Erratum: An anti-CD3 antibody, teplizumab, in relatives at risk for type 1 diabetes (New England Journal of Medicine (2019) 381 (603-613) DOI: 10.1056/NEJMoa1902226);An anti-CD3 antibody, teplizumab, in relatives at risk for type 1 diabetes

New England Journal of Medicine

Volumn 381, Issue 7, 2019, Pages 603-613

  Herold, Kevan C ^a   Bundy, Brian N ^b   Alice Long, S ^c   Bluestone, Jeffrey A ^d   DiMeglio, Linda A ^e   Dufort, Matthew J ^f   Gitelman, Stephen E ^g   Gottlieb, Peter A ^h   Krischer, Jeffrey P ⁱ   Linsley, Peter S ^j   Marks, Jennifer B ^k   Moore, Wayne ^l   Moran, Antoinette ^m   Rodriguez, Henry ⁿ   Russell, William E ^a   Schatz, Desmond ^b   Skyler, Jay S ^c   Tsalikian, Eva ^d   Wherrett, Diane K ^d   Ziegler, Anette Gabriele ^f   Greenbaum, Carla J ^a   more..

^a YALE UNIVERSITY   (United States)

^b UNIVERSITY OF SOUTH FLORIDA   (United States)

^c UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

^d UNIVERSITY OF FLORIDA COLLEGE OF MEDICINE   (United States)

^e BENAROYA RESEARCH INSTITUTE   (United States)

^f UNIVERSITY OF CALIFORNIA   (United States)

^g INDIANA UNIVERSITY   (United States)

^h UNIVERSITY OF COLORADO DENVER   (United States)

ⁱ CHILDREN S MERCY HOSPITAL   (United States)

^j UNIVERSITY OF MINNESOTA   (United States)

^k VANDERBILT UNIVERSITY   (United States)

^l UNIVERSITY OF IOWA   (United States)

^m HOSPITAL FOR SICK CHILDREN   (Canada)

ⁿ TECHNICAL UNIVERSITY OF MUNICH   (Germany)

more..

Author keywords

[No Author keywords available]

Indexed keywords

GLUCOSE; PLACEBO; TEPLIZUMAB; CD3 ANTIGEN; HLA DR3 ANTIGEN; HLA DR4 ANTIGEN; MONOCLONAL ANTIBODY;

ADOLESCENT; ADULT; ALLERGY; ARTICLE; BLEEDING; BONE MARROW DISEASE; CHILD; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; ENDOCRINE DISEASE; EYE DISEASE; FEMALE; FOLLOW UP; GASTROINTESTINAL DISEASE; HEART DISEASE; HEMATOLOGIC DISEASE; HEPATOBILIARY DISEASE; HIGH RISK POPULATION; HUMAN; HUMAN EXPERIMENT; IMMUNOPATHOLOGY; INFECTION; INSULIN DEPENDENT DIABETES MELLITUS; LUNG DISEASE; MALE; METABOLIC DISORDER; MULTICENTER STUDY; MUSCULOSKELETAL DISEASE; NEUROLOGIC DISEASE; NORMAL HUMAN; ORAL GLUCOSE TOLERANCE TEST; PAIN; PANCREAS DISEASE; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROPHYLAXIS; RANDOMIZED CONTROLLED TRIAL; RELATIVE; SKIN DISEASE; SOFT TISSUE DISEASE; SYNDROME; VASCULAR DISEASE; ANTAGONISTS AND INHIBITORS; CHEMICALLY INDUCED; CLINICAL TRIAL; DISEASE EXACERBATION; GENETICS; GLUCOSE TOLERANCE TEST; IMMUNOLOGY; LYMPHOCYTE COUNT; LYMPHOCYTOPENIA; MIDDLE AGED; PROPORTIONAL HAZARDS MODEL; RASH; T LYMPHOCYTE; YOUNG ADULT;

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; T-LYMPHOCYTES; YOUNG ADULT;

EID: 85070816928     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMx190033     Document Type: Erratum

References (36)

