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  1. Article ; Online: Response to Comment on Russell et al. Abatacept for Delay of Type 1 Diabetes Progression in Stage 1 Relatives at Risk: A Randomized, Double-Masked, Controlled Trial. Diabetes Care 2023;46:1005-1013.

    Russell, William E / Moore, Daniel J / Herold, Kevan C

    Diabetes care

    2023  Volume 46, Issue 11, Page(s) e210–e211

    MeSH term(s) Humans ; Diabetes Mellitus, Type 1/drug therapy ; Abatacept/therapeutic use ; Diabetes Mellitus, Type 2 ; Double-Blind Method
    Chemical Substances Abatacept (7D0YB67S97)
    Language English
    Publishing date 2023-10-27
    Publishing country United States
    Document type Randomized Controlled Trial ; Research Support, Non-U.S. Gov't ; Letter ; Research Support, N.I.H., Extramural ; Comment
    ZDB-ID 441231-x
    ISSN 1935-5548 ; 0149-5992
    ISSN (online) 1935-5548
    ISSN 0149-5992
    DOI 10.2337/dci23-0050
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  2. Article ; Online: High proinsulin:C-peptide ratio identifies individuals with stage 2 type 1 diabetes at high risk for progression to clinical diagnosis and responses to teplizumab treatment.

    Sims, Emily K / Geyer, Susan M / Long, S Alice / Herold, Kevan C

    Diabetologia

    2023  Volume 66, Issue 12, Page(s) 2283–2291

    Abstract: Aims/hypothesis: Tractable precision biomarkers to identify immunotherapy responders are lacking in type 1 diabetes. We hypothesised that proinsulin:C-peptide (PI:C) ratios, a readout of beta cell stress, could provide insight into type 1 diabetes ... ...

    Abstract Aims/hypothesis: Tractable precision biomarkers to identify immunotherapy responders are lacking in type 1 diabetes. We hypothesised that proinsulin:C-peptide (PI:C) ratios, a readout of beta cell stress, could provide insight into type 1 diabetes progression and responses to immunotherapy.
    Methods: In this post hoc analysis, proinsulin and C-peptide levels were determined in baseline serum samples from 63 participants with stage 2 type 1 diabetes in the longitudinal TrialNet Teplizumab Prevention Study (n=41 in the teplizumab arm; n=22 in the placebo arm). In addition, previously tested demographic, C-peptide, glucose and proinsulin data were used for the new data analyses. The ratio of intact (unprocessed) proinsulin to C-peptide was analysed and relationships with progression to stage 3 diabetes were investigated.
    Results: Elevated baseline PI:C was strongly associated with more rapid progression of diabetes in both the placebo and teplizumab treatment groups, but teplizumab abrogated the impact of high pre-treatment PI:C on type 1 diabetes progression. Differential responses of drug treatment in those with high vs low PI:C ratios were independent of treatment effects of teplizumab on the PI:C ratio or on relevant immune cells.
    Conclusions/interpretation: High pre-treatment PI:C identified individuals with stage 2 type 1 diabetes who were exhibiting rapid progression to stage 3 disease and who displayed benefit from teplizumab treatment. These data suggest that readouts of active disease, such as PI:C ratio, could serve to identify optimal candidates or timing for type 1 diabetes disease-modifying therapies.
    MeSH term(s) Humans ; Proinsulin ; C-Peptide ; Diabetes Mellitus, Type 1 ; Antibodies, Monoclonal, Humanized/therapeutic use ; Insulin/metabolism
    Chemical Substances Proinsulin (9035-68-1) ; C-Peptide ; teplizumab (S4M959U2IJ) ; Antibodies, Monoclonal, Humanized ; Insulin
    Language English
    Publishing date 2023-09-04
    Publishing country Germany
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 1694-9
    ISSN 1432-0428 ; 0012-186X
    ISSN (online) 1432-0428
    ISSN 0012-186X
    DOI 10.1007/s00125-023-06003-5
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  3. Article ; Online: The β-Cell in Type 1 Diabetes Pathogenesis: A Victim of Circumstances or an Instigator of Tragic Events?

