A randomized, placebo-controlled trial with anti-interleukin-2 receptor antibody for immunosuppressive induction therapy after liver transplantation

Clinical Transplantation

Volumn 12, Issue 4, 1998, Pages 303-312

  Langrehr, Jan M ^a   Glanemann, Matthias ^a   Guckelberger, Olaf ^a   Klupp, Jochen ^a   Neumann, Ulf ^a   Machens, Christine ^a   Lohmann, Rüdiger ^a   Knoop, Michael ^a   Lobeck, Hartmut ^a   Schlag, Helmut ^b   Keck, Heinrich ^a   Settmacher, Utz ^a   Bechstein, Wolf Otto ^a   Neuhaus, Peter J ^a  

^a HUMBOLDT UNIVERSITY   (Germany)

^b BIOTEST AG   (Germany)

Author keywords

Immunosuppression; Interleukin 2 receptor antibody; Liver transplantation

Indexed keywords

AZATHIOPRINE; CYCLOSPORIN A; INOLIMOMAB; INTERLEUKIN 2 RECEPTOR ANTIBODY; PREDNISOLONE;

ADOLESCENT; ADULT; AGED; ARTICLE; CHILD; CHOLANGITIS; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; CYTOMEGALOVIRUS INFECTION; FEMALE; FOLLOW UP; GRAFT SURVIVAL; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; INTRAVENOUS DRUG ADMINISTRATION; KIDNEY GRAFT REJECTION; LIVER TRANSPLANTATION; MALE; ORAL DRUG ADMINISTRATION; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEPSIS; TARGET CELL; URINARY TRACT INFECTION;

ACUTE DISEASE; ADOLESCENT; ADULT; AGED; ANTIBODIES, MONOCLONAL; AZATHIOPRINE; CHOLANGITIS; CYCLOSPORINE; CYTOMEGALOVIRUS INFECTIONS; FEMALE; FOLLOW-UP STUDIES; GRAFT REJECTION; GRAFT SURVIVAL; HUMANS; IMMUNOSUPPRESSION; IMMUNOSUPPRESSIVE AGENTS; INCIDENCE; LIVER TRANSPLANTATION; MALE; MIDDLE AGED; PLACEBOS; PNEUMONIA; PREDNISOLONE; RECEPTORS, INTERLEUKIN-2; SEPSIS; SURVIVAL RATE; URINARY TRACT INFECTIONS;

EID: 7144261070     PISSN: 09020063     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (37)

