Safety and tolerability of the T-cell depletion protocol coupled with anakinra and etanercept for clinical islet cell transplantation

Clinical Transplantation

Volumn 26, Issue 5, 2012, Pages

  Takita, Morihito ^a,b   Matsumoto, Shinichi ^a,b   Shimoda, Masayuki ^c   Chujo, Daisuke ^d   Itoh, Takeshi ^a   Sorelle, Jeffrey A ^e   Purcell, Kerri ^f   Onaca, Nicholas ^f   Naziruddin, Bashoo ^f   Levy, Marlon F ^f  

^a BAYLOR RESEARCH INSTITUTE   (United States)

^b UNIVERSITY OF TOKYO   (Japan)

^c BAYLOR UNIVERSITY MEDICAL CENTER   (United States)

^d BAYLOR INSTITUTE FOR IMMUNOLOGY RESEARCH   (United States)

^e BAYLOR UNIVERSITY   (United States)

^f Annette C and Harold C Simmons Transplant Institute   (United States)

Author keywords

Adverse event; Anti inflammatory agents; Antithymocyte globulin; Sirolimus; Type 1 diabetes

Indexed keywords

ALEMTUZUMAB; BASILIXIMAB; BELATACEPT; COTRIMOXAZOLE; DACLIZUMAB; DIPHENHYDRAMINE; EFALIZUMAB; ETANERCEPT; EXENDIN 4; INFLIXIMAB; LIVER ENZYME; METHYLPREDNISOLONE; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PARACETAMOL; RAPAMYCIN; RECOMBINANT INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; SITAGLIPTIN; TACROLIMUS; THYMOCYTE ANTIBODY; VALGANCICLOVIR;

ACNE; ACUTE CHOLECYSTITIS; ADULT; ALLERGIC RHINITIS; ALOPECIA; AMNESIA; ANEMIA; ANOREXIA; ANXIETY; ANXIETY DISORDER; ARTICLE; ASPIRATION PNEUMONIA; BLEEDING; BONE MARROW SUPPRESSION; CHILL; CLINICAL ARTICLE; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DEPRESSION; DIARRHEA; DIZZINESS; DRUG SAFETY; DRUG TOLERABILITY; ECZEMA; ELECTROLYTE DISTURBANCE; ERYTHEMA; FATIGUE; FEMALE; FEVER; FLUSHING; GLOMERULUS FILTRATION RATE; GRAFT RECIPIENT; GRAFT REJECTION; GYNECOLOGIC INFECTION; HEADACHE; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HUMAN; HYPERLIPIDEMIA; HYPERTENSION; HYPOPIGMENTATION; ILEUS; INSOMNIA; INSULIN DEPENDENT DIABETES MELLITUS; LARYNX PAIN; LEUKOPENIA; LIMB PAIN; LYMPHOCYTOPENIA; LYMPHOPROLIFERATIVE DISEASE; MACROALBUMINURIA; MALE; MENSTRUAL IRREGULARITY; MOUTH ULCER; MUCOSA INFLAMMATION; MUSCLE NECROSIS; NAUSEA; NEUTROPENIA; PANCREAS ISLET TRANSPLANTATION; PARESTHESIA; PARVOVIRUS INFECTION; PERCUTANEOUS CORONARY INTERVENTION; PERIPHERAL EDEMA; PNEUMOCYSTOSIS; PORTAL VEIN THROMBOSIS; PRIORITY JOURNAL; PROTEINURIA; PRURITUS; RASH; RENAL DYSFUNCTION; RIGOR; SIDE EFFECT; SKIN BRUISING; SORE THROAT; STOMATITIS; T CELL DEPLETION; THROMBOCYTOPENIA; TREMOR; UPPER RESPIRATORY TRACT INFECTION; URINARY FREQUENCY; URINARY URGENCY; VOMITING; WEIGHT GAIN; WEIGHT REDUCTION; WOUND;

ADULT; ANTIRHEUMATIC AGENTS; COHORT STUDIES; COMBINED MODALITY THERAPY; DIABETES MELLITUS, TYPE 1; FEMALE; HUMANS; IMMUNOGLOBULIN G; IMMUNOSUPPRESSION; IMMUNOSUPPRESSIVE AGENTS; INTERLEUKIN 1 RECEPTOR ANTAGONIST PROTEIN; ISLETS OF LANGERHANS TRANSPLANTATION; LYMPHOCYTE DEPLETION; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; PROGNOSIS; RECEPTORS, TUMOR NECROSIS FACTOR; T-LYMPHOCYTES;

