التفاصيل البيبلوغرافية
| العنوان: |
An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes |
| المؤلفون: |
Herold, Kevan C, Bundy, Brian N, Long, S Alice, Bluestone, Jeffrey A, DiMeglio, Linda A, Dufort, Matthew J, Gitelman, Stephen E, Gottlieb, Peter A, Krischer, Jeffrey P, Linsley, Peter S, Marks, Jennifer B, Moore, Wayne, Moran, Antoinette, Rodriguez, Henry, Russell, William E, Schatz, Desmond, Skyler, Jay S, Tsalikian, Eva, Wherrett, Diane K, Ziegler, Anette-Gabriele, Greenbaum, Carla J |
| المصدر: |
New England Journal of Medicine, vol 381, iss 7 |
| بيانات النشر: |
eScholarship, University of California |
| سنة النشر: |
2019 |
| المجموعة: |
University of California: eScholarship |
| مصطلحات موضوعية: |
Clinical Research, Clinical Trials and Supportive Activities, Diabetes, Autoimmune Disease, Prevention, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Metabolic and endocrine, Adolescent, Adult, Antibodies, Monoclonal, Humanized, CD3 Complex, Child, Diabetes Mellitus, Type 1, Disease Progression, Double-Blind Method, Exanthema, Female, Glucose Tolerance Test, HLA-DR3 Antigen, HLA-DR4 Antigen, Humans, Lymphocyte Count, Lymphopenia, Male, Middle Aged, Proportional Hazards Models |
| جغرافية الموضوع: |
603 - 613 |
| الوصف: |
BackgroundType 1 diabetes is a chronic autoimmune disease that leads to destruction of insulin-producing beta cells and dependence on exogenous insulin for survival. Some interventions have delayed the loss of insulin production in patients with type 1 diabetes, but interventions that might affect clinical progression before diagnosis are needed.MethodsWe conducted a phase 2, randomized, placebo-controlled, double-blind trial of teplizumab (an Fc receptor-nonbinding anti-CD3 monoclonal antibody) involving relatives of patients with type 1 diabetes who did not have diabetes but were at high risk for development of clinical disease. Patients were randomly assigned to a single 14-day course of teplizumab or placebo, and follow-up for progression to clinical type 1 diabetes was performed with the use of oral glucose-tolerance tests at 6-month intervals.ResultsA total of 76 participants (55 [72%] of whom were ≤18 years of age) underwent randomization - 44 to the teplizumab group and 32 to the placebo group. The median time to the diagnosis of type 1 diabetes was 48.4 months in the teplizumab group and 24.4 months in the placebo group; the disease was diagnosed in 19 (43%) of the participants who received teplizumab and in 23 (72%) of those who received placebo. The hazard ratio for the diagnosis of type 1 diabetes (teplizumab vs. placebo) was 0.41 (95% confidence interval, 0.22 to 0.78; P = 0.006 by adjusted Cox proportional-hazards model). The annualized rates of diagnosis of diabetes were 14.9% per year in the teplizumab group and 35.9% per year in the placebo group. There were expected adverse events of rash and transient lymphopenia. KLRG1+TIGIT+CD8+ T cells were more common in the teplizumab group than in the placebo group. Among the participants who were HLA-DR3-negative, HLA-DR4-positive, or anti-zinc transporter 8 antibody-negative, fewer participants in the teplizumab group than in the placebo group had diabetes diagnosed.ConclusionsTeplizumab delayed progression to clinical type 1 diabetes in high-risk ... |
| نوع الوثيقة: |
article in journal/newspaper |
| وصف الملف: |
application/pdf |
| اللغة: |
unknown |
| العلاقة: |
qt5tr3k1cf; https://escholarship.org/uc/item/5tr3k1cfTest |
| الإتاحة: |
https://escholarship.org/uc/item/5tr3k1cfTest |
| حقوق: |
public |
| رقم الانضمام: |
edsbas.7418A2F2 |
| قاعدة البيانات: |
BASE |
