture and enrich HBPs in plasma obtained from AD (n=62) and control (n=47) samples. These profiles were then correlated to a consensus AD brain proteome, as well as with Aβ, tau and phosphorylated tau (pTau) CSF biomarkers from the same individuals. We then leveraged published human postmortem brain proteome datasets to assess the overlap with the heparin-enriched plasma proteome. Results: Heparin-enrichment from plasma was highly reproducible, enriched well-known HBPs like APOE and thrombin, and depleted high-abundance proteins such as albumin. A total of 2865 proteins, spanning 10 orders of magnitude were detectable. Utilizing a consensus AD brain protein co-expression network, we observed that specific plasma HBPs exhibited consistent direction of change in both brain and plasma, whereas others displayed divergent changes highlighting the complex interplay between the two compartments. Elevated HBPs in AD plasma, when compared to controls, included members of the matrisome module in brain that accumulate within Aβ deposits, such as SMOC1, SMOC2, SPON1, MDK, OLFML3, FRZB, GPNMB, and APOE. Additionally, heparin enriched plasma proteins demonstrated significant correlations with conventional AD CSF biomarkers, including Aβ, total tau, pTau, and plasma pTau from the same individuals. Conclusion: These findings support the utility of a heparin-affinity approach for enriching amyloid-associated proteins, as well as a wide spectrum of plasma biomarkers that reflect pathological changes in the AD brain.
Language	English
Publishing date	2024-02-23
Publishing country	United States
Document type	Preprint
DOI	10.21203/rs.3.rs-3933136/v1
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Article ; Online: Resident Training and the Assessment of Orthopaedic Surgical Skills.

Bagley, Joshua J / Piazza, Brian / Lazarus, Michelle D / Fox, Edward J / Zhan, Xiang

JB & JS open access

2021 Volume 6, Issue 4

Abstract: Medical knowledge and technical skills are foundations of surgical competency. The American Board of Orthopaedic Surgery (ABOS) and the Resident Review Committee for Orthopaedic Surgery recently mandated simulation training to improve surgical skills, ... ...

Abstract	Medical knowledge and technical skills are foundations of surgical competency. The American Board of Orthopaedic Surgery (ABOS) and the Resident Review Committee for Orthopaedic Surgery recently mandated simulation training to improve surgical skills, listing 17 surgical skills modules to improve residents' technical skills. However, there is no established tool to measure the effectiveness of these modules. The Global Index for Technical Skills (GRITS) tool has been previously validated for evaluating general surgery residents. The aim of this study was to determine whether the GRITS tool is valid, practical, and reliable in evaluating the skills of orthopaedic residents in a simulation setting, whether the outcomes correlate to performance in the operating room, and to what extent these simulation modules are valued by residents. Methods: Simulation performance was assessed longitudinally on 5 residents using the GRITS assessment through postgraduate years (PGY) 1 to 5 (n = 25 evaluations) in a simulated volar forearm approach using cadaveric specimens. An additional 20 PGY-1 residents were evaluated cross-sectionally in this same time frame. Written, open-ended feedback on the simulation experience was sought and analyzed via a thematic analysis. For correlative data, evaluations (n = 65 evaluations) of a variety of authentic surgical procedures were compiled on PGY-2 through PGY-5 orthopaedic residents and compared with the simulated experiences. Results: GRITS scores were averaged for each group of residents, and validity and reliability were assessed using R-software. PGY-1 residents' mean GRITS evaluation score (expressed as a value from 1 to 5) was 3.4. Longitudinally, this mean score increased over the PGY years 2-5 to 4.4, 4.7, 4.9, and 4.8, respectively. Of the parameters measured by GRITS, the lowest average scores were "flow of operation" and "time and motion" across all levels, although these did improve over PGY years 2 to 5. Findings were consistent between simulation and "real-world" procedures. Open-ended responses evaluating the module were positive. Conclusions: Our study suggests that the GRITS tool shows promise as an effective and reliable method for assessing orthopaedic resident's technical skills based on an ABOS module system.
Language	English
Publishing date	2021-12-23
Publishing country	United States
Document type	Journal Article ; Review
ISSN	2472-7245
ISSN (online)	2472-7245
DOI	10.2106/JBJS.OA.20.00173
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Article ; Online: Clinical Perspectives on the Molecular and Pharmacological Attributes of Anti-CD20 Therapies for Multiple Sclerosis.