EID: 84867621661     PISSN: 09020063     EISSN: 13990012     Source Type: Journal    
DOI: 10.1111/ctr.12011     Document Type: Article

References (63)

1. de Kort H, de Koning EJ, Rabelink TJ, Bruijn JA, Bajema IM. Islet transplantation in type 1 diabetes. BMJ 2011: 342: d217.
2. Fiorina P, Shapiro AM, Ricordi C, Secchi A. The clinical impact of islet transplantation. Am J Transplant 2008: 8: 1990.
3. Ryan EA, Paty BW, Senior PA et al. Five-year follow-up after clinical islet transplantation. Diabetes 2005: 54: 2060.
4. Bellin MD, Kandaswamy R, Parkey J et al. Prolonged insulin independence after islet allotransplants in recipients with type 1 diabetes. Am J Transplant 2008: 8: 2463.
5. Froud T, Baidal DA, Faradji R et al. Islet transplantation with alemtuzumab induction and calcineurin-free maintenance immunosuppression results in improved short- and long-term outcomes. Transplantation 2008: 86: 1695.
6. Posselt AM, Bellin MD, Tavakol M et al. Islet transplantation in type 1 diabetics using an immunosuppressive protocol based on the anti-LFA-1 antibody efalizumab. Am J Transplant 2010: 10: 1870.
7. Posselt AM, Szot GL, Frassetto LA et al. Islet transplantation in type 1 diabetic patients using calcineurin inhibitor-free immunosuppressive protocols based on T-cell adhesion or costimulation blockade. Transplantation 2010: 90: 1595.
8. Turgeon NA, Avila JG, Cano JA et al. Experience with a novel efalizumab-based immunosuppressive regimen to facilitate single donor islet cell transplantation. Am Transplant J 2010: 10: 2082.
9. Shapiro AM. State of the art of clinical islet transplantation and novel protocols of immunosuppression. Curr Diab Rep 2011: 11: 345.
10. Bellin MD, Barton FB, Heitman A et al. Potent induction immunotherapy promotes long-term insulin independence after islet transplantation in Type 1 diabetes. Am J Transplant 2012: 12: 1576.
11. Matsumoto S, Takita M, Chaussabel D et al. Improving efficacy of clinical islet transplantation with iodixanol based islet purification, thymoglobulin induction and blockage of IL-1 beta and TNF alpha. Cell Transplant 2011: 20: 1641.
12. Khan MH, Harlan DM. Counterpoint: clinical islet transplantation: not ready for prime time. Diabetes Care 2009: 32: 1570.
13. Ojo AO, Held PJ, Port FK et al. Chronic renal failure after transplantation of a nonrenal organ. N Engl J Med 2003: 349: 931.
14. Niclauss N, Bosco D, Morel P, Giovannoni L, Berney T, Parnaud G. Rapamycin impairs proliferation of transplanted islet β cells. Transplantation 2011: 91: 714.
15. Zhang N, Su D, Qu S et al. Sirolimus is associated with reduced islet engraftment and impaired beta-cell function. Diabetes 2006: 55: 2429.
16. CITR Coordinating Center; the EMMES Corporation. The seventh annual report. Rockville, MD, 2011. Retrieved from https://web.emmes.com/study/isl/reports/01062012_7thAnnualReport.pdf.
17. Matsumoto S, Noguichi H, Shimoda M et al. Seven consecutive successful clinical islet isolations with pancreatic ductal injection. Cell Transplant 2010: 19: 291.
18. Ichii H, Sakuma Y, Pileggi A et al. Shipment of human islets for transplantation. Am J Transplant 2007: 7: 1010.
19. Shapiro AM, Lakey JR, Ryan EA et al. Islet transplantation in seven patients with type 1 diabetes mellitus using a glucocorticoid-free immunosuppressive regimen. N Engl J Med 2000: 343: 230.
20. Shapiro AM, Ricordi C, Hering BJ et al. International trial of the Edmonton protocol for islet transplantation. N Engl J Med 2006: 355: 1318.
21. Collaborative Islet Transplant Registry. Terminology criteria for adverse events (TCAE) in trials of adult pancreatic islet transplantation, Version 4.0. Rockville, MD: EMMES Corporation, 2008.
22. Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D, Modification of Diet in Renal Disease Study Group. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Ann Intern Med 1999: 130: 461.
