Efficacy and safety of basiliximab and antithymocyte globulin in immune induction in kidney transplantation: a Meta-analysis / 器官移植

Objective To evaluate the efficacy and safety of basiliximab (BAS) and antithymocyte globulin (ATG) in immune induction therapy in kidney transplantation by systematic review and Meta-analysis. Methods Prospective randomized controlled clinical trials screening and comparing BAS and ATG in immune induction therapy in kidney transplantation were systematically searched from global databases, screened and compared. The quality of clinical trials was evaluated by Jadad scoring system and data extraction was performed. The effects of BAS and ATG on the incidence of acute rejection, survival rate of kidney allografts, survival rate of recipients, incidence of delayed graft function, infection, cytomegalovirus infection, malignant tumor, leukopenia and thrombocytopenia at 1 year after kidney transplantation were analyzed. Results A total of 10 clinical trials in English consisting of 1 721 kidney transplant recipients were searched, including 883 cases in the ATG group and 838 cases in the BAS group. No significant differences were observed in the incidence of acute rejection, survival rate of kidney allografts, survival rate of recipients, incidence of delayed graft function, infection, cytomegalovirus infection and thrombocytopenia at postoperative 1 year between the ATG and BAS groups (all P > 0.05). The incidence of malignant tumor and leukopenia at postoperative 1 year in the ATG group were significantly higher than those in the BAS group (both P < 0.05). Conclusions The use of ATG and BAS for immune induction therapy in kidney transplantation yield equivalent efficacy at postoperative 1 year, but BAS is safer than ATG. Clinical trials related to stratified analyses of immune risk are urgently required to achieve individualized precision treatment.

Efficacy of basiliximab in the treatment of 87 cases of steroid-refractory or steroid-dependent acute graft-versus-host disease / 中华血液学杂志

Objective: To evaluate the efficacy and prognosis of basiliximab in the treatment of steroid-refractory or steroid-dependent acute graft-versus-host disease (SR/SD-aGVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT) . Methods: Clinical data of 87 patients with SR/SD-aGVHD in the skin, intestine, and liver after allo-HSCT at the Institute of Hematology & Blood Diseases Hospital Transplantation Center from January 2015 to December 2018 were retrospectively analyzed. The administration plan of basiliximab was as follows: 20 mg for adults and children weighing ≥35 kg and 10 mg for children weighing<35 kg. The drug was administered once on the 1st, 4th, and 8th days, respectively, and then once weekly. The efficacy was evaluated on the 7th, 14th, 21st, and 28th days after basiliximab treatment. Results: ①There were 51 males (58.6%) and 36 females (41.4%) , with a median (range) age of 34 (4-63) years. There were 54 cases of classic aGVHD, 33 of late aGVHD, 49 of steroid-refractory aGVHD, and 38 of steroid-dependent aGVHD. ②Thirty-five patients (40.2%) achieved complete remission (CR) , 23 (26.4%) achieved partial remission (PR) , and 29 had no remission (NR) . The total effective rate[overall response rate (ORR) ] was 66.7% (58/87) . ③The ORR of the classic and late aGVHD groups was 77.8% (42/54) and 48.5% (16/33) , respectively. ④The median (range) follow-up time was 154 (4-1813) days, the 6-month overall survival (OS) rate of the 87 patients was 44.8% (95% CI 39.5%-50.1%) and the 1-year OS was 39.4% (95%CI 34.2%-44.3%) . ⑤After treatment with basiliximab, the 6-month OS in the CR (35 cases) , PR (23 cases) , and NR (29 cases) groups was 80.0% (95%CI 73.2%-86.8%) , 39.1% (95%CI 28.9%-49.3%) , and 6.9% (95%CI 2.2%-11.6%) , respectively (χ(2)=34.679, P<0.001) , and the 1-year OS was 74.3% (95%CI 66.9%-81.7%) , 30.4% (95%CI 20.8%-40.0%) , and 3.4% (95%CI 0%-6.8%) , respectively (χ(2)=43.339, P<0.001) . The OS of the classic and late aGVHD groups was 57.4% (95%CI 50.7%-64.1%) and 24.2% (95%CI 16.7%-31.7%) , respectively (χ(2)=9.109, P=0.004) , and the 1-year OS was 51.9% (95%CI 45.1%-58.7%) and 18.2% (95%CI 11.5%-24.9%) , respectively (χ(2)=9.753, P=0.003) . ⑥Univariate and multivariate analyses showed that late aGVHD (OR=3.121, 95%CI 1.770-5.503, P<0.001) , Minnesota score high-risk group before medication (OR=3.591, 95%CI 1.931-6.679, P<0.001) , active infection before medication (OR=1.881, 95%CI 1.029-3.438, P=0.040) , and impairment of important organ function caused by non-GVHD (OR=3.100, 95%CI 1.570-6.121, P=0.001) were independent risk factors affecting the efficacy of basiliximab. Conclusion: Basiliximab has good efficacy and safety for SR/SD-aGVHD, but not in patients with late aGVHD, high-risk group of Minnesota score, and infection or impaired function of important organs.

