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3. A Genetic Mouse Model Recapitulates Immune Checkpoint Inhibitor-Associated Myocarditis and Supports a Mechanism-Based Therapeutic Intervention.

Author

Wei, Spencer, Meijers, Wouter, Axelrod, Margaret, Anang, Nana-Ama, Screever, Elles, Wescott, Elizabeth, Johnson, Douglas, Whitley, Elizabeth, Lehmann, Lorenz, Courand, Pierre-Yves, Mancuso, James, Himmel, Lauren, Lebrun-Vignes, Benedicte, Wleklinski, Matthew, Knollmann, Bjorn, Srinivasan, Jayashree, Li, Yu, Atolagbe, Oluwatomisin, Rao, Xiayu, Zhao, Yang, Wang, Jing, Ehrlich, Lauren, Sharma, Padmanee, Salem, Joe-Elie, Balko, Justin, Moslehi, Javid, and Allison, James

Subjects
Animals, Biomarkers, Tumor, Cardiotoxicity, Disease Management, Disease Models, Animal, Disease Susceptibility, Electrocardiography, Humans, Immune Checkpoint Inhibitors, Mice, Molecular Targeted Therapy, Myocarditis, Neoplasms
Abstract

Immune checkpoint inhibitors (ICI) targeting CTLA4 or PD-1/PD-L1 have transformed cancer therapy but are associated with immune-related adverse events, including myocarditis. Here, we report a robust preclinical mouse model of ICI-associated myocarditis in which monoallelic loss of Ctla4 in the context of complete genetic absence of Pdcd1 leads to premature death in approximately half of mice. Premature death results from myocardial infiltration by T cells and macrophages and severe ECG abnormalities, closely recapitulating the clinical and pathologic hallmarks of ICI-associated myocarditis observed in patients. Using this model, we show that Ctla4 and Pdcd1 functionally interact in a gene dosage-dependent manner, providing a mechanism by which myocarditis arises with increased frequency in the setting of combination ICI therapy. We demonstrate that intervention with CTLA4-Ig (abatacept) is sufficient to ameliorate disease progression and additionally provide a case series of patients in which abatacept mitigates the fulminant course of ICI myocarditis. SIGNIFICANCE: We provide a preclinical model of ICI-associated myocarditis which recapitulates this clinical syndrome. Using this model, we demonstrate that CTLA4 and PD-1 (ICI targets) functionally interact for myocarditis development and that intervention with CTLA4-Ig (abatacept) attenuates myocarditis, providing mechanistic rationale and preclinical support for therapeutic clinical studies.See related commentary by Young and Bluestone, p. 537.This article is highlighted in the In This Issue feature, p. 521.

Published
2021

4. Effects of ertugliflozin on uric acid and gout‐related outcomes in persons with type 2 diabetes and cardiovascular disease: Post hoc analyses from VERTIS CV.

Author

Sridhar, Vikas S., Cosentino, Francesco, Dagogo‐Jack, Samuel, McGuire, Darren K., Pratley, Richard E., Cater, Nilo B., Noyes Essex, Margaret, Mancuso, James P., Zhao, Yujie, and Cherney, David Z. I.

Subjects
CLINICAL trials, TYPE 2 diabetes, DIABETIC nephropathies, GLOMERULAR filtration rate, CHRONIC kidney failure
Abstract

