Developing combination immunotherapies for type 1 diabetes: Recommendations from the ITN-JDRF Type 1 Diabetes Combination Therapy Assessment Group

Clinical and Experimental Immunology

Volumn 160, Issue 2, 2010, Pages 176-184

  Matthews, J B ^a   Staeva, T P ^b   Bernstein, P L ^a   Peakman, M ^d,e   Von Herrath, M ^c  

^a Immune Tolerance Network   (United States)

^b Juvenile Diabetes Research Foundation International   (United States)

^c LA JOLLA INSTITUTE FOR ALLERGY AND IMMUNOLOGY   (United States)

^d KING'S COLLEGE LONDON   (United Kingdom)

^e GUY'S AND ST THOMAS' NHS FOUNDATION TRUST   (United Kingdom)

Author keywords

Clinical trials; Combination therapies; Interventions; Type 1 diabetes

Indexed keywords

ABATACEPT; BHT 3021; CD20 ANTIBODY; DACLIZUMAB; DIAMYD; ETANERCEPT; EXENDIN 4; GLUTAMATE DECARBOXYLASE 65; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; INSULIN; MONOCLONAL ANTIBODY CD3; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; OTELIXIZUMAB; PROINSULIN; RAPAMYCIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RECOMBINANT INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; RECOMBINANT INTERLEUKIN 2; REGENERON; RILONACEPT; RITUXIMAB; TEPLIZUMAB; THYMOCYTE ANTIBODY; TOLER X; TUMOR NECROSIS FACTOR ALPHA ANTIBODY; UNCLASSIFIED DRUG;

AUTOIMMUNITY; CLINICAL PROTOCOL; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; DIABETES MELLITUS; DISEASE MARKER; DRUG EFFICACY; DRUG SAFETY; HUMAN; IMMUNOLOGICAL TOLERANCE; IMMUNOMODULATION; IMMUNOTHERAPY; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN TREATMENT; NONHUMAN; PRIORITY JOURNAL; REVIEW;

ANIMALS; ANTIGEN PRESENTATION; AUTOANTIBODIES; CLINICAL PROTOCOLS; CLINICAL TRIALS AS TOPIC; COMBINED MODALITY THERAPY; DIABETES MELLITUS, TYPE 1; DRUG APPROVAL; DRUG DESIGN; DRUG EVALUATION, PRECLINICAL; DRUG THERAPY, COMBINATION; DRUGS, INVESTIGATIONAL; HUMANS; HYPOGLYCEMIC AGENTS; IMMUNOLOGIC FACTORS; IMMUNOSUPPRESSIVE AGENTS; IMMUNOTHERAPY; ISLETS OF LANGERHANS; LYMPHOCYTE ACTIVATION; LYMPHOCYTE SUBSETS; MICE; MICE, INBRED NOD; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77950649733     PISSN: 00099104     EISSN: 13652249     Source Type: Journal    
DOI: 10.1111/j.1365-2249.2010.04153.x     Document Type: Review

References (31)

