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Article ; Online: A review of serial coronary computed tomography angiography (CTA) to assess plaque progression and therapeutic effect of anti-atherosclerotic drugs.

Taron, Jana / Lee, Saeyun / Aluru, John / Hoffmann, Udo / Lu, Michael T

The international journal of cardiovascular imaging

2020 Volume 36, Issue 12, Page(s) 2305–2317

Abstract: Change in coronary artery plaque on serial catheter intravascular ultrasound (IVUS) is an established technique to monitor the therapeutic effect of drugs on coronary atherosclerosis. Recent advances in coronary computed tomography angiography (CTA) now ... ...

Abstract	Change in coronary artery plaque on serial catheter intravascular ultrasound (IVUS) is an established technique to monitor the therapeutic effect of drugs on coronary atherosclerosis. Recent advances in coronary computed tomography angiography (CTA) now allow for non-invasive assessment of change in coronary plaque. Because coronary CTA is noninvasive, it enables clinical trials with lower-risk populations, higher retention rates, and lower costs. This review presents an overview of serial coronary CTA as a noninvasive imaging technique to gauge the therapeutic effect of anti-atherosclerotic therapies. Furthermore, it reviews the increasing use of serial CTA as an imaging endpoint in completed and ongoing clinical trials.
MeSH term(s)	Cardiovascular Agents/therapeutic use ; Computed Tomography Angiography ; Coronary Angiography ; Coronary Artery Disease/diagnostic imaging ; Coronary Artery Disease/drug therapy ; Coronary Vessels/diagnostic imaging ; Coronary Vessels/drug effects ; Disease Progression ; Humans ; Plaque, Atherosclerotic ; Predictive Value of Tests ; Treatment Outcome
Chemical Substances	Cardiovascular Agents
Language	English
Publishing date	2020-02-19
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2055311-0
ISSN	1875-8312 ; 1573-0743 ; 1569-5794 ; 0167-9899
ISSN (online)	1875-8312 ; 1573-0743
ISSN	1569-5794 ; 0167-9899
DOI	10.1007/s10554-020-01793-w
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Article ; Online: Distinct transcriptomes and autocrine cytokines underpin maturation and survival of antibody-secreting cells in systemic lupus erythematosus.

Chen, Weirong / Hong, So-Hee / Jenks, Scott A / Anam, Fabliha A / Tipton, Christopher M / Woodruff, Matthew C / Hom, Jennifer R / Cashman, Kevin S / Faliti, Caterina Elisa / Wang, Xiaoqian / Kyu, Shuya / Wei, Chungwen / Scharer, Christopher D / Mi, Tian / Hicks, Sakeenah / Hartson, Louise / Nguyen, Doan C / Khosroshahi, Arezou / Lee, Saeyun /

Wang, Youliang / Bugrovsky, Regina / Ishii, Yusho / Lee, F Eun-Hyung / Sanz, Ignacio

Nature communications

2024 Volume 15, Issue 1, Page(s) 1899

Abstract: Systemic lupus erythematosus (SLE) is an autoimmune disease characterized by multiple autoantibody types, some of which are produced by long-lived plasma cells (LLPC). Active SLE generates increased circulating antibody-secreting cells (ASC). Here, we ... ...

Abstract	Systemic lupus erythematosus (SLE) is an autoimmune disease characterized by multiple autoantibody types, some of which are produced by long-lived plasma cells (LLPC). Active SLE generates increased circulating antibody-secreting cells (ASC). Here, we examine the phenotypic, molecular, structural, and functional features of ASC in SLE. Relative to post-vaccination ASC in healthy controls, circulating blood ASC from patients with active SLE are enriched with newly generated mature CD19
MeSH term(s)	Humans ; Cytokines ; Transcriptome ; Lupus Erythematosus, Systemic/genetics ; Antibody-Producing Cells ; Autoimmune Diseases
Chemical Substances	Cytokines
Language	English
Publishing date	2024-03-01
Publishing country	England
Document type	Journal Article
ZDB-ID	2553671-0
ISSN	2041-1723 ; 2041-1723
ISSN (online)	2041-1723
ISSN	2041-1723
DOI	10.1038/s41467-024-46053-w
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Article: SLE Antibody-Secreting Cells Are Characterized by Enhanced Peripheral Maturation and Survival Programs.