Aim: To conduct post hoc analyses of the VERTIS CV (NCT01986881) trial to explore the effects of ertugliflozin on serum uric acid (UA) and gout‐related outcomes. Materials and Methods: Participants with type 2 diabetes and atherosclerotic cardiovascular disease were randomised (1:1:1) to placebo, ertugliflozin 5 mg or ertugliflozin 15 mg. Mean UA over time (260 weeks) was evaluated for pooled ertugliflozin versus placebo overall, and by baseline quintile of UA (≤4.3 mg/dL [≤255.8 µmol/L], >4.3–5.1 mg/dL [>255.8–303.4 µmol/L], >5.1–5.8 mg/dL [>303.4–345.0 µmol/L], >5.8–6.9 mg/dL [>345.0–410.4 µmol/L] and >6.9 mg/dL [>410.4 µmol/L]), glycated haemoglobin level, albuminuria status, estimated glomerular filtration rate and KDIGO (Kidney Disease: Improving Global Outcomes in Chronic Kidney Disease) risk category. The effect of ertugliflozin on a composite of gout onset or initiation of anti‐gout medication was assessed. Results: The mean UA levels at baseline were 5.67 and 5.62 mg/dL in the placebo and ertugliflozin groups, respectively. Ertugliflozin reduced UA over Weeks 6–260 compared with placebo, with least squares mean (LSM) changes (95% confidence interval [CI]) from baseline at Week 260 of 0.07 mg/dL (−0.02, 0.15) and −0.19 mg/dL (−0.25, −0.13) in the placebo and pooled ertugliflozin groups, respectively. At Week 260, placebo‐adjusted LSM change (95% CI) from baseline in UA was −0.26 mg/dL (−0.36, −0.16) with ertugliflozin. Ertugliflozin was associated with reductions in UA across baseline UA quintiles compared with placebo. The incidence of the composite of gout‐related outcomes was 84/2539 (3.3%) for placebo and 133/5091 (2.6%) for ertugliflozin (hazard ratio for the composite 0.76 [95% CI 0.580, 1.002]). Conclusions: Ertugliflozin was generally associated with lowering UA overall and across subgroups compared with placebo, and numerically reduced rates of gout‐related outcome events. [ABSTRACT FROM AUTHOR]

Published
2024
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9. Serologic Response to the Epstein-Barr Virus Peptidome and the Risk for Multiple Sclerosis

Author

Cortese, Marianna, Leng, Yumei, Bjornevik, Kjetil, Mitchell, Moriah, Healy, Brian C., Mina, Michael J., Mancuso, James D., Niebuhr, David W., Munger, Kassandra L., Elledge, Stephen J., and Ascherio, Alberto

Abstract

IMPORTANCE: It remains unclear why only a small proportion of individuals infected with the Epstein-Barr virus (EBV) develop multiple sclerosis (MS) and what the underlying mechanisms are. OBJECTIVE: To assess the serologic response to all EBV peptides before the first symptoms of MS occur, determine whether the disease is associated with a distinct immune response to EBV, and evaluate whether specific EBV epitopes drive this response. DESIGN, SETTING, AND PARTICIPANTS: In this prospective, nested case-control study, individuals were selected among US military personnel with serum samples stored in the US Department of Defense Serum Repository. Individuals with MS had serum collected at a median 1 year before onset (reported to the military in 2000-2011) and were matched to controls for age, sex, race and ethnicity, blood collection, and military branch. No individuals were excluded. The data were analyzed between September 1, 2022, and August 31, 2023. EXPOSURE: Antibodies (enrichment z scores) to the human virome measured using VirScan (phage-displayed immunoprecipitation and sequencing). MAIN OUTCOME AND MEASURE: Rate ratios (RRs) for MS for antibodies to 2263 EBV peptides (the EBV peptidome) were estimated using conditional logistic regression, adjusting for total anti–EBV nuclear antigen 1 (EBNA-1) antibodies, which have consistently been associated with a higher MS risk. The role of antibodies against other viral peptides was also explored. RESULTS: A total of 30 individuals with MS were matched with 30 controls. Mean (SD) age at sample collection was 27.8 (6.5) years; 46 of 60 participants (76.7%) were male. The antibody response to the EBV peptidome was stronger in individuals with MS, but without a discernible pattern. The antibody responses to 66 EBV peptides, the majority mapping to EBNA antigens, were significantly higher in preonset sera from individuals with MS (RR of highest vs lowest tertile of antibody enrichment, 33.4; 95% CI, 2.5-448.4; P for trend = .008). Higher total anti-EBNA-1 antibodies were also associated with an elevated MS risk (top vs bottom tertile: RR, 27.6; 95% CI, 2.3-327.6; P for trend = .008). After adjusting for total anti-EBNA-1 antibodies, risk estimates from most EBV peptides analyses were attenuated, with 4 remaining significantly associated with MS, the strongest within EBNA-6/EBNA-3C, while the association between total anti-EBNA-1 antibodies and MS persisted. CONCLUSION AND RELEVANCE: These findings suggest that antibody response to EBNA-1 may be the strongest serologic risk factor for MS. No single EBV peptide stood out as being selectively targeted in individuals with MS but not controls. Larger investigations are needed to explore possible heterogeneity of anti-EBV humoral immunity in MS.