Bar-Or, Amit / O'Brien, Susan M / Sweeney, Michael L / Fox, Edward J / Cohen, Jeffrey A

CNS drugs

2021 Volume 35, Issue 9, Page(s) 985–997

Abstract: Anti-CD20 therapies have demonstrated considerable efficacy in the treatment of relapsing multiple sclerosis, constituting a high-efficacy treatment approach for reducing relapse risk and mitigating disability progression. These therapies have been shown ...

Abstract	Anti-CD20 therapies have demonstrated considerable efficacy in the treatment of relapsing multiple sclerosis, constituting a high-efficacy treatment approach for reducing relapse risk and mitigating disability progression. These therapies have been shown to strongly deplete circulating B cells and small subsets of CD3+ CD4 and CD8 T cells that express low levels of CD20. While the clinical profiles of the various anti-CD20 monoclonal antibodies used in treating multiple sclerosis are well-described in the literature, greater understanding of the implications of their distinct molecular and pharmacological attributes is needed. In this review, we focus on four anti-CD20 monoclonal antibodies-rituximab, ocrelizumab, ofatumumab, and ublituximab-that are currently used, approved, or in late-stage clinical development for the treatment of multiple sclerosis. We provide clinical perspectives on the potential implications of differences in molecular structures, target epitopes, dosing regimens, mechanisms and impact on B-cell depletion and reconstitution, immunogenicity, administration-related reactions, and infection risks.
MeSH term(s)	Antibodies, Monoclonal/administration & dosage ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antigens, CD20/immunology ; Antigens, CD20/metabolism ; B-Lymphocytes, Regulatory/drug effects ; B-Lymphocytes, Regulatory/immunology ; Humans ; Immunologic Factors/administration & dosage ; Multiple Sclerosis/drug therapy ; Multiple Sclerosis/immunology ; Multiple Sclerosis/metabolism ; Rituximab/administration & dosage
Chemical Substances	Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Antigens, CD20 ; Immunologic Factors ; Rituximab (4F4X42SYQ6) ; ocrelizumab (A10SJL62JY) ; ofatumumab (M95KG522R0) ; ublituximab (U59UGK3IPC)
Language	English
Publishing date	2021-08-09
Publishing country	New Zealand
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	1203800-3
ISSN	1179-1934 ; 1172-7047
ISSN (online)	1179-1934
ISSN	1172-7047
DOI	10.1007/s40263-021-00843-8
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Article ; Online: Emerging oral agents for multiple sclerosis.

Fox, Edward J

The American journal of managed care

2010 Volume 16, Issue 8 Suppl, Page(s) S219–26

Abstract: A variety of emerging therapies for the treatment of multiple sclerosis (MS) are currently in development or have recently been approved by the US Food and Drug Administration (FDA). These new agents offer novel mechanisms of action and potentially ... ...

Abstract	A variety of emerging therapies for the treatment of multiple sclerosis (MS) are currently in development or have recently been approved by the US Food and Drug Administration (FDA). These new agents offer novel mechanisms of action and potentially improved efficacy over existing first-line MS therapies. Much attention has been given to emerging therapies delivered orally which, at minimum, will likely improve long-term adherence over existing agents delivered via injection. This article reviews the mechanisms of action, efficacy, and safety and tolerability of 4 emerging oral therapies for MS: cladribine, laquinimod, fingolimod, and dalfampridine. The first 3 of these agents are in late development and may enter the market within the next year and a half. Cladribine, laquinimod, and fingolimod have demonstrated impressive efficacy in terms of clinical outcomes, such as annualized relapse rate and change in disability scores, as well as magnetic resonance imaging variables. Dalfampridine, which has already been approved by the FDA, is indicated as a symptomatic therapy to improve walking in MS patients. Based on existing data, these agents appear to have tolerable side-effect profiles, although the long-term safety profiles of these drugs have yet to be elucidated. It remains to be seen whether the safety profiles of these disease-modifying drugs will allow them to displace existing first-line therapies or if agents such as dalfampridine will become additional options alongside current dominant therapies.
MeSH term(s)	4-Aminopyridine/therapeutic use ; Cladribine/therapeutic use ; Clinical Trials as Topic ; Fingolimod Hydrochloride ; Humans ; Immunosuppressive Agents/administration & dosage ; Immunosuppressive Agents/adverse effects ; Immunosuppressive Agents/therapeutic use ; Multiple Sclerosis/drug therapy ; Propylene Glycols/therapeutic use ; Quinolones/therapeutic use ; Sphingosine/analogs & derivatives ; Sphingosine/therapeutic use
Chemical Substances	Immunosuppressive Agents ; Propylene Glycols ; Quinolones ; Cladribine (47M74X9YT5) ; laquinimod (908SY76S4G) ; 4-Aminopyridine (BH3B64OKL9) ; Fingolimod Hydrochloride (G926EC510T) ; Sphingosine (NGZ37HRE42)
Language	English
Publishing date	2010-09
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2035781-3
ISSN	1936-2692 ; 1088-0224 ; 1096-1860
ISSN (online)	1936-2692
ISSN	1088-0224 ; 1096-1860
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Zs.A 5353: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Alemtuzumab in the treatment of relapsing-remitting multiple sclerosis.