Clinical observation of basiliximab plus single steroid induced immunotherapy during pediatric liver transplantation / 中华器官移植杂志

Objective:To evaluate the efficacy of basiliximab plus single steroid induced immunotherapy during donor-recipient ABO-compatible pediatric liver transplantation(LT).Methods:From January 1, 2019 to January 19, 2020, a total of 150 children of donor-recipient ABO-compatible LT were randomly divided into basiliximab group(basiliximab plus single steroid induction and postoperative immunosuppression with tacrolimus alone)and steroid group(conventional dose of steroid induction plus postoperative immunosuppression with tacrolimus and steroid). Clinical characteristics, survival rate of recipients and liver allografts, rejection rate and infection rate were observed.Results:The median follow-up time was 9.2(0.7~15.5)months.No significant inter-group differences existed in survival rate of recipients/grafts or the incidence of acute rejection, early postoperative pulmonary infection, cytomegalovirus and Epstein Barr virus infection. However, in 56 living donor LT, acute rejection(6cases, 10.7%)occurred in basiliximab group versus(12cases, 25.5%)in steroid group. During living donor LT, the incidence of acute rejection declined markedly in bsiliximab group as compared with steroid group( P=0.043). Conclusions:Both safe and effective for donor-recipient ABO-compatible pediatric LT, basiliximab plus single steroid induced immunotherapy can significantly lower the occurrences of acute rejection during living donor LT.

Clinical application progress of immune induction regimen for kidney transplantation / 器官移植

With the development of immunosuppressants and optimization of immunosuppressive regimens, the survival rates of kidney transplant recipients and grafts have been significantly increased, whereas the incidence of acute rejection and delayed graft function have also been significantly reduced. However, the standard triple immunosuppressive regimen (calcineurin inhibitor+antimetabolite+glucocorticoid) still cannot effectively control the rejection of transplant kidney. Consequently, immune induction before transplantation has been proposed. Immune induction therapy may delay the application time and reduce the dosage of calcineurin inhibitor, lower the incidence of short-term acute rejection after operation, and improve the middle- and long-term prognosis of the recipients. In this article, research progresses on monoclonal antibody-based immune induction regimen, polyclonal antibody-based immune induction regimen and mesenchymal stem cell-based immune induction regime were investigated, aiming to provide reference for optimizing the immune induction regime for kidney transplantation.

Number Needed To Treat As A Tool For Cost Effectiveness Analysis: A Case Study In Renal Transplantation

Objective: To assess the utility of number needed to treat (NNT) as a tool for cost effectiveness analysis. Methods: Two monoclonal antibodies (MAbs), used for induction therapy viz basiliximab and daclizumab in renal transplantation, were identified. Pivotal placebo controlled clinical trials, mentioned in the innovator package inserts, were compared and analyzed for acute graft rejection and graft survival at 12 mo. NNT viz-a-vis cost was calculated and compared. Results: Daclizumab was comparable to basiliximab for acute graft rejection (NNT 10 vs. 9) but better for graft survival (20 vs. 25) at 12 mo, when used along with triple drug regimen (cyclosporine, azathioprine and corticosteroid). However, considering the cost of regimen for these drugs, in terms of NNT, basiliximab was more cost effective (INR 12,52,044 vs. 28,70,400 for acute rejection and INR 34,77,900 vs. 57,40,800 for graft survival). On the other hand, when these MAbs were used along with dual drug regimen (cyclosporine and corticosteroid), daclizumab was more cost effective for graft survival at 12 mo. The higher cost of daclizumab regimen (INR 2,87,040 vs. 1,39,116 for basiliximab) was offset by its substantially lower NNT (20 vs. 58-75 for one extra graft survival at 12 mo). Conclusion: This study demonstrates the utility of NNT in ascertaining relative effectiveness of treatment modalities that would help to formulate appropriate healthcare policies.

