Clinical impact of replacing Minnesota antilymphocyte globulin with ATGAM

In August 1992, we replaced Minnesota antilymphocyte globulin (MALG) with lymphocyte immune globulin, antithymocyte globulin (equine) (ATGAM) in our immunosuppression protocols. The clinical impression of increased graft rejection prompted our assessment of the effect of this change on patient and g...

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Veröffentlicht in:Transplantation 1995-02, Vol.59 (3), p.371-376
Hauptverfasser: LUM, C. T, UMEN, A. J, PAVEL, D, KASISKE, B, GOERDT, P, HEIM-DUTHOY, K. L, ANDERSEN, R. C, ODLAND, M. D, NEY, A. L, JACOBS, D. M, VENKATESWARA RAO, K
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container_end_page 376
container_issue 3
container_start_page 371
container_title Transplantation
container_volume 59
creator LUM, C. T
UMEN, A. J
PAVEL, D
KASISKE, B
GOERDT, P
HEIM-DUTHOY, K. L
ANDERSEN, R. C
ODLAND, M. D
NEY, A. L
JACOBS, D. M
VENKATESWARA RAO, K
description In August 1992, we replaced Minnesota antilymphocyte globulin (MALG) with lymphocyte immune globulin, antithymocyte globulin (equine) (ATGAM) in our immunosuppression protocols. The clinical impression of increased graft rejection prompted our assessment of the effect of this change on patient and graft outcome. The initial study group consisted of 426 renal transplant recipients transplanted between October 1, 1987, and September 21, 1993. After exclusions, 388 transplant events, with a minimum 8-month follow-up, made up the final study cohort: 323 patients received MALG and 65 received ATGAM. Immunosuppression included intravenous methylprednisolone, oral prednisone, oral AZA, CsA in some cases, and intravenous MALG or ATGAM, 15 mg/kg/day, for 7 to 14 days. Acute rejection was treated with high dose intravenous steroids and steroid-resistant episodes were treated additionally with either MALG or OKT3. Statistical comparisons were stratified for multiple patient characteristics and treatment variations. There was a greater incidence of rejection in general, and a higher incidence of steroid-resistant episodes requiring subsequent antilymphocyte globulin therapy (P = 0.0073) in patients receiving ATGAM versus MALG. No difference was seen in the incidence of CMV infection or blood-borne sepsis. Lymphoma occurred in 3 MALG and 2 ATGAM recipients. MALG recipients were significantly less likely to experience rejection within the first 60 days after transplant (P = 0.0127 using unstratified data; P < 0.0001 when data were stratified for patient characteristics). The relative risk of acute rejection for posttransplant days 5, 7, 10, and 14 was consistently higher for ATGAM-treated patients. We conclude that MALG and ATGAM are not equivalent drugs, and that MALG is a more effective immunosuppressant, and is just as safe as ATGAM in our protocol environment.
doi_str_mv 10.1097/00007890-199502000-00012
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T ; UMEN, A. J ; PAVEL, D ; KASISKE, B ; GOERDT, P ; HEIM-DUTHOY, K. L ; ANDERSEN, R. C ; ODLAND, M. D ; NEY, A. L ; JACOBS, D. M ; VENKATESWARA RAO, K</creator><creatorcontrib>LUM, C. T ; UMEN, A. J ; PAVEL, D ; KASISKE, B ; GOERDT, P ; HEIM-DUTHOY, K. L ; ANDERSEN, R. C ; ODLAND, M. D ; NEY, A. L ; JACOBS, D. M ; VENKATESWARA RAO, K</creatorcontrib><description>In August 1992, we replaced Minnesota antilymphocyte globulin (MALG) with lymphocyte immune globulin, antithymocyte globulin (equine) (ATGAM) in our immunosuppression protocols. The clinical impression of increased graft rejection prompted our assessment of the effect of this change on patient and graft outcome. The initial study group consisted of 426 renal transplant recipients transplanted between October 1, 1987, and September 21, 1993. After exclusions, 388 transplant events, with a minimum 8-month follow-up, made up the final study cohort: 323 patients received MALG and 65 received ATGAM. Immunosuppression included intravenous methylprednisolone, oral prednisone, oral AZA, CsA in some cases, and intravenous MALG or ATGAM, 15 mg/kg/day, for 7 to 14 days. Acute rejection was treated with high dose intravenous steroids and steroid-resistant episodes were treated additionally with either MALG or OKT3. Statistical comparisons were stratified for multiple patient characteristics and treatment variations. There was a greater incidence of rejection in general, and a higher incidence of steroid-resistant episodes requiring subsequent antilymphocyte globulin therapy (P = 0.0073) in patients receiving ATGAM versus MALG. No difference was seen in the incidence of CMV infection or blood-borne sepsis. Lymphoma occurred in 3 MALG and 2 ATGAM recipients. MALG recipients were significantly less likely to experience rejection within the first 60 days after transplant (P = 0.0127 using unstratified data; P &lt; 0.0001 when data were stratified for patient characteristics). The relative risk of acute rejection for posttransplant days 5, 7, 10, and 14 was consistently higher for ATGAM-treated patients. We conclude that MALG and ATGAM are not equivalent drugs, and that MALG is a more effective immunosuppressant, and is just as safe as ATGAM in our protocol environment.