Wang, Youliang / Bugrovsky, Regina / Ishii, Yusho / Lee, F Eun-Hyung / Sanz, Ignacio

Research square

2023

Abstract: Systemic Lupus Erythematosus (SLE) is an autoimmune disease characterized by multiple autoantibodies, some of which are present in high titers in a sustained, B cell-independent fashion consistent with their generation from long-lived plasma cells (LLPC). ...

Abstract	Systemic Lupus Erythematosus (SLE) is an autoimmune disease characterized by multiple autoantibodies, some of which are present in high titers in a sustained, B cell-independent fashion consistent with their generation from long-lived plasma cells (LLPC). Active SLE displays high numbers of circulating antibody-secreting cells (ASC). Understanding the mechanisms of generation and survival of SLE ASC would contribute important insight into disease pathogenesis and novel targeted therapies. We studied the properties of SLE ASC through a systematic analysis of their phenotypic, molecular, structural, and functional features. Our results indicate that in active SLE, relative to healthy post-immunization responses, blood ASC contain a much larger fraction of newly generated mature CD19
Language	English
Publishing date	2023-06-27
Publishing country	United States
Document type	Preprint
DOI	10.21203/rs.3.rs-3016327/v1
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Article: Dominant extrafollicular B cell responses in severe COVID-19 disease correlate with robust viral-specific antibody production but poor clinical outcomes.

medRxiv : the preprint server for health sciences

2020

Abstract: A wide clinical spectrum has become a hallmark of the SARS-CoV-2 (COVID-19) pandemic, although its immunologic underpinnings remain to be defined. We have performed deep characterization of B cell responses through high-dimensional flow cytometry to ... ...

Abstract	A wide clinical spectrum has become a hallmark of the SARS-CoV-2 (COVID-19) pandemic, although its immunologic underpinnings remain to be defined. We have performed deep characterization of B cell responses through high-dimensional flow cytometry to reveal substantial heterogeneity in both effector and immature populations. More notably, critically ill patients displayed hallmarks of extrafollicular B cell activation as previously described in autoimmune settings. Extrafollicular activation correlated strongly with large antibody secreting cell expansion and early production of high levels of SARS-CoV-2-specific antibodies. Yet, these patients fared poorly with elevated inflammatory biomarkers, multi-organ failure, and death. Combined, the findings strongly indicate a major pathogenic role for immune activation in subsets of COVID-19 patients. Our study suggests that, as in autoimmunity, targeted immunomodulatory therapy may be beneficial in specific patient subpopulations that can be identified by careful immune profiling.
Keywords	covid19
Language	English
Publishing date	2020-06-22
Publishing country	United States
Document type	Preprint
DOI	10.1101/2020.04.29.20083717
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Article ; Online: Extrafollicular B cell responses correlate with neutralizing antibodies and morbidity in COVID-19.

Woodruff, Matthew C / Ramonell, Richard P / Nguyen, Doan C / Cashman, Kevin S / Saini, Ankur Singh / Haddad, Natalie S / Ley, Ariel M / Kyu, Shuya / Howell, J Christina / Ozturk, Tugba / Lee, Saeyun / Suryadevara, Naveenchandra / Case, James Brett / Bugrovsky, Regina / Chen, Weirong / Estrada, Jacob / Morrison-Porter, Andrea / Derrico, Andrew / Anam, Fabliha A /

Sharma, Monika / Wu, Henry M / Le, Sang N / Jenks, Scott A / Tipton, Christopher M / Staitieh, Bashar / Daiss, John L / Ghosn, Eliver / Diamond, Michael S / Carnahan, Robert H / Crowe, James E / Hu, William T / Lee, F Eun-Hyung / Sanz, Ignacio

Nature immunology

2020 Volume 21, Issue 12, Page(s) 1506–1516

Abstract: A wide spectrum of clinical manifestations has become a hallmark of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) COVID-19 pandemic, although the immunological underpinnings of diverse disease outcomes remain to be defined. We ... ...