Fox, Edward J

Expert review of neurotherapeutics

2010 Volume 10, Issue 12, Page(s) 1789–1797

Abstract: Multiple sclerosis (MS) is an autoimmune disorder characterized by CNS inflammation, demyelination and cellular damage with atrophy. Most patients with MS initially present with a relapsing-remitting course, with periodic episodes of neurologic ... ...

Abstract	Multiple sclerosis (MS) is an autoimmune disorder characterized by CNS inflammation, demyelination and cellular damage with atrophy. Most patients with MS initially present with a relapsing-remitting course, with periodic episodes of neurologic symptomatology that do not follow a predictable pattern. In order to maintain a stable clinical course, it is felt to be important to control the number and severity of relapses, as disability, at least in part, is a cumulative effect of damage from multiple lesions within the brain and spinal cord. Historically, MS has not been considered curable, because the immune system could not be adequately normalized over the course of a lifetime. Alemtuzumab (Campath-1H; Campath(®), Genzyme, MA, USA) has recently been investigated in a Phase II clinical trial in the treatment of relapsing-remitting MS. The results observed in the study are very encouraging and multiple insights have been made into the nature of autoimmunity in general based on the clinical response to this monoclonal antibody. Enrollment in two pivotal Phase III clinical trials of alemtuzumab in MS is now complete.
MeSH term(s)	Alemtuzumab ; Antibodies, Monoclonal/therapeutic use ; Antibodies, Monoclonal, Humanized ; Antibodies, Neoplasm/therapeutic use ; Atrophy ; Brain/pathology ; Clinical Trials, Phase II as Topic ; Clinical Trials, Phase III as Topic ; Disability Evaluation ; Disease Progression ; Female ; Humans ; Male ; Multiple Sclerosis, Relapsing-Remitting/drug therapy ; Multiple Sclerosis, Relapsing-Remitting/pathology ; Recurrence
Chemical Substances	Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Antibodies, Neoplasm ; Alemtuzumab (3A189DH42V)
Language	English
Publishing date	2010-12
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2112534-X
ISSN	1744-8360 ; 1473-7175
ISSN (online)	1744-8360
ISSN	1473-7175
DOI	10.1586/ern.10.135
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Article: Proteomic Changes in the Human Cerebrovasculature in Alzheimer's Disease and Related Tauopathies Linked to Peripheral Biomarkers in Plasma and Cerebrospinal Fluid.

Wojtas, Aleksandra M / Dammer, Eric B / Guo, Qi / Ping, Lingyan / Shantaraman, Ananth / Duong, Duc M / Yin, Luming / Fox, Edward J / Seifar, Fatemeh / Lee, Edward B / Johnson, Erik C B / Lah, James J / Levey, Allan I / Levites, Yona / Rangaraju, Srikant / Golde, Todd E / Seyfried, Nicholas T

medRxiv : the preprint server for health sciences

2024

Abstract: Dysfunction of the neurovascular unit stands as a significant pathological hallmark of Alzheimer's disease (AD) and age-related neurodegenerative diseases. Nevertheless, detecting vascular changes in the brain within bulk tissues has proven challenging, ... ...