Hallazgos histológicos en biopsia por protocolo asociados con reducción en función renal 12 meses postrasplante, en receptores de trasplante renal con bajo riesgo inmunológico, recibiendo inducción con basiliximab / Histological findings in protocol biopsy associated with reduction in renal function 12 months post transplant in renal transplant recipients with low immunological risk

Resumen Introducción: identificar los factores asociados con pérdida de la función del injerto puede ser un paso importante hacia la prolongación de la sobrevida del injerto renal. Objetivo: determinar la asociación entre los cambios histológicos presentes en las biopsias por protocolo, en el primer año postrasplante en receptores de bajo riesgo inmunológico, recibiendo inducción con basiliximab y pérdida en la función del injerto 12 meses postrasplante. Métodos: se incluyeron pacientes receptores de riñones de donante cadavérico (95 %) o donante vivo (5 %) trasplantados entre agosto de 2007 y julio de 2012. El desenlace primario fue pérdida en la tasa de filtración glomerular calculada (Cockroft & Gault) mayor a 5ml/min 12 meses postrasplante, en comparación con la función renal previa a la biopsia por protocolo. Resultados: la cohorte de estudio estuvo conformada por 114 pacientes, de los cuales 25 presentaron el desenlace principal. Los hallazgos asociados con pérdida de función fueron glomerulitis (p=0,024), inflamación intersticial (p=0,001), tubulitis (p=0,001), capilaritis (p=0,001), glomerulitis + capilaritis (p=0,001), nefropatía por polioma virus (p=0,04) y la presencia de rechazo subclínico (p=0,015). Por análisis de regresión logística la presencia de inflamación intersticial (OR = 2,11; IC 95 %: 1,13-3,95) y capilaritis (0R=7,12; IC 95 %:1,57-32,27) fueron las variables asociadas con pérdida de función del injerto renal 12 meses postrasplante renal. Conclusión: la inflamación intersticial y capilaritis son variables histológicas asociadas con pérdida de función del injerto renal, 12 meses postrasplante, independiente de otras variables.

Abstract Introduction: Identifying factors that are associated of allograft function loss might be an important step toward prolonging kidney allograft survival. Purpose: In this study we found to determine the association between histologic changes on 1-year surveillance biopsies and changes in graft function. Methods: Recipients of kidneys from deceased donors (95%) or living donors (5%) trasplanted between 2007 and 2012. The primary end point was reduction in calculated glomerular filtration rate (Cockroft anf Gault) higher 5ml/min 12 months post transplant vs calculated glomerular filtration rate previous surveillance biopsie. Results: This analysis included 114 adults, recipients of kidneys with low immunological risk receiving basiliximab induction from deceased donors (95%) or living donors (5%), transplanted between august 2007 and july 2012. The primary end point was reduction in calculated glomerular filtration rate (Cockroft & Gault) higher 5ml/min 12 months post trasplant. 25 of 114 patientes showing reduction; The histologic changes associated with renal function reduction were glomerulitis (p=0,024), interstitial inflamation (p=0,001), tubulitis (p=0,001), capilaritis (p=0,001), glomerulitis + capilaritis (p=0,001), polyoma virus nephropathy (p=0,04) and subclinical rejection (p=0,015). By regression analyses, interstitial inflamation (OR = 2,11; IC 95%: 1,13-3,95) and capilaritis (0R=7,12; IC 95%: 1,57-32,27) were associated with renal function reduction 12 month post-transplant. Conclusion: inflammation and capilaritis in protocol biopsies in first year post-transplant predict loss of graft function and independently of other variables.

Effect of different induction therapies on the clinical outcomes of ABO-incompatible living donor kidney transplantation recipients / 中华器官移植杂志

Objective To compare the clinical outcomes of low-dose rabbit antithymocyte globulin (rATG ) vs basiliximab as induction therapy in recipients of ABO-incompatible kidney transplantation (ABOi-KT) .Methods Retrospective analysis was conducted for e the clinical data of 40 ABOi-KT recipients between March 2017 and March 2019 .17 recipients of them received induction therapy with basiliximab (basiliximab group) while another 23 recipients received low-dose rATG (rATG group ,rATG 25 mg/d × 3 d) .During a median follow-up period of 282 days , the data of serum creatinine and eGFR at 1 week and 1 month ,graft survival rate and complication rate of two groups were compared .Results No significant difference existed in age ,gender ,dialytic modality/ duration , blood groups of recipients , HLA mis-match , blood group antibody titers , dose of rituximab ,blood groups of donors or donor age ( P > 0 .05 ) . The times of double filtration plasmapheresis in Basiliximab group were more (P< 0 .05) .No significant difference existed in serum creatinine and eGFR at 1 week or 1 month ( P > 0 .05 ) . No significant difference existed in graft survival rate . No significant difference existed in rate of acute rejection ,parvovirus B19 infection , urinary tract infection or hematoma .Conclusions Low-dose of rATG is as effective as basiliximab for ABOi-KT recipients .And rATG does not increase the rate of infection .

