Preliminary experience with alemtuzumab (Campath-1H) and low-dose tacrolimus immunosuppression in adult liver transplantation

Andreas G. Tzakis, Panagiotis Tryphonopoulos, Tomoaki Kato, Seigo Nishida, David M. Levi, Juan R. Madariaga, Jeffrey Gaynor, Werviston De Faria, Arie Regev, Violet Esquenazi, Debbie Weppler, Phillip Ruiz, Joshua Miller

Research output: Contribution to journalArticle

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Abstract

Background. The administration of alemtuzumab (Campath-1H [C1H]; Berlex Laboratories, Montville, NJ) at transplantation prevents a vigorous immune response and is believed to allow a gradual engagement of the host immune system. We report our preliminary experience with C1H and tacrolimus (Tac) immunosuppression in adult liver transplantation. Methods. We administered C1H and low-dose Tac to 40 adult recipients of cadaveric liver allografts between December 2001 and April 2003. A control group who met the same eligibility criteria consisted of 50 liver transplant recipients treated with our standard Tac and steroids protocol. Results. Baseline characteristics and patient and graft survival were similar (P>0.15). The incidence of acute rejection was significantly lower during the first 2 months posttransplantation (P=0.002) and slightly lower overall in the study group versus the control group at 12 months (46% vs. 55%, P=0.12, log-rank test). Median time to rejection among those experiencing rejection was significantly longer in the study group versus control group (2.76 vs. 0.34 months, P=0.0007). The mean Tac dose, 12-hr trough level, and percentage of patients receiving maintenance steroids were significantly lower in the group receiving C1H and Tac (P<0.0001 during the first 3 months, P<0.05 thereafter), as were the mean creatinine levels (P<0.05) and incidence of nephrotoxicity (P=0.004, conversion from Tac to other agents). Finally, in the group receiving C1H/Tac, patients with an average Tac trough level less than 6.5 ng/mL during the first 2 months posttransplantation demonstrated a significantly higher rejection rate beyond that time (P=0.02). Conclusion. C1H and low-dose Tac seems to be at least as effective as our standard Tac and steroids regimen in preventing acute rejection in adult liver allotransplantation with less renal toxicity and less use of maintenance steroids.

Original languageEnglish
Pages (from-to)1209-1214
Number of pages6
JournalTransplantation
Volume77
Issue number8
StatePublished - Apr 27 2004

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Tacrolimus
Liver Transplantation
Immunosuppression
Steroids
Control Groups
Liver
Maintenance
alemtuzumab
Incidence
Graft Survival
Allografts
Immune System
Creatinine
Transplantation
Kidney

ASJC Scopus subject areas

  • Transplantation
  • Immunology

Cite this

Tzakis, A. G., Tryphonopoulos, P., Kato, T., Nishida, S., Levi, D. M., Madariaga, J. R., ... Miller, J. (2004). Preliminary experience with alemtuzumab (Campath-1H) and low-dose tacrolimus immunosuppression in adult liver transplantation. Transplantation, 77(8), 1209-1214.

Preliminary experience with alemtuzumab (Campath-1H) and low-dose tacrolimus immunosuppression in adult liver transplantation. / Tzakis, Andreas G.; Tryphonopoulos, Panagiotis; Kato, Tomoaki; Nishida, Seigo; Levi, David M.; Madariaga, Juan R.; Gaynor, Jeffrey; De Faria, Werviston; Regev, Arie; Esquenazi, Violet; Weppler, Debbie; Ruiz, Phillip; Miller, Joshua.

In: Transplantation, Vol. 77, No. 8, 27.04.2004, p. 1209-1214.

Research output: Contribution to journalArticle

Tzakis, AG, Tryphonopoulos, P, Kato, T, Nishida, S, Levi, DM, Madariaga, JR, Gaynor, J, De Faria, W, Regev, A, Esquenazi, V, Weppler, D, Ruiz, P & Miller, J 2004, 'Preliminary experience with alemtuzumab (Campath-1H) and low-dose tacrolimus immunosuppression in adult liver transplantation', Transplantation, vol. 77, no. 8, pp. 1209-1214.
Tzakis AG, Tryphonopoulos P, Kato T, Nishida S, Levi DM, Madariaga JR et al. Preliminary experience with alemtuzumab (Campath-1H) and low-dose tacrolimus immunosuppression in adult liver transplantation. Transplantation. 2004 Apr 27;77(8):1209-1214.
Tzakis, Andreas G. ; Tryphonopoulos, Panagiotis ; Kato, Tomoaki ; Nishida, Seigo ; Levi, David M. ; Madariaga, Juan R. ; Gaynor, Jeffrey ; De Faria, Werviston ; Regev, Arie ; Esquenazi, Violet ; Weppler, Debbie ; Ruiz, Phillip ; Miller, Joshua. / Preliminary experience with alemtuzumab (Campath-1H) and low-dose tacrolimus immunosuppression in adult liver transplantation. In: Transplantation. 2004 ; Vol. 77, No. 8. pp. 1209-1214.
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abstract = "Background. The administration of alemtuzumab (Campath-1H [C1H]; Berlex Laboratories, Montville, NJ) at transplantation prevents a vigorous immune response and is believed to allow a gradual engagement of the host immune system. We report our preliminary experience with C1H and tacrolimus (Tac) immunosuppression in adult liver transplantation. Methods. We administered C1H and low-dose Tac to 40 adult recipients of cadaveric liver allografts between December 2001 and April 2003. A control group who met the same eligibility criteria consisted of 50 liver transplant recipients treated with our standard Tac and steroids protocol. Results. Baseline characteristics and patient and graft survival were similar (P>0.15). The incidence of acute rejection was significantly lower during the first 2 months posttransplantation (P=0.002) and slightly lower overall in the study group versus the control group at 12 months (46{\%} vs. 55{\%}, P=0.12, log-rank test). Median time to rejection among those experiencing rejection was significantly longer in the study group versus control group (2.76 vs. 0.34 months, P=0.0007). The mean Tac dose, 12-hr trough level, and percentage of patients receiving maintenance steroids were significantly lower in the group receiving C1H and Tac (P<0.0001 during the first 3 months, P<0.05 thereafter), as were the mean creatinine levels (P<0.05) and incidence of nephrotoxicity (P=0.004, conversion from Tac to other agents). Finally, in the group receiving C1H/Tac, patients with an average Tac trough level less than 6.5 ng/mL during the first 2 months posttransplantation demonstrated a significantly higher rejection rate beyond that time (P=0.02). Conclusion. C1H and low-dose Tac seems to be at least as effective as our standard Tac and steroids regimen in preventing acute rejection in adult liver allotransplantation with less renal toxicity and less use of maintenance steroids.",
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T1 - Preliminary experience with alemtuzumab (Campath-1H) and low-dose tacrolimus immunosuppression in adult liver transplantation