Abstract	A wide spectrum of clinical manifestations has become a hallmark of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) COVID-19 pandemic, although the immunological underpinnings of diverse disease outcomes remain to be defined. We performed detailed characterization of B cell responses through high-dimensional flow cytometry to reveal substantial heterogeneity in both effector and immature populations. More notably, critically ill patients displayed hallmarks of extrafollicular B cell activation and shared B cell repertoire features previously described in autoimmune settings. Extrafollicular activation correlated strongly with large antibody-secreting cell expansion and early production of high concentrations of SARS-CoV-2-specific neutralizing antibodies. Yet, these patients had severe disease with elevated inflammatory biomarkers, multiorgan failure and death. Overall, these findings strongly suggest a pathogenic role for immune activation in subsets of patients with COVID-19. Our study provides further evidence that targeted immunomodulatory therapy may be beneficial in specific patient subpopulations and can be informed by careful immune profiling.
MeSH term(s)	Antibodies, Neutralizing/immunology ; Antibodies, Viral/immunology ; B-Lymphocytes/immunology ; COVID-19/immunology ; Humans ; Immunophenotyping ; SARS-CoV-2/immunology
Chemical Substances	Antibodies, Neutralizing ; Antibodies, Viral
Keywords	covid19
Language	English
Publishing date	2020-10-07
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	2016987-5
ISSN	1529-2916 ; 1529-2908
ISSN (online)	1529-2916
ISSN	1529-2908
DOI	10.1038/s41590-020-00814-z
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Article: Elevated SARS-CoV-2 Antibodies Distinguish Severe Disease in Early COVID-19 Infection.

Haddad, Natalie S / Nguyen, Doan C / Kuruvilla, Merin E / Morrison-Porter, Andrea / Anam, Fabliha / Cashman, Kevin S / Ramonell, Richard P / Kyu, Shuya / Saini, Ankur Singh / Cabrera-Mora, Monica / Derrico, Andrew / Alter, David / Roback, John D / Horwath, Michael / O'Keefe, James B / Wu, Henry M / Ian Wong, An-Kwok / Dretler, Alexandra W / Gripaldo, Ria /

Lane, Andrea N / Wu, Hao / Lee, Saeyun / Hernandez, Mindy / Engineer, Vanessa / Varghese, John / Le, Sang / Sanz, Iñaki / Daiss, John L / Eun-Hyung Lee, F

bioRxiv : the preprint server for biology

2020

Abstract: Background: SARS-CoV-2 has caused over 36,000,000 cases and 1,000,000 deaths globally. Comprehensive assessment of the multifaceted anti-viral antibody response is critical for diagnosis, differentiation of severe disease, and characterization of long- ... ...

Abstract	Background: SARS-CoV-2 has caused over 36,000,000 cases and 1,000,000 deaths globally. Comprehensive assessment of the multifaceted anti-viral antibody response is critical for diagnosis, differentiation of severe disease, and characterization of long-term immunity. Initial observations suggest that severe disease is associated with higher antibody levels and greater B cell/plasmablast responses. A multi-antigen immunoassay to define the complex serological landscape and clinical associations is essential. Methods: We developed a multiplex immunoassay and evaluated serum/plasma from adults with RT-PCR-confirmed SARS-CoV-2 infections during acute illness (N=52) and convalescence (N=69); and pre-pandemic (N=106) and post-pandemic (N=137) healthy adults. We measured IgA, IgG, and/or IgM against SARS-CoV-2 Nucleocapsid (N), Spike domain 1 (S1), receptor binding domain (S1-RBD) and S1-N-terminal domain (S1-NTD). Results: To diagnose infection, the combined [IgA+IgG+IgM] or IgG for N, S1, and S1-RBD yielded AUC values -0.90 by ROC curves. From days 6-30 post-symptom onset, the levels of antigen-specific IgG, IgA or [IgA+IgG+IgM] were higher in patients with severe/critical compared to mild/moderate infections. Consistent with excessive concentrations of antibodies, a strong prozone effect was observed in sera from severe/critical patients. Notably, mild/moderate patients displayed a slower rise and lower peak in anti-N and anti-S1 IgG levels compared to severe/critical patients, but anti-RBD IgG and neutralization responses reached similar levels at 2-4 months. Conclusion: This SARS-CoV-2 multiplex immunoassay measures the magnitude, complexity and kinetics of the antibody response against multiple viral antigens. The IgG and combined-isotype SARS-CoV-2 multiplex assay is highly diagnostic of acute and convalescent disease and may prognosticate severity early in illness. One sentence summary: In contrast to patients with moderate infections, those with severe COVID-19 develop prominent, early antibody responses to S1 and N proteins.
Language	English
Publishing date	2020-12-06
Publishing country	United States
Document type	Preprint
DOI	10.1101/2020.12.04.410589
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Article ; Online: Critically ill SARS-CoV-2 patients display lupus-like hallmarks of extrafollicular B cell activation