    Mallone, Roberto / Halliez, Clémentine / Rui, Jinxiu / Herold, Kevan C

    Diabetes

    2022  Volume 71, Issue 8, Page(s) 1603–1610

    Abstract: Recent reports have revived interest in the active role that β-cells may play in type 1 diabetes pathogenesis at different stages of disease. In some studies, investigators suggested an initiating role and proposed that type 1 diabetes may be primarily a ...

    Abstract Recent reports have revived interest in the active role that β-cells may play in type 1 diabetes pathogenesis at different stages of disease. In some studies, investigators suggested an initiating role and proposed that type 1 diabetes may be primarily a disease of β-cells and only secondarily a disease of autoimmunity. This scenario is possible and invites the search for environmental triggers damaging β-cells. Another major contribution of β-cells may be to amplify autoimmune vulnerability and to eventually drive it into an intrinsic, self-detrimental state that turns the T cell-mediated homicide into a β-cell suicide. On the other hand, protective mechanisms are also mounted by β-cells and may provide novel therapeutic targets to combine immunomodulatory and β-cell protective agents. This integrated view of autoimmunity as a disease of T-cell/β-cell cross talk will ultimately advance our understanding of type 1 diabetes pathogenesis and improve our chances of preventing or reversing disease progression.
    MeSH term(s) Autoimmunity ; Diabetes Mellitus, Type 1 ; Humans ; Immunomodulation ; Insulin-Secreting Cells/pathology ; T-Lymphocytes
    Language English
    Publishing date 2022-08-08
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural ; Review
    ZDB-ID 80085-5
    ISSN 1939-327X ; 0012-1797
    ISSN (online) 1939-327X
    ISSN 0012-1797
    DOI 10.2337/dbi21-0036
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  4. Article ; Online: Comparisons of Metabolic Measures to Predict T1D vs. Detect a Preventive Treatment Effect in High-Risk Individuals.

    Sims, Emily K / Cuthbertson, David / Jacobsen, Laura / Ismail, Heba M / Nathan, Brandon M / Herold, Kevan C / Redondo, Maria J / Sosenko, Jay

    The Journal of clinical endocrinology and metabolism

    2024  

    Abstract: Context: Metabolic measures are frequently used to predict T1D and to understand effects of disease-modifying therapies.: Objective: Compare metabolic endpoints for their ability to detect preventive treatment effects and predict T1D.: Design: Six- ...

    Abstract Context: Metabolic measures are frequently used to predict T1D and to understand effects of disease-modifying therapies.
    Objective: Compare metabolic endpoints for their ability to detect preventive treatment effects and predict T1D.
    Design: Six-month changes in metabolic endpoints were assessed for: 1) detecting treatment effects by comparing placebo and treatment arms from the randomized controlled teplizumab prevention trial and 2) predicting T1D in the TrialNet Pathway to Prevention natural history study.
    Setting: Multicenter clinical trial network.
    Intervention: 14-day intravenous teplizumab infusion.
    Main outcome measures: T-values from t tests for detecting a treatment effect were compared to Chi-square values from proportional hazards regression for predicting T1D for each metabolic measure.
    Patients or other participants: Participants in the teplizumab prevention trial and participants in the Pathway to Prevention study selected with the same inclusion criteria used for the teplizumab trial were studied.
    Results: Six-month changes in glucose-based endpoints predicted diabetes better than C-peptide-based endpoints, yet the latter were better at detecting a teplizumab effect. Combined measures of glucose and C-peptide were more balanced than measures of glucose alone or C-peptide alone for predicting diabetes and detecting a teplizumab effect.
    Conclusions: The capacity of a metabolic endpoint to detect a treatment effect does not necessarily correspond to its accuracy for predicting T1D. However, combined glucose and C-peptide endpoints appear to be effective for both predicting diabetes and detecting a response to immunotherapy. These findings suggest that combined glucose and C-peptide endpoints should be incorporated into the design of future T1D prevention trials.
    Language English
    Publishing date 2024-01-24
    Publishing country United States
    Document type Journal Article
    ZDB-ID 3029-6
    ISSN 1945-7197 ; 0021-972X
    ISSN (online) 1945-7197
    ISSN 0021-972X
    DOI 10.1210/clinem/dgae048
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  5. Article ; Online: The immunology of type 1 diabetes.