Abstract	Dysfunction of the neurovascular unit stands as a significant pathological hallmark of Alzheimer's disease (AD) and age-related neurodegenerative diseases. Nevertheless, detecting vascular changes in the brain within bulk tissues has proven challenging, limiting our ability to characterize proteomic alterations from less abundant cell types. To address this challenge, we conducted quantitative proteomic analyses on both bulk brain tissues and cerebrovascular-enriched fractions from the same individuals, encompassing cognitively unimpaired control, progressive supranuclear palsy (PSP), and AD cases. Protein co-expression network analysis identified modules unique to the cerebrovascular fractions, specifically enriched with pericytes, endothelial cells, and smooth muscle cells. Many of these modules also exhibited significant correlations with amyloid plaques, cerebral amyloid angiopathy (CAA), and/or tau pathology in the brain. Notably, the protein products within AD genetic risk loci were found concentrated within modules unique to the vascular fractions, consistent with a role of cerebrovascular deficits in the etiology of AD. To prioritize peripheral AD biomarkers associated with vascular dysfunction, we assessed the overlap between differentially abundant proteins in AD cerebrospinal fluid (CSF) and plasma with a vascular-enriched network modules in the brain. This analysis highlighted matrisome proteins, SMOC1 and SMOC2, as being increased in CSF, plasma, and brain. Immunohistochemical analysis revealed SMOC1 deposition in both parenchymal plaques and CAA in the AD brain, whereas SMOC2 was predominantly localized to CAA. Collectively, these findings significantly enhance our understanding of the involvement of cerebrovascular abnormalities in AD, shedding light on potential biomarkers and molecular pathways associated with CAA and vascular dysfunction in neurodegenerative diseases.
Language	English
Publishing date	2024-01-11
Publishing country	United States
Document type	Preprint
DOI	10.1101/2024.01.10.24301099
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Article: An exploratory analysis of the efficacy of ocrelizumab in patients with multiple sclerosis with increased disability.

Wolinsky, Jerry S / Engmann, Natalie J / Pei, Jinglan / Pradhan, Ashish / Markowitz, Clyde / Fox, Edward J

Multiple sclerosis journal - experimental, translational and clinical

2020 Volume 6, Issue 1, Page(s) 2055217320911939

Abstract: Background: Ocrelizumab, an anti-CD20 humanized monoclonal antibody, reduced disease progression in pivotal trials of patients with relapsing (OPERA I, OPERA II) and primary progressive (ORATORIO) multiple sclerosis (MS). These effects may be ... ...

Abstract	Background: Ocrelizumab, an anti-CD20 humanized monoclonal antibody, reduced disease progression in pivotal trials of patients with relapsing (OPERA I, OPERA II) and primary progressive (ORATORIO) multiple sclerosis (MS). These effects may be particularly important among patients with increased disability. Objective: In this post hoc exploratory analysis, we evaluated the efficacy of ocrelizumab on disability progression among a subgroup of patients with MS who had increased baseline disability levels (Expanded Disability Status Scale scores ≥4.0) in the pivotal trials. Methods: During the double-blind period, patients received ocrelizumab 600 mg intravenously every 24 weeks for 96 weeks in the OPERA trials (versus interferon β-1a 44 μg subcutaneously three times per week) and for 120 weeks in ORATORIO (versus placebo). Kaplan-Meier and Cox survival analyses were used to assess disability outcome measures. Results: Baseline demographic, disease, and treatment characteristics were generally comparable across treatment groups in patients with increased disability from the OPERA and ORATORIO trials. Ocrelizumab treatment numerically, and in some instances significantly, reduced confirmed disability progression versus the comparator in these patients. Conclusions: In patients with increased baseline disability, ocrelizumab reduced the risk of confirmed disability progression versus interferon β-1a in patients with relapsing-onset MS and versus placebo in patients with progression-onset MS.
Language	English
Publishing date	2020-03-16
Publishing country	United States
Document type	Journal Article
ZDB-ID	2841884-0
ISSN	2055-2173 ; 2055-2173
ISSN (online)	2055-2173
ISSN	2055-2173
DOI	10.1177/2055217320911939
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Article ; Online: Cancer: One cell at a time.

Fox, Edward J / Loeb, Lawrence A

Nature

2014 Volume 512, Issue 7513, Page(s) 143–144

MeSH term(s)	Breast Neoplasms/genetics ; Clonal Evolution ; Female ; Genome/genetics ; Humans
Language	English
Publishing date	2014-07-30
Publishing country	England
Document type	Journal Article ; Comment
ZDB-ID	120714-3
ISSN	1476-4687 ; 0028-0836
ISSN (online)	1476-4687
ISSN	0028-0836
DOI	10.1038/nature13650
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Article ; Online: Monomethyl fumarate has better gastrointestinal tolerability profile compared with dimethyl fumarate.

Wynn, Daniel / Lategan, Thomas W / Sprague, Tiffany N / Rousseau, Franck S / Fox, Edward J

Multiple sclerosis and related disorders

2020 Volume 45, Page(s) 102335

Abstract: Background: Monomethyl fumarate (MMF) is the pharmacologically active metabolite of dimethyl fumarate (DMF). MMF formulated as Bafiertam™ 190 mg and DMF formulated as Tecfidera 240 mg deliver bioequivalent exposure of MMF and therefore possess the same ... ...