medRxiv

Abstract: Wide heterogeneity of disease course ranging from asymptomatic spread to respiratory failure and death has become a hallmark of the SARS-CoV-2 pandemic. While this clinical spectrum is well documented, its immunologic underpinnings are less clear. We ... ...

Abstract	Wide heterogeneity of disease course ranging from asymptomatic spread to respiratory failure and death has become a hallmark of the SARS-CoV-2 pandemic. While this clinical spectrum is well documented, its immunologic underpinnings are less clear. We have therefore, initiated studies of the B cell responses as they would participate in both early effector responses and in the initiation of memory formation. In terms of effector responses, we were particularly interested in the engagement and clinical correlates of the extra-follicular pathway (EF), we recently described in flaring SLE. In this systemic autoimmune disease, the EF pathway is initiated by newly activated naive B cell (aN) leading to large expansion of autoantibody-producing antibody-secreting cells through the generation of an epigenetically primed B cell precursor which are double negative (DN) for naive (IgD) and memory markers (CD27) and lacking expression of CXCR5 and CD21 (DN2). These highly activated D2 cells are also distinguished by high expression of CD11c and T-bet and are TLR7-driven. Both, TLR7-stimulation which is triggered by ssRNA and the central role played by their murine counterparts (typically characterized as Age-Associated B cells), in viral clearance, strongly supported the hypothesis that DN2 cells and the global EF pathway could be prominently engaged in COVID-19 patients. Also of note, EF B cell activation is particularly prominent in SLE patients of African-American ancestry, a population disproportionately represented in severe COVID-19. In this study we find that critically-ill patients with COVID-19 robustly upregulate constituents of the extrafollicular pathway, produce enormous numbers of antibody secreting cells, and lose unique transitional B cell populations that correlate with positive prognosis. This patient cluster associates tightly with biomarkers of poor outcomes and exhibits high rates of mortality. Thus, this B cell phenotype might serve as an immunological marker of severe COVID infection at early stages and could therefore identify a patient subset likely to benefit from targeted immunomodulatory therapy aimed at alleviating disease burden.
Keywords	covid19
Language	English
Publishing date	2020-05-03
Publisher	Cold Spring Harbor Laboratory Press
Document type	Article ; Online
DOI	10.1101/2020.04.29.20083717
Database	COVID19

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Article ; Online: One-Stop Serum Assay Identifies COVID-19 Disease Severity and Vaccination Responses.

Haddad, Natalie S / Nguyen, Doan C / Kuruvilla, Merin E / Morrison-Porter, Andrea / Anam, Fabliha / Cashman, Kevin S / Ramonell, Richard P / Kyu, Shuya / Saini, Ankur Singh / Cabrera-Mora, Monica / Derrico, Andrew / Alter, David / Roback, John D / Horwath, Michael / O'Keefe, James B / Wu, Henry M / Wong, An-Kwok Ian / Dretler, Alexandra W / Gripaldo, Ria /

Lane, Andrea N / Wu, Hao / Chu, Helen Y / Lee, Saeyun / Hernandez, Mindy / Engineer, Vanessa / Varghese, John / Patel, Rahul / Jalal, Anum / French, Victoria / Guysenov, Ilya / Lane, Christopher E / Mengistsu, Tesfaye / Normile, Katherine Elizabeth / Mnzava, Onike / Le, Sang / Sanz, Ignacio / Daiss, John L / Lee, F Eun-Hyung

ImmunoHorizons

2021 Volume 5, Issue 5, Page(s) 322–335

Abstract: SARS-CoV-2 has caused over 100,000,000 cases and almost 2,500,000 deaths globally. Comprehensive assessment of the multifaceted antiviral Ab response is critical for diagnosis, differentiation of severity, and characterization of long-term immunity, ... ...