    Herold, Kevan C / Delong, Thomas / Perdigoto, Ana Luisa / Biru, Noah / Brusko, Todd M / Walker, Lucy S K

    Nature reviews. Immunology

    2024  

    Abstract: Following the seminal discovery of insulin a century ago, treatment of individuals with type 1 diabetes (T1D) has been largely restricted to efforts to monitor and treat metabolic glucose dysregulation. The recent regulatory approval of the first ... ...

    Abstract Following the seminal discovery of insulin a century ago, treatment of individuals with type 1 diabetes (T1D) has been largely restricted to efforts to monitor and treat metabolic glucose dysregulation. The recent regulatory approval of the first immunotherapy that targets T cells as a means to delay the autoimmune destruction of pancreatic β-cells highlights the critical role of the immune system in disease pathogenesis and tends to pave the way for other immune-targeted interventions for T1D. Improving the efficacy of such interventions across the natural history of the disease will probably require a more detailed understanding of the immunobiology of T1D, as well as technologies to monitor residual β-cell mass and function. Here we provide an overview of the immune mechanisms that underpin the pathogenesis of T1D, with a particular emphasis on T cells.
    Language English
    Publishing date 2024-02-02
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2062776-2
    ISSN 1474-1741 ; 1474-1733
    ISSN (online) 1474-1741
    ISSN 1474-1733
    DOI 10.1038/s41577-023-00985-4
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  6. Article ; Online: Adverse events induced by immune checkpoint inhibitors.

    Perdigoto, Ana Luisa / Kluger, Harriet / Herold, Kevan C

    Current opinion in immunology

    2021  Volume 69, Page(s) 29–38

    Abstract: Immune checkpoint inhibitors have revolutionized the treatments of cancers but are also associated with immune related adverse events that can interfere with their use. The types and severity of adverse events vary with checkpoint inhibitors. A single ... ...

    Abstract Immune checkpoint inhibitors have revolutionized the treatments of cancers but are also associated with immune related adverse events that can interfere with their use. The types and severity of adverse events vary with checkpoint inhibitors. A single mechanism of pathogenesis has not emerged: postulated mechanisms involve direct effects of the checkpoint inhibitor, emergence of autoantibodies or autoreactive T cells, and destruction by toxic effects of activated T cells. Several host factors such as genotypes, preexisting autoimmune disease, inflammatory responses and others may have predictive value. Ongoing investigations seek to identify ways of modulating the autoimmunity without affecting the anti-tumor response with agents that are specific for the autoimmune mechanisms.
    MeSH term(s) Animals ; Autoantibodies/metabolism ; Autoantigens/immunology ; Autoimmune Diseases/etiology ; Autoimmune Diseases/prevention & control ; Autoimmunity ; Cytotoxicity, Immunologic ; Drug-Related Side Effects and Adverse Reactions/prevention & control ; Gene-Environment Interaction ; Genetic Predisposition to Disease ; Humans ; Immune Checkpoint Inhibitors/adverse effects ; Immune Checkpoint Inhibitors/therapeutic use ; Immunotherapy/adverse effects ; Lymphocyte Activation ; Neoplasms/genetics ; Neoplasms/immunology ; Neoplasms/therapy ; T-Lymphocytes/immunology
    Chemical Substances Autoantibodies ; Autoantigens ; Immune Checkpoint Inhibitors
    Language English
    Publishing date 2021-02-25
    Publishing country England
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Review
    ZDB-ID 1035767-1
    ISSN 1879-0372 ; 0952-7915
    ISSN (online) 1879-0372
    ISSN 0952-7915
    DOI 10.1016/j.coi.2021.02.002
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  7. Article ; Online: Immune responses to gut bacteria associated with time to diagnosis and clinical response to T cell-directed therapy for type 1 diabetes prevention.