Clinical efficacy of basiliximab-induced glucose-free corticosteroid immunosuppressive regimen after liver transplantation / 中华消化外科杂志

Objective To investigate the clinical efficacy of basiliximab-induced glucose-free corticosteroid immunosuppressive regimen after liver transplantation.Methods The retrospective cohort study was conducted.The clinicopathological data of 227 patients with liver transplantation who were admitted to Bayi Hospital affiliated to Nanjing University of Traditional Chinese Medicine from January 2010 to October 2016 were collected.Of the 227 patients,125 who postoperatively received a glucose-free corticosteroid immunosuppressive regimen using a monoclonal antibody + tacrolimus + mycophenolate mofetil tablets were allocated into the hormone-free group,and 102 who were postoperatively treated with the immunosuppressive regimen using glucocorticoid steroid + tacrolimus + mycophenolate mofetil tablets were allocated into the hormone group.Observation indicators:(1) comparison of follow-up and survival;(2) comparison of postoperative infection,rejection and biliary stenosis between groups.Follow-up using outpatient examination and telephone interview was performed to detect postoperative survival,infection,rejection and biliary stenosis up to June 2017.The measurement data with normal distribution were represented as (x) ± s,and comparison between groups was done by the t test.Measurement data with skewed distribution were described as M (P25,P75) and M (range),and comparison between groups was analyzed using the rank sum test.The count data were compared by the chi-square test.Kaplan-meier method was used to draw survival curve and calculated survival rate.Log-rank test was used for survival analysis.Results (1) Comparison of follow-up and survival:patients between groups were followed up for 9-89 months,with a median time of 45 months.The 1-and 3-year overall survival rates were respectively 93.25％,85.24％ in the hormone-free group and 89.89 ％,74.22％ in the hormone group,with a statistically significant difference (x2 =8.450,P＜0.05).(2) Comparison of postoperative infection,rejection and biliary stenosis between groups:① The total cases with postoperative infections,cases with infection of Klebsiella pneumoniae,Staphylococcus aureus,Candida,Acinetobacter baumannii and Stenotrophomonas maltophilia were 25,18,3,2,2,0 in the hormone-free group and 40,26,6,3,3,2 in the hormone group,respectively,showing a statistically significant difference between groups (x2 =10.149,P＜0.05).The patients between groups with postoperative infection were treated with active anti-infective symptomatic treatment.Three patients in the hormone group died of severe pulmonary infection,and the remaining patients in both groups were improved.② The cases with postoperative rejection in the hormone-free group and hormone group were 6 and 5,respectively,with no statistically significant difference (x2 =0.950,P＞ 0.05).The rejection of both groups occurred within 1 week postoperatively.Two patients in the hormone group were treated with glucocorticoid hormonal shock.The other patients in the 2 groups were improved by adjusting the amount of tacrolimus and mycophenolate mofetil tablets.③ The cases with postoperative biliary stenosis in the hormone-free group and the hormone group were 32 and 8 respectively,with a statistically significant difference (x2 =12.200,P＜0.05).In the hormone group,biliary stenosis occurred after stopping glucocorticoids.The patients with biliary stenosis were improved after biliary stent implantation by endoscopic retrograde cholangio pancreatography (ERCP).Conclusion The basiliximab-induced glucose-free corticosteroid immunosuppressive regimen after liver transplantation is safe and feasible,and it can significantly reduce the incidence of postoperative infection and improve long-term overall survival compared with the conventional glucocorticoid immunosuppressive regimen,but increased postoperative biliary stenesis.

Basiliximab-Induced Non-Cardiogenic Pulmonary Edema in a Kidney Transplant Patient / 대한이식학회지

Induction therapy with basiliximab is widely administered after kidney transplantation to prevent acute rejection. Herein, we report a case of non-cardiogenic pulmonary edema induced by basiliximab. To the best of our knowledge, such case has not been reported to date in Korea. A 54-year-old man with polycystic kidney disease received kidney transplantation. As induction therapy, he was prescribed basiliximab. On day 4, the second dose of basiliximab was administered. The patient complained of acute hypoxia 23 hours later, which led to circulatory collapse. He was discharged 3 weeks later with stable renal function. Pulmonary edema was presumed to have been caused by increased pulmonary capillary permeability. A possible hypothesis for this event occurring after the second basiliximab injection is steroid-related effects. Non-cardiogenic pulmonary edema is a complication that might occur after basiliximab induction therapy. Physicians should be aware of this potentially life-threatening complication.

Clinical efficacy of steroid-free immunosuppressive regimen after liver transplantation for patients with primary liver cancer / 中华肝胆外科杂志