1. Menke A, Orchard TJ, Imperatore G, Bullard KM, Mayer-Davis E, Cowie CC. The prevalence of type 1 diabetes in the United States. Epidemiology 2013; 24: 773-4.
2. Miller KM, Foster NC, Beck RW, et al. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care 2015; 38: 971-8.
3. Livingstone SJ, Levin D, Looker HC, et al. Estimated life expectancy in a Scottish cohort with type 1 diabetes, 2008-2010. JAMA 2015; 313: 37-44.
4. Rawshani A, Sattar N, Franzen S, et al. Excess mortality and cardiovascular disease in young adults with type 1 diabetes in relation to age at onset: a nationwide, register-based cohort study. Lancet 2018; 392: 477-86.
5. Insel RA, Dunne JL, Atkinson MA, et al. Staging presymptomatic type 1 diabetes: a scientific statement of JDRF, the Endocrine Society, and the American Diabetes Association. Diabetes Care 2015; 38: 1964-74.
6. Atkinson MA, Roep BO, Posgai A, Wheeler DCS, Peakman M. The challenge of modulating ?-cell autoimmunity in type 1 diabetes. Lancet Diabetes Endocrinol 2019; 7: 52-64.
7. Herold KC, Gitelman SE, Ehlers MR, et al. Teplizumab (anti-CD3 mAb) treatment preserves C-peptide responses in patients with new-onset type 1 diabetes in a randomized controlled trial: metabolic and immunologic features at baseline identify a subgroup of responders. Diabetes 2013; 62: 3766-74.
8. Herold KC, Hagopian W, Auger JA, et al. Anti-CD3 monoclonal antibody in new-onset type 1 diabetes mellitus. N Engl J Med 2002; 346: 1692-8.
9. Keymeulen B, Vandemeulebroucke E, Ziegler AG, et al. Insulin needs after CD3-antibody therapy in new-onset type 1 diabetes. N Engl J Med 2005; 352: 2598-608.
10. Hagopian W, Ferry RJ Jr, Sherry N, et al. Teplizumab preserves C-peptide in recentonset type 1 diabetes: two-year results from the randomized, placebo-controlled Protege trial. Diabetes 2013; 62: 3901-8.
11. Sherry N, Hagopian W, Ludvigsson J, et al. Teplizumab for treatment of type 1 diabetes (Protege study): 1-year results from a randomised, placebo-controlled trial. Lancet 2011; 378: 487-97.
12. Tooley JE, Vudattu N, Choi J, et al. Changes in T-cell subsets identify responders to FcR-nonbinding anti-CD3 mAb (teplizumab) in patients with type 1 diabetes. Eur J Immunol 2016; 46: 230-41.
13. Long SA, Thorpe J, DeBerg HA, et al. Partial exhaustion of CD8 T cells and clinical response to teplizumab in newonset type 1 diabetes. Sci Immunol 2016; 1(5): eaai7793.
14. Bingley PJ, Wherrett DK, Shultz A, Rafkin LE, Atkinson MA, Greenbaum CJ. Type 1 Diabetes TrialNet: a multifaceted approach to bringing disease-modifying therapy to clinical use in type 1 diabetes. Diabetes Care 2018; 41: 653-61.
15. American Diabetes Association. Classification and diagnosis of diabetes: Standards of Medical Care in Diabetes-2019. Diabetes Care 2019; 42: Suppl 1: S13-S28.
16. Diabetes Prevention Trial-Type 1 Diabetes Study Group. Effects of insulin in relatives of patients with type 1 diabetes mellitus. N Engl J Med 2002; 346: 1685-91.
17. Therneau TM, Grambsch PM. Modeling survival data: extending the Cox Model. New York: Springer-Verlag, 2000.
18. Cox DR. Regression model and lifetables. J R Stat Soc [B] 1972; 34: 187-220.
19. Schoenfeld DA. Sample-size formula for the proportional-hazards regression model. Biometrics 1983; 39: 499-503.
20. Lan KKG, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika 1983; 70: 659-63.
21. Junker AK, Chan KW, Lirenman DS. Epstein-Barr virus infections following OKT3 treatment. Transplantation 1989; 47: 574-5.
22. Keymeulen B, Candon S, Fafi-Kremer S, et al. Transient Epstein-Barr virus reactivation in CD3 monoclonal antibodytreated patients. Blood 2010; 115: 1145-55.
23. Perdigoto AL, Preston-Hurlburt P, Clark P, et al. Treatment of type 1 diabetes with teplizumab: clinical and immunological follow-up after 7 years from diagnosis. Diabetologia 2019; 62: 655-64.
24. Herold KC, Burton JB, Francois F, Poumian-Ruiz E, Glandt M, Bluestone JA. Activation of human T cells by FcR nonbinding anti-CD3 mAb, hOKT3gamma1(Ala-Ala). J Clin Invest 2003; 111: 409-18.
25. Herold KC, Vignali DA, Cooke A, Bluestone JA. Type 1 diabetes: translating mechanistic observations into effective clinical outcomes. Nat Rev Immunol 2013; 13: 243-56.
26. Greenbaum CJ, Beam CA, Boulware D, et al. Fall in C-peptide during first 2 years from diagnosis: evidence of at least two distinct phases from composite Type 1 Diabetes TrialNet data. Diabetes 2012; 61: 2066-73.
27. Wherrett DK, Chiang JL, Delamater AM, et al. Defining pathways for development of disease-modifying therapies in children with type 1 diabetes: a consensus report. Diabetes Care 2015; 38: 1975-85.
28. Herold KC, Usmani-Brown S, Ghazi T, et al. ? Cell death and dysfunction during type 1 diabetes development in at-risk individuals. J Clin Invest 2015; 125: 1163-73.
29. Chatenoud L, Thervet E, Primo J, Bach JF. Anti-CD3 antibody induces long-term remission of overt autoimmunity in nonobese diabetic mice. Proc Natl Acad Sci U S A 1994; 91: 123-7.
30. Chatenoud L, Primo J, Bach JF. CD3 antibody-induced dominant self tolerance in overtly diabetic NOD mice. J Immunol 1997; 158: 2947-54.
31. Esplugues E, Huber S, Gagliani N, et al. Control of TH17 cells occurs in the small intestine. Nature 2011; 475: 514-8.
32. Waldron-Lynch F, Henegariu O, Deng S, et al. Teplizumab induces human guttropic regulatory cells in humanized mice and patients. Sci Transl Med 2012; 4: 118ra12.
33. Wherry EJ. T cell exhaustion. Nat Immunol 2011; 12: 492-9.
34. Wherry EJ, Ha SJ, Kaech SM, et al. Molecular signature of CD8+ T cell exhaustion during chronic viral infection. Immunity 2007; 27: 670-84.
35. McKinney EF, Lee JC, Jayne DR, Lyons PA, Smith KG. T-cell exhaustion, co-stimulation and clinical outcome in autoimmunity and infection. Nature 2015; 523: 612-6.
36. Long SA, Thorpe J, Herold KC, et al. Remodeling T cell compartments during anti-CD3 immunotherapy of type 1 diabetes. Cell Immunol 2017; 319: 3-9.