Comparison of Quadruple Immunosuppression After Liver Transplantation With Atg or Il-2 Receptor Antibody

Neuhaus, P.; Bechstein, Wolf O.; Blumhardt, G.; Wiens, Matthias; Lemmens, P.; Langrehr, Jan M.; Lohmann, R; Steffen, Robert P.; H, Schlag; Slama, K J

doi:10.1097/00007890-199306000-00021

Cited by 119 publications

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“…11 The selective immunosuppressive effects of murine anti-CD25 mAbs have been shown in transplantation studies to be effective in preventing acute rejection episodes while being associated with fewer infections and side effects compared with antithymocyte globulin. [12][13][14][15] The immunosuppressive effects of anti-CD25 mAbs also are enhanced by the widely used cyclosporine. 16 The use of murine anti-CD25 mAbs is limited by the rapid development of neutralizing antibodies to the heterologous murine immunoglobulin in up to 80% of transplant recipients.…”

mentioning

confidence: 99%

“…20,21 To date, the use of anti-CD25 mAbs in liver transplantation has been confined to a few pilot studies, which lacked sufficient statistical power to determine efficacy. [12][13][14] The phase III study described here represents the first large-scale trial to investigate the prophylactic use of the anti-CD25 antibody basiliximab in liver transplantation. The primary aim of the study is to evaluate the efficacy of basiliximab in the prevention of acute rejection episodes during the first 6 months after transplantation in patients receiving a primary cadaveric liver transplant.…”

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confidence: 99%

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Improved treatment response with basiliximab immunoprophylaxis after liver transplantation: Results from a double-blind randomized placebo-controlled trial

Neuhaus¹,

Clavien

Kittur

et al. 2002

Liver Transplantation

179

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for the CHIC 304 International Liver Study GroupBasiliximab, a high-affinity chimeric monoclonal antibody, is effective in reducing acute rejection episodes in renal allograft recipients. We assessed the ability of this antibody to similarly improve the outcome in liver transplant recipients. Adult recipients of a primary cadaveric liver transplant were randomized to treatment, stratified by hepatitis C virus (HCV) seropositivity. Patients were administered 40 mg of basiliximab (n ‫؍‬ 188) or placebo (n ‫؍‬ 193) as two 20-mg bolus injections days 0 and 4, plus cyclosporine and steroids. Primary efficacy variables were biopsy-confirmed acute rejection and its composite end point, including death or graft loss, and were assessed at 6 and 12 months and by HCV cohort. Because of differential efficacy responses between HCV-positive and HCVnegative cohorts, an additional analysis incorporating HCV recurrence as a component of treatment failure, termed problem-free transplant, was introduced. Safety and tolerability were monitored over the 12 months of the study. All 381 patients were assessable, and no meaningful differences in background characteristics were apparent between treatment groups. Biopsy-confirmed acute rejection rates 6 months after transplantation were 35.1% in the basiliximab group versus 43.5% in the placebo group. For death, graft loss, or first biopsy-confirmed acute rejection, rates were 44.1% versus 52.8%, respectively. The reduction in rejection episodes was concentrated in the HCV-negative cohort (14.5% relative to placebo; P ‫؍‬ .034), with a much smaller difference (2.9%) in the HCV-positive cohort. For HCV-positive patients, problem-free transplant was shown at 12 months in 26.6% of the basiliximab group versus 11.6% in the placebo group (P ‫؍‬ .020) and for all patients at 12 months in 39.7% of the basiliximab group versus 30.1% in the placebo group (P ‫؍‬ .035). The incidence of infection and other adverse events was similar across the two treatment groups. There were 56 deaths (25 deaths, basiliximab group; 31 deaths, placebo group) over the 12-month study.

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confidence: 99%

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confidence: 99%

Improved treatment response with basiliximab immunoprophylaxis after liver transplantation: Results from a double-blind randomized placebo-controlled trial

Neuhaus¹,

Clavien

Kittur

et al. 2002

Liver Transplantation

179

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“…16 Prednisolone and azathioprine doses were reduced and ideally withdrawn within the first 12 months after transplantation. Cyclosporine dosage was adapted according to blood levels and patient course.…”

Section: Patient Populationmentioning

confidence: 99%

In liver transplantation, T tube bile represents total bile flow: Physiological and scintigraphic studies on biliary secretion of organic anions

et al. 1999

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The present study was performed to clarify the recovery of hepatocellular uptake and the biliary secretion of bile acids during the first 14 days after orthotopic liver transplantation (OLT) and to determine the fraction of bile flow appearing outside through the T tube and entering the duodenum. Therefore, we determined primary and secondary bile acids in bile samples obtained from the T tube at day 5 after OLT, while the T tube was permanently open, and at days 10 and 14 after OLT, i.e., 4 and 9 days after closure of the T tube, respectively, thus restoring enterohepatic bile acid circulation. In addition, we performed hepatobiliary scintigraphy using technetium 99m-labeled [2,4,6 trimethyl-3-bromo]imino-diacetic acid (technetium 99m-BRIDA) in 12 patients between days 4 and 17 after OLT. Chromatographic analyses of biliary bile acids showed no secondary bile acids during the first 5 days after OLT, as opposed to 10 and 14 days after OLT when enterohepatic circulation was restored. Eleven patients with an uncomplicated postoperative course after OLT showed a significantly reduced hepatic uptake and biliary secretion of 99m Tc-BRIDA during the first days after OLT with progressive recovery. One patient with an acute allograft rejection episode showed almost no uptake and only minimal secretion. The bile fraction appearing outside through the inserted T tube represented 94.6% ؎ 6.2% of the injected 99m Tc-BRIDA. We conclude that OLT results in markedly impaired hepatocellular uptake and biliary secretion of organic anions. Simultaneously, bile acid synthesis is significantly reduced, which, in addition, diminishes bile secretion of the graft. We show that T tube bile is a valid tool for bile physiological studies in patients in whom transplantation was successfully performed.

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“…However, use of these preparations was accompanied by numerous side-effects such as fever, rashes and cardiovascular problems, which were attributed to the polyclonal nature of the utilized antibody preparation (3,6,7). Therefore, monoclonal antibodies being directed to various cell-surface molecules became major tools for clinical immune modulation (8)(9)(10)(11)(12)(13).…”

Section: Introductionmentioning

confidence: 99%

“…Several anti-IL-2R MAbs have been successfully introduced into immunosuppressive protocols after liver transplantation. In early studies with murine MAb's like BT563 (an IgG1, kappa MAb of murine origin) less episodes of acute rejection and missing side-effects were demonstrated after liver transplantation (6,17,20,26) were demonstrated. However, the use of these antibodies was limited…”

Section: Introductionmentioning

confidence: 99%

Long-term Safety, Tolerability and Efficacy of Daclizumab (Zenapax®) in a Two-dose Regimen in Liver Transplant Recipients

Koch¹,

Light²,

Kuse³

2002

American Journal of Transplantation

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Comparison of Quadruple Immunosuppression After Liver Transplantation With Atg or Il-2 Receptor Antibody

Cited by 119 publications

References 0 publications

Improved treatment response with basiliximab immunoprophylaxis after liver transplantation: Results from a double-blind randomized placebo-controlled trial

Improved treatment response with basiliximab immunoprophylaxis after liver transplantation: Results from a double-blind randomized placebo-controlled trial

In liver transplantation, T tube bile represents total bile flow: Physiological and scintigraphic studies on biliary secretion of organic anions

Long-term Safety, Tolerability and Efficacy of Daclizumab (Zenapax®) in a Two-dose Regimen in Liver Transplant Recipients

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