Objective To study the clinical efficacy of steroid-free immunosuppressive therapy after liver transplantation in patients with primary liver cancer.Methods A retrospective study was conducted on the clinical data from January 2010 to October 2016 on 112 patients with primary liver cancer.There were 59 patients who had no steroid immunosuppressive regimen after operation,and 53 patients were in the steroid group.The immunosuppressive regimen used in the postoperative steroid-free group was tacrolimus + mycophenolate mofetil + basiliximab.For the steroid group it was:tacrolimus + mycophenolate moxibustion.The steroid was reduced daily in the first day after transplantation and was discontinued 3 months after transplantation.Follow-up observation of the differences between the two groups of patients on rejection,infection,tumor recurrence,hepatitis B virus recurrence and survival were compared.Results The infection rate was 18.6％ in the postoperative steroid-free group,which was significantly lower than that in the steroid group (37.7％,P ＜0.05).The recurrence rate of hepatitis B virus in the postoperative steroid-free group was 5.1％,which was significantly lower than that in the steroid group (20.8％,P ＜ 0.05).For patients who exceeded the Milan Criteria,the tumor recurrence rate was 70.0％ in the postoperative steroid-free group,which was lower than the 100％ in the steroid group (P ＜0.05).The 1-year,3-year and 5-year survival rates in the postoperative steroid-free group were 96.4％,84.9％ and 69.3％,respectively,which were better than the 87.8％,64.9％ and 44.3％ (P ＜0.05) in the steroid group.The incidences of rejection were not significantly different (P ＞ 0.05).Conclusions The use of the steroid-free immunosuppressive regimen in patients with hepatocellular carcinoma after transplantation was safe and did not increase the incidence of acute rejection.The regimen reduced the incidences of postoperative infection and hepatitis B virus recurrence,especially in patients who exceeded the Milan Criteria.It reduced the risk of tumor recurrence and improved patient survival.

Clinical efficacy of steroid-free immunosuppressive regimen after liver transplantation for patients with primary liver cancer / 中华肝胆外科杂志

Objective To study the clinical efficacy of steroid-free immunosuppressive therapy after liver transplantation in patients with primary liver cancer.Methods A retrospective study was conducted on the clinical data from January 2010 to October 2016 on 112 patients with primary liver cancer.There were 59 patients who had no steroid immunosuppressive regimen after operation,and 53 patients were in the steroid group.The immunosuppressive regimen used in the postoperative steroid-free group was tacrolimus + mycophenolate mofetil + basiliximab.For the steroid group it was:tacrolimus + mycophenolate moxibustion.The steroid was reduced daily in the first day after transplantation and was discontinued 3 months after transplantation.Follow-up observation of the differences between the two groups of patients on rejection,infection,tumor recurrence,hepatitis B virus recurrence and survival were compared.Results The infection rate was 18.6％ in the postoperative steroid-free group,which was significantly lower than that in the steroid group (37.7％,P ＜0.05).The recurrence rate of hepatitis B virus in the postoperative steroid-free group was 5.1％,which was significantly lower than that in the steroid group (20.8％,P ＜ 0.05).For patients who exceeded the Milan Criteria,the tumor recurrence rate was 70.0％ in the postoperative steroid-free group,which was lower than the 100％ in the steroid group (P ＜0.05).The 1-year,3-year and 5-year survival rates in the postoperative steroid-free group were 96.4％,84.9％ and 69.3％,respectively,which were better than the 87.8％,64.9％ and 44.3％ (P ＜0.05) in the steroid group.The incidences of rejection were not significantly different (P ＞ 0.05).Conclusions The use of the steroid-free immunosuppressive regimen in patients with hepatocellular carcinoma after transplantation was safe and did not increase the incidence of acute rejection.The regimen reduced the incidences of postoperative infection and hepatitis B virus recurrence,especially in patients who exceeded the Milan Criteria.It reduced the risk of tumor recurrence and improved patient survival.

Efficacy and safety of basiliximab in pediatric liver transplantation / 中华器官移植杂志

Objective To evaluate the safety of basillixirnab in pediatric liver transplantation (PLT).Methods Retrospectively,256 cases (hospitalized from Jan.2014 to Dec.2015) were divide into groups in terms of inclusion and exclusion criteria.A group of 137 children transplanted under tacrolimus-steroid as baseline immunosuppressants combined with basilliximab induction (basilliximab group),and a group of 84 PLT recipients were treated with a tacrolimus-steroid regimen (control group) were set up.Two groups were compared regarding rejection incidence,infectious complications,as well as the kidney function and electrolyte within the three months after operations.Results Infectious complications and rejection incidence were 32.8％ and 8.3％ in basilliximab group,versus 27.4％ and 14.3％ in control group (all P＞0.05).There was no statistically significant difference in the levels of blood urea nitrogen,creatinine,calcium,potassium and phosphate between two groups.Conclusion Although basilliximab may decrease the rejection incidence,the effect is not significant.The main reason may be the small sample size,and further observation is still needed.