Published
2024
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11. Ertugliflozin and hospitalization for heart failure across the spectrum of pre-trial ejection fraction: post-hoc analyses of the VERTIS CV trial.

Author

Pandey, Ambarish, Kolkailah, Ahmed A, Cosentino, Francesco, Cannon, Christopher P, Frederich, Robert C, Cherney, David Z I, Dagogo-Jack, Samuel, Pratley, Richard E, Cater, Nilo B, Gantz, Ira, Mancuso, James P, and McGuire, Darren K

Subjects
VENTRICULAR ejection fraction, HEART failure, TYPE 2 diabetes, HOSPITAL care, SODIUM-glucose cotransporter 2 inhibitors
Abstract

This article discusses the results of a post-hoc analysis of the VERTIS CV trial, which examined the effects of the medication ertugliflozin on the risk of hospitalization for heart failure (HHF) in patients with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease. The study found that ertugliflozin significantly reduced the risk of first HHF in the overall cohort of participants. However, the treatment effect was more pronounced in individuals with a pre-trial ejection fraction (EF) of less than 45% and attenuated in those with an EF greater than 60%. These findings contribute to the understanding of the efficacy of SGLT2 inhibitors in reducing the risk of HHF across different EF ranges. [Extracted from the article]

Published
2023
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13. HYPOGLYCEMIA AND CV OUTCOMES IN PARTICIPANTS WITH TYPE 2 DIABETES AND ATHEROSCLEROTIC CARDIOVASCULAR DISEASE: OBSERVATIONS FROM THE VERTIS CV TRIAL

Author

Pratley, Richard E., primary, McGuire, Darren K., additional, Fu, Wei, additional, Cannon, Christopher P., additional, Cherney, David Z.I., additional, Cosentino, Francesco, additional, Liu, Jie, additional, Frederich, Robert, additional, Mancuso, James P., additional, and Dagogo-Jack, Samuel, additional

Published
2023
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16. Potential for residual cardiovascular risk reduction: Eligibility for icosapent ethyl in the VERTIS CV population with type 2 diabetes and atherosclerotic cardiovascular disease

Author

Kim, Joseph M., primary, Bhatt, Deepak L., additional, Dagogo‐Jack, Samuel, additional, Cherney, David Z. I., additional, Cosentino, Francesco, additional, McGuire, Darren K., additional, Pratley, Richard E., additional, Liu, Chih‐Chin, additional, Cater, Nilo B., additional, Frederich, Robert, additional, Mancuso, James P., additional, and Cannon, Christopher P., additional

Published
2023
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19. Cardiorenal Outcomes With Ertugliflozin by Baseline Metformin Use: Post Hoc Analyses of the VERTIS CV Trial

Author

Cosentino, Francesco, primary, Cannon, Christopher P., additional, Frederich, Robert, additional, Cherney, David Z.I., additional, Dagogo-Jack, Samuel, additional, Pratley, Richard E., additional, Mancuso, James P., additional, Maldonado, Mario, additional, Cater, Nilo B., additional, Wang, Shuai, additional, and McGuire, Darren K., additional

Published
2022
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21. 481-P: Eligibility for Icosapent Ethyl in Patients with Type 2 Diabetes and Atherosclerotic Cardiovascular Disease: An Analysis of VERTIS CV

Author

KIM, JOSEPH M., primary, BHATT, DEEPAK L., additional, DAGOGO-JACK, SAMUEL, additional, CHERNEY, DAVID, additional, COSENTINO, FRANCESCO, additional, MCGUIRE, DARREN K., additional, PRATLEY, RICHARD E., additional, LIU, CHIH-CHIN, additional, CATER, NILO B., additional, FREDERICH, ROBERT, additional, MANCUSO, JAMES P., additional, and CANNON, CHRISTOPHER P., additional

Published
2022
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25. Symposium on Youth: Their Values, Goals, and Career Concepts. Third Monograph.

Author

State Univ. of New York, Albany. Two Year Coll. Student Development Center. and Mancuso, James C.