Abstract	Background: Monomethyl fumarate (MMF) is the pharmacologically active metabolite of dimethyl fumarate (DMF). MMF formulated as Bafiertam™ 190 mg and DMF formulated as Tecfidera 240 mg deliver bioequivalent exposure of MMF and therefore possess the same efficacy/safety profiles. DMF is a widely used oral treatment for relapsing-remitting forms of multiple sclerosis (RRMS) but is limited in some patients, primarily female, by issues with gastrointestinal (GI) tolerability. Methods: This was a randomized, double-blind, head-to-head, 5-week study evaluating the GI tolerability of MMF 190 mg vs DMF 240 mg, administered twice daily in healthy subjects, using a derivative of the self-administered Modified Overall Gastrointestinal Symptom Scale (MOGISS). Subjects were stratified (3:1, female:male) and randomized (1:1) to the treatments. The primary endpoint was the Area Under the Curve (AUC) in each of the individual symptoms in the MOGISS over the 5-week treatment period. Other endpoints included the AUC over the 5-week treatment period in the MOGISS composite and total scores; duration and severity of GI events; Number and percentage of subjects reporting GI events during the overall treatment period, and assessment of safety/tolerability. Results: Inferential analysis of the hierarchical testing of overall treatment differences in each MOGISS symptom AUC occurred in a predefined sequence starting with Abdominal Pain. For each symptom, LSMean AUC values were lower for MMF than DMF, however, the first primary endpoint, Abdominal Pain, was not statistically different between treatments; thus, all subsequent statistical analyses were considered exploratory. The side effects and safety profiles observed were consistent with the known profiles of DMF, with no new or unique safety concerns noted. Conclusions: Bafiertam showed an improved gastrointestinal tolerability profile compared with Tecfidera, with less severe GI events and fewer days of self-assessed GI symptoms, fewer GI adverse events, and lower discontinuation rates because of GI adverse events.
MeSH term(s)	Dimethyl Fumarate/adverse effects ; Female ; Fumarates/adverse effects ; Humans ; Immunosuppressive Agents ; Male ; Multiple Sclerosis, Relapsing-Remitting
Chemical Substances	Fumarates ; Immunosuppressive Agents ; monomethyl fumarate (45IUB1PX8R) ; Dimethyl Fumarate (FO2303MNI2)
Language	English
Publishing date	2020-06-25
Publishing country	Netherlands
Document type	Journal Article ; Randomized Controlled Trial
ZDB-ID	2645330-7
ISSN	2211-0356 ; 2211-0348
ISSN (online)	2211-0356
ISSN	2211-0348
DOI	10.1016/j.msard.2020.102335
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Article ; Online: Unveiling Resilience to Alzheimer's Disease: Insights From Brain Regional Proteomic Markers.

Huang, Zhi / Merrihew, Gennifer E / Larson, Eric B / Park, Jea / Plubell, Deanna / Fox, Edward J / Montine, Kathleen S / Keene, C Dirk / Latimer, Caitlin S / Zou, James Y / MacCoss, Michael J / Montine, Thomas J

Neuroscience insights

2023 Volume 18, Page(s) 26331055231201600

Abstract: Studying proteomics data of the human brain could offer numerous insights into unraveling the signature of resilience to Alzheimer's disease. In our previous study with rigorous cohort selection criteria that excluded 4 common comorbidities, we harnessed ...

Abstract	Studying proteomics data of the human brain could offer numerous insights into unraveling the signature of resilience to Alzheimer's disease. In our previous study with rigorous cohort selection criteria that excluded 4 common comorbidities, we harnessed multiple brain regions from 43 research participants with 12 of them displaying cognitive resilience to Alzheimer's disease. Based on the previous findings, this work focuses on 6 proteins out of the 33 differentially expressed proteins associated with resilience to Alzheimer's disease. These proteins are used to construct a decision tree classifier, enabling the differentiation of 3 groups: (i) healthy control, (ii) resilience to Alzheimer's disease, and (iii) Alzheimer's disease with dementia. Our analysis unveiled 2 important regional proteomic markers: Aβ peptides in the hippocampus and PA1B3 in the inferior parietal lobule. These findings underscore the potential of using distinct regional proteomic markers as signatures in characterizing the resilience to Alzheimer's disease.
Language	English
Publishing date	2023-10-05
Publishing country	United States
Document type	Journal Article ; Comment
ISSN	2633-1055
ISSN (online)	2633-1055
DOI	10.1177/26331055231201600
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