Title: Improved treatment response with basiliximab immunoprophylaxis after liver transplantation: Results from a double-blind randomized placebo-controlled trial
Abstract: Liver TransplantationVolume 8, Issue 2 p. 132-142 Original ArticleFree Access Improved treatment response with basiliximab immunoprophylaxis after liver transplantation: Results from a double-blind randomized placebo-controlled trial Peter Neuhaus, Peter Neuhaus Rudolf Virchow University, BerlinSearch for more papers by this authorPierre-Alain Clavien, Pierre-Alain Clavien Duke University Medical Center, Durham, NCSearch for more papers by this authorDilip Kittur, Dilip Kittur Johns Hopkins Hospital, Baltimore, MDSearch for more papers by this authorMauro Salizzoni, Mauro Salizzoni Molinette Hospital, Torino, ItalySearch for more papers by this authorAntoni Rimola, Antoni Rimola Hospital Clínic, Barcelona, SpainSearch for more papers by this authorKamal Abeywickrama, Kamal Abeywickrama Novartis Pharma, Basel, SwitzerlandSearch for more papers by this authorElke Ortmann, Elke Ortmann Novartis Pharma, Basel, SwitzerlandSearch for more papers by this authorLawrence Chodoff, Lawrence Chodoff Novartis Pharma, Basel, SwitzerlandSearch for more papers by this authorMichael Hall, Michael Hall Novartis Pharma, Basel, SwitzerlandSearch for more papers by this authorAlexander Korn, Alexander Korn Novartis Pharma, Basel, SwitzerlandSearch for more papers by this authorBjörn Nashan MD, Corresponding Author Björn Nashan MD [email protected] Medizinische Hochschule Hannover, Hannover, GermanyMedizinische Hochschule Hannover, Carl-Neubergstr 1, 30525 Hannover, Germany. Telephone: 49-511-532-2267; FAX: 49-511-532-2265Search for more papers by this author Peter Neuhaus, Peter Neuhaus Rudolf Virchow University, BerlinSearch for more papers by this authorPierre-Alain Clavien, Pierre-Alain Clavien Duke University Medical Center, Durham, NCSearch for more papers by this authorDilip Kittur, Dilip Kittur Johns Hopkins Hospital, Baltimore, MDSearch for more papers by this authorMauro Salizzoni, Mauro Salizzoni Molinette Hospital, Torino, ItalySearch for more papers by this authorAntoni Rimola, Antoni Rimola Hospital Clínic, Barcelona, SpainSearch for more papers by this authorKamal Abeywickrama, Kamal Abeywickrama Novartis Pharma, Basel, SwitzerlandSearch for more papers by this authorElke Ortmann, Elke Ortmann Novartis Pharma, Basel, SwitzerlandSearch for more papers by this authorLawrence Chodoff, Lawrence Chodoff Novartis Pharma, Basel, SwitzerlandSearch for more papers by this authorMichael Hall, Michael Hall Novartis Pharma, Basel, SwitzerlandSearch for more papers by this authorAlexander Korn, Alexander Korn Novartis Pharma, Basel, SwitzerlandSearch for more papers by this authorBjörn Nashan MD, Corresponding Author Björn Nashan MD [email protected] Medizinische Hochschule Hannover, Hannover, GermanyMedizinische Hochschule Hannover, Carl-Neubergstr 1, 30525 Hannover, Germany. Telephone: 49-511-532-2267; FAX: 49-511-532-2265Search for more papers by this author First published: 30 December 2003 https://doi.org/10.1053/jlts.2002.30302Citations: 158AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Abstract Basiliximab, 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 HCV-negative 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. The intravenous bolus injection was well tolerated. Immunoprophylaxis with 40 mg of basiliximab, in combination with cyclosporine and steroids, reduces the incidence of acute rejection episodes with no clinically relevant safety or tolerability concerns. The influence of HCV recurrence on efficacy results can be accounted for in future trials by using the concept of problem-free transplant, incorporating recurrence as a component of treatment failure. References 1 Neuhaus P, Nashan B, Clavien PA, Kittur D, Salizzoni M, Rimola A, et al. Basiliximab reduces the rate and severity of acute rejection in adult liver transplant recipients [abstract 26]. Transplant 2000, Chicago, IL, May 13–17, 2000. 2 Nashan B, Neuhaus P, Clavien PA, Kittur D, Salizzoni M, Rimola A, et al. Basiliximab reduces the rate/severity of acute rejection in adult liver transplant recipients [abstract 0292]. International Congress of the Transplantation Society, Rome, Italy, August 27-September 1, 2000. 3 Hotta SS. Assessment of liver transplantation. 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