    Xie, Quin Yuhui / Oh, Sean / Wong, Anthony / Yau, Christopher / Herold, Kevan C / Danska, Jayne S

    Science translational medicine

    2023  Volume 15, Issue 719, Page(s) eadh0353

    Abstract: Immune-targeted therapies have efficacy for treatment of autoinflammatory diseases. For example, treatment with the T cell-specific anti-CD3 antibody teplizumab delayed disease onset in participants at high risk for type 1 diabetes (T1D) in the TrialNet ... ...

    Abstract Immune-targeted therapies have efficacy for treatment of autoinflammatory diseases. For example, treatment with the T cell-specific anti-CD3 antibody teplizumab delayed disease onset in participants at high risk for type 1 diabetes (T1D) in the TrialNet 10 (TN-10) trial. However, heterogeneity in therapeutic responses in TN-10 and other immunotherapy trials identifies gaps in understanding disease progression and treatment responses. The intestinal microbiome is a potential source of biomarkers associated with future T1D diagnosis and responses to immunotherapy. We previously reported that antibody responses to gut commensal bacteria were associated with T1D diagnosis, suggesting that certain antimicrobial immune responses may help predict disease onset. Here, we investigated anticommensal antibody (ACAb) responses against a panel of taxonomically diverse intestinal bacteria species in sera from TN-10 participants before and after teplizumab or placebo treatment. We identified IgG2 responses to three species that were associated with time to T1D diagnosis and with teplizumab treatment responses that delayed disease onset. These antibody responses link human intestinal bacteria with T1D progression, adding predictive value to known T1D risk factors. ACAb analysis provides a new approach to elucidate heterogeneity in responses to immunotherapy and identify individuals who may benefit from teplizumab, recently approved by the U.S. Food and Drug Administration for delaying T1D onset.
    MeSH term(s) Humans ; Diabetes Mellitus, Type 1/drug therapy ; Immunotherapy ; T-Lymphocytes ; Bacteria ; Immunity
    Language English
    Publishing date 2023-10-25
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2518854-9
    ISSN 1946-6242 ; 1946-6234
    ISSN (online) 1946-6242
    ISSN 1946-6234
    DOI 10.1126/scitranslmed.adh0353
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  8. Article ; Online: Immunotherapy: Building a bridge to a cure for type 1 diabetes.

    Bluestone, Jeffrey A / Buckner, Jane H / Herold, Kevan C

    Science (New York, N.Y.)

    2021  Volume 373, Issue 6554, Page(s) 510–516

    Abstract: Type 1 diabetes (T1D) is an autoimmune disease in which T cells attack and destroy the insulin-producing β cells in the pancreatic islets. Genetic and environmental factors increase T1D risk by compromising immune homeostasis. Although the discovery and ... ...