1. GULANIKAR AC, MACDONALD AS, SUNGURTEKIN B, BELITSKY P. The incidence and impact of early rejection episodes on graft outcome in recipients of first cadaver kidney transplants. Transplantation 1992: 53: 323.
2. BASADONNA GP, MATAS AJ, GILLINGHAM KJ, PAYNE WD. DUNN DL, SUTHERLAND DER, GORES PF, GRUESSNER RWG, NAJARIAN JS. Early versus late acute renal allograft rejection: impact on chronic rejection. Transplantation 1993: 55: 993.
3. KALAYOGLU M, STRATTA RJ, HOFFMANN RM, SOLLINGER HW, BELZER FO. Quadruple immunosuppressive therapy for liver transplantation. Transplant Proc 1988: 20: 524.
4. NEUHAUS P, BECHSTEIN WO, BLUMHARDT G, WIENS M, LEMMENS HP, LANGREHR JM, LOHMANN R, STEFFEN R, SCHLAG H, SLAMA KJ, LOBECK H. Comparison of quadruple immunosuppression after liver transplantation with ATG or IL-2 receptor antibody. Transplantation 1993: 55: 1320.
5. DEBETS JMH, LEUNISSEN KML, VAN HOOFF HJ, VAN DER LINDEN CJ, BUURMAN WA. Evidence of involvement of tumor necrosis factor in adverse reactions during treatment of kidney allograft rejection with anti-thymocyte globulin. Transplantation 1989: 47: 487.
6. GRINO JM, CASTELAO AM, SERÓN D, GONZALEZ C, GALCERAN JM, GIL-VERNET S, ANDRÉS E, MESTRE M, TORRAS J, ALSINA J. Anti-lymphocyte globulin versus OKT3 induction therapy in cadaveric kidney transplantation: a prospective randomized study. Am J Kid Dis 1992: 20: 603.
7. MEULDERS Q, DALLEL T, PERALDI MN, KANFER A, SRAER JD, RONDEAU E. Réduction de la libération de TNF-α et des effects cliniques de la première injection d'OKT3. Presse Méd 1992: 21: 2024.
8. SPIEKER C, BARENBROCK M, BUCHHOLZ B, HEIDENREICH S, ZIDEK W. Cardiovascular effects of ATG and OKT3 in renal allograft recipients. Transplant Proc 1992: 24: 2594.
9. BATIUK TD, BENNETT WM, NORMAN DJ. Cytokine nephropathy during anti-lymphocyte therapy. Transplant Proc 1993: 25: 27.
10. KREIS H. Adverse events associated with OKT3 immunesuppression in the prevention or treatment of allograft rejection. Clin Transplantation 1993: 7: 431.
11. LEONARD WJ, DEPPER JM, CRABTREE GR, RUDIKOFF S, PUMPHREY J, ROBB RJ, KRÖNKE M, SVETLIK PB, PEFFER NJ, WALDMANN TA, GREENE WC. Molecular cloning and expression of cDNAs for the human interleukin-2 receptor. Nature 1985: 311: 626.
12. SMITH K. Interleukin 2: inception, impact and implications. Science 1988: 240: 1169.
13. HESSE CJ, VAN GELDER T, VAESSEN LMB, KNOOP CJ, BALK AHMM, YZERMANS JNM, JUTTE NHPM, WEIMAR W. Pharmacodynamics of prophylactic antirejection therapy with an anti interleukin-2 receptor monoclonal antibody (BT563) after heart and kidney transplantation. Immunopharmacology 1995: 30: 237.
14. OTTO G, THIES J, MANNER M, HERFARTH CH, HOFMANN WJ, SCHLAG H, MEUER S. Monoclonal antibody to interleukin 2 receptor in liver graft rejection. Lancet 1990: 335: 1596.
15. OTTO G, THIES J, KRAUS TH, MANNER M, HERFARTH CH, HOFMANN WJ, SCHLAG H, MEUER S. Monoclonal anti-CD25 for acute rejection after liver transplantation. Lancet 1991: 338: 195.
16. NASHAN B, SCHLITT HJ, SCHWINZER R, RINGE B, KUSE E, TUSCH G, WONIGEIT K, PICHLMAYR R. Immunoprophylaxis with a monoclonal anti-IL-2 receptor antibody in liver transplant patients. Transplantation 1996: 61: 546.
17. LANGREHR JM, NUSSLER NC, NEUMANN U, GUCKELBERGER O, LOHMANN R, RADTKE A, JONAS S, KLUPP J, STEINMÜLLER T, LOBECK H, MEUER S, SCHLAG H, LEMMENS HP, KNOOP M, KECK H, BECHSTEIN WO, NEUHAUS P. 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 1997: 63: 1772.
18. BECHSTEIN WO, RIESS H, BLUMHARDT G, HIMMELREICH G, JOCHUM M, GERLACH H, ROSSAINT R, KECK H, NEUHAUS P. Aprotinin in orthotopic liver transplantation. Semin Thromb Hemost 1993: 19: 262.
19. 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.
20. STEFFEN R, REINHARTZ O, BLUMHARDT G, BECHSTEIN WO, RAAKOW R, LANGREHR JM, ROSSAINT R, SLAMA K, NEUHAUS P. Bacterial and fungal colonization and infections using oral selective bowel decontamination in orthotopic liver transplantations. Transplant Int 1994: 7: 101.
