Randomized Trial of Alemtuzumab for Prevention of Graft Rejection and Preservation of Renal Function after Kidney Transplantation1

Vathsala, Anantharaman; Ona, E.T.; Tan, S. P.; Suresh, Shirley; Lou, Huei-Xin; Casasola, Concesa; Wong, Hung-Chew; Machin, David; Chiang, G. S. C.; Danguilan, Romina; Calne, R. Y.

doi:10.1097/01.tp.0000166921.14670.33

Cited by 102 publications

(48 citation statements)

References 13 publications

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“…28,13 Bacterial pneumonia was more frequent in the alemtuzumab group (33% vs 0%, p<0.029), as also reported in the study by Vathsala et als. 28 Cytomegalovirus infection was equally present in both groups (22% vs. 39%, p= ns), but with a higher incidence than that reported in another series (6.5% vs. 3.3%) 29 , possibly due to the non systematic use of prophylaxis at our center. The prophylactic treatment has been associated with reduced incidences of CMV infection in other series using induction therapy with alemtuzumab (5%) 28 or thymoglobulin (10.4%).…”

Section: Discussionsupporting

confidence: 76%

“…27 Prospective studies have also compared the use of induction therapies with thymoglobulin or alemtuzumab in renal transplant recipients receiving TAC, TAC and MMF, or SRL. 20,21,28 Acute rejection incidences were 18%, 23%, and 28%, respectively. Despite the high proportion of organs from extended-criteria donors and acute rejection incidence, patients receiving alemtuzumab achieved renal function on average 8.9 mL/min higher than that observed in patients receiving thymoglobulin (61.6 vs. 52.7 mL/ min).…”

Section: Discussionmentioning

confidence: 99%

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Terapia de indução com alentuzumabe em receptores de transplante renal

Sampaio¹,

Freitas²,

Galante³

et al. 2010

J. Bras. Nefrol.

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Introduction: Induction therapy has been used in sensitized patients, re-transplants, and in patients who have high risk to delayed graft function (DGF) after renal transplantation. Methods: Retrospective study with aim to compare transplant endpoints between recipients of deceased donors which have received induction with alemtuzumab (n = 9) versus thymoglobulin (n = 18). Patients were matched for age, duration of dialysis treatment and cold ischemia time. Results: There were no differences at demographic characteristics. All patients received kidney grafts from deceased donors and 67% of these donors met the expanded criteria. The incidence of DFG was similar in alemtuzumab and thymoglobulin groups, 55% and 56%. At 12 months, rates of rejection free survival (67% versus 89%, p = 0,13), graft survival (62,5% versus 76,6%; p = 0,73), graft with death censored (62,5% versus 76,6%; p = 0,82) and patient survival (83,3% versus 81,2%; p = 0,63) were similar between the two groups. Viral infections and renal function were similar between groups. At the end of the first month, alemtuzumab patients displayed a fewer lymphocyte number (135 ± 78 versus 263 ± 112 N/mm 3 , p < 0,05) followed by a more rapid recovery after 3 months (day 90: 683 ± 367 versus 282 ± 72 N/mm 3 ; p < 0,05). Cost associated with alemtuzumab and thymoglobulin inductions therapies were R$ 1,388.00 and R$ 7,398.00. Conclusion: In this cohort of patients, alemtuzumab induction showed efficacy and safety comparable to thymoglobulin but with significant cost reduction.

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Section: Discussionsupporting

confidence: 76%

Section: Discussionmentioning

confidence: 99%

Terapia de indução com alentuzumabe em receptores de transplante renal

Sampaio¹,

Freitas²,

Galante³

et al. 2010

J. Bras. Nefrol.

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“…Total CNI avoidance, 3,5,9 -38 CNI minimization, 17,39 -55 and delayed introduction of CNI 49,50,[55][56][57][58][59][60][61][62] were investigated in 32 (n ϭ 5791), 17 (n ϭ 4131), and 10 studies (n ϭ 1519) respectively. Two studies 50,55 investigated CNI delay followed by minimization: to avoid "double counting" these were analyzed as "delay" studies initially, but if subgroup analyses were necessary (due to heterogeneity), then the same study was considered separately in both the "minimization" and "delay" subanalyses.…”

Section: Resultsmentioning

confidence: 99%

Meta-Analysis of Calcineurin-Inhibitor-Sparing Regimens in Kidney Transplantation

