A prospective randomized trial comparing interleukin-2 receptor antibody versus antithymocyte globulin as part of a quadruple immunosuppressive induction therapy following orthotopic liver transplantation

Transplantation

Volumn 63, Issue 12, 1997, Pages 1772-1781

  Langrehr, Jan M ^a   Nüssler, Natascha C ^a   Neumann, Ulf ^a   Guckelberger, Olaf ^a   Lohmann, Rüdiger ^a   Radtke, Arnold ^a   Jonas, Sven ^a   Klupp, Jochen ^a   Steinmüller, Thomas ^a   Lobeck, Hartmut ^a   Meuer, Stephan ^b   Schlag, Helmut ^c   Lemmens, Hans Peter ^a   Knoop, Michael ^a   Keck, Heinrich ^a   Bechstein, Wolf O ^a   Neuhaus, Peter ^a  

^a HUMBOLDT UNIVERSITY   (Germany)

^b GERMAN CANCER RESEARCH CENTER DKFZ   (Germany)

^c BIOTEST AG   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ACICLOVIR; AZATHIOPRINE; BILIRUBIN; CEFOTAXIME; CYCLOSPORIN; DIMETINDENE; HYPERIMMUNE GLOBULIN; IMMUNOGLOBULIN 7S; INOLIMOMAB; INTERLEUKIN 2 RECEPTOR; INTERLEUKIN 2 RECEPTOR ANTIBODY; METRONIDAZOLE; MONOCLONAL ANTIBODY; NYSTATIN; POLYCLONAL ANTIBODY; POLYMYXIN B; PREDNISOLONE; RANITIDINE; STEROID; THYMOCYTE ANTIBODY; TOBRAMYCIN;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; GRAFT REJECTION; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; INFECTION; INTRAVENOUS DRUG ADMINISTRATION; LIVER TRANSPLANTATION; MAJOR CLINICAL STUDY; MALE; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SURVIVAL;

ADULT; ANIMALS; ANTIBODIES, MONOCLONAL; ANTILYMPHOCYTE SERUM; CYTOMEGALOVIRUS INFECTIONS; GRAFT REJECTION; HUMANS; IMMUNOSUPPRESSION; IMMUNOSUPPRESSIVE AGENTS; LIVER TRANSPLANTATION; MICE; PNEUMONIA; PROSPECTIVE STUDIES; RECEPTORS, INTERLEUKIN-2;

EID: 0343144798     PISSN: 00411337     EISSN: None     Source Type: Journal    
DOI: 10.1097/00007890-199706270-00012     Document Type: Article

References (66)