1. Bekris LM, Kavanagh TJ, Lernmark A. Targeting type 1 diabetes before and at the clinical onset of disease. Endocr Metab Immune Disord Drug Targets 2006 6 : 103 124.
2. Karlsson FA, Berne C, Bjork E et al. Beta-cell activity and destruction in type 1 diabetes. Ups J Med Sci 2000 105 : 85 95.
3. Meier JJ, Bhushan A, Butler AE, Rizza RA, Butler PC. Sustained beta cell apoptosis in patients with long-standing type 1 diabetes: indirect evidence for islet regeneration? Diabetologia 2005 48 : 2221 2228.
4. Stiller CR, Dupre J, Gent M et al. Effects of cyclosporine immunosuppression in insulin-dependent diabetes mellitus of recent onset. Science 1984 223 : 1362 1367.
5. 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 1698.
6. 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 2608. (Pubitemid 41007846)
7. Bougneres PF, Carel JC, Castano L et al. Factors associated with early remission of type I diabetes in children treated with cyclosporine. N Engl J Med 1988 318 : 663 670.
8. Bougneres PF, Landais P, Boisson C et al. Limited duration of remission of insulin dependency in children with recent overt type I diabetes treated with low-dose cyclosporin. Diabetes 1990 39 : 1264 1272.
9. Cook JJ, Hudson I, Harrison LC et al. Double-blind controlled trial of azathioprine in children with newly diagnosed type I diabetes. Diabetes 1989 38 : 779 783.
10. Dantal J, Soulillou JP. Immunosuppressive drugs and the risk of cancer after organ transplantation. N Engl J Med 2005 352 : 1371 1373.
11. Herold KC, Gitelman SE, Masharani U et al. A single course of anti-CD3 monoclonal antibody hOKT3gamma1(Ala-Ala) results in improvement in C-peptide responses and clinical parameters for at least 2 years after onset of type 1 diabetes. Diabetes 2005 54 : 1763 1769.
12. Pescovitz MD, Greenbaum CJ, Krause-Steinrauf H et al. Rituximab, B-lymphocyte depletion, and preservation of beta-cell function. N Engl J Med 2009 361 : 2143 2152.
13. Herold KC, Gitelman S, Greenbaum C et al. Treatment of patients with new onset Type 1 diabetes with a single course of anti-CD3 mAb Teplizumab preserves insulin production for up to 5 years. Clin Immunol 2009 132 : 166 173.
14. Willcox A, Richardson SJ, Bone AJ, Foulis AK, Morgan NG. Analysis of islet inflammation in human type 1 diabetes. Clin Exp Immunol 2009 155 : 173 181.
15. Spencer J, Peakman M. Post-mortem analysis of islet pathology in type 1 diabetes illuminates the life and death of the beta cell. Clin Exp Immunol 2009 155 : 125 127.
16. Thrower SL, James L, Hall W et al. Proinsulin peptide immunotherapy in type 1 diabetes: report of a first-in-man Phase I safety study. Clin Exp Immunol 2009 155 : 156 165.
17. Staeva-Vieira T, Peakman M, von Herrath M. Translational mini-review series on type 1 diabetes: immune-based therapeutic approaches for type 1 diabetes. Clin Exp Immunol 2007 148 : 17 31. (Pubitemid 46364996)
18. Rother KI, Spain LM, Wesley RA et al. Effects of exenatide alone and in combination with daclizumab on beta-cell function in long-standing type 1 diabetes. Diabetes Care 2009 32 : 2251 2257.
19. Gottlieb PA, Quinlan S, Krause-Steinrauf H et al., for the Type 1 Diabetes TrialNet MMF/DZB Study Group. Failure to preserve beta-cell function with mycophenolate mofetil and daclizumab combined therapy in patients with new onset type 1 diabetes. Diabetes Care 2010 Jan 12. [Epub ahead of print] PMID: 20067954.
20. Rabinovitch A, Suarez-Pinzon WL, Shapiro AM, Rajotte RV, Power R. Combination therapy with sirolimus and interleukin-2 prevents spontaneous and recurrent autoimmune diabetes in NOD mice. Diabetes 2002 51 : 638 645.
21. Ludvigsson J, Faresjo M, Hjorth M et al. GAD treatment and insulin secretion in recent-onset type 1 diabetes. N Engl J Med 2008 359 : 1909 1920.
22. Greenbaum CJ, Harrison LC. Guidelines for intervention trials in subjects with newly diagnosed type 1 diabetes. Diabetes 2003 52 : 1059 1065.
23. Asare AL, Kolchinsky SA, Gao Z et al. Differential gene expression profiles are dependent upon method of peripheral blood collection and RNA isolation. BMC Genomics 2008 9 : 474.
24. Herold KC, Brooks-Worrell B, Palmer J et al. Validity and reproducibility of measurement of islet autoreactivity by T-cell assays in subjects with early type 1 diabetes. Diabetes 2009 58 : 2588 2595.
25. Roep BO. Are insights gained from NOD mice sufficient to guide clinical translation? Another inconvenient truth. Ann NY Acad Sci 2007 1103 : 1 10.
26. Roep BO, Peakman M. Surrogate end points in the design of immunotherapy trials: emerging lessons from type 1 diabetes. Nat Rev Immunol 2010 10 : 145 152.
27. National Institutes of Health (NIH). RFA-OD-10-010 - Recovery Act Limited Competition: Research on Biosamples from Selected Diabetes Clinical Studies (RC4), Bethesda (MD), 2010.
28. Juvenile Diabetes Research Foundation International. JDRF Autoimmunity Centers Consortium (ACC). New York, 2010. Available at: http://www.jdrf.org/ index.cfm?page-id=111042 (accessed D, Togher L, Rodrigo E et al. Anti-CD3 and nasal proinsulin combination therapy enhances remission from recent-onset autoimmune diabetes by inducing Tregs. J Clin Invest 2006 116 : 1371 1381.
29. Bresson D, Fradkin M, Manenkova Y, Rottembourg D, von Herrath M. Genetic-induced variations in the GAD65 T-cell repertoire governs efficacy of anti-CD3/GAD65 combination therapy in new-onset type 1 diabetes. Mol Ther 2009 18 : 18.
30. Sherry NA, Chen W, Kushner JA et al. Exendin-4 improves reversal of diabetes in NOD mice treated with anti-CD3 monoclonal antibody by enhancing recovery of beta-cells. Endocrinology 2007 148 : 5136 5144.
31. von Herrath M, Chan A. How can we improve the translational landscape for a faster cure of type 1 diabetes? J Clin Invest 2009 119 : 1061 1065.