Abstract	SARS-CoV-2 has caused over 100,000,000 cases and almost 2,500,000 deaths globally. Comprehensive assessment of the multifaceted antiviral Ab response is critical for diagnosis, differentiation of severity, and characterization of long-term immunity, especially as COVID-19 vaccines become available. Severe disease is associated with early, massive plasmablast responses. We developed a multiplex immunoassay from serum/plasma of acutely infected and convalescent COVID-19 patients and prepandemic and postpandemic healthy adults. We measured IgA, IgG, and/or IgM against SARS-CoV-2 nucleocapsid (N), spike domain 1 (S1), S1-receptor binding domain (RBD) and S1-N-terminal domain. For diagnosis, the combined [IgA + IgG + IgM] or IgG levels measured for N, S1, and S1-RBD yielded area under the curve values ≥0.90. Virus-specific Ig levels were higher in patients with severe/critical compared with mild/moderate infections. A strong prozone effect was observed in sera from severe/critical patients-a possible source of underestimated Ab concentrations in previous studies. Mild/moderate patients displayed a slower rise and lower peak in anti-N and anti-S1 IgG levels compared with severe/critical patients, but anti-RBD IgG and neutralization responses reached similar levels at 2-4 mo after symptom onset. Measurement of the Ab responses in sera from 18 COVID-19-vaccinated patients revealed specific responses for the S1-RBD Ag and none against the N protein. This highly sensitive, SARS-CoV-2-specific, multiplex immunoassay measures the magnitude, complexity, and kinetics of the Ab response and can distinguish serum Ab responses from natural SARS-CoV-2 infections (mild or severe) and mRNA COVID-19 vaccines.
MeSH term(s)	Adult ; Aged ; Antibodies, Viral/blood ; Antibodies, Viral/immunology ; COVID-19/blood ; COVID-19/immunology ; COVID-19/prevention & control ; COVID-19 Vaccines/administration & dosage ; Female ; Humans ; Immunoassay ; Male ; Middle Aged ; SARS-CoV-2/immunology ; SARS-CoV-2/metabolism ; Severity of Illness Index ; Vaccination
Chemical Substances	Antibodies, Viral ; COVID-19 Vaccines
Language	English
Publishing date	2021-05-17
Publishing country	United States
Document type	Journal Article
ISSN	2573-7732
ISSN (online)	2573-7732
DOI	10.4049/immunohorizons.2100011
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Article ; Online: Rationale and design of the Mechanistic Substudy of the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE): Effects of pitavastatin on coronary artery disease and inflammatory biomarkers.

Hoffmann, Udo / Lu, Michael T / Olalere, Devvora / Adami, Elizabeth C / Osborne, Michael T / Ivanov, Alex / Aluru, John Sukumar / Lee, Saeyun / Arifovic, Nadja / Overton, Edgar Turner / Fichtenbaum, Carl J / Aberg, Judith A / Alston-Smith, Beverly / Klingman, Karin L / Waclawiw, Myron / Burdo, Tricia H / Williams, Kenneth C / Zanni, Markella V / Desvigne-Nickens, Patrice /

Cooper-Arnold, Katharine / Fitch, Kathleen V / Ribaudo, Heather / Douglas, Pamela S / Grinspoon, Steven K

American heart journal

2019 Volume 212, Page(s) 1–12

Abstract: Background: People with HIV (PWH) have increased cardiovascular events, inflammation, and high-risk coronary atherosclerosis. Statin therapy has been shown to lower the risk of cardiovascular disease (CVD) in the general population, but whether this ... ...