Abstract

This monograph contains papers presented at a symposium on the values, goals and career concepts of youth. The first article discusses cognitive personality theory which maintains that all behavior is a judgmental process carried out upon stimuli which impinge upon the organism. Major issues in general behavior theory are presented followed by a discussion of how these issues might be regarded within a cognitive theory approach. The second paper brings to bear some of the recent conceptions and findings from the area of person perception to the understanding of perception of self with attention focused on ways in which such ideas can be relevant to the work of college counselors. The next paper deals with the application of some social learning concepts to an analysis of some salient problems in our society. It is concerned with the following four areas in which our society has built into it serious culture conflicts: education, occupation, and recreation; love and marriage; friendship and social acceptance; and morality. The last article presents an overview of student personnel services in Georgia's Area Vocational Technical Schools. (RSM)

Published
1969

26. Glycemic efficacy and safety of the SGLT2 inhibitor ertugliflozin in patients with type 2 diabetes and stage 3 chronic kidney disease: an analysis from the VERTIS CV randomized trial

Author

Dagogo-Jack, Samuel, primary, Pratley, Richard E, additional, Cherney, David Z I, additional, McGuire, Darren K, additional, Cosentino, Francesco, additional, Shih, Weichung J, additional, Liu, Jie, additional, Frederich, Robert, additional, Mancuso, James P, additional, Raji, Annaswamy, additional, and Gantz, Ira, additional

Published
2021
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27. 786-P: Glycemic Efficacy and Safety of Ertugliflozin (ERTU) in Patients with Type 2 Diabetes (T2D) and Chronic Kidney Disease Stage 3 (CKD 3): An Analysis from VERTIS CV

Author

DAGOGO-JACK, SAMUEL, primary, PRATLEY, RICHARD E., additional, CHERNEY, DAVID, additional, CHARBONNEL, BERNARD, additional, MCGUIRE, DARREN K., additional, COSENTINO, FRANCESCO, additional, SHIH, WEICHUNG J., additional, LIU, JIE, additional, FREDERICH, ROBERT, additional, MANCUSO, JAMES P., additional, RAJI, ANNASWAMY, additional, and GANTZ, IRA, additional

Published
2021
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28. 783-P: Cardiorenal Outcomes with Ertugliflozin by Baseline (BL) Glucose-Lowering Agent (GLA): An Analysis from VERTIS CV

Author

CHARBONNEL, BERNARD, primary, DAGOGO-JACK, SAMUEL, additional, CANNON, CHRISTOPHER P., additional, CHERNEY, DAVID, additional, COSENTINO, FRANCESCO, additional, MCGUIRE, DARREN K., additional, SHIH, WEICHUNG J., additional, LIU, JIE, additional, PONG, ANNPEY, additional, GANTZ, IRA, additional, FREDERICH, ROBERT, additional, MANCUSO, JAMES P., additional, and PRATLEY, RICHARD E., additional

Published
2021
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29. 796-P: Cardiorenal Outcomes with Ertugliflozin by Baseline Cardiorenal Medications: An Analysis from VERTIS CV

Author

CHERNEY, DAVID, primary, COSENTINO, FRANCESCO, additional, MCGUIRE, DARREN K., additional, CHARBONNEL, BERNARD, additional, DAGOGO-JACK, SAMUEL, additional, PRATLEY, RICHARD E., additional, SHIH, WEICHUNG J., additional, MALDONADO, MARIO, additional, PONG, ANNPEY, additional, GANTZ, IRA, additional, FREDERICH, ROBERT, additional, MANCUSO, JAMES P., additional, MASIUKIEWICZ, URSZULA, additional, and CANNON, CHRISTOPHER P., additional

Published
2021
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31. Effects of an inhibitor of cholesteryl ester transfer protein on HDL cholesterol

Author

Brousseau, Margaret E., Schaefer, Ernst J., Wolfe, Megan L., Bloedon, LeAnne T., Digenio, Andres G., Clark, Ronald W., Mancuso, James P., and Rader, Daniel J.

Subjects
Blood lipoproteins -- Analysis, Statins -- Dosage and administration, Coronary heart disease -- Risk factors
Abstract

A single-blind, placebo controlled study to examine the effects of torcetrapid, on plasma lipoprotein levels in subjects with low levels of high-density lipoprotein (HDL) cholesterol was conducted. The distribution among HDL and low-density lipoprotein (LDL) was found to be altered by torcetrapid.