1. Bismuth H. The need for a consensus agreement on indications of liver transplantation. Hepatology 1994; 20: 1S.
2. Neuhaus P, Blumhardt G, Bechstein WO, et al. Comparison of FK506- and cyclosporine-based immunosuppression in primary orthotopic liver transplantation. Transplantation 1995; 59: 31.
3. Busuttil RW, Colonna JO II, Hiatt JR, et al. The first 100 liver transplants at UCLA. Ann Surg 1987; 206: 387.
4. Ascher N, Stock PG, Bumgardner GL, Payne WD, Najarian JS. Infection and rejection of primary hepatic transplant in 93 consecutive patients treated with triple immunosuppressive therapy. Surg Gynecol Obstet 1988; 167: 474.
5. O'Grady JG, Forbes A, Rolles K, Calne RY, Williams R. An analysis of cyclosporine efficacy and toxicity after liver transplantation. Transplantation 1988; 45: 575.
6. Gugenheim J, Samuel D, Saliba F, Castaing D, Bismuth H. Use of flexible triple-drug immunosuppressive therapy in liver transplantation. Transplant Proc 1987; 19: 3805.
7. Klompmaker IJ, Haagsma EB, Gouw ASH, Verwer R, Sloof MJH. Azathioprine and prednisolone immunosuppression versus maintenance triple therapy including cyclosporine for orthotopic liver transplantation. Transplantation 1989; 48: 814.
8. Starzl TE, Demetris AJ. Liver transplantation. Chicago: Year Book Medical Publishers, Inc., 1990: 1.
9. Otte JB. Recent developments in liver transplantation: lessons from a 5-year experience. J Hepatol 1991; 12: 386.
10. Deierhoi MH, Sollinger HW, Kalayoglu M, Belzer FO. Quadruple immunosuppression in 305 consecutive cadaver renal allografts. Clin Transplant 1987; 1: 71.
11. Ford HR, Fryd DS, Canafax DM, et al. Adjunctive azathioprine and antilymphocyte serum immunosuppression with cyclosporine. Transplant Proc 1988; 20: 8.
12. Stratta RJ, D'Allessandro AM, Armbrust MJ, et al. Sequential antilymphocyte globulin/cyclosporine immunosuppression in cadaveric renal transplantation: effect of duration of ALG therapy. Transplantation 1989; 47: 96.
13. Stratta RJ, Mason B, Lorentzen DF, et al. Cadaveric renal transplantation with quadruple immunosuppression in patients with a positive antiglobulin crossmatch. Transplantation 1989; 47: 282.
14. Kalayoglu M, Stratta RJ, Hoffmann RM, Sollinger HW, Belzer FO. Quadruple immunosuppressive therapy for liver transplantation. Transplant Proc 1988; 20: 524.
15. Neuhaus P, Bechstein WO, Blumhardt G, et al. Comparison of quadruple immunosuppression after liver transplantation with ATG or IL-2 receptor antibody. Transplantation 1993; 55: 1320.
16. Kormos RL, Armitage JM, Dummer JS, Miyamotot Y, Griffith BP, Hardesty RL. Optimal perioperative immunosuppressionfin cardiac transplantation using rabbit antithymocyte globulin. Transplantation 1990; 49: 306.
17. Sollinger HW, Stratta RJ, Kalayoglu M, Pirsch JD, Belzer FO. Pancreas transplantation with pancreaticocystostomy and quadruple immunosuppression. Surgery 1987; 102: 674.
18. D'Alessandro AM, Pirsch JD, Stratta RJ, et al. OKT3 salvage therapy in a quadruple immunosuppressive protocol in cadaveric renal transplantation. Transplantation 1989; 47: 297.
19. Ortho Multicenter Transplant Study Group. A randomized clinical trial of OKT3 monoclonal antibody for acute rejection of cadaveric renal transplants. N Engl J Med 1985; 313: 337.
20. Oh CS, Stratta RJ, Fox BC, Sollinger HW, Belzer FO, Maki DG. Increased infections associated with the use of OKT3 for treatment of steroid-resistant rejection in renal transplantation. Transplantation 1988; 45: 68.
21. Swinnen LJ, Constanzo-Nordin MR, Fisher SG, et al. Increased incidence of lymphoproliferative disorder after immunosuppression with the monoclonal antibody OKT3 in cardiac transplant recipients. N Engl J Med 1990; 323: 1723.
22. Millis JM, McDiarmid SV, Hiatt JR, et al. Randomized prospective trial of OKT 3 for early prophylaxis of rejection after liver transplantation. Transplantation 1989; 47: 82.
23. McDiarmid SV, Busuttil RW, Levy P, Millis MJ, Terasaki PI, Ament ME. The long-term outcome of OKT 3 compared with cyclosporine prophylaxis after liver transplantation. Transplantation 1991; 52: 91.
