2024
Early Metabolic Endpoints Identify Persistent Treatment Efficacy in Recent-Onset Type 1 Diabetes Immunotherapy Trials.
Jacobsen L, Cuthbertson D, Bundy B, Atkinson M, Moore W, Haller M, Russell W, Gitelman S, Herold K, Redondo M, Sims E, Wherrett D, Moran A, Pugliese A, Gottlieb P, Sosenko J, Ismail H. Early Metabolic Endpoints Identify Persistent Treatment Efficacy in Recent-Onset Type 1 Diabetes Immunotherapy Trials. Diabetes Care 2024, 47: 1048-1055. PMID: 38621411, PMCID: PMC11294635, DOI: 10.2337/dc24-0171.Peer-Reviewed Original ResearchConceptsC-peptide area-under-the-curveArea under the curveC-peptideRecent-onset type 1 diabetesTreatment efficacyEarly-phase clinical trialsC-peptide preservationPrimary end pointB cell functionDetect treatment efficacyType 1 diabetesPost hoc analysisRandomized controlled trialsImmune therapyImmunotherapy trialsMonths posttherapyClinical trialsTreatment effectsEnd pointsMetabolic indicesHoc analysisControlled trialsType 1 diabetes trialsMetabolic endpointsIntervention trials
2020
Immune responses to SARS-CoV-2 infection in hospitalized pediatric and adult patients
Pierce CA, Preston-Hurlburt P, Dai Y, Aschner CB, Cheshenko N, Galen B, Garforth SJ, Herrera NG, Jangra RK, Morano NC, Orner E, Sy S, Chandran K, Dziura J, Almo SC, Ring A, Keller MJ, Herold KC, Herold BC. Immune responses to SARS-CoV-2 infection in hospitalized pediatric and adult patients. Science Translational Medicine 2020, 12: eabd5487. PMID: 32958614, PMCID: PMC7658796, DOI: 10.1126/scitranslmed.abd5487.Peer-Reviewed Original ResearchConceptsImmune responsePediatric patientsAntibody titersAdult patientsSerum concentrationsT cellsSevere acute respiratory syndrome coronavirus 2IFN-γ serum concentrationsAcute respiratory syndrome coronavirus 2Robust T cell responsesSARS-CoV-2 infectionAntibody-dependent cellular phagocytosisRespiratory syndrome coronavirus 2Frequency of IFNMultisystem inflammatory syndromeT cell responsesCellular immune responsesSyndrome coronavirus 2Adaptive immune responsesAntiviral immune responseTumor necrosis factorMetropolitan hospital systemCoronavirus disease 2019COVID-19Age-dependent factors
2019
An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes
Herold KC, Bundy BN, Long SA, Bluestone JA, DiMeglio LA, Dufort MJ, Gitelman SE, Gottlieb PA, Krischer JP, Linsley PS, Marks JB, Moore W, Moran A, Rodriguez H, Russell WE, Schatz D, Skyler JS, Tsalikian E, Wherrett DK, Ziegler AG, Greenbaum CJ. An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes. New England Journal Of Medicine 2019, 381: 603-613. PMID: 31180194, PMCID: PMC6776880, DOI: 10.1056/nejmoa1902226.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAntibodies, Monoclonal, HumanizedCD3 ComplexChildDiabetes Mellitus, Type 1Disease ProgressionDouble-Blind MethodExanthemaFemaleGlucose Tolerance TestHLA-DR3 AntigenHLA-DR4 AntigenHumansLymphocyte CountLymphopeniaMaleMiddle AgedProportional Hazards ModelsT-LymphocytesYoung AdultConceptsType 1 diabetesClinical type 1 diabetesTeplizumab groupPlacebo groupOral glucose tolerance testInsulin-producing beta cellsDouble-blind trialChronic autoimmune diseaseGlucose tolerance testRelatives of patientsRate of diagnosisHigh-risk participantsTransient lymphopeniaAdverse eventsHazard ratioHLA-DR3HLA-DR4Median timeClinical progressionAutoimmune diseasesExogenous insulinCD3 antibodyT cellsTeplizumabClinical disease