BACKGROUND: Retrospective comparison of treatment-related kidney transplant outcomes may be facilitated by multivariable statistical adjustments and case-matching. METHODS: We studied Organ Procurement and Transplantation Network registry data for kidney transplants in 2001 to 2005 managed with thymoglobulin, basiliximab, or no antibody induction and discharge maintenance immunosuppression regimens of tacrolimus and mycophenolate mofetil. The primary outcome was the 6 month, Food and Drug Administration-approved composite endpoint of rejection, graft failure, or death. Outcomes according to induction exposure were compared using logistic regression analysis, exposure likelihood matching, and outcome risk score matching. RESULTS: All statistical approaches demonstrated lower rates of the 6-month triple endpoint with thymoglobulin compared with basiliximab when steroids were present, with approximately 22% adjusted, relative reduction by logistic regression analysis and 3% absolute reductions by matching approaches. When steroids were absent, risk reduction among thymoglobulin versus basiliximab-treated patients was of larger magnitude but borderline statistical significance. Triple endpoint incidence was lower with both induction regimens compared with no induction across methods. Estimated sample sizes necessary to detect the observed differences between induction types in the presence of steroids in a prospective trial ranged from 1600 to nearly 7000 patients. CONCLUSIONS: Consistency across statistical approaches suggests superiority of thymoglobulin compared with basiliximab or no antibody induction therapy for 6-month kidney transplant outcomes in the modern immunosuppression era. As the sample sizes necessary to power a prospective superiority trial are likely prohibitive, studies such as these provide clinically relevant information that may not be otherwise attainable.
BACKGROUND: Retrospective comparison of treatment-related kidney transplant outcomes may be facilitated by multivariable statistical adjustments and case-matching. METHODS: We studied Organ Procurement and Transplantation Network registry data for kidney transplants in 2001 to 2005 managed with thymoglobulin, basiliximab, or no antibody induction and discharge maintenance immunosuppression regimens of tacrolimus and mycophenolate mofetil. The primary outcome was the 6 month, Food and Drug Administration-approved composite endpoint of rejection, graft failure, or death. Outcomes according to induction exposure were compared using logistic regression analysis, exposure likelihood matching, and outcome risk score matching. RESULTS: All statistical approaches demonstrated lower rates of the 6-month triple endpoint with thymoglobulin compared with basiliximab when steroids were present, with approximately 22% adjusted, relative reduction by logistic regression analysis and 3% absolute reductions by matching approaches. When steroids were absent, risk reduction among thymoglobulin versus basiliximab-treated patients was of larger magnitude but borderline statistical significance. Triple endpoint incidence was lower with both induction regimens compared with no induction across methods. Estimated sample sizes necessary to detect the observed differences between induction types in the presence of steroids in a prospective trial ranged from 1600 to nearly 7000 patients. CONCLUSIONS: Consistency across statistical approaches suggests superiority of thymoglobulin compared with basiliximab or no antibody induction therapy for 6-month kidney transplant outcomes in the modern immunosuppression era. As the sample sizes necessary to power a prospective superiority trial are likely prohibitive, studies such as these provide clinically relevant information that may not be otherwise attainable.
Authors: N Ahsan; D Hricik; A Matas; S Rose; S Tomlanovich; A Wilkinson; M Ewell; M McIntosh; D Stablein; E Hodge Journal: Transplantation Date: 1999-12-27 Impact factor: 4.939
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Authors: Richard J Knight; Ronald H Kerman; Linda Schoenberg; Hemangshu Podder; Charles T Van Buren; Stephen Katz; Barry D Kahan Journal: Transplantation Date: 2004-09-27 Impact factor: 4.939
Authors: Wida S Cherikh; H M Kauffman; Maureen A McBride; Jude Maghirang; Lode J Swinnen; Douglas W Hanto Journal: Transplantation Date: 2003-11-15 Impact factor: 4.939
Authors: Bekir Tanriover; Song Zhang; Malcolm MacConmara; Ang Gao; Burhaneddin Sandikci; Mehmet U S Ayvaci; Mutlu Mete; Demetra Tsapepas; Nilum Rajora; Prince Mohan; Ronak Lakhia; Christopher Y Lu; Miguel Vazquez Journal: Clin J Am Soc Nephrol Date: 2015-05-15 Impact factor: 8.237
Authors: JiYoon B Ahn; Sunjae Bae; Nadia M Chu; Lingyu Wang; Jongyeon Kim; Mark Schnitzler; Gregory P Hess; Krista L Lentine; Dorry L Segev; Mara A McAdams-DeMarco Journal: Transplant Direct Date: 2021-06-18
Authors: Bekir Tanriover; Vishal Jaikaransingh; Malcolm P MacConmara; Justin R Parekh; Swee-Ling Levea; Venkatesh K Ariyamuthu; Song Zhang; Ang Gao; Mehmet U S Ayvaci; Burhaneddin Sandikci; Nilum Rajora; Vaqar Ahmed; Christopher Y Lu; Sumit Mohan; Miguel A Vazquez Journal: Clin J Am Soc Nephrol Date: 2016-06-30 Impact factor: 8.237
Authors: Vikas R Dharnidharka; Abhijit S Naik; David A Axelrod; Mark A Schnitzler; Zidong Zhang; Sunjae Bae; Dorry L Segev; Daniel C Brennan; Tarek Alhamad; Rosemary Ouseph; Ngan N Lam; Mustafa Nazzal; Henry Randall; Bertram L Kasiske; Mara McAdams-Demarco; Krista L Lentine Journal: Transpl Int Date: 2017-11-02 Impact factor: 3.782