24. Leonard WJ, Depper JM, Crabtree GR, et al. Molecular cloning and expression of cDNAs for the human interleukin-2 receptor. Nature 1985; 311: 626.
25. Kupiec-Weglinski JW, Diamantstein T, Tilney NL. Interleukin 2 receptor-targeted therapy: rationale and applications in organ transplantation. Transplantation 1988; 46: 785.
26. Smith K. Interleukin 2: inception, impact and implications. Science 1988; 240: 1169.
27. Hesse CJ, van Gelder T, Vaessen LMB, et al. Pharmacodynamics of prophylactic antirejection therapy with an anti-interleukin-2 receptor monoclonal antibody (BT563) after heart and kidney transplantation. Immunopharmacology 1995; 30: 237.
28. Wijdenes J, Clement C, Morel-Fourrier B, Beliard R, Herve P, Peters A. A monoclonal antibody against the human IL-2 receptor with high inhibitory activity on IL-2 induced proliferation of T-cells, experimental and clinical results. In: Kaplan JG, Green DR, eds. Cellular basis of immunomodulation. New York: Alan R. Liss, 1989: 551.
29. Kirkman RL, Barrett LV, Gaulton GN, Kelley VE, Ythier A, Strom TB. Administration of an anti-interleukin 2 receptor monoclonal antibody prolongs cardiac allograft survival in mice. J Exp Med 1985; 162: 358.
30. Brown PS Jr, Parenteau GL, Dirbas FM, et al. Anti-Tac-H, a humanized antibody to the interleukin 2 receptor, prolongs primate cardiac allograft survival. Immunology 1991; 88: 2663.
31. Hervé P, Wijdenes J, Bergerat JP, Milpied N, Gaud C, Bordigoni P. Treatment of acute graft-versus-host disease with monoclonal antibody to IL-2 receptor. Lancet 1988; 2: 1072.
32. Hervé P, Wijdenes J, Bergerat JP, et al. Treatment of corticosteroid resistant acute graft-versus-host disease by in vivo administration of anti-interleukin-2 receptor antibody (B-B10). Blood 1990; 75: 1017.
33. Cuthbert RJG, Philips GL, Barnett MJ, et al. Anti-interleukin-2 receptor monoclonal antibody (BT563) in the treatment of severe acute GvHD refractory to systemic corticosteroid therapy. Bone Marrow Transplant 1992; 10: 451.
34. Cantarovich D, Le Mauff B, Hourmant M, et al. Prophylactic use of a monoclonal antibody (33B3.1) directed against interleukin 2 receptor following human renal transplantation. Am J Kidney Dis 1988; 11: 101.
35. Cantarovich D, Le Mauff B, Hourmant M, et al. Anti-interleukin 2 receptor monoclonal antibody in the treatment of ongoing acute rejection episodes of human kidney graft: a pilot study. Transplantation 1989; 47: 454.
36. Kirkman RL, Shapiro ME, Carpenter CB, et al. A randomized prospective trial of anti-Tac monoclonal antibody in human renal transplantation. Transplantation 1991; 51: 107.
37. Otto G, Thies J, Manner M, et al. Monoclonal antibody to interleukin 2 receptor in liver graft rejection. Lancet 1990; 335: 1596.
38. Otto G, Thies J, Kraus TH, et al. Monoclonal anti-CD25 for acute rejection after liver transplantation. Lancet 1991; 338: 195.
39. Friend PJ, Waldmann H, Cobbold S, et al. The anti-IL-2 receptor monoclonal antibody YTH-906 in liver transplantation. Transplant Proc 1991; 23(1): 1390.
40. Blumhardt G, Lemmens HP, Topalidis T, et al. Increased flow rate of preservation solution in the hepatic artery during organ preservation can improve postischemic liver function. Transplant Proc 1993; 25: 2540.
41. Knoop M, Schnoy N, Keck H, Neuhaus P. Morphological changes of human common bile ducts after extended cold preservation. Transplantation 1993; 56: 735.
42. Neuhaus P, Blumhardt G, Bechstein WO, Steffen R, Platz KP, Keck H. Technique and results of biliary reconstruction using side-to-side choledochocholedochostomy in 300 orthotopic liver transplants. Ann Surg 1994; 219: 426.
43. Bechstein WO, Riess H, Blumhardt G, et al. Aprotinin in orthotopic liver transplantation. Semin Thromb Hemost 1993; 19: 262.
44. Bethke U, Rohm D, Kloft M, Rudnick D, Kothe N. Development and application of media in the production of monoclonal antibodies. Dev Biol Stand 1990; 71: 55.
45. Soulillou JP, Cantarovich D, LeMauff B, et al. Randomized controlled trial of monoclonal antibody against the interleukin-2 receptor (33B3.1) as compared with rabbit anti-thymocyte globulin for prophylaxis against rejection of renal allografts. N Engl J Med 1990; 322: 1175.