21. LANGREHR JM, LEMMENS HP, KECK H, LOHMANN R, KNOOP M, NEUMANN U, MULLER AR, PLATZ KP, KLING N, HOPF U, BECHSTEIN WO, BLUMHARDT G, NEUHAUS P. Liver transplantation in hepatitis B surface antigen positive patients with postoperative long-term immunoprophylaxis. Transplant Proc 1995: 27: 1215.
22. Banff schema for grading liver allograft rejection: an international consensus document. Hepatology 1997; 25: 658.
23. SCHMIDT CA, OETTLE H, PENG R, NEUHAUS P, BLUMHARDT G, LOHMANN R, WILBORN F, OSTHOFF K, OERTEL J, TIMM H, SIEGERT W. 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.
24. BUHL A, ZÖFEL P. Nichtparametrische tests. In: BUHL A, ZOFEL P, eds. SPSS für Windows, Version 6.1, 2nd edition. New York: Addison-Wesley, 1995: 209-231.
25. BÜHL A, ZÖFEL P. Kreuztabellen. In: BUHL A, ZÖFEL P, eds. SPSS für Windows, Version 6.1, 2nd edition. New York: Addison-Wesley, 1995: 267-295.
26. BAILAR III JC, MOSTELLER F. Statistical analysis of survival data. In: BAILAR III JC, MOSTELLER F, eds. Medical uses of statistics, 2nd edition Boston: NEJM Books, 1992: 281-291.
27. MUELLER AR, PLATZ KP, BECHSTEIN WO, SCHATTENFROH N, STOLTENBURG-DIDINGER G, BLUMHARDT G, CHRISTE W, NEUHAUS P. Neurotoxicity after orthotopic liver transplantation. A comparison between cyclosporine and FK506. Transplantation 1994: 58: 155.
28. HOOFNAGLE JH, LOMBARDERO M, ZETTERMAN RK, LAKE J, PORAYKO M, EVERHART J, BELLE SH, DETRE K. Donor age and outcome of liver transplantation. Hepatology 1996: 24: 89.
29. FUNG JJ, ELIASZIW M, TODO S, JAIN A, DEMETRIS AJ, MCMICHAEL JP, STARZL TE, MEIER P, DONNER A. The Pittsburgh randomized trial of tacrolimus compared to cyclosporine for hepatic transplantation. J Am Coll Surg 1996: 183: 117.
30. NORMAN DJ, LEONE MR. The role of OKT3 in clinical transplantation. Pediatr Nephrol 1991: 5: 130.
31. FREY D, MATAS A, GILLINGHAM K, CANAFAX D, PAYNE DL, DUNN DL, SUTHERLAND DER, NAJARIAN JS. Sequential therapy: a prospective randomised trial of MALG versus OKT3 for prophylactic immunosuppression in cadaver renal allograft recipients. Transplantation 1992: 54: 50.
32. SWINNEN LJ, CONSTANZO-NORDIN MR, FISHER SG, O'SULLIVAN EJ, JOHNSON MR, HEROUX AL, DIZIKES GJ, PIFARRE R, FISHER RI. Increased incidence of lymphoproliferative disorder after immunosuppression with the monoclonal antibody OKT3 in cardiac transplant recipients. N Engl J Med 1990: 323: 1723.
33. RENARD TH, ANDREWS WS, FOSTER ME. Relationship between OKT3 administration, EBV seroconversion. and the lymphproliferative syndrome in pediatric liver tansplant recipients. Transplant Proc 1991: 23: 1473.
34. FRIEND PJ, WALDMANN H, COBBOLD S, TIGHE H, REBELLO P, WIGHT D, GORE S, POLLARD S, LIM S, JOHN-STON P, WILLIAMS R, O'GRADY J, CALNE RY. The anti-IL-2 receptor monoclonal antibody YTH-906 in liver transplantation. Transplant Proc 1991: 23 (1): 1390.
35. REDING R, VRAUX H, DE-VILLE-DE-GOYET J, SOKAL E, DE-HEMPTINNE B, LATINNE D, RAHIER J, JAMART J, VINCENZOTTO C, CORMONT F, DE-LA-PARRA B, DEBRUYERE M, SOKAL G, BAZIN H, OTTE JB. Monoclonal antibodies in prophylactic immunosuppression after liver transplantation. A randomized controlled trial comparing OKT3 and anti-IL-2 receptor monoclonal antibody LOTact-1. Transplantation 1993: 55: 534.
36. UEDA H, CHEUNG YC, MASETTI P, DIACO M, MARTIN M, KUPIEC-WEGLINSKI JW, TILNEY NL. Synergy between cyclosporine and anti-IL2 receptor monoclonal antibodies in rats. Transplantation 1991: 52: 437.
37. LANGREHR JM, SCHNELLER A, GUCKELBERGER O, LOHMANN R, NEUMANN U, JONAS S, KLUPP J, SETTMACHER U, KNOOP M, BECHSTEIN WO, NEUHAUS PJ. Comparison of quadruple induction including ATG or IL-2R antibody with FK506-based therapy after liver transplantation. Transplant Proc (in press).