Comparative study of application of standard double-and single-dose of basiliximab in renal ;transplantation / 器官移植

Objective To compare clinical efficacy and safety between standard double-and single-dose of basiliximab in renal transplantation.Methods A total of 121 patients undergoing allogeneic cadaveric renal transplantation in Department of Urology of Renmin Hopsital of Wuhan University from January 2008 to May 2011 were recruited as study subjects.Among them,53 patients were assigned into the double-dose of basiliximab group and they were intravenously administered with 20 mg of basiliximab before and 4 d after surgery according to product description.Sixty-eight cases were allocated in the single-dose of basiliximab group and they were given with 20 mg of basiliximab before renal transplantation.The changes of immune function in two groups during perioperative period were monitored.The incidence of adverse reactions including delayed graft function (DGF),acute rejection,pulmonary infection and the survival of patients and renal grafts were statistically compared between two groups.Results There was no significant difference in preoperative humoral immune and cellular immune function between two groups.Compared with preoperative period,cellular and humoral immune function in both groups were inhibited by varying degree at 5 d after surgery (both in P <0.05).Compared with patients in the single-dose group,cellular and humoral immune functions were evidently suppressed in the double-dose group (both in P <0.05).Compared with the parameters assessed at 5 d after surgery,cellular and humoral immune functions were restored to varying degree at 15 d after surgery,whereas still significantly lower than preoperative levels (CD3,CD4,IgM and IgA).Partial parameters (CD8 and IgG)were persistently inhibited and continued to decline compared with the levels at 5 d after surgery.The incidence of DGF was 8% in the double-dose group,and 7% in the single-dose group.During 1-year follow-up,the rejection rates in the double-and single-dose groups were 13% and 12%,and the incidence of pulmonary infection was 9% and 10%.No statistical significance was noted between two groups in terms of these parameters (all in P >0.05).The 1-year survival of patients in the double-and single-dose groups was 94% and 98%,93% and 96% for the survival of renal grafts.No statistical significance was found between two groups (both in P >0.05).Conclusions Both double-and single-dose of basiliximab are efficacious in renal transplantation and do not increase the incidence of adverse reaction.The 1-year survival rates of patients and renal grafts between two groups are almost equivalent.Detection of immune function during perioperative period effectively guides individualized immune induction therapy.

Comparison of the Clinical Outcomes between Anti-thymocyte Globulin and Basiliximab Induction Therapy in Deceased Donor Kidney Transplantation: Single Center Experience / 대한이식학회지

BACKGROUND: The aim of this study is to evaluate the clinical outcomes between anti-thymocyte globulin (ATG) and basiliximab induction in deceased donor kidney transplantation (DDKT). METHODS: Between May 2006 and February 2015, 40 patients underwent DDKT at our institution. Three cases (7.5%) of them were lost during the following-up schedule. In this study, ATG induction criteria were donor age >50 years old or donor creatinine level >1.3 mg/dL except hepatitis B virus positive and hepatitis C virus positive recipients. Recipients were divided into two groups: the ATG group (n=20) and the basiliximab group (n=17). RESULTS: The 1-year patient survival in the ATG group was 89.4% compared to 93.8% in the basiliximab group (P=0.989). Graft survival for a 1 year in the ATG and the basiliximab group was 89.1% and 93.8%, respectively (P=0.967). Incidences of acute rejection episodes were more prevalent in the basiliximab group (15.0% vs. 29.4%, P=0.428). The glomerular filtration rate level by period of recipients was not different in both group (12th month, 64.60+/-16.17 mg/dL vs. 68.51+/-18.60 mg/dL, P=0.544). The overall complications during the follow-up were not significantly different in both groups (90.0% vs. 76.5%, P=0.383). CONCLUSIONS: The results showed that there was no difference in the patient survival and graft survival between induction of ATG and basiliximab of the DDKT were not different. Therefore, use of both induction agents led to a good patient and graft survival and ATG might be a safe and preferable agent for relatively poor renal function of donor in kidney transplantation.

Effect of two biological immunologic induction therapies on renal transplant recipients / 器官移植

Objective Toevaluateefficacyandsafetyoftwodifferentbiologicalsinimmunologic inductiontherapyonrenaltransplantrecipients.Methods Clinicaldataof78renaltransplantrecipientswho received biological immunologic induction therapy in Department of Urology of the 452nd Hospital of Chinese People's Liberation Army from June 2008 to April 2013,were retrospectively analyzed. According to different biological immunologic induction therapy,the recipients were divided into two groups,monoclonal antibody group (group A,n=35,received treatment of basiliximab)and polyclonal antibody group [group B,n=43, received treatment of antithymocyte globulin (ATG)]. And the other recipients who didn't receive immunologic induction therapy in the hospital during the corresponding period were chosen as control group (group C,n=32). The survival rates of recipient and kidney in 3 groups at 12th weeks after transplantation were analyzed.The levels of serum creatinine (Scr)of recipients in 3 groups were monitored at 7,14,30,60 d after transplantation. The occurrence rates of complications including acute rejection,delayed graft function and infectionwerecomparedamong3groups.Results At12thweeksaftertransplantation,thesurvivalratesof recipient and kidney in 3 groups were 100% and 100% in group A,97.7% and 97.7% in group B,100%and 96.9% in group C. There was no significant difference among 3 groups (all in P>0.05 ). Compared with group C,the Scr levels in group A and B decreased significantly at 7,14 d after transplantation (all in P<0.05 ). Compared with group C,the incidence rates of acute rejection decreased in group A and B(all in P<0.05 ). There was no significant difference in the incidence rates of delayed graft function among 3 groups (all in P>0.05 ). The incidence rate of infection in group B was significantly higher than those in group A and C (allinP<0.05).Conclusions Immunologicinductiontherapyissafeandeffectiveintheapplicationon renal transplant recipients.