46. Steffen R, Reinhartz O, Blumhardt G, et al. Bacterial and fungal colonization and infections using oral selective bowel decontamination in orthotopic liver transplantations. Transpl Int 1994; 7: 101.
47. Langrehr JM, Lemmens HP, Keck H, et al. Liver transplantation in hepatitis B surface antigen positive patients with post-operative long-term immunoprophylaxis. Transplant Proc 1995; 27: 1215.
48. Schmidt CA, Oettle H, Peng R, et al. Comparison of polymerase chain reaction from plasma and buffy coat with antigen detection and occurrence of immunoglobulin M for the demonstration of cytomegalovirus infection after liver transplantation. Transplantation 1995; 59: 1133.
49. Jonas S, Bechstein WO, Lemmens HP, Neuhaus R, Thalmann U, Neuhaus P. Liver graft-transmitted glioblastoma multiforme: a case report and experience with 13 multiorgan donors suffering from primary cerebral neoplasia. Transpl Int 1996; 9: 426.
50. European FK506 Multicentre Liver Study Group. Randomised trial comparing tacrolimus (FK506) and cyclosporin in prevention of liver allograft rejection. Lancet 1994; 344: 423.
51. Cosimi AB, Jenkins RL, Rohrer RJ, Delmonico FL, Hoffman M, Monaco AP. A randomized clinical trial of prophylactic OKT3 monoclonal antibody in liver allograft recipients. Arch Surg 1990; 125: 781.
52. Ericzon BG, Salmela K, Barkholt L, Höckerstedt K. OKT3 prophylaxis in liver transplantation: the Scandinavian experience. Transplant Proc 1990; 22: 223.
53. Steininger R, Mühlbacher F, Hamilton G, et al. Comparison of CyA, OKT3 and ATG immunoprophylaxis in human liver transplantation. Transplant Proc 1991; 23: 2269.
54. Schattenfroh N, Lange D, Bechstein WO, et al. Induction therapy with anti-T-lymphocyte globulin following orthotopic liver transplantation. Transplant Proc 1993; 25: 2702.
55. Reding R, Vraux H, de Ville de Goyet J, et al. Monoclonal antibodies in prophylactic immunosuppression after liver transplantation: a randomized controlled trial comparing OKT3 and anti-IL-2 receptor monoclonal antibody LO-Tact-1. Transplantation 1993; 55: 534.
56. Nashan B, Schutt HJ, Schwinzer R, et al. Immunoprophylaxis with a monoclonal anti-IL-2 receptor antibody in liver transplant patients. Transplantation 1996; 61: 546.
57. Taniguchi T, Minami Y. The IL-2/IL-2 receptor system: a current overview. Cell 1993; 73: 5.
58. Siegel JP, Sharon M, Smith PL, Leonard WJ. The IL-2 receptor β chain (p70): role in mediating signals for LAK, NK and proliferative activities. Science 1987; 238: 75.
59. Jankovic DL, Rebolo A, Kumar A, Bidert M, Theze J. IL-2 dependent proliferation of murine T cells requires expression of both the p55 and p70 subunits of the IL-2 receptor. J Immunol 1990; 145: 4136.
60. Herwatz C, Steinmann J, Bethke U, et al. Rejection prophylaxis with interleukin-2 receptor antibody BT563: mechanisms of action on human cells. Transpl Int 1992; 5 (suppl): S684.
61. van Gelder T, Daane CR, Vaessen LMB, et al. In vitro and in vivo effects of BT563, an anti-interleukin 2 receptor monoclonal antibody. Transpl Int 1994; 7 (suppl 1): S556.
62. van Gelder T, Zietse R, Mulder AH, et al. A double-blind, placebo-controlled study of monoclonal anti-interleukin-2 receptor antibody (BT563) administration to prevent acute rejection after kidney transplantation. Transplantation 1995; 60: 248.
63. Grino JM, Castelao AM, Serón D, et al. Antilymphocyte globulin versus OKT3 induction therapy in cadaveric kidney transplantation: a prospective randomized study. Am J Kidney Dis 1992; 20: 603.
64. Kreis H. Adverse events associated with OKT3 immunosuppression in the prevention or treatment of allograft rejection. Clin Transplant 1993; 7: 431.
65. Penn I. Occurrence of cancers in immunosuppressed organ transplant recipients. In: Terasaki PI, ed. Clinical transplant 1990. Los Angeles: UCLA Tissue Typing Laboratory, 1991: 53.
66. Hardy MA, Benvenisty AI, Cohen D, Barr M, Rose E, Suciu-Foca N. Incidence of malignancies in renal and cardiac transplant recipients in relation to treatment with biologic agents. Clin Transplant 1992; 6 (special issue): 269.