Published
2004

36. 453_Supplementary_Fig1 – Supplemental material for Efficacy of ertugliflozin in monotherapy or combination therapy in patients with type 2 diabetes: A pooled analysis of placebo-controlled studies

Author

Liu, Jie, Tarasenko, Lisa, Terra, Steven G, Huyck, Susan, Wu, Larry, Annpey Pong, Calle, Roberto A, Gallo, Silvina, Darekar, Amanda, and Mancuso, James P

Subjects
FOS: Clinical medicine, 111199 Nutrition and Dietetics not elsewhere classified, Cardiology, 110323 Surgery, FOS: Health sciences, 110306 Endocrinology
Abstract

Supplemental material, 453_Supplementary_Fig1 for Efficacy of ertugliflozin in monotherapy or combination therapy in patients with type 2 diabetes: A pooled analysis of placebo-controlled studies by Jie Liu, Lisa Tarasenko, Steven G Terra, Susan Huyck, Larry Wu, Annpey Pong, Roberto A Calle, Silvina Gallo, Amanda Darekar and James P Mancuso in Diabetes & Vascular Disease Research

Published
2019
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39. 1197-P: Two-Year Effects of Ertugliflozin on Renal Function

Author

CHERNEY, DAVID, primary, HEERSPINK, HIDDO L., additional, FREDERICH, ROBERT, additional, MALDONADO, MARIO, additional, PONG, ANNPEY, additional, XU, ZHI JIN, additional, LIU, JIE, additional, MANCUSO, JAMES P., additional, GANTZ, IRA, additional, and TERRA, STEVEN G., additional

Published
2019
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41. Results of VERTIS SU extension study: safety and efficacy of ertugliflozin treatment over 104 weeks compared to glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin

Author

Hollander, Priscilla, primary, Hill, Julie, additional, Johnson, Jeremy, additional, Wei Jiang, Zhi, additional, Golm, Gregory, additional, Huyck, Susan, additional, Terra, Steven G., additional, Mancuso, James P., additional, Engel, Samuel S., additional, Lauring, Brett, additional, and Liu, Jie, additional

Published
2019
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44. A Constructivist Framework for Helping Parents Develop Positive Parenting Concepts.

Author

Eimer, Bruce N. and Mancuso, James C.

Abstract

This paper presents the rudiments of a constructivist conceptual framework which school psychologists can use to help parents develop positive parenting concepts. Problems arise if school psychologists rely solely on a mechanistic paradigm when they identify causes of unwanted behaviors and suggest specific remedial strategies. Operating within a constructivist framework, which assumes several cognitive processes such as anticipation, accommodation and assimilation in the child and sees parents as moderators of discrepancy or novelty and regulators of arousal, a sensitive parent (1) understands the child's characteristic ways of construing events, (2) presents the child with sensory input that is moderately discrepant from the child's existing cognitive organizations, and (3) provides the child with support in his efforts at accommodating his cognitive organizations to assimilate novel input. Parents can be taught to sensitively present an orderly world to their children. Experience in a parent training program based on constructivist principles of psychological functioning suggests the following hypotheses: parents who rely on coercive strategies to promote compliance operate on the basis of evaluatively negative, unidimensional constructions of the motives for their children's activities; parents who rely on persuasion and reasoning to promote compliance operate on the basis of less evaluative, integrated, multivalent constructions of the motives for their children's behavior. (Author/RH)

Published
1980

45. Effects of Therapist Behavior on People's Mental Illness Judgments

Author

Yaffe, Peter E. and Mancuso, James C.

Abstract

College students (N=308) were asked to function in a judgmental activity assumed to correspond to the diagnostic activity of categorizing a target person as "mentally ill." Analysis of scores shows subjects regard the target person as more negative and more "maladjusted" when the interviewer enacts expected appropriate professional interest. (Author)

Published
1977

47. A Constructivist View of Reprimand in the Classroom.

Author

Mancuso, James C. and Eimer, Bruce N.

Abstract

Shortcomings of contingency management techniques used for student discipline are delineated, and personal construct studies with some pertinence to classroom reprimand are reviewed. Behavior science specialists should be involved in the constructivist approach, which considers the individual psychological frameworks that students and teachers bring to situations requiring reprimand. (PP)

Published
1982

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