Impact of immunosuppressant therapy on early recurrence of hepatocellular carcinoma after liver transplantation

BACKGROUND/AIMS: The most commonly used immunosuppressant therapy after liver transplantation (LT) is a combination of tacrolimus and steroid. Basiliximab induction has recently been introduced; however, the most appropriate immunosuppression for hepatocellular carcinoma (HCC) patients after LT is still debated. METHODS: Ninety-three LT recipients with HCC who took tacrolimus and steroids as major immunosuppressants were included. Induction with basiliximab was implemented in 43 patients (46.2%). Mycophenolate mofetil (MMF) was added to reduce the tacrolimus dosage (n=28, 30.1%). The 1-year tacrolimus exposure level was 7.2 +/- 1.3 ng/mL (mean +/- SD). RESULTS: The 1- and 3-year recurrence rates of HCC were 12.9% and 19.4%, respectively. Tacrolimus exposure, cumulative steroid dosages, and MMF dosages had no impact on HCC recurrence. Induction therapy with basiliximab, high alpha fetoprotein (AFP; >400 ng/mL) and protein induced by vitamin K absence/antagonist-II (PIVKA-II; >100 mAU/mL) levels, and microvascular invasion were significant risk factors for 1-year recurrence (P<0.05). High AFP and PIVKA-II levels, and positive 18fluoro-2-deoxy-d-glucose positron-emission tomography findings were significantly associated with 3-year recurrence (P<0.05). CONCLUSIONS: Induction therapy with basiliximab, a strong immunosuppressant, may have a negative impact with respect to early HCC recurrence (i.e., within 1 year) in high-risk patients.

Long-term effectiveness of anti-interleukin-2 receptor antibodies vs.rabbit antithymocyte globulin as induction therapy in kidney transplantation / 中华器官移植杂志

Objective To compare the long-term effectiveness of anti-interleukin-2 receptor antibodies vs.rabbit antithymocyte globulin as induction therapy in kidney transplantation.Methods Between 2006 and 2010,371 recipients of kidney transplants were treated with calcineurin inhibitors (CNI),mycophenolate mofetil and prednisone.261 patients of them received induction therapy with anti-interleukin-2 receptor antibodies (IL2Ra group),and 88 patients received rabbit antithymocyte globulin (rATG group).All the patients received ganciclovir against cytomegalovirus and SMZ against pneumocystis carinii.The data of delayed graft function (DGF),the rate of acute rejectin (AR) and infection in the first year and patient/allograft long survival rate in two groups were retrospectively analyzed during a follow-up period of 1 to 5 years postoperatively.Results There was no significant difference in the sex,age and causes of end-stage renal disease between the two groups.The rATG group had more kidney transplants from deceased donors (P＜0.01 ) and the cold ischemia time was longer than that of the IL2Ra group (P＜0.01 ).The IL2Ra group and the rATG group had similar incidence of DGF (3.1％ vs.1.8％,P＞0.05).One year after operation,the incidence of AR in IL2Ra group and rATG group was 10.7％ and 2.7％ respectively (P＜0.05),and the incidence of infection in IL2Ra group and rATG group was 14.9％ and 21.8％ respectively (P＞0.05).One-,two- and three-year patient survival rate in IL2Ra group was 98.9％,98.9％ and 98.5％ respectively,and that in rATG group was all 98.2％ (P＞0.05).The one-,two- and three-year allograft survival rate in IL2Ra group was 98.5％,98.1％ and 97.7％ respectively,and that in rATG group was all 97.3％ (P＞0.05).Conclusion rATG is more effective than IL2Ra preventing from acute rejection and does not increase the risk of infection for induction in kidney transplant recipients.