    Abstract Type 1 diabetes (T1D) is an autoimmune disease in which T cells attack and destroy the insulin-producing β cells in the pancreatic islets. Genetic and environmental factors increase T1D risk by compromising immune homeostasis. Although the discovery and use of insulin have transformed T1D treatment, insulin therapy does not change the underlying disease or fully prevent complications. Over the past two decades, research has identified multiple immune cell types and soluble factors that destroy insulin-producing β cells. These insights into disease pathogenesis have enabled the development of therapies to prevent and modify T1D. In this review, we highlight the key events that initiate and sustain pancreatic islet inflammation in T1D, the current state of the immunological therapies, and their advantages for the treatment of T1D.
    MeSH term(s) Adaptive Immunity ; Animals ; Anti-Inflammatory Agents/therapeutic use ; Autoantibodies/blood ; B-Lymphocytes/immunology ; Cytokines/immunology ; Cytokines/metabolism ; Diabetes Mellitus, Type 1/genetics ; Diabetes Mellitus, Type 1/immunology ; Diabetes Mellitus, Type 1/therapy ; Humans ; Immunity, Innate ; Immunologic Factors/therapeutic use ; Immunotherapy ; Insulin-Secreting Cells/physiology ; Interleukin-2/therapeutic use ; T-Lymphocytes/immunology
    Chemical Substances Anti-Inflammatory Agents ; Autoantibodies ; Cytokines ; Immunologic Factors ; Interleukin-2
    Language English
    Publishing date 2021-07-29
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 128410-1
    ISSN 1095-9203 ; 0036-8075
    ISSN (online) 1095-9203
    ISSN 0036-8075
    DOI 10.1126/science.abh1654
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  9. Article ; Online: A little help from residual β cells has long-lasting clinical benefits.

    Lam, Anna / Dayan, Colin / Herold, Kevan C

    The Journal of clinical investigation

    2021  Volume 131, Issue 3

    Abstract: Following type 1 diabetes (T1D) diagnosis, declining C-peptide levels reflect deteriorating β cell function. However, the precise C-peptide levels that indicate protection from severe hypoglycemia remain unknown. In this issue of the JCI, Gubitosi-Klug ... ...

    Abstract Following type 1 diabetes (T1D) diagnosis, declining C-peptide levels reflect deteriorating β cell function. However, the precise C-peptide levels that indicate protection from severe hypoglycemia remain unknown. In this issue of the JCI, Gubitosi-Klug et al. studied participants from the landmark and ongoing Diabetes Control and Complications Trial (DCCT) and the Epidemiology of Diabetes Interventions and Complications (EDIC) study that had long-standing (about 35 years) T1D. The authors correlated severe hypoglycemia and other disease outcomes with residual C-peptide levels. While C-peptide secretion failed to associate with hemoglobin A1c (HbA1c) or microvascular complications, C-peptide levels greater than 0.03 nmol/L were linked with fewer episodes of severe hypoglycemia. These findings suggest that efforts to preserve finite β cell function early in T1D can have meaningful, long-standing health benefits for patients.
    MeSH term(s) C-Peptide ; Diabetes Complications ; Diabetes Mellitus, Type 1 ; Glycated Hemoglobin ; Humans ; Hypoglycemia
    Chemical Substances C-Peptide ; Glycated Hemoglobin A
    Language English
    Publishing date 2021-02-02
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Comment
    ZDB-ID 3067-3
    ISSN 1558-8238 ; 0021-9738
    ISSN (online) 1558-8238
    ISSN 0021-9738
    DOI 10.1172/JCI143683
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  10. Article ; Online: Restoring immune balance in type 1 diabetes.

    Herold, Kevan C

    The lancet. Diabetes & endocrinology

    2013  Volume 1, Issue 4, Page(s) 261–263

    MeSH term(s) Alefacept ; Diabetes Mellitus, Type 1/blood ; Diabetes Mellitus, Type 1/drug therapy ; Drug Delivery Systems/methods ; Female ; Humans ; Immunologic Memory/drug effects ; Male ; Recombinant Fusion Proteins/administration & dosage ; T-Lymphocytes/drug effects
    Chemical Substances Recombinant Fusion Proteins ; Alefacept (ELK3V90G6C)
    Language English
    Publishing date 2013-09-23
    Publishing country England
    Document type Journal Article ; Comment
    ISSN 2213-8595
    ISSN (online) 2213-8595
    DOI 10.1016/S2213-8587(13)70123-2
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