23. Ryan TA. Significance tests for multiple comparison of proportions, variances, and other statistics. Psychol Bull 1960: 57: 318.
24. Onaca N, Naziruddin B, Randall HB et al. False aneurysm of a hepatic artery branch complicating intrahepatic islet transplantation. Transpl Int 2009: 22: 663.
25. Al Knawy B, Shiffman M. Percutaneous liver biopsy in clinical practice. Liver Int 2007: 27: 1166.
26. Villiger P, Ryan EA, Owen R et al. Prevention of bleeding after islet transplantation: lessons learned from a multivariate analysis of 132 cases at a single institution. Am J Transplant 2005: 5: 2992.
27. Movahedi B, Keymeulen B, Lauwers MH, Goes E, Cools N, Delvaux G. Laparoscopic approach for human islet transplantation into a defined liver segment in type-1 diabetic patients. Transpl Int 2003: 16: 186.
28. Papalois A, Bonatsos G, Birbas C, Toutouzas K, Golematis B. Development of a laparoscopic approach for islet transplantation. Transplant Proc 1997: 29: 2099.
29. Vincenti F, Kirkman R, Light S et al., Daclizumab Triple Therapy Study Group. Interleukin-2-receptor blockade with daclizumab to prevent acute rejection in renal transplantation. N Engl J Med 1998: 338: 161.
30. Van Assche G, Sandborn WJ, Feagan BG et al. Daclizumab, a humanised monoclonal antibody to the interleukin 2 receptor (CD25), for the treatment of moderately to severely active ulcerative colitis: a randomised, double blind, placebo controlled, dose ranging trial. Gut 2006: 55: 1568.
31. Sehgal SN. Immunosuppressive profile of rapamycin. Ann N Y Acad Sci 1993: 696: 1.
32. Augustine JJ, Bodziak KA, Hricik DE. Use of sirolimus in solid organ transplantation. Drugs 2007: 67: 369.
33. Cole OJ, Shehata M, Rigg KM. Effect of SDZ RAD on transplant arteriosclerosis in the rat aortic model. Transplant Proc 1998: 30: 2200.
34. Salminen US, Alho H, Taskinen E, Maasilta P, Ikonen T, Harjula AL. Effects of rapamycin analogue SDZ RAD on obliterative lesions in a porcine heterotopic bronchial allograft model. Transplant Proc 1998: 30: 2204.
35. Gaber AO, Kahan BD, Van Buren C, Schulman SL, Scarola J, Neylan JF, Sirolimus High-Risk Study Group. Comparison of sirolimus plus tacrolimus versus sirolimus plus cyclosporine in high-risk renal allograft recipients: results from an open-label, randomized trial. Transplantation 2008: 86: 1187.
36. Kahan BD. Efficacy of sirolimus compared with azathioprine for reduction of acute renal allograft rejection: a randomised multicentre study. The Rapamune US Study Group. Lancet 2000: 356: 194.
37. Larson TS, Dean PG, Stegall MD et al. Complete avoidance of calcineurin inhibitors in renal transplantation: a randomized trial comparing sirolimus and tacrolimus. Am J Transplant 2006: 6: 514.
38. Patel SJ, Elliott EN, Knight RJ, Gaber LW, Gaber AO. Considerations in sirolimus use in the early and late post-transplant periods. Expert Opin Drug Saf 2009: 8: 421.
39. Faradji RN, Tharavanij T, Messinger S et al. Long-term insulin independence and improvement in insulin secretion after supplemental islet infusion under exenatide and etanercept. Transplantation 2008: 86: 1658.
40. Fineman MS, Shen LZ, Taylor K, Kim DD, Baron AD. Effectiveness of progressive dose-escalation of exenatide (exendin-4) in reducing dose-limiting side effects in subjects with type 2 diabetes. Diabetes Metab Res Rev 2004: 20: 411.
41. Kendall DM, Riddle MC, Rosenstock J et al. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea. Diabetes Care 2005: 28: 1083.
42. Norris SL, Lee N, Thakurta S, Chan BK. Exenatide efficacy and safety: a systematic review. Diabet Med 2009: 26: 837.
43. Kim SJ, Nian C, Doudet DJ, McIntosh CH. Inhibition of dipeptidyl peptidase IV with sitagliptin (MK0431) prolongs islet graft survival in streptozotocin-induced diabetic mice. Diabetes 2008: 57: 1331.
