Corticosteroid-Free Immunosuppression with Tacrolimus, Mycophenolate Mofetil, and Daclizumab Induction in Renal Transplantation

Rostaing, Lionel; Cantarovich, Diego; Mourad, Georges; Budde, Klemens; Rigotti, Paolo; Mariat, Christophe; Margreiter, Raimund; Capdevilla, L; Lang, P.; Vialtel, P; Ortuño-Mirete, Joaquin; Charpentier, B; Legendre, Christophe; Sánchez-Plumed, Jaime; Oppenheimer, Federico; Kessler, Michèle

doi:10.1097/01.tp.0000154915.20524.0a

Cited by 223 publications

(171 citation statements)

References 19 publications

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“…The de novo use of hypoglycemic agents was less in the steroid-free group (4.5%) compared to the steroid withdrawal (12.2%) or standard steroid group (14.7%). The CARMEN study randomized 538 kidney transplant recipients to daclizumab/tacrolimus/MMF with steroid maintenance compared to the same regimen without steroids (18). The incidence of NODAT was 5.9% in patients maintained on steroids compared to 0.4% in the steroid-free regimen (p ¼ 0.003).…”

Section: Discussionmentioning

confidence: 99%

New-Onset Diabetes After Transplantation:Results From a Double-Blind Early Corticosteroid Withdrawal Trial

Pirsch

Henning

First

et al. 2015

American Journal of Transplantation

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New-onset diabetes after transplantation (NODAT) is an important complication following kidney transplantation. Data from the 5-year early steroid withdrawal double-blind randomized trial were analyzed to determine if steroid avoidance reduced the NODAT risk. Incidence, timing and risk factors for NODAT were evaluated using eight definitions. By American Diabetes Association definition, 36.3% of patients on chronic corticosteroids (CCS) and 35.9% on early corticosteroid withdrawal (CSWD) were diagnosed with NODAT by 5 years. The definition combining fasting blood glucose !126 mg/dL on two occasions or treatment identified slightly more cases of NODAT: CCS (39.3%) and CSWD (39.4%). Through 5 years posttransplant, the proportion of NODAT patients requiring treatment were similar (CSWD 22.5% vs. CCS 21.5%); however, insulin therapy was lower with CSWD (3.7% vs. 11.6%; p ¼ 0.049). By multivariate analysis, only age, but not corticosteroid use, was a significant risk factor for NODAT for more than one definition. Numerical, but not statistically significant trends toward lower NO-DAT rates with CSWD were observed through 5 years for insulin use, HbA1c !6.0% and !6.5% on two occasions. This prospective, randomized trial of CSWD indicates that CSWD has a limited impact in reducing NODAT when compared to low-dose prednisone (5 mg/day from month 6 to 5 years).

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Section: Discussionmentioning

confidence: 99%

New-Onset Diabetes After Transplantation:Results From a Double-Blind Early Corticosteroid Withdrawal Trial

Pirsch

Henning

First

et al. 2015

American Journal of Transplantation

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“…Whereas successes with early steroid withdrawal have been limited by the risk of acute rejection and the perceived or actual reduction of longterm outcomes, some recent trials have been published with encouraging results with early graft survival and acute rejection incidence similar to steroid-based protocols, especially when concomitant antibody induction is administered (1), dosages of cyclosporine are high (2,3), or maintenance therapy consists of tacrolimus and/ or mycophenolate mofetil (4,5).…”

Section: Introductionmentioning

confidence: 99%

Outcomes Associated with Steroid Avoidance and Alemtuzumab among Kidney Transplant Recipients

Serrano

Friedmann

Ahsanuddin

et al. 2015

Clinical Journal of the American Society of Nephrology

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Background and objectives Alemtuzumab is a humanized anti-CD52 monoclonal antibody used as induction in kidney transplantation (KTX) since 2003. Few studies have evaluated long-term outcomes of this agent or changes in outcomes over time.Design, setting, participants, & measurements A retrospective cohort study was performed examining United States registry data from 2003 to 2014 of primary KTX recipients receiving induction with alemtuzumab (AZ; n=5521) or antithymocyte globulin (ATG; n=8504) and maintenance immunosuppression with tacrolimus and mycophenolate mofetil and early withdrawal of steroids. The primary outcome was overall death-censored graft survival (DCGS), and secondary outcomes were overall patient survival and 1-year acute rejection. Multivariate models were fit with donor, recipient, and transplant covariates. Because poorer outcomes with AZ may occur from a learning curve impact with the use of a new medication, transplant year was categorized into three time periods to evaluate outcomes over time (2003-2005, 2006-2008, $2009), and an interaction term of induction type with transplant year category was included in all models to test for era impacts.Results On multivariate analysis of DCGS there was a significant interaction between AZ and era (P,0.001). Risk-adjusted patient survival (aHR, 1.32; 95% CI, 1.08 to 1.61; aHR, 1.26; 95% CI, 1.09 to 1.46; and aHR, 1.10; 95% CI, 0.93 to 1.29 by era, respectively) and acute rejection (adjusted odds ratio [aOR], 1.17; 95% CI, 0.96 to 1.42; aOR, 0.94; 95% CI, 0.82 to 1.07; aOR, 0.89; 95% CI, 0.81 to 0.98 by era, respectively) with AZ was comparable with ATG in the most recent era; however, there was no significant interaction with time (P=0.13 and P=0.06, respectively).Conclusions Current alemtuzumab utilization is associated with comparable graft and patient survival and acute rejection compared with ATG. Graft survival with alemtuzumab has improved over time.

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“…The feasibility of complete avoidance of steroids in adults after renal transplantation was first suggested by an open label Canadian multicenter trial [5]. Since then, reports from other centers have also confirmed the efficacy and safety of various steroid minimization or avoidance regimens in adults [6][7][8][9]. These studies have also provided evidence that renal allograft recipients managed with less steroid exposure experience benefits such as a lower incidence of hypertension, diabetes, weight gain and hyperlipidemia.…”

Section: Introductionmentioning

confidence: 70%

Steroid Minimization in Pediatric Renal Transplantation

Lau¹,

Butani

2012

J Nephrol Therapeutic

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Corticosteroid-Free Immunosuppression with Tacrolimus, Mycophenolate Mofetil, and Daclizumab Induction in Renal Transplantation

Cited by 223 publications

References 19 publications

New-Onset Diabetes After Transplantation:Results From a Double-Blind Early Corticosteroid Withdrawal Trial

New-Onset Diabetes After Transplantation:Results From a Double-Blind Early Corticosteroid Withdrawal Trial

Outcomes Associated with Steroid Avoidance and Alemtuzumab among Kidney Transplant Recipients

Steroid Minimization in Pediatric Renal Transplantation

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