</description><identifier>ISSN: 0041-1337</identifier><identifier>EISSN: 1534-6080</identifier><identifier>DOI: 10.1097/00007890-199502000-00012</identifier><identifier>PMID: 7871567</identifier><identifier>CODEN: TRPLAU</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott</publisher><subject>Adult ; Antilymphocyte Serum - administration &amp; dosage ; Antilymphocyte Serum - adverse effects ; Biological and medical sciences ; Drug Administration Schedule ; Follow-Up Studies ; Graft Rejection - prevention &amp; control ; Humans ; Injections, Intravenous ; Kidney Transplantation ; Medical sciences ; Retrospective Studies ; Surgery (general aspects). 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T</creatorcontrib><creatorcontrib>UMEN, A. J</creatorcontrib><creatorcontrib>PAVEL, D</creatorcontrib><creatorcontrib>KASISKE, B</creatorcontrib><creatorcontrib>GOERDT, P</creatorcontrib><creatorcontrib>HEIM-DUTHOY, K. L</creatorcontrib><creatorcontrib>ANDERSEN, R. C</creatorcontrib><creatorcontrib>ODLAND, M. D</creatorcontrib><creatorcontrib>NEY, A. L</creatorcontrib><creatorcontrib>JACOBS, D. M</creatorcontrib><creatorcontrib>VENKATESWARA RAO, K</creatorcontrib><title>Clinical impact of replacing Minnesota antilymphocyte globulin with ATGAM</title><title>Transplantation</title><addtitle>Transplantation</addtitle><description>In August 1992, we replaced Minnesota antilymphocyte globulin (MALG) with lymphocyte immune globulin, antithymocyte globulin (equine) (ATGAM) in our immunosuppression protocols. The clinical impression of increased graft rejection prompted our assessment of the effect of this change on patient and graft outcome. The initial study group consisted of 426 renal transplant recipients transplanted between October 1, 1987, and September 21, 1993. After exclusions, 388 transplant events, with a minimum 8-month follow-up, made up the final study cohort: 323 patients received MALG and 65 received ATGAM. Immunosuppression included intravenous methylprednisolone, oral prednisone, oral AZA, CsA in some cases, and intravenous MALG or ATGAM, 15 mg/kg/day, for 7 to 14 days. Acute rejection was treated with high dose intravenous steroids and steroid-resistant episodes were treated additionally with either MALG or OKT3. Statistical comparisons were stratified for multiple patient characteristics and treatment variations. There was a greater incidence of rejection in general, and a higher incidence of steroid-resistant episodes requiring subsequent antilymphocyte globulin therapy (P = 0.0073) in patients receiving ATGAM versus MALG. No difference was seen in the incidence of CMV infection or blood-borne sepsis. Lymphoma occurred in 3 MALG and 2 ATGAM recipients. MALG recipients were significantly less likely to experience rejection within the first 60 days after transplant (P = 0.0127 using unstratified data; P &lt; 0.0001 when data were stratified for patient characteristics). The relative risk of acute rejection for posttransplant days 5, 7, 10, and 14 was consistently higher for ATGAM-treated patients. 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M</au><au>VENKATESWARA RAO, K</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinical impact of replacing Minnesota antilymphocyte globulin with ATGAM</atitle><jtitle>Transplantation</jtitle><addtitle>Transplantation</addtitle><date>1995-02-15</date><risdate>1995</risdate><volume>59</volume><issue>3</issue><spage>371</spage><epage>376</epage><pages>371-376</pages><issn>0041-1337</issn><eissn>1534-6080</eissn><coden>TRPLAU</coden><abstract>In August 1992, we replaced Minnesota antilymphocyte globulin (MALG) with lymphocyte immune globulin, antithymocyte globulin (equine) (ATGAM) in our immunosuppression protocols. The clinical impression of increased graft rejection prompted our assessment of the effect of this change on patient and graft outcome. The initial study group consisted of 426 renal transplant recipients transplanted between October 1, 1987, and September 21, 1993. 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subjects Adult
Antilymphocyte Serum - administration & dosage
Antilymphocyte Serum - adverse effects
Biological and medical sciences
Drug Administration Schedule
Follow-Up Studies
Graft Rejection - prevention & control
Humans
Injections, Intravenous
Kidney Transplantation
Medical sciences
Retrospective Studies
Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases
Surgery of the urinary system
title Clinical impact of replacing Minnesota antilymphocyte globulin with ATGAM
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