Clinical analysis of infection following ATG and IL-2 receptor antagonists-based induction therapy after renal transplantation / 中华器官移植杂志

Objective To investigate the infection following the lymphocytes deleted agent (ATG) and IL-2 receptor antagonists (Basilixinab and Daclizumab)-based induction therapy after renal trausplantation.Methods A retrospective analysis was carried out on 701 kidney transplant recipients between Jan. 1,2005 to Dec.31,2010.According to exclusive and inclusive criteria,finally 549 patients were evaluated,including 429 patients treated with ATG (ATG group) and 120 patients with anti-CD25 monoclonal antibodies (monoclonal antibodies group; 86 patients with Basiliximab,and 34 patients with Daclizumab).The incidence of acute rejection,infection rate,infection time,hospital stay,severe infection rate and mortality were analyzed.After operation,the patients received an immunosuppression therapy including Tacrolimus (cyclosporine A),Mycophenolate-Mofetil and prednisone to present rejection. Part of the patients were treated with ganciclovir and sulfamethoxazole sulfadiazine and trimethoprim for infection prevention.Results The acute rejection rate in ATG group and monoclonal antibodies group was 15.9％ (68/429) and 10.0％ (12/120),and there was no statistically significant difference (P＞0.05).The infection rate in ATG group was 11.9％ (51/429),including 13.7％ (7/51) with severe infection,and mortality was 7.8％(4/51).The infection rate was 15.0％ (18/120) in monoclonal antibodies group,including 11.1％ (2/18) with severe infection,and mortality was 5.6％ (1/18).There was no statistically significnat difference in infection rate,severe infection rate and mortality between two groups (P＞0.05).The hospital stay in ATG group and monoclonal antibodies group was 25.8 days and 19.1 days respectively (P＜0.05).Dead cases had not received regular anti-infection treatment,and the patients age was over 50 years.Conclusion The infection risk and mortality between these two induction therapies are identical,but hn comparison to the patients using ATG,the infection of patients using anti-CD25 monoclonal antibodies is easier to control.Anti-infection prophylaxis is important to reduce infection rate and decrease infectious mortality.

Basiliximab combined with triad resisting immune rejection scheme prevents the incidence of immune rejection after heart transplantation / 中华器官移植杂志

ObjectiveTo evaluate the clinical effect and reliability of basiliximab as immune inducer combined with classic triad resisting immune rejection scheme in preventing immune rejection after heart transplant.MethodsWe continuously collected the clinical information of 214 patients undergoing heart transplantation from June 2004 to January 2011.Basiliximab was used at 1st h before heart transplant and 4 days after the operation by 20 mg each time.Triad resisting immune rejection scheme included methylprednisone,cyclosporine A and mycophenolate mofetil.The endocardial biopsy was done to diagnose rejection postoperatively,and the severity of acute rejection was graded according to the standardized criteria of the International Society for Heart and Lung Transplantation (ISHLT).The recipients were followed up for 1year after the surgery,the data of the endocardial biopsy and rejection were collected,and the postoperative complications and deaths were observed.Results The first time of recipients to accept the endocardial biopsy was 20.1±7.3 days postoperatively,including 63 (29.4％) cases of Grade Ⅰ A,8 (3.7％) cases of grade Ⅰ B,and 12 (5.6％) cases of grade Ⅱ.One year after operation,143 recipients accepted the endocardial biopsy,including 29 (20.3％) cases of grade Ⅰ A,1(0.7％) case of grade Ⅰ B,12 (7.7％) cases of grade Ⅱ.During hospitalization,5 recipients died,including 3 cases due to transplant heart failure,1case due to multiple organ failure and 1due to sudden death.One year after discharge,there were 2 deaths,including one case of serious rejection and 1case of multiple organ failure One month after operation,infection occurred in 7 cases (3.3％),and acute renal insufficiency in 11cases (5.1％).ConclusionCombined use of Basiliximab with triad resisting immune rejection scheme was a kind of safe and effective therapy to prevent early acute rejection after heart transplantation.

Prospective Controlled Protocol for Three Months Steroid Withdrawal with Tacrolimus, Basiliximab, and Mycophenolate Mofetil in Renal Transplant Recipients

During the past few years, new immunosuppressants, such as tacrolimus, mycophenolate mofetil (MMF) and basiliximab, have been shown to successfully decrease the incidence of acute rejection, possibly acting as potent substrates for safe steroid withdrawal. Therefore, clinical outcome of 3 months steroid withdrawal, while using the above immunosuppressants, was analyzed. Clinical trial registry No. was NCT 01550445. Thirty de novo renal transplant recipients were enrolled, and prednisolone was slowly withdrawn 3 months post-transplantation by 2.5 mg at every two weeks, until 8 weeks. During steroid withdrawal, 10 patients (30.0%) discontinued the protocol and they were maintained on steroid treatment. Among 20 steroid free patients, 8 patients (40.0%) re-started the steroid within 12 months post-transplantation. By the study endpoint, 12 (40%) recipients did not take steroid and survival of patients and grafts was 100%. In conclusion, in kidney transplant patients, 3 months steroid withdrawal while taking tacrolimus, basiliximab and mycophenolate mofetil was not associated with increased mortality or graft loss. Despite various causes of failure of steroid withdrawal during the follow-up period, it is a strategy well advised for kidney transplant recipients with regard to long-term steroid-related complications.