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Acute graft rejection remains a major problem among additional sequelae in liver transplant recipients. Basiliximab, a chimeric monoclonal antibody with high affinity for the CD25 chain of the interleukin-2 receptor, has significantly reduced the incidence of acute rejection episodes in renal transplant recipients. This single-arm, open-label, multicenter study investigated the efficacy and tolerability of basiliximab immunoprophylaxis in adult patients undergoing first elective liver transplantation. One hundred one patients (70 hepatitis C virus [HCV]-negative patients, 31 HCV-positive patients) were administered basiliximab, 20 mg, by intravenous bolus injection the day of transplantation (day 0) and day 4. In addition, all patients were administered triple immunosuppressive therapy with cyclosporine, steroids, and azathioprine. The efficacy of basiliximab was assessed by conventional parameters, and tolerability was assessed by the incidence of adverse events, infections, and laboratory test result abnormalities. At 6 months, the incidence of first acute biopsy-confirmed rejection episodes was 22.8%. Rejections were more frequent in the HCV-positive (29.0%) than HCV-negative subgroup (20.0%; P =.441). No rejection episode was graded histologically as severe, and no patient required antibody therapy for the management of acute rejection. Ten patients (9.9%) required treatment with tacrolimus for acute rejection episodes. Patient and graft survival rates at 12 months were 90.1% and 88.1%, respectively. Basiliximab caused no injection-site reactions, anaphylaxis, or cytokine release syndrome. Five malignancies were reported at 12 months: of these, three malignancies predated transplantation surgery. Compared with earlier studies, the addition of basiliximab immunoprophylaxis to triple immunosuppressive therapy provides increased efficacy in reducing the incidence of acute rejection episodes, with no clinically significant increase in adverse events.

Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation.

A 5-year-old girl with T-cell acute lymphoblastic leukemia (T-ALL) developed a progressive eruption of crusted papules and ulcerative plaques involving 80% of her body surface area with histopathology consistent with febrile ulceronecrotic Mucha-Habermann disease (FUMHD), although multiple specimens also contained clonal leukemic cells. Her skin disease was refractory to many classic treatments for FUMHD, including methotrexate, and became so severe that concern about superinfection prevented intensification of chemotherapy for her malignancy. The addition of basiliximab promoted gradual improvement of the skin, allowing for chemotherapy intensification and subsequent bone marrow transplantation, after which the eruption resolved completely. This report describes a severe case of FUMHD-like eruption associated with clonal leukemic cells that improved with basiliximab, suggesting anti-CD25 therapy as a novel treatment for ulceronecrotic skin disease in the setting of high interleukin-2 levels.

Purpose: Demonstrate that low dose Thymoglobulin (3 mg/kg total) has similar efficacy (DGF, SGF, BPAR, hospitalizations, adverse events, graft loss and death) than Basiliximab induction. Methods: Prospective randomized study of patients undergoing renal transplanta‐tion (NCT03006419). Inclusion Criteria: Graft recipients >18 years, first living donor kidney transplant. Exclusion Criteria: 2nd kidney transplant, multiple organ recipients, ABO incompatibility, positive cross‐match test prior to transplantation, PRA> 30%, positive DS A HIV, HBsAg or HCV positive patients, leukocyte count <2000/mm3, platelet count <75, 000/mm3, history of malignancy. 100 patients were randomized from 12/2016‐05/2018. Group A: Induction with Basiliximab 20 mg IV day 0 and day 4. Group B: rATG (Thymoglobulin) 1 mg/kg body weight per day for days 0, 1 and 2 up to a total dose of 3 mg/kg day. If WBC<2000/mm3 and/or platelets <75, 000/mm3), administration may be postponed until day 7 post‐transplant. Posttransplant immunosuppression: TAC, MMF and steroids. Outcome measures (12 months): DGF, SGF, BPAR, infections, adverse events, graft loss, death. EGFR was measured by MDRD. Results: Group A (Basiliximab) (n=53) had longer dialysis time than group B (Thymoglobulin) (n=47) (p<0. 05). ESRD etiology were similar in both groups. Both PRA were < 5% in both clases but class I was higher (s. s) in group B. Donor characteristics were similar between groups. [Table Presented] Mean Thymoglobulin dose was 3. 1 ± 0. 44 mg/kg. Initial TAC dose was 0. 07 ± 0. 07 mg/kg. All patients have completed six months follow‐up minimum. There were no differences in DGF, SGF and BPAR between groups. All BPAR were Banff IB. 3‐month TAC level and MMF dose was higher (s. s.) in Thymoglobulin group. No differences in EGFR AE, hospitalizations, patient and graft survival were noted between groups. [Table Presented] Conclusions: Our results suggest that 3mg/kg Thymoglobulin induction therapy has similar efficacy and safety outcomes than Basiliximab in low‐risk living donor kidney transplantation during follow‐up.

A prospective, open, randomized trial, in which the investigators aim to achieve optimal immunosuppression after renal renal transplantation with maximal reduction of side effects, especially of vascular injury, chronic allograft nephropathy, osteoporosis and malignancies. Immunosuppression without steroids and CNI minimization is compared to standard immunosuppression, consisting of tacrolimus OD, mycophenolic acid and corticosteroids.

CONTEXT:

Thymoglobulin is used effectively as induction agent in kidney transplantation but the optimal dose is not well established.

OBJECTIVE:

Demonstrate that low-dose thymoglobulin (3 mg/kg) has similar efficacy and safety compared to basiliximab induction in low-risk kidney transplantation under standard maintenance immunosuppression

DESIGN, SETTING, PARTICIPANTS:

Prospective randomized study in kidney transplant patients (12/2016-05/2018).

INCLUSION CRITERIA:

Recipients > 18 years, first living donor transplant.

EXCLUSION CRITERIA:

Second and multiorgan transplant, ABO incompatibility, positive cross-match, panel reactive antibodies (PRA) > 30%, positive donor-specific antibody, human immunodeficiency virus, hepatitis B surface antigen, hepatitis C virus positive, white blood cells < 2000 cells/mm3, platelets < 75,000 cells/mm3 and malignancy.

INTERVENTION:

Group A: basiliximab (20 mg D0 and D4). Group B: thymoglobulin (3 mg/kg total). Maintenance immunosuppression: tacrolimus, mycophenolate mofetil, and steroids.

MAIN OUTCOME MEASURES:

Biopsy-proven acute rejection (BPAR), delayed graft function, slow graft function, leukopenia, infections, adverse events, graft loss, estimated glomerular filtration rate, and death within 12 months.

RESULTS:

100 patients (basiliximab, n = 53) (thymoglobulin, n = 47) were included. Donor and recipient characteristics were similar except for longer dialysis (basiliximab), PRA class I (1.2% basiliximab, 4.5% thymoglobulin), HLA match (basiliximab 2.8, thymoglobulin 2.2), and cytomegalovirus status. BPAR rate was basiliximab 3.8% and thymoglobulin 6.4% (P = ns). Delayed graft function (basiliximab 3.8%; thymoglobulin 4.3%), slow graft function, and 12-month leukopenia (basiliximab 11.3%, thymoglobulin 21.3%) were similar between groups (P = ns). There was no difference in infections and adverse events between groups. Patient and graft survival were as follows: basiliximab 98.1% and 92.5%, thymoglobulin 100% and 93.6% (P = ns).

CONCLUSION:

Low-dose thymoglobulin induction (3 mg/kg) can be used effectively and safely in low-risk kidney transplantation with good results during the first year post-transplant.

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