Sharif

Shabir

Chand

et al. 2011

Journal of the American Society of Nephrology

126

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Calcineurin-inhibitor-sparing strategies in kidney transplantation may spare patients the adverse effects of these drugs, but the efficacy of these strategies is unknown. Here, we conduct a meta-analysis to assess outcomes associated with reducing calcineurin inhibitor exposure from the time of transplantation. We search Medline, Embase, and Cochrane Register of Controlled Trials for randomized controlled trials published between 1966 and 2010 that compared de novo calcineurin-inhibitor-sparing regimens to calcineurin-inhibitor-based regimens. In this analysis, we include 56 studies comprising data from 11337 renal transplant recipients. Use of the contemporary agents belatacept or tofacitinib, in combination with mycophenolate, decreased the odds of overall graft failure (OR 0.61; 95% CI 0.39 -0.96; P ϭ 0.03). Similarly, minimization of calcineurin inhibitors in combination with various induction and adjunctive agents reduces the odds of graft failure (OR 0.73; 95% CI 0.58 -0.92; P ϭ 0.009). Conversely, the use of inhibitors of mammalian target of rapamycin (mTOR), in combination with mycophenolate, increases the odds of graft failure (OR 1.43; 95% CI 1.08 -1.90; P ϭ 0.01). Calcineurin-inhibitor-sparing strategies are associated with less delayed graft function (OR 0.89; 95% CI 0.80 -0.98; P ϭ 0.02), improved graft function, and less new-onset diabetes. The more contemporary protocols did not seem to increase rates of acute rejection. In conclusion, this meta-analysis suggests that reducing exposure to calcineurin inhibitors immediately after kidney transplantation may improve clinical outcomes.

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“…[202][203][204]207,208 In one large series of transplant patients, more serious infections were reported in patients with lung, intestinal, or multivisceral transplants compared with other solid organ transplants and when alemtuzumab was used to treat rejection than if used for induction. 209 3.3.1.2 Pregnancy Classifi cation-Alemtuzumab is pregnancy category C. 205 No reports of alemtuzumab use in pregnancy and lactation have been published.…”

Section: Antithymocyte Globulinmentioning

confidence: 99%

“…[199][200][201] A summary of common clinically signifi cant side effects of alemtuzumab is presented in Table 14 . [202][203][204] A summary of other clinically signifi cant side effects of alemtuzumab is presented in Table 15 . 205,206 Table 16 summarizes the one report on using alemtuzumab for lung disease.…”

Section: Information For Patientsmentioning

confidence: 99%

Monitoring of Nonsteroidal Immunosuppressive Drugs in Patients With Lung Disease and Lung Transplant Recipients

Baughman

Meyer

Nathanson

et al. 2012

Chest

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Objectives: Immunosuppressive pharmacologic agents prescribed to patients with diffuse interstitial and infl ammatory lung disease and lung transplant recipients are associated with potential risks for adverse reactions. Strategies for minimizing such risks include administering these drugs according to established, safe protocols; monitoring to detect manifestations of toxicity; and patient education. Hence, an evidence-based guideline for physicians can improve safety and optimize the likelihood of a successful outcome. To maximize the likelihood that these agents will be used safely, the American College of Chest Physicians established a committee to examine the clinical evidence for the administration and monitoring of immunosuppressive drugs (with the exception of corticosteroids) to identify associated toxicities associated with each drug and appropriate protocols for monitoring these agents. Methods: Committee members developed and refi ned a series of questions about toxicities of immunosuppressives and current approaches to administration and monitoring. A systematic review was carried out by the American College of Chest Physicians. Committee members were supplied with this information and created this evidence-based guideline. Conclusions: It is hoped that these guidelines will improve patient safety when immunosuppressive drugs are given to lung transplant recipients and to patients with diffuse interstitial lung disease. CHEST 2012; 142(5):e1S-e111SAbbreviations: ACCP 5 American College of Chest Physicians; ALT 5 alanine aminotransferase; ATG 5 antithymocyte globulin; CHF 5 congestive heart failure; CMV 5 cytomegalovirus; CNI 5 calcineurin inhibitor; COI 5 confl ict of interest; CsA 5 cyclosporin A; FDA 5 US Food and Drug Administration; HBV 5 hepatitis B virus; HMG-CoA 5 b -hydroxy-bmethylglutaryl-coenzyme A; HSP 5 Health and Science Policy Committee; IL2RA 5 IL-2 receptor a ; ILD 5 interstitial lung disease; IPF 5 idiopathic pulmonary fi brosis; ITP 5 idiopathic thrombocytopenia purpura; LAM 5 lymphangioleiomyomatosis; MESNA 5 sodium 2-sulfonylethanesufonate; MPA 5 mycophenolic acid; mTOR 5 mammalian target of rapamycin; PTLD 5 posttransplant lymphoproliferative disease; RCT 5 randomized controlled trial; SIRS 5 systemic infl ammatory response syndrome; TNF 5 tumor necrosis factor; TPMT 5 thiopurine methyltransferase

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Randomized Trial of Alemtuzumab for Prevention of Graft Rejection and Preservation of Renal Function after Kidney Transplantation1

Abstract: These results suggest that Alemtuzumab is an effective induction agent that permits low-dose steroid-free immunosuppression in RTx.

Cited by 102 publications

References 13 publications

Terapia de indução com alentuzumabe em receptores de transplante renal

Terapia de indução com alentuzumabe em receptores de transplante renal

Meta-Analysis of Calcineurin-Inhibitor-Sparing Regimens in Kidney Transplantation

Monitoring of Nonsteroidal Immunosuppressive Drugs in Patients With Lung Disease and Lung Transplant Recipients

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