Abstract	Background: People with HIV (PWH) have increased cardiovascular events, inflammation, and high-risk coronary atherosclerosis. Statin therapy has been shown to lower the risk of cardiovascular disease (CVD) in the general population, but whether this results from reductions in coronary atherosclerosis and is mediated by decreased inflammation remains unknown. Methods: REPRIEVE is a randomized, placebo-controlled trial of pitavastatin calcium (4 mg/day) vs. placebo enrolling at least 7500 PWH between 40-75 years, on antiretroviral therapy (ART), with low to moderate traditional CVD risk. The Mechanistic Substudy of REPRIEVE (A5333s) is co-enrolling 800 participants from 31 US sites. These participants undergo serial contrast enhanced coronary computed tomography angiography (CCTA) and measurements of biomarkers of inflammation and immune activation at baseline and after 2 years of follow-up. The primary objectives are to determine the effects of pitavastatin on noncalcified coronary atherosclerotic plaque (NCP) volume, low attenuation plaque, and positive remodeling and on changes in immune activation and inflammation and to assess relationships between the two. Changes in CAD will be assessed in a standardized fashion by a core lab with expert readers blinded to time points and participant information; immune activation and inflammation assessment is also performed centrally. Results: To date the Mechanistic Substudy has completed planned enrollment, with 805 participants. Conclusion: This study represents the first large, randomized, CCTA-based assessment of the effects of a primary prevention strategy for CVD on high-risk CAD, immune activation and inflammation among PWH. The study will assess pitavastatin's effects on coronary plaque, and the interrelationship of these changes with biomarkers of immune activation and inflammation in PWH to determine mechanisms of CVD prevention and improved outcomes in this population.
MeSH term(s)	Adult ; Aged ; Female ; Humans ; Male ; Middle Aged ; Anti-HIV Agents/therapeutic use ; Biomarkers/blood ; Computed Tomography Angiography ; Coronary Angiography ; Coronary Artery Disease/complications ; Coronary Artery Disease/immunology ; Coronary Artery Disease/prevention & control ; Double-Blind Method ; HIV Infections/complications ; HIV Infections/drug therapy ; HIV Infections/immunology ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use ; Inflammation/prevention & control ; Plaque, Atherosclerotic/diagnostic imaging ; Plaque, Atherosclerotic/prevention & control ; Primary Prevention ; Prospective Studies ; Quinolines/therapeutic use ; Risk Factors ; Multicenter Studies as Topic ; Clinical Trials, Phase III as Topic ; Randomized Controlled Trials as Topic
Chemical Substances	Anti-HIV Agents ; Biomarkers ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; pitavastatin (M5681Q5F9P) ; Quinolines
Language	English
Publishing date	2019-03-04
Publishing country	United States
Document type	Clinical Trial Protocol ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	80026-0
ISSN	1097-6744 ; 0002-8703
ISSN (online)	1097-6744
ISSN	0002-8703
DOI	10.1016/j.ahj.2019.02.011
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Article: Extrafollicular B cell responses correlate with neutralizing antibodies and morbidity in COVID-19

Nat Immunol

Abstract	A wide spectrum of clinical manifestations has become a hallmark of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) COVID-19 pandemic, although the immunological underpinnings of diverse disease outcomes remain to be defined. We performed detailed characterization of B cell responses through high-dimensional flow cytometry to reveal substantial heterogeneity in both effector and immature populations. More notably, critically ill patients displayed hallmarks of extrafollicular B cell activation and shared B cell repertoire features previously described in autoimmune settings. Extrafollicular activation correlated strongly with large antibody-secreting cell expansion and early production of high concentrations of SARS-CoV-2-specific neutralizing antibodies. Yet, these patients had severe disease with elevated inflammatory biomarkers, multiorgan failure and death. Overall, these findings strongly suggest a pathogenic role for immune activation in subsets of patients with COVID-19. Our study provides further evidence that targeted immunomodulatory therapy may be beneficial in specific patient subpopulations and can be informed by careful immune profiling.
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #840532
Database	COVID19

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