AU - Tzakis, Andreas G.

AU - Tryphonopoulos, Panagiotis

AU - Kato, Tomoaki

AU - Nishida, Seigo

AU - Levi, David M.

AU - Madariaga, Juan R.

AU - Gaynor, Jeffrey

AU - De Faria, Werviston

AU - Regev, Arie

AU - Esquenazi, Violet

AU - Weppler, Debbie

AU - Ruiz, Phillip

AU - Miller, Joshua

PY - 2004/4/27

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N2 - Background. The administration of alemtuzumab (Campath-1H [C1H]; Berlex Laboratories, Montville, NJ) at transplantation prevents a vigorous immune response and is believed to allow a gradual engagement of the host immune system. We report our preliminary experience with C1H and tacrolimus (Tac) immunosuppression in adult liver transplantation. Methods. We administered C1H and low-dose Tac to 40 adult recipients of cadaveric liver allografts between December 2001 and April 2003. A control group who met the same eligibility criteria consisted of 50 liver transplant recipients treated with our standard Tac and steroids protocol. Results. Baseline characteristics and patient and graft survival were similar (P>0.15). The incidence of acute rejection was significantly lower during the first 2 months posttransplantation (P=0.002) and slightly lower overall in the study group versus the control group at 12 months (46% vs. 55%, P=0.12, log-rank test). Median time to rejection among those experiencing rejection was significantly longer in the study group versus control group (2.76 vs. 0.34 months, P=0.0007). The mean Tac dose, 12-hr trough level, and percentage of patients receiving maintenance steroids were significantly lower in the group receiving C1H and Tac (P<0.0001 during the first 3 months, P<0.05 thereafter), as were the mean creatinine levels (P<0.05) and incidence of nephrotoxicity (P=0.004, conversion from Tac to other agents). Finally, in the group receiving C1H/Tac, patients with an average Tac trough level less than 6.5 ng/mL during the first 2 months posttransplantation demonstrated a significantly higher rejection rate beyond that time (P=0.02). Conclusion. C1H and low-dose Tac seems to be at least as effective as our standard Tac and steroids regimen in preventing acute rejection in adult liver allotransplantation with less renal toxicity and less use of maintenance steroids.

AB - Background. The administration of alemtuzumab (Campath-1H [C1H]; Berlex Laboratories, Montville, NJ) at transplantation prevents a vigorous immune response and is believed to allow a gradual engagement of the host immune system. We report our preliminary experience with C1H and tacrolimus (Tac) immunosuppression in adult liver transplantation. Methods. We administered C1H and low-dose Tac to 40 adult recipients of cadaveric liver allografts between December 2001 and April 2003. A control group who met the same eligibility criteria consisted of 50 liver transplant recipients treated with our standard Tac and steroids protocol. Results. Baseline characteristics and patient and graft survival were similar (P>0.15). The incidence of acute rejection was significantly lower during the first 2 months posttransplantation (P=0.002) and slightly lower overall in the study group versus the control group at 12 months (46% vs. 55%, P=0.12, log-rank test). Median time to rejection among those experiencing rejection was significantly longer in the study group versus control group (2.76 vs. 0.34 months, P=0.0007). The mean Tac dose, 12-hr trough level, and percentage of patients receiving maintenance steroids were significantly lower in the group receiving C1H and Tac (P<0.0001 during the first 3 months, P<0.05 thereafter), as were the mean creatinine levels (P<0.05) and incidence of nephrotoxicity (P=0.004, conversion from Tac to other agents). Finally, in the group receiving C1H/Tac, patients with an average Tac trough level less than 6.5 ng/mL during the first 2 months posttransplantation demonstrated a significantly higher rejection rate beyond that time (P=0.02). Conclusion. C1H and low-dose Tac seems to be at least as effective as our standard Tac and steroids regimen in preventing acute rejection in adult liver allotransplantation with less renal toxicity and less use of maintenance steroids.

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