44. Brennan DC, Daller JA, Lake KD, Cibrik D, Del Castillo D. Thymoglobulin Induction Study Group. Rabbit antithymocyte globulin versus basiliximab in renal transplantation. N Engl J Med 2006: 355: 1967.
45. Lebranchu Y, Bridoux F, Buchler M et al. Immunoprophylaxis with basiliximab compared with antithymocyte globulin in renal transplant patients receiving MMF-containing triple therapy. Am J Transplant 2002: 2: 48.
46. Chae JJ, Aksentijevich I, Kastner DL. Advances in the understanding of familial Mediterranean fever and possibilities for targeted therapy. Br J Haematol 2009: 146: 467.
47. Roldan R, Ruiz AM, Miranda MD, Collantes E. Anakinra: new therapeutic approach in children with familial Mediterranean fever resistant to colchicine. Joint Bone Spine 2008: 75: 504.
48. Pascual V, Allantaz F, Arce E, Punaro M, Banchereau J. Role of interleukin-1 (IL-1) in the pathogenesis of systemic onset juvenile idiopathic arthritis and clinical response to IL-1 blockade. J Exp Med 2005: 201: 1479.
49. Scott BL, Ramakrishnan A, Fosdal M et al. Anti-thymocyte globulin plus etanercept as therapy for myelodysplastic syndromes (MDS): a phase II study. Br J Haematol 2010: 149: 706.
50. Cohen SB, Moreland LW, Cush JJ et al., 990145 Study Group. A multicentre, double blind, randomised, placebo controlled trial of anakinra (Kineret), a recombinant interleukin 1 receptor antagonist, in patients with rheumatoid arthritis treated with background methotrexate. Ann Rheum Dis 2004: 63: 1062.
51. Mertens M, Singh JA. Anakinra for rheumatoid arthritis: a systematic review. J Rheumatol 2009: 36: 1118.
52. Flynn JL, Chan J. Immunology of tuberculosis. Annu Rev Immunol 2001: 19: 93.
53. Garcia I, Miyazaki Y, Marchal G, Lesslauer W, Vassalli P. High sensitivity of transgenic mice expressing soluble TNFR1 fusion protein to mycobacterial infections: synergistic action of TNF and IFN-gamma in the differentiation of protective granulomas. Eur J Immunol 1997: 27: 3182.
54. Mohan AK, Coté TR, Block JA, Manadan AM, Siegel JN, Braun MM. Tuberculosis following the use of etanercept, a tumor necrosis factor inhibitor. Clin Infect Dis 2004: 39: 295.
55. Winthrop KL, Siegel JN, Jereb J, Taylor Z, Iademarco MF. Tuberculosis associated with therapy against tumor necrosis factor alpha. Arthritis Rheum 2005: 52: 2968.
56. Genovese MC, Cohen S, Moreland L et al., 20000223 Study Group. Combination therapy with etanercept and anakinra in the treatment of patients with rheumatoid arthritis who have been treated unsuccessfully with methotrexate. Arthritis Rheum 2004: 50: 1412.
57. McCall M, Pawlick R, Kin T, Shapiro AM. Anakinra potentiates the protective effects of etanercept in transplantation of marginal mass human islets in immunodeficient mice. Am J Transplant 2012: 12: 322.
58. European Mycophenolate Mofetil Cooperative Study Group. Placebo-controlled study of mycophenolate mofetil combined with cyclosporin and corticosteroids for prevention of acute rejection. Lancet 1995: 345: 1321.
59. Sollinger HW. Mycophenolate mofetil for the prevention of acute rejection in primary cadaveric renal allograft recipients. U.S. Renal Transplant Mycophenolate Mofetil Study Group. Transplantation 1995: 60: 225.
60. The Tricontinental Mycophenolate Mofetil Renal Transplantation Study Group. A blinded, randomized clinical trial of mycophenolate mofetil for the prevention of acute rejection in cadaveric renal transplantation. Transplantation 1996: 61: 1029.
61. Hering BJ, Kandaswamy R, Ansite JD et al. Single-donor, marginal-dose islet transplantation in patients with type 1 diabetes. JAMA 2005: 293: 830.
62. Froud T, Ricordi C, Baidal DA et al. Islet transplantation in type 1 diabetes mellitus using cultured islets and steroid-free immunosuppression: Miami experience. Am J Transplant 2005: 5: 2037.
63. Gangemi A, Salehi P, Hatipoglu B et al. Islet transplantation for brittle type 1 diabetes: the UIC protocol. Am J